ISO 10993-1 : 2009

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BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS

Publisher: International Organization for Standardization

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Available Formats: PDF - French, Hardcopy - French, PDF - French, Hardcopy - French, PDF - English - French, Hardcopy - English - French
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Published
Document Type	Standard
Status	Withdrawn
Publisher	International Organization for Standardization
Pages
ISBN
Superseded By	ISO 10993-1:2018

International Equivalents – Equivalent Standard(s) & Relationship - (Show below) - (Hide below)

Equivalent Standard(s)	Relationship
NEN-EN-ISO 10993-1:2009-10	Identical
SN EN ISO 10993-1:2010	Identical
SS-EN ISO 10993-1:2009	Identical
PN-EN ISO 10993-1:2010	Identical
DIN EN ISO 10993-1 : 2010-04	Identical
DS EN ISO 10993-1 : 2009	Identical
AAMI ISO 10993-1 : 2009	Identical
GOST R ISO 10993-1 : 2009	Identical
EN ISO 10993-1 : 2009	Identical
PN EN ISO 10993-1 : 2010 AC 2010	Identical
NBR ISO 10993-1 : 2013	Identical
SN EN ISO 10993-1:2010	Identical
SANS 10993-1 : 2ED 2010	Identical
SS-EN ISO 10993-1:2009	Identical
GOST ISO 10993-1 : 2011	Identical
AAMI ISO 10993-1 : 2009	Identical
NEN ISO 10993-1 : 1994	Similar to
PN-EN ISO 10993-1:2010	Identical
UNE-EN ISO 10993-1:2010	Identical
BS EN 30993-1 : 1994	Similar to
BS EN ISO 10993-1 : 2009-10	Identical
I.S. EN ISO 10993-1:2009+AC:2010	Identical
CSA ISO 10993-1 : 2001	Identical
DIN EN ISO 10993-1 E : 2010	Identical
AAMI ISO 10993-1 : 2009 : R2013	Identical
AAMI ISO 10993-1 : 2009 : INC : ERR 1 : 2013	Identical
EN ISO 10993-1 : 2009 COR 2010	Identical
NEN-EN-ISO 10993-1:2009-10	Identical

Standards Referenced By This Book - (Show below) - (Hide below)

AAMI ISO 5366-1 : 2000	ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEOSTOMY TUBES - PART 1: TUBES AND CONNECTORS FOR USE IN ADULTS
ISO 20697 : 1ED 2018	STERILE DRAINAGE CATHETERS AND ACCESSORY DEVICES FOR SINGLE USE
13/30271558 DC : 0	BS EN ISO 15841 - DENTISTRY - WIRES FOR USE IN ORTHODONTICS
ASTM F 2224 : 2009 : R2014	Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical Implants
99/562423 DC : DRAFT APR 99	BS:ENISO 14937 - STERILIZATION OF HEALTH CARE PRODUCTS - GENERAL CRITERIA FOR CHARACTERIZATION OF A STERILIZING AGENT AND DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS
DIN EN ISO 20126 E : 2012	DENTISTRY - MANUAL TOOTHBRUSHES - GENERAL REQUIREMENTS AND TEST METHODS (ISO 20126:2012)
08/30156451 DC : DRAFT AUG 2008	BS EN ISO 10993-13 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 13: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM POLYMERIC MEDICAL DEVICES
BS EN ISO 3630-5 : 2011	DENTISTRY - ENDODONTIC INSTRUMENTS - PART 5: SHAPING AND CLEANING INSTRUMENTS (ISO 3630-5:2011)
DIN EN ISO 16061 : 2015	INSTRUMENTATION FOR USE IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS (ISO 16061:2015)
DIN EN ISO 20857 E : 2013	STERILIZATION OF HEALTH CARE PRODUCTS - DRY HEAT - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES (ISO 20857:2010)
CSA ISO 11607-1 : 2016	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS
DIN EN ISO 9693-2 E : 2016	DENTISTRY - COMPATIBILITY TESTING - PART 2: CERAMIC-CERAMIC SYSTEMS (ISO 9693-2:2016)
EN ISO 6872 : 2015 AMD 1 2018	DENTISTRY - CERAMIC MATERIALS (ISO 6872:2015/AMD 1:2018)
DIN EN ISO 28399 : 2011	DENTISTRY - PRODUCTS FOR EXTERNAL TOOTH BLEACHING
15/30270433 DC : 0	BS EN ISO 17254 - DENTISTRY - COILED SPRINGS FOR USE IN ORTHODONTICS
ISO 16971 : 2015	OPHTHALMIC INSTRUMENTS - OPTICAL COHERENCE TOMOGRAPH FOR THE POSTERIOR SEGMENT OF THE HUMAN EYE
AAMI ISO 8638 : 2010	CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - EXTRACORPOREAL BLOOD CIRCUIT FOR HEMODIALYZERS, HEMODIAFILTERS AND HEMOFILTERS
03/108761 DC : DRAFT MAY 2003	EN ISO 10477 - DENTISTRY - POLYMER-BASED CROWN AND BRIDGE MATERIALS
DIN EN ISO 5840-3 E : 2013	CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 3: HEART VALVE SUBSTITUTES IMPLANTED BY TRANSCATHETER TECHNIQUES (ISO 5840-3:2013)
NBR ISO 26782 : 2015	ANAESTHETIC AND RESPIRATORY EQUIPMENT - SPIROMETERS INTENDED FOR THE MEASUREMENT OF TIME FORCED EXPIRED VOLUMES IN HUMANS
UNE-EN ISO 25539-2:2013	CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 2: VASCULAR STENTS (ISO 25539-2:2012)
EN ISO 10555-1 : 2013 AMD 1 2017	INTRAVASCULAR CATHETERS - STERILE AND SINGLE-USE CATHETERS - PART 1: GENERAL REQUIREMENTS (ISO 10555-1:2013/AMD 1:2017)
12/30210881 DC : DRAFT APR 2012	BS EN ISO 5367 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - BREATHING SETS AND CONNECTORS
ISO 14708-1 : 2014	IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND FOR INFORMATION TO BE PROVIDED BY THE MANUFACTURER
DIN EN ISO 20072 : 2013	AEROSOL DRUG DELIVERY DEVICE DESIGN VERIFICATION - REQUIREMENTS AND TEST METHODS (ISO 20072:2009)
CSA Z23747 : 2008	ANAESTHETIC AND RESPIRATORY EQUIPMENT - PEAK EXPIRATORY FLOW METERS FOR THE ASSESSMENT OF PULMONARY FUNCTION IN SPONTANEOUSLY BREATHING HUMANS
BS EN ISO 28399 : 2011	DENTISTRY - PRODUCTS FOR EXTERNAL TOOTH BLEACHING
DIN EN ISO 11135-1 : 2007	STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
ONORM EN ISO 11070 : 2015	STERILE SINGLE-USE INTRAVASCULAR INTRODUCERS, DILATORS AND GUIDEWIRES (ISO 11070:2014)
DIN EN ISO 18397 : 2016	DENTISTRY - POWERED SCALER (ISO 18397:2016)
PREN ISO 14160 : DRAFT 2009	STERILIZATION OF HEALTH CARE PRODUCTS - LIQUID CHEMICAL STERILIZING AGENTS FOR SINGLE-USE MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - REQUIREMENTS FOR CHARACTERIZATION, DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
CSA Z17665-2 : 2009 : FR(R2019)	STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ISO 17665-1
ISO 18190 : 2016	ANAESTHETIC AND RESPIRATORY EQUIPMENT - GENERAL REQUIREMENTS FOR AIRWAYS AND RELATED EQUIPMENT
BS ISO 14949 : 2001	IMPLANTS FOR SURGERY - TWO-PART ADDITION-CURE SILICONE ELASTOMERS
DIN EN ISO 20795-1 E : 2013	DENTISTRY - BASE POLYMERS - PART 1: DENTURE BASE POLYMERS (ISO 20795-1:2013)
DIN EN ISO 3826-4 : 2015	PLASTICS COLLAPSIBLE CONTAINERS FOR HUMAN BLOOD AND BLOOD COMPONENTS - PART 4: APHAERESIS BLOOD BAG SYSTEMS WITH INTEGRATED FEATURES (ISO 3826-4:2015)
DIN EN ISO 5840-3 : 2013	CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 3: HEART VALVE SUBSTITUTES IMPLANTED BY TRANSCATHETER TECHNIQUES (ISO 5840-3:2013)
DIN ISO 8536-12 E : 2013	INFUSION EQUIPMENT FOR MEDICAL USE - PART 12: CHECK VALVES (ISO 8536-12:2007 + AMD. 1:2012)
DIN EN ISO 3826-4 E : 2015	PLASTICS COLLAPSIBLE CONTAINERS FOR HUMAN BLOOD AND BLOOD COMPONENTS - PART 4: APHERESIS BLOOD BAG SYSTEMS WITH INTEGRATED FEATURES (ISO 3826-4:2015)
UNI EN ISO 20795-2 : 2013	DENTISTRY - BASE POLYMERS - PART 2: ORTHODONTIC BASE POLYMERS
DIN EN ISO 8637 : 2014	CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS (ISO 8637:2010, INCLUDING AMENDMENT 1:2013-04-01)
04/30048118 DC : DRAFT MAY 2004	BS EN ISO 11135 - STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
UNI EN ISO 81060-1 : 2012	NON-INVASIVE SPHYGMOMANOMETERS - PART 1: REQUIREMENTS AND TEST METHODS FOR NON-AUTOMATED MEASUREMENT TYPE
UNI EN ISO 26782 : 2009	ANAESTHETIC AND RESPIRATORY EQUIPMENT - SPIROMETERS INTENDED FOR THE MEASUREMENT OF TIME FORCED EXPIRED VOLUMES IN HUMANS
ISO 13960 : 2010	CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - PLASMAFILTERS
CSA Z23747 : 2008 : R2013	ANAESTHETIC AND RESPIRATORY EQUIPMENT - PEAK EXPIRATORY FLOW METERS FOR THE ASSESSMENT OF PULMONARY FUNCTION IN SPONTANEOUSLY BREATHING HUMANS
16/30339096 DC : 0	BS EN ISO 7886-3 - STERILE HYPODERMIC SYRINGES FOR SINGLE USE - PART 3: AUTO-DISABLE SYRINGES FOR FIXED-DOSE IMMUNIZATION
06/30160058 DC : 0	BS EN ISO 8536-4 - INFUSION EQUIPMENT FOR MEDICAL USE - PART 4: INFUSION SETS FOR SINGLE USE, GRAVITY FEED
15/30275224 DC : 0	BS ISO 18242 - CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - CENTRIFUGAL BLOOD PUMPS
BS ISO 17966 : 2016	ASSISTIVE PRODUCTS FOR PERSONAL HYGIENE THAT SUPPORT USERS - REQUIREMENTS AND TEST METHODS
EN ISO 7494-1 : 2011	DENTISTRY - DENTAL UNITS - PART 1: GENERAL REQUIREMENTS AND TEST METHODS
13/30263420 DC : 0	BS EN ISO 17730 - DENTISTRY - FLUORIDE VARNISHES
CSA ISO 27427 : 2014	ANAESTHETIC AND RESPIRATORY EQUIPMENT - NEBULIZING SYSTEMS AND COMPONENTS
AAMI ISO 20857 : 2010 : R2015	STERILIZATION OF HEALTH CARE PRODUCTS - DRY HEAT - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
BS EN ISO 20072 : 2013	AEROSOL DRUG DELIVERY DEVICE DESIGN VERIFICATION - REQUIREMENTS AND TEST METHODS (ISO 20072:2009)
DIN EN ISO 3630-5 E : 2012	DENTISTRY - ENDODONTIC INSTRUMENTS - PART 5: SHAPING AND CLEANING INSTRUMENTS (ISO 3630-5:2011)
BS EN ISO 20857 : 2013	STERILIZATION OF HEALTH CARE PRODUCTS - DRY HEAT - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
BS ISO 17218 : 2014	STERILE ACUPUNCTURE NEEDLES FOR SINGLE USE
I.S. EN ISO 81060-1:2012	NON-INVASIVE SPHYGMOMANOMETERS - PART 1: REQUIREMENTS AND TEST METHODS FOR NON-AUTOMATED MEASUREMENT TYPE (ISO 81060-1:2007)
DIN EN ISO 10555-6 E : 2017	INTRAVASCULAR CATHETERS - STERILE AND SINGLE-USE CATHETERS - PART 6: SUBCUTANEOUS IMPLANTED PORTS (ISO 10555-6:2015)
BS ISO 16840-2 : 2018	WHEELCHAIR SEATING - PART 2: DETERMINATION OF PHYSICAL AND MECHANICAL CHARACTERISTICS OF SEAT CUSHIONS INTENDED TO MANAGE TISSUE INTEGRITY
ISO 14708-7 : 2013	IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 7: PARTICULAR REQUIREMENTS FOR COCHLEAR IMPLANT SYSTEMS
08/30184486 DC : DRAFT JUNE 2008	BS EN ISO 1135-4 - TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 4: TRANSFUSION SETS FOR SINGLE USE
BS EN ISO 25424 : 2011	STERILIZATION OF MEDICAL DEVICES - LOW TEMPERATURE STEAM AND FORMALDEHYDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
BS EN ISO 25539-1 : 2017	CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES
I.S. EN ISO 9693-1:2012	DENTISTRY - COMPATIBILITY TESTING - PART 1: METAL-CERAMIC SYSTEMS (ISO 9693-1:2012)
08/30192448 DC : DRAFT DEC 2008	BS ISO 14708-5 - IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 5: CIRCULATORY SUPPORT DEVICES
DIN EN ISO 1135-3 : 2014	TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 3: BLOOD-TAKING SETS FOR SINGLE USE (ISO 1135-3:2016)
BS ISO TR 11991 : 1995	GUIDANCE ON AIRWAY MANAGEMENT DURING LASER SURGERY OF UPPER AIRWAY
DIN EN ISO 13504 E : 2012	DENTISTRY - GENERAL REQUIREMENTS FOR INSTRUMENTS AND RELATED ACCESSORIES USED IN DENTAL IMPLANT PLACEMENT AND TREATMENT (ISO 13504:2012)
13/30260084 DC : 0	BS ISO 17256 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - RESPIRATORY THERAPY TUBING AND CONNECTORS
15/30281262 DC : 0	BS ISO 18666 - TRADITIONAL CHINESE MEDICINE - GENERAL REQUIREMENTS OF MOXIBUSTION DEVICES
ISO 10993-16 : 2017	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 16: TOXICOKINETIC STUDY DESIGN FOR DEGRADATION PRODUCTS AND LEACHABLES
DIN EN ISO 25539-2 E : 2013	CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 2: VASCULAR STENTS (ISO 25539-2:2012)
ISO 20126 : 2012	DENTISTRY - MANUAL TOOTHBRUSHES - GENERAL REQUIREMENTS AND TEST METHODS
ISO 13019 : 1ED 2018	TISSUE-ENGINEERED MEDICAL PRODUCTS - QUANTIFICATION OF SULFATED GLYCOSAMINOGLYCANS (SGAG) FOR EVALUATION OF CHONDROGENESIS
09/30168905 DC : 0	BS ISO 28158 - DENTISTRY - INTEGRATED DENTAL FLOSS HOLDERS
DIN EN ISO 5367 E : 2015	ANAESTHETIC AND RESPIRATORY EQUIPMENT - BREATHING SETS AND CONNECTORS (ISO 5367:2014)
AAMI ISO 11137-1 : 2006 : INC : AMD 1 : 2013 : R201000	STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
16/30337378 DC : 0	BS EN ISO 28319 - DENTISTRY - LASER WELDING
13/30285624 DC : 0	BS EN ISO 16061 - INSTRUMENTATION FOR USE IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS
07/30164125 DC : 0	BS ISO 20795-1 - DENTISTRY - BASE POLYMERS - PART 1: DENTURE BASE POLYMERS
DIN EN ISO 7199 E : 2017	CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - BLOOD-GAS EXCHANGERS (OXYGENATORS) (ISO 7199:2016)
11/30215841 DC : 0	BS EN ISO 14457 - DENTISTRY - HAND PIECES AND MOTORS
I.S. EN ISO 20795-2:2013	DENTISTRY - BASE POLYMERS - PART 2: ORTHODONTIC BASE POLYMERS (ISO 20795-2:2013)
NBR 14760 : 2001	NON ACTIVE SURGICAL - BODY CONTOURING IMPLANTS - SPECIFIC REQUIREMENTS FOR MAMMARY IMPLANTS
13/30283691 DC : 0	BS EN ISO 1135-4 - TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 4: TRANSFUSION SETS FOR SINGLE USE, GRAVITY FEED
UNE EN ISO 17730 : 2015	DENTISTRY - FLUORIDE VARNISHES (ISO 17730:2014)
AAMI ISO 81060-1 : 2007	NON INVASIVE SPHYGMOMANOMETERS - PART 1: REQUIREMENTS AND TEST METHODS FOR NON-AUTOMATED MEASUREMENT TYPE
ISO 11199-2 : 2005(R2016)	WALKING AIDS MANIPULATED BY BOTH ARMS - REQUIREMENTS AND TEST METHODS - PART 2: ROLLATORS
17/30345938 DC : 0	BS ISO 20698 - CATHETER SYSTEMS FOR NEURAXIAL APPLICATION - STERILE AND SINGLE-USE CATHETERS AND ACCESSORIES
I.S. EN ISO 21563:2013	DENTISTRY - HYDROCOLLOID IMPRESSION MATERIALS (ISO 21563:2013)
UNE EN ISO 16061 : 2015	INSTRUMENTATION FOR USE IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS (ISO 16061:2015)
07/30169357 DC : 0	BS ISO 25841 - FEMALE CONDOMS - REQUIREMENTS AND TEST METHODS
10/30214551 DC : 0	BS ISO 20126 - DENTISTRY - MANUAL TOOTHBRUSHES - GENERAL REQUIREMENTS AND TEST METHODS
ASTM F 2224 : 2009	Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical Implants
UNI EN 868-10 : 2009	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 10: ADHESIVE COATED NONWOVEN MATERIALS OF POLYOLEFINES - REQUIREMENTS AND TEST METHODS
AAMI RD17 : 2007	CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - EXTRACORPOREAL BLOOD CIRCUIT FOR HEMODIALYZERS, HEMODIAFILTERS AND HEMOFILTERS
DIN EN ISO 9693-1 E : 2012	DENTISTRY - COMPATIBILITY TESTING - PART 1: METAL-CERAMIC SYSTEMS (ISO 9693-1:2012)
I.S. EN ISO 5364:2016	ANAESTHETIC AND RESPIRATORY EQUIPMENT - OROPHARYNGEAL AIRWAYS (ISO 5364:2016)
01/562154 DC : DRAFT JUNE 2001	BS EN ISO 10993-12 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 12: SAMPLE PREPARATION AND REFERENCE MATERIALS
12/30228200 DC : 0	BS ISO 8600-1 - ENDOSCOPES - MEDICAL ENDOSCOPES AND ENDOTHERAPY DEVICES - PART 1: GENERAL REQUIREMENTS
10/30212297 DC : 0	BS ISO 11040-6 - PREFILLED SYRINGES - PART 6: PLASTIC BARRELS FOR INJECTABLES
CSA ISO 5361 : 2014	ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEAL TUBES AND CONNECTORS
DD ISO/TS 10993-20 : 2006	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 20: PRINCIPLES AND METHODS FOR IMMUNOTOXICOLOGY TESTING OF MEDICAL DEVICES
AAMI ISO 10993-3 : 2014	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 3: TESTS FOR GENOTOXICITY, CARCINOGENICITY, AND REPRODUCTIVE TOXICITY
AAMI ISO 14937 : 2009 : R2013	STERILIZATION OF HEALTH CARE PRODUCTS - GENERAL REQUIREMENTS FOR CHARACTERIZATION OF A STERILIZING AGENT AND THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
ISO 8536-12 : 2007(R2016)	INFUSION EQUIPMENT FOR MEDICAL USE - PART 12: CHECK VALVES
01/561789 DC : DRAFT APR 2001	BS ISO 13960 - CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - PLASMAFILTERS
04/30105055 DC : DRAFT MAY 2004	ISO 8600-1 - OPTICS AND OPTICAL INSTRUMENTS - MEDICAL ENDOSCOPES AND ENDOTHERAPY DEVICES - PART 1: GENERAL REQUIREMENTS
02/563797 DC : DRAFT SEP 2002	BS EN ISO 11199-3 - WALKING AIDS MANIPULATED BY BOTH ARMS - REQUIREMENTS AND TEST METHODS - PART 3: WALKING TABLES
NBR 16506-1 : 2016	HEALTH TEXTILE ARTICLE - PART 1: SURGICAL HYPOALLERGENIC ADHESIVE TAPE - REQUIREMENTS AND TEST METHODS
PREN 45502-1 : DRAFT 2013	ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND INFORMATION TO BE PROVIDED BY THE MANUFACTURER
13/30290370 DC : 0	BS ISO 17510 - MEDICAL DEVICES - SLEEP APNOEA BREATHING THERAPY - MASKS AND APPLICATION ACCESSORIES
I.S. EN ISO 25539-2:2012	CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 2: VASCULAR STENTS (ISO 25539-2:2012)
02/121895 DC : DRAFT APR 2002	BS EN 13060 - SMALL STEAM STERILIZERS
AAMI ISO 11607-1 : 2006 : INC : AMD 1 : 2014 : R201000	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS, AND PACKAGING SYSTEMS
CSA Z8836 : 2011	SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT
DIN EN ISO 28319 : 2016	DENTISTRY - LASER WELDING
10/30168824 DC : 0	BS EN ISO 6876 - DENTISTRY - ROOT CANAL SEALING MATERIALS
BS EN ISO 27020 : 2010	DENTISTRY - BRACKETS AND TUBES FOR USE IN ORTHODONTICS
ISO 16038 : 2017	MALE CONDOMS - GUIDANCE ON THE USE OF ISO 4074 AND ISO 23409 IN THE QUALITY MANAGEMENT OF CONDOMS
BS ISO 11712 : 2009	ANAESTHETIC AND RESPIRATORY EQUIPMENT - SUPRALARYNGEAL AIRWAYS AND CONNECTORS
AAMI ISO 10993-14 : 2001	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 14: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM CERAMICS
15/30304642 DC : 0	BS ISO 11040-8 - PREFILLED SYRINGES - PART 8: REQUIREMENTS AND TEST METHODS FOR FINISHED PRIFILLED SYRINGES
UNI EN ISO 13688 : 2013	PROTECTIVE CLOTHING - GENERAL REQUIREMENTS
I.S. EN ISO 5367:2014	ANAESTHETIC AND RESPIRATORY EQUIPMENT - BREATHING SETS AND CONNECTORS (ISO 5367:2014)
BS ISO 8009 : 2014	MECHANICAL CONTRACEPTIVES - REUSABLE NATURAL AND SILICONE RUBBER CONTRACEPTIVE DIAPHRAGMS - REQUIREMENTS AND TESTS
11/30243761 DC : 0	BS ISO 14708-7 - IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 7: PARTICULAR REQUIREMENTS FOR COCHLEAR IMPLANT SYSTEMS
ISO 6877 : 2006(R2014)	DENTISTRY - ROOT-CANAL OBTURATING POINTS
17/30361518 DC : 0	BS ISO 6474-2 - IMPLANTS FOR SURGERY - CERAMIC MATERIALS - PART 2: COMPOSITE MATERIALS BASED ON A HIGH-PURITY ALUMINA MATRIX WITH ZIRCONIA REINFORCEMENT
05/30093244 DC : DRAFT FEB 2005	EN ISO 11334-1 - WALKING AIDS MANIPULATED BY ONE ARM - REQUIREMENTS AND TEST METHODS - PART 1: ELBOW CRUTCHES
ISO 29942:2011(R2016)	PROPHYLACTIC DAMS - REQUIREMENTS AND TEST METHODS
BS EN ISO 10993-4 : 2017	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 4: SELECTION OF TESTS FOR INTERACTIONS WITH BLOOD
EN ISO 16671 : 2015 AMD 1 2017	OPHTHALMIC IMPLANTS - IRRIGATING SOLUTIONS FOR OPHTHALMIC SURGERY (ISO 16671:2015/AMD 1:2017)
14/30255135 DC : 0	BS EN ISO 11607-1:2009/A1 - PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS
I.S. EN ISO 10139-1:2005	DENTISTRY - SOFT LINING MATERIALS FOR REMOVABLE DENTURES - PART 1: MATERIALS FOR SHORT-TERM USE (ISO 10139-1:2018)
I.S. EN ISO 9693-2:2016	DENTISTRY - COMPATIBILITY TESTING - PART 2: CERAMIC-CERAMIC SYSTEMS (ISO 9693-2:2016)
PREN 868-10 : DRAFT 2017	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 10: ADHESIVE COATED NONWOVEN MATERIALS OF POLYOLEFINES - REQUIREMENTS AND TEST METHODS
NBR ISO 10282 : 2014	SINGLE-USE STERILE RUBBER SURGICAL GLOVES - SPECIFICATION
BS ISO 15675 : 2009	CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - CARDIOPULMONARY BYPASS SYSTEMS - ARTERIAL BLOOD LINE FILTERS
BS ISO 7198 : 1998	CARDIOVASCULAR IMPLANTS - TUBULAR VASCULAR PROSTHESES
BS ISO 10555-6 : 2015	INTRAVASCULAR CATHETERS - STERILE AND SINGLE-USE CATHETERS - PART 6: SUBCUTANEOUS IMPLANTED PORTS
11/30243462 DC : 0	BS EN ISO 9394 - OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - DETERMINATION OF BIOCOMPATIBILITY BY OCULAR STUDY WITH RABBIT EYES
AAMI BE83 : 2006	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 18: CHEMICAL CHARACTERIZATION OF MATERIALS
ISO 8637-1 : 2017	EXTRACORPOREAL SYSTEMS FOR BLOOD PURIFICATION - PART 1: HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS
BS ISO 25841 : 2017	FEMALE CONDOMS - REQUIREMENTS AND TEST METHODS
BS EN ISO 8836 : 2014	SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT (ISO 8836:2014)
AAMI ISO 10993-11 : 2006 : R2010	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 11: TESTS FOR SYSTEMIC TOXICITY
BS ISO 8600-1 : 2015	ENDOSCOPES - MEDICAL ENDOSCOPES AND ENDOTHERAPY DEVICES - PART 1: GENERAL REQUIREMENTS
BS ISO 5832-14 : 2007	IMPLANTS FOR SURGERY - METALLIC MATERIALS - PART 14: WROUGHT TITANIUM 15-MOLYBDENUM 5-ZIRCONIUM 3-ALUMINIUM ALLOY
DIN EN 868-10 : 2009	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 10: ADHESIVE COATED NONWOVEN MATERIALS OF POLYOLEFINES - REQUIREMENTS AND TEST METHODS
CSA Z23747 : 2008	ANAESTHETIC AND RESPIRATORY EQUIPMENT - PEAK EXPIRATORY FLOW METERS FOR THE ASSESSMENT OF PULMONARY FUNCTION IN SPONTANEOUSLY BREATHING HUMANS
13/30276989 DC : 0	BS EN ISO 11070 - STERILE, SINGLE-USE INTRAVASCULAR CATHETER INTRODUCERS
BS EN ISO 5840-2 : 2015	CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 2: SURGICALLY IMPLANTED HEART VALVE SUBSTITUTES
08/30168851 DC : DRAFT JULY 2008	BS EN ISO 11609 - DENTISTRY - DENTIFRICES - REQUIREMENTS, TEST METHODS AND MARKING
16/30331656 DC : 0	BS ISO 8637-3 - EXTRACORPOREAL SYSTEMS FOR BLOOD PURIFICATION - PART 3: PLASMAFILTERS
ASTM F 1441 : 2003	Standard Specification for Soft-Tissue Expander Devices
BS EN ISO 1135-3 : 2017	TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 3: BLOOD-TAKING SETS FOR SINGLE USE (ISO 1135-3:2016)
DIN EN ISO 10873 : 2010	DENTISTRY - DENTURE ADHESIVES
I.S. EN ISO 13504:2012	DENTISTRY - GENERAL REQUIREMENTS FOR INSTRUMENTS AND RELATED ACCESSORIES USED IN DENTAL IMPLANT PLACEMENT AND TREATMENT (ISO 13504:2012)
10/30203224 DC : 0	BS ISO 13022 - MEDICAL PRODUCTS CONTAINING VIABLE HUMAN CELLS - APPLICATION OF RISK MANAGEMENT AND REQUIREMENTS FOR PROCESSING PRACTICES
15/30316155 DC : 0	BS ISO 16840-2 - WHEELCHAIR SEATING - PART 2: DETERMINATION OF PHYSICAL AND MECHANICAL CHARACTERISTICS OF DEVICES INTENDED TO MANAGE TISSUE INTEGRITY - SEAT CUSHIONS
10/30233840 DC : 0	BS ISO 3826-1 - PLASTICS COLLAPSIBLE CONTAINERS FOR HUMAN BLOOD AND BLOOD COMPONENTS - PART 1: CONVENTIONAL CONTAINERS
I.S. EN ISO 13688:2013	PROTECTIVE CLOTHING - GENERAL REQUIREMENTS (ISO 13688:2013)
BS EN ISO 13504 : 2012	DENTISTRY - GENERAL REQUIREMENTS FOR INSTRUMENTS AND RELATED ACCESSORIES USED IN DENTAL IMPLANT PLACEMENT AND TREATMENT (ISO 13504:2012)
AAMI ISO TIR 17665-2 : 2009	STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ANSI/AAMI/ISO 17665-1
BS EN ISO 18397 : 2016	DENTISTRY - POWERED SCALER
BS ISO 6474-2 : 2012	IMPLANTS FOR SURGERY - CERAMIC MATERIALS - PART 2: COMPOSITE MATERIALS BASED ON A HIGH-PURITY ALUMINA MATRIX WITH ZIRCONIA REINFORCEMENT
ISO 14949 : 2001(R2013)	IMPLANTS FOR SURGERY - TWO-PART ADDITION-CURE SILICONE ELASTOMERS
CSA ISO 5366-1 : 2014	ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEOSTOMY TUBES - PART 1: TUBES AND CONNECTORS FOR USE IN ADULTS
11/30219230 DC : 0	BS ISO 13175-3 - IMPLANTS FOR SURGERY - CALCIUM PHOSPHATES - PART 3: HYDROXYAPATITE AND BETA-TRICALCIUM PHOSPHATE BONE SUBSTITUTES
04/30109833 DC : 0	ISO 8836 - SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT
BS EN ISO 7197 : 2009	NEUROSURGICAL IMPLANTS - STERILE, SINGLE-USE HYDROCEPHALUS SHUNTS AND COMPONENTS
DIN EN ISO 18397 E : 2016	DENTISTRY - POWERED SCALER (ISO 18397:2016)
DIN EN ISO 25539-1 : 2015	CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES (ISO 25539-1:2017)
DIN EN ISO 8637 E : 2014	CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS (ISO 8637:2010, INCLUDING AMENDMENT 1 2013-04-01)
09/30168911 DC : 0	BS ISO 28399 - DENTISTRY - PRODUCTS FOR EXTERNAL TOOTH BLEACHING
AAMI ISO TIR 15499 : 2017	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - GUIDANCE ON THE CONDUCT OF BIOLOGICAL EVALUATION WITHIN A RISK MANAGEMENT PROCESS
DIN EN ISO 10873 E : 2010	DENTISTRY - DENTURE ADHESIVES
15/30310645 DC : 0	BS EN ISO 8536-14 - INFUSION EQUIPMENT FOR MEDICAL USE - PART 14: CLAMPS AND FLOW REGULATORS FOR TRANSFUSION AND INFUSION EQUIPMENT WITHOUT FLUID CONTACT
UNE EN ISO 13504 : 2013	DENTISTRY - GENERAL REQUIREMENTS FOR INSTRUMENTS AND RELATED ACCESSORIES USED IN DENTAL IMPLANT PLACEMENT AND TREATMENT (ISO 13504:2012)
04/30085448 DC : DRAFT MARCH 2004	ISO 15854 - DENTISTRY - CASTING AND BASEPLATE WAXES
16/30346829 DC : 0	BS ISO 16038 - MALE CONDOMS - GUIDANCE ON THE USE OF ISO 4074 AND ISO 23409 IN THE QUALITY MANAGEMENT CONDOMS
DIN EN ISO 9693-1 : 2012	DENTISTRY - COMPATIBILITY TESTING - PART 1: METAL-CERAMIC SYSTEMS (ISO 9693-1:2012)
CSA Z8638 : 2008	CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - EXTRACORPOREAL BLOOD CIRCUIT FOR HAEMODIALYSERS, HAEMODIAFILTERS AND HAEMOFILTERS
I.S. EN ISO 8536-14:2018	INFUSION EQUIPMENT FOR MEDICAL USE - PART 14: CLAMPS AND FLOW REGULATORS FOR TRANSFUSION AND INFUSION EQUIPMENT WITHOUT FLUID CONTACT (ISO 8536-14:2016)
PREN 14683 : DRAFT 2017	MEDICAL FACE MASKS - REQUIREMENTS AND TEST METHODS
BS PD CEN ISO/TS 16775 : 2014	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - GUIDANCE ON THE APPLICATION OF ISO 11607-1 AND ISO 11607-2
PREN 13795-1 : DRAFT 2017	SURGICAL CLOTHING AND DRAPES - REQUIREMENTS AND TEST METHODS - PART 1: SURGICAL DRAPES AND GOWNS
BS ISO 19614 : 2017	TRADITIONAL CHINESE MEDICINE - PULSE GRAPH FORCE TRANSDUCER
13/30267665 DC : 0	BS EN ISO 24234 - DENTISTRY - DENTAL AMALGAM
BS PD ISO/TS 17665-3 : 2013	STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 3: GUIDANCE ON THE DESIGNATION OF A MEDICAL DEVICE TO A PRODUCT FAMILY AND PROCESSING CATEGORY FOR STEAM STERILIZATION
ISO TS 20993 : 2006	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - GUIDANCE ON A RISK-MANAGEMENT PROCESS
I.S. EN ISO 11137-1:2015	STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 1: REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES (ISO 11137-1:2006, INCLUDING AMD 1:2013)
04/30103836 DC : DRAFT JUL 2004	ISO 11979-5 - OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 5: BIOCOMPATIBILITY
DIN EN ISO 20795-2 E : 2013	DENTISTRY - BASE POLYMERS - PART 2: ORTHODONTIC BASE POLYMERS (ISO 20795-2:2013)
16/30331650 DC : 0	BS EN ISO 8637-1 - EXTRACORPOREAL SYSTEMS FOR BLOOD PURIFICATION - PART 1: HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS
I.S. EN ISO 1135-5:2015	TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 5: TRANSFUSION SETS FOR SINGLE USE WITH PRESSURE INFUSION APPARATUS (ISO 1135-5:2015)
17/30302767 DC : 0	BS ISO 13779-2 - IMPLANTS FOR SURGERY - HYDROXYAPATITE - PART 2: THERMALLY SPRAYED COATINGS OF HYDROXYAPATITE
BS ISO 27427 : 2013	ANAESTHETIC AND RESPIRATORY EQUIPMENT - NEBULIZING SYSTEMS AND COMPONENTS
17/30358658 DC : 0	BS EN 13795-1 - SURGICAL CLOTHING AND DRAPES - REQUIREMENTS AND TEST METHODS - PART 1: SURGICAL DRAPES AND GOWNS
DIN EN ISO 12417-1 : 2016	CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS - PART 1: GENERAL REQUIREMENTS (ISO 12417-1:2015)
AAMI ISO 10993-9 : 2009	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 9: FRAMEWORK FOR IDENTIFICATION AND QUANTIFICATION OF POTENTIAL DEGRADATION PRODUCTS
ASTM F 2224 : 2009	SPECIFICATION FOR HIGH PURITY CALCIUM SULFATE HEMIHYDRATE OR DIHYDRATE FOR SURGICAL IMPLANTS
AAMI ISO 10993-10 : 2010 : R2014	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 10: TESTS FOR IRRITATION AND SKIN SENSITIZATION
UNE EN ISO 5840-3 : 2013	CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 3: HEART VALVE SUBSTITUTES IMPLANTED BY TRANSCATHETER TECHNIQUES (ISO 5840-3:2013)
14/30273278 DC : 0	BS EN ISO 18397 - DENTISTRY - POWERED SCALER
NBR 16163 : 2013	PLASTIC CONTAINERS FOR INTRAVENOUS INJECTIONS
BS EN ISO 10873 : 2010	DENTISTRY - DENTURE ADHESIVES
PREN 455-3 : DRAFT 2013	MEDICAL GLOVES FOR SINGLE USE - PART 3: REQUIREMENTS AND TESTING FOR BIOLOGICAL EVALUATION
15/30289037 DC : 0	BS EN ISO 7886-1 - STERILE HYPODERMIC SYRINGES FOR SINGLE USE - PART 1: SYRINGES FOR MANUAL USE
UNE EN ISO 8536-13 : 2017	INFUSION EQUIPMENT FOR MEDICAL USE - PART 13: GRADUATED FLOW REGULATORS FOR SINGLE USE WITH FLUID CONTACT (ISO 8536-13:2016)
11/30219211 DC : 0	BS EN ISO 5840-3 - CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 3: HEART VALVE SUBSTITUTES IMPLANTED BY MINIMALLY INVASIVE TECHNIQUES
CEI UNI EN ISO 14971 : 2013	MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES
13/30283636 DC : 0	BS ISO 13179-1 - IMPLANTS FOR SURGERY - PLASMA-SPRAYED UNALLOYED TITANIUM COATINGS ON SURGICAL IMPLANTS - PART 1: GENERAL REQUIREMENTS
BS ISO 11040-4 : 2015	PREFILLED SYRINGES - PART 4: GLASS BARRELS FOR INJECTABLES AND STERILIZED SUBASSEMBLED SYRINGES READY FOR FILLING
04/30075452 DC : DRAFT FEB 2004	BS EN ISO 6874 - DENTISTRY - POLYMER-BASED PIT AND FISSURE SEALANTS
DIN EN ISO 11070 E : 2015	STERILE SINGLE-USE INTRAVASCULAR INTRODUCERS, DILATORS AND GUIDEWIRES (ISO 11070:2014)
14/30295064 DC : 0	BS EN ISO 16672 - OPHTHALMIC IMPLANTS - OCULAR ENDOTAMPONADES
UNE EN ISO 20857 : 2013	STERILIZATION OF HEALTH CARE PRODUCTS - DRY HEAT - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES (ISO 20857:2010)
I.S. EN ISO 20857:2013	STERILIZATION OF HEALTH CARE PRODUCTS - DRY HEAT - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES (ISO 20857:2010)
14/30296389 DC : 0	BS EN ISO 7864 - STERILE HYPODERMIC NEEDLES FOR SINGLE USE - REQUIREMENTS AND TEST METHODS
ISO 19023 : 2018	DENTISTRY - ORTHODONTIC ANCHOR SCREWS
04/30057302 DC : DRAFT DEC 2004	BS EN ISO 9333 - DENTAL BRAZING MATERIALS
DIN EN ISO 11607-1 : 2014	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS (ISO 11607-1:2006 + AMD 1.:2014)
BS EN ISO 9693-1 : 2012	DENTISTRY - COMPATIBILITY TESTING - PART 1: METAL-CERAMIC SYSTEMS (ISO 9693-1:2012)
11/30227250 DC : 0	BS EN ISO 21563 - DENTISTRY - HYDROCOLLOID IMPRESSION MATERIALS
BS ISO 18190 : 2016	ANAESTHETIC AND RESPIRATORY EQUIPMENT - GENERAL REQUIREMENTS FOR AIRWAYS AND RELATED EQUIPMENT
BS EN ISO 81060-1 : 2012	NON-INVASIVE SPHYGMOMANOMETERS - PART 1: REQUIREMENTS AND TEST METHODS FOR NON-AUTOMATED MEASUREMENT TYPE
17/30343686 DC : 0	BS EN ISO 7405 - DENTISTRY - EVALUATION OF BIOCOMPATIBILITY OF MEDICAL DEVICES USED IN DENTISTRY
DIN EN ISO 26782 : 2010	ANAESTHETIC AND RESPIRATORY EQUIPMENT - SPIROMETERS INTENDED FOR THE MEASUREMENT OF TIME FORCED EXPIRED VOLUMES IN HUMANS
BS EN ISO 5364 : 2016	ANAESTHETIC AND RESPIRATORY EQUIPMENT - OROPHARYNGEAL AIRWAYS (ISO 5364:2016)
17/30319534 DC : 0	BS ISO 13019 - TISSUE-ENGINEERED MEDICAL PRODUCTS - QUANTIFICATION OF SULPHATED GLYCOSAMINOGLYCANS (SGAG) FOR EVALUATION OF CHONDROGENESIS
PREN ISO 11608-2 : DRAFT 2010	NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 2: NEEDLES
BS EN ISO 12417-1 : 2015	CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS - PART 1: GENERAL REQUIREMENTS
BS EN ISO 20795-2 : 2013	DENTISTRY - BASE POLYMERS - PART 2: ORTHODONTIC BASE POLYMERS
13/30257549 DC : 0	BS EN ISO 11499 - DENTISTRY - SINGLE-USE CARTRIDGES FOR LOCAL ANAESTHETICS
I.S. EN ISO 3630-5:2011	DENTISTRY - ENDODONTIC INSTRUMENTS - PART 5: SHAPING AND CLEANING INSTRUMENTS (ISO 3630-5:2011)
UNI EN ISO 7494-1 : 2011	DENTISTRY - DENTAL UNITS - PART 1: GENERAL REQUIREMENTS AND TEST METHODS
02/561161 DC : DRAFT FEB 2002	BS EN ISO 16408 - DENTISTRY - ORAL HYGIENE PRODUCTS - ORAL RINSES
ISO 8536-14 : 2016	INFUSION EQUIPMENT FOR MEDICAL USE - PART 14: CLAMPS AND FLOW REGULATORS FOR TRANSFUSION AND INFUSION EQUIPMENT WITHOUT FLUID CONTACT
CSA ISO 5364 : 2016	ANAESTHETIC AND RESPIRATORY EQUIPMENT - OROPHARYNGEAL AIRWAYS
AAMI ISO 5364 : 2008	ANAESTHETIC AND RESPIRATORY EQUIPMENT - OROPHARYNGEAL AND NASOPHARYNGEAL AIRWAYS
UNI EN ISO 10873 : 2010	DENTISTRY - DENTURE ADHESIVES
08/30168815 DC : DRAFT MAR 2008	BS EN ISO 4049 - DENTISTRY - POLYMER-BASED RESTORATIVE MATERIALS
16/30332214 DC : 0	BS EN ISO 9917-2 - DENTISTRY - WATER-BASED CEMENTS - PART 2: RESIN-MODIFIED CEMENTS
AAMI ISO 15675 : 2016	CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - CARDIOPULMONARY BYPASS SYSTEMS - ARTERIAL BLOOD LINE FILTERS
03/105714 DC : DRAFT MAR 2003	ISO 24234 - DENTISTRY - MERCURY AND ALLOYS FOR DENTAL AMALGAM
08/30179586 DC : DRAFT MAR 2008	BS ISO 7199 - CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - BLOOD-GAS EXCHANGERS (OXYGENATORS)
AAMI ISO 5361 : 2012	ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEAL TUBES AND CONNECTORS
07/30167336 DC : DRAFT AUG 2007	BS EN 868-10 - PACKAGING MATERIALS FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 10: ADHESIVE COATED NONWOVEN MATERIALS OF POLYOLEFINES FOR USE IN THE MANUFACTURE OF SEALABLE POUCHES, REELS AND LIDS - REQUIREMENTS AND TEST METHODS
DIN EN ISO 1135-5 : 2016	TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 5: TRANSFUSION SETS FOR SINGLE USE WITH PRESSURE INFUSION APPARATUS (ISO 1135-5:2015)
DIN EN ISO 1135-3 E : 2017	TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 3: BLOOD-TAKING SETS FOR SINGLE USE (ISO 1135-3:2016)
ISO 20696 : 1ED 2018	STERILE URETHRAL CATHETERS FOR SINGLE USE
BS EN ISO 21563 : 2013	DENTISTRY - HYDROCOLLOID IMPRESSION MATERIALS (ISO 21563:2013)
UNI EN ISO 5367 : 2015	ANAESTHETIC AND RESPIRATORY EQUIPMENT - BREATHING SETS AND CONNECTORS
I.S. EN ISO 10555-1:2013	INTRAVASCULAR CATHETERS - STERILE AND SINGLE-USE CATHETERS - PART 1: GENERAL REQUIREMENTS (ISO 10555-1:2013/AMD 1:2017)
DIN EN ISO 13017 : 2016	DENTISTRY - MAGNETIC ATTACHMENTS (ISO 13017:2012 + AMD.1:2015)
AAMI ISO 10993-11 : 2006 : R2014	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 11: TESTS FOR SYSTEMIC TOXICITY
BS ISO 18562-4 : 2017	BIOCOMPATIBILITY EVALUATION OF BREATHING GAS PATHWAYS IN HEALTHCARE APPLICATIONS - PART 4: TESTS FOR LEACHABLES IN CONDENSATE
ISO/DIS 20795-1 : 60.00 (2013)	DENTISTRY - BASE POLYMERS - PART 1: DENTURE BASE POLYMERS
DIN EN ISO 28399 E : 2011	DENTISTRY - PRODUCTS FOR EXTERNAL TOOTH BLEACHING
ANSI/AAMI/ISO 11607-1:2006/(R)2015	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS, AND PACKAGING SYSTEMS
CSA Z10535.1 : 2015	HOISTS FOR THE TRANSFER OF DISABLED PERSONS - REQUIREMENTS AND TEST METHODS
04/300654 DC : DRAFT JAN 2004	BS EN ISO 14630 - NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS
NBR ISO 7199 : 1998	IMPLANTES CARDIOVASCULARES E ORGAOS ARTIFICIAIS - OXIGENADORES DE SANGUE EXTRACORPOREOS (TROCADORES DE GAS-SANGUE)
14/30295067 DC : 0	BS EN ISO 16671 - OPHTHALMIC IMPLANTS - IRRIGATING SOLUTIONS FOR OPHTHALMIC SURGERY
13/30232902 DC : 0	BS ISO 14708-1 - IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND FOR INFORMATION TO BE PROVIDED BY THE MANUFACTURER
02/564514 DC : DRAFT OCT 2002	BS EN ISO 8536-4 - INFUSION EQUIPMENT FOR MEDICAL USE - PART 4: INFUSION SETS FOR SINGLE USE, GRAVITY FEED
AAMI ISO 10993-15 : 2000	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 15: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM METALS AND ALLOYS
I.S. EN ISO 18397:2016	DENTISTRY - POWERED SCALER (ISO 18397:2016)
VDI 5700-2 : 2017	REPROCESSING HAZARDS - RISK MANAGEMENT IN REPROCESSING OF MEDICAL DEVICES - TRAININGS
BS ISO 20749 : 2017	DENTISTRY - PRE-CAPSULATED DENTAL AMALGAM
CSA ISO 14971: 2007	MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES
16/30335531 DC : 0	BS EN ISO 10993-16 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 16: TOXICOKINETIC STUDY DESIGN FOR DEGRADATION PRODUCTS AND LEACHABLES
DD ISO/TS 10993-19 : 2006	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 19: PHYSICO-CHEMICAL, MORPHOLOGICAL AND TOPOGRAPHICAL CHARACTERIZATION OF MATERIALS
I.S. EN ISO 10873:2010	DENTISTRY - DENTURE ADHESIVES
BS PD ISO/TS 16506 : 2017	DENTISTRY - POLYMER-BASED LUTING MATERIALS CONTAINING ADHESIVE COMPONENTS
09/30180393 DC : 0	BS EN ISO 10451 - DENTISTRY - CONTENTS OF TECHNICAL FILE FOR DENTAL IMPLANT SYSTEMS
13/30259011 DC : 0	BS ISO 17218 - STERILE ACUPUNCTURE NEEDLES FOR SINGLE USE
14/30281859 DC : 0	BS ISO 5361 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEAL TUBES AND CONNECTORS
AAMI ISO 8637 : 2010	CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - HEMODIALYZERS, HEMODIAFILTERS, HEMOFILTERS AND HEMOCONCENTRATORS
16/30310674 DC : 0	BS EN ISO 14457 - DENTISTRY - HANDPIECES AND MOTORS
13/30273499 DC : 0	BS ISO 11040-4 - PREFILLED SYRINGES - PART 4: GLASS BARRELS FOR INJECTABLES AND STERILIZED SUBASSEMBLED SYRINGES READY FOR FILLING
BS PD ISO/TR 15499 : 2016	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - GUIDANCE ON THE CONDUCT OF BIOLOGICAL EVALUATION WITHIN A RISK MANAGEMENT PROCESS
14/30302761 DC : 0	BS ISO 11249 - MECHANICAL CONTRACEPTIVES - GUIDANCE FOR CLINICAL EVALUATION OF INTRA-UTERINE CONTRACEPTIVE DEVICES (IUDS)
UNE EN ISO 5364 : 2017	ANAESTHETIC AND RESPIRATORY EQUIPMENT - OROPHARYNGEAL AIRWAYS (ISO 5364:2016)
NBR ISO 14949 : 2011	IMPLANTS FOR SURGERY - TWO-PART ADDITION-CURE SILICONE ELASTOMERS
DIN EN ISO 17730 E : 2015	DENTISTRY - FLUORIDE VARNISHES (ISO 17730:2014)
02/562119 DC : DRAFT MAY 2002	BS EN ISO 7376 - LARYNGOSCOPES FOR TRACHEAL INTUBATION
UNE EN ISO 16671 : 2016	OPHTHALMIC IMPLANTS - IRRIGATING SOLUTIONS FOR OPHTHALMIC SURGERY (ISO 16671:2015)
UNI EN ISO 25424 : 2011	STERILIZATION OF MEDICAL DEVICES - LOW TEMPERATURE STEAM AND FORMALDEHYDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
EN ISO 10555-6 : 2017	INTRAVASCULAR CATHETERS - STERILE AND SINGLE-USE CATHETERS - PART 6: SUBCUTANEOUS IMPLANTED PORTS (ISO 10555-6:2015)
AAMI ISO 25539-1 : 2017	CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES
14/30263397 DC : 0	BS EN ISO 22674 - DENTISTRY - METALLIC MATERIALS FOR FIXED AND REMOVABLE RESTORATIONS AND APPLIANCES
AAMI ISO 10993-7 : 2008 : R2012	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 7: ETHYLENE OXIDE STERILIZATION RESIDUALS
AAMI ISO 81060-1 : 2007	NON INVASIVE SPHYGMOMANOMETERS - PART 1: REQUIREMENTS AND TEST METHODS FOR NON-AUTOMATED MEASUREMENT TYPE
BS EN ISO 8536-13 : 2016	INFUSION EQUIPMENT FOR MEDICAL USE - PART 13: GRADUATED FLOW REGULATORS FOR SINGLE USE WITH FLUID CONTACT (ISO 8536-13:2016)
DIN EN ISO 13017 E : 2016	DENTISTRY - MAGNETIC ATTACHMENTS (ISO 13017:2012 + AMD.1:2015)
15/30321715 DC : 0	BS ISO 15675 - CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - CARDIOPULMONARY BYPASS SYSTEMS - ARTERIAL BLOOD LINE FILTERS
17/30357741 DC : 0	BS ISO 11040-6 - PREFILLED SYRINGES - PART 6: PLASTIC BARRELS FOR INJECTABLES AND STERILIZED SUBASSEMBLED SYRINGES READY FOR FILLING
VDI 5700-1 : 2015	REPROCESSING HAZARDS - RISK MANAGEMENT IN REPROCESSING OF MEDICAL DEVICES - MEASURES FOR RISK CONTROL
DIN EN ISO 8836 E : 2015	SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT (ISO 8836:2014)
DIN EN ISO 7197 : 2009	NEUROSURGICAL IMPLANTS - STERILE, SINGLE-USE HYDROCEPHALUS SHUNTS AND COMPONENTS
16/30339666 DC : 0	BS EN ISO 11609 - DENTISTRY - DENTIFRICES - REQUIREMENTS, TEST METHODS AND MARKING
05/30138123 DC : DRAFT AUG 2005	BS ISO 8836 - SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT
03/100426 DC : DRAFT JAN 2003	BS EN ISO 10993-18 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 18: CHEMICAL CHARACTERIZATION OF MATERIALS
AAMI ISO 20857 : 2010	STERILIZATION OF HEALTH CARE PRODUCTS - DRY HEAT - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
BS ISO 29942 : 2011	PROPHYLACTIC DAMS - REQUIREMENTS AND TEST METHODS
12/30251858 DC : 0	BS ISO 4074 - NATURAL RUBBER LATEX MALE CONDOMS - REQUIREMENTS AND TEST METHODS
16/30312836 DC : 0	BS ISO 19227 - CLEANING OF ORTHOPEDIC IMPLANTS - GENERAL REQUIREMENTS
BS PD ISO/TR 37137 : 2014	CARDIOVASCULAR BIOLOGICAL EVALUATION OF MEDICAL DEVICES - GUIDANCE FOR ABSORBABLE IMPLANTS
CSA ISO 10993-2 : 1997	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 2: ANIMAL WELFARE REQUIREMENTS
DIN EN 14683 : 2014	MEDICAL FACE MASKS - REQUIREMENTS AND TEST METHODS
BS EN ISO 3826-4 : 2015	PLASTICS COLLAPSIBLE CONTAINERS FOR HUMAN BLOOD AND BLOOD COMPONENTS - PART 4: APHAERESIS BLOOD BAG SYSTEMS WITH INTEGRATED FEATURES
AAMI BE83 : 2006 : R2011	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 18: CHEMICAL CHARACTERIZATION OF MATERIALS
DD CEN ISO/TS 17665-2 : 2009	STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ISO 17665-1
AAMI ISO 11607-1 : 2006	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS, AND PACKAGING SYSTEMS
UNE EN ISO 27020 : 2011	DENTISTRY - BRACKETS AND TUBES FOR USE IN ORTHODONTICS
BS EN ISO 9917-2 : 2017	DENTISTRY - WATER-BASED CEMENTS - PART 2: RESIN-MODIFIED CEMENTS (ISO 9917-2:2017)
DIN EN ISO 27020 : 2011	DENTISTRY - BRACKETS AND TUBES FOR USE IN ORTHODONTICS
AAMI ISO 7199 : 2009	CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - BLOOD-GAS EXCHANGERS (OXYGENATORS)
07/30163763 DC : 0	BS ISO 7405 - DENTISTRY - PRECLINICAL EVALUATION OF BIOCOMPATIBILITY OF MEDICAL DEVICES USED IN DENTISTRY - TEST METHODS FOR DENTAL MATERIALS
BS EN ISO 10477 : 2004	DENTISTRY - POLYMER-BASED CROWN AND BRIDGE MATERIALS
13/30233325 DC : 0	BS EN 45502-1 - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND INFORMATION TO BE PROVIDED BY THE MANUFACTURER
02/564513 DC : DRAFT OCT 2002	BS EN ISO 1135-4 - INFUSION EQUIPMENT FOR MEDICAL USE - PART 4: TRANSFUSION SETS FOR SINGLE USE
I.S. EN ISO 10477:2004	DENTISTRY - POLYMER-BASED CROWN AND BRIDGE MATERIALS
ANSI/AAMI/ISO 11607-1:2006/(R)2015	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS, AND PACKAGING SYSTEMS
UNI EN ISO 13504 : 2012	DENTISTRY - GENERAL REQUIREMENTS FOR INSTRUMENTS AND RELATED ACCESSORIES USED IN DENTAL IMPLANT PLACEMENT AND TREATMENT
14/30257546 DC : 0	BS ISO 17966 - ASSISTIVE PRODUCTS FOR PERSONAL HYGIENE THAT SUPPORT USERS - REQUIREMENTS AND TEST METHODS
CSA ISO 8638 :2012	CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - EXTRACORPOREAL BLOOD CIRCUIT FOR HAEMODIALYSERS, HAEMODIAFILTERS AND HAEMOFILTERS
DIN EN ISO 25539-1 E : 2017	CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES (ISO 25539-1:2017)
17/30336573 DC : 0	BS EN ISO 20696 - STERILE URETHAL CATHETERS FOR SINGLE USE
BS ISO 8536-12 : 2007	INFUSION EQUIPMENT FOR MEDICAL USE - PART 12: CHECK VALVES
ASTM F 2347 : 2015 : REDLINE	Standard Guide for Characterization and Testing of Hyaluronan as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications
14/30290166 DC : 0	BS ISO 16142-1 - MEDICAL DEVICES - RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES - PART 1: GENERAL ESSENTIAL PRINCIPLES AND ADDITIONAL SPECIFIC ESSENTIAL PRINCIPLES FOR ALL NON-IVD MEDICAL DEVICES AND GUIDANCE ON THE SELECTION OF STANDARDS
ISO 11040-6 : 2012	PREFILLED SYRINGES - PART 6: PLASTIC BARRELS FOR INJECTABLES
14/30303657 DC : 0	BS EN ISO 1135-3 - TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 3: BLOOD-TAKING SET FOR SINGLE USE
I.S. EN ISO 5840-3:2013	CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 3: HEART VALVE SUBSTITUTES IMPLANTED BY TRANSCATHETER TECHNIQUES (ISO 5840-3:2013)
14/30281560 DC : 0	BS EN ISO 5840-2 - CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 2: SURGICALLY IMPLANTED HEART VALVE SUBSTITUTES
16/30301330 DC : 0	BS ISO 19614 - TRADITIONAL CHINESE MEDICINE - PULSE GRAPH FORCE TRANSDUCER
BS ISO 11658 : 2012	CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - BLOOD/TISSUE CONTACT SURFACE MODIFICATIONS FOR EXTRACORPOREAL PERFUSION SYSTEMS
14/30292011 DC : 0	BS EN ISO 23747 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - PEAK EXPIRATORY FLOW METERS FOR THE ASSESSMENT OF PULMONARY FUNCTION IN SPONTANEOUSLY BREATHING HUMANS
DIN EN ISO 26782 E : 2010	ANAESTHETIC AND RESPIRATORY EQUIPMENT - SPIROMETERS INTENDED FOR THE MEASUREMENT OF TIME FORCED EXPIRED VOLUMES IN HUMANS
ISO 20308 : 2017	TRADITIONAL CHINESE MEDICINE - GUA SHA INSTRUMENTS
00/561676 DC : DRAFT APRIL 2000	DRAFT BS EN ISO 10993-3 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 3: TESTS FOR GENOTOXICITY, CARCINOGENICITY AND REPRODUCTIVE TOXICITY
08/30187781 DC : DRAFT AUG 2008	BS EN ISO 10993-16 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 16: TOXICOKINETIC STUDY DESIGN FOR DEGRADATION PRODUCTS AND LEACHABLES
BS ISO 13175-3 : 2012	IMPLANTS FOR SURGERY - CALCIUM PHOSPHATES - PART 3: HYDROXYAPATITE AND BETA-TRICALCIUM PHOSPHATE BONE SUBSTITUTES
ISO 10993-11 : 2017	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 11: TESTS FOR SYSTEMIC TOXICITY
17/30332162 DC : 0	BS EN ISO 7494-1 - DENTISTRY - STATIONARY DENTAL UNITS AND DENTAL PATIENT CHAIRS - PART 1: GENERAL REQUIREMENTS AND TEST METHODS
ISO 13179-1 : 2014	IMPLANTS FOR SURGERY - PLASMA-SPRAYED UNALLOYED TITANIUM COATINGS ON METALLIC SURGICAL IMPLANTS - PART 1: GENERAL REQUIREMENTS
04/30081258 DC : DRAFT MARCH 2004	BS EN ISO 11737-1 - STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 1 - DETERMINATION OF A POPULATION OF MICRO ORGANISMS ON PRODUCTS
I.S. EN ISO 10555-6:2017	INTRAVASCULAR CATHETERS - STERILE AND SINGLE-USE CATHETERS - PART 6: SUBCUTANEOUS IMPLANTED PORTS (ISO 10555-6:2015)
DIN EN ISO 14607 E : 2009	NON-ACTIVE SURGICAL IMPLANTS - MAMMARY IMPLANTS - PARTICULAR REQUIREMENTS
11/30212473 DC : 0	BS EN ISO 10993-3 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 3: TESTS FOR GENOTOXICITY, CARCINOGENICITY AND REPRODUCTIVE TOXICITY
DIN EN ISO 8638 : 2014	CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - EXTRACORPOREAL BLOOD CIRCUIT FOR HAEMODIALYSERS, HAEMODIAFILTERS AND HAEMOFILTERS (ISO 8638:2010)
PREN ISO 11499 : DRAFT 2013	DENTISTRY - SINGLE-USE CARTRIDGES FOR LOCAL ANAESTHETICS (ISO/DIS 11499:2013)
BS ISO 16840-10 : 2014	WHEELCHAIRS - RESISTANCE TO IGNITION OF NON-INTEGRATED SEAT AND BACK SUPPORT CUSHIONS - PART 10: REQUIREMENTS AND TEST METHODS
08/30179589 DC : DRAFT MAR 2008	BS ISO 15674 - CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - HARD-SHELL CARDIOTOMY/VENOUS RESERVOIR SYSTEMS (WITH/WITHOUT FILTER) AND SOFT VENOUS RESERVOIR BAGS
CSA Z8637 : 2008	CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS
16/30310949 DC : 0	BS ISO 5910 - CARDIOVASCULAR IMPLANTS AND EXTRACOPOREAL SYSTEMS - CARDIAC VALVE REPAIR DEVICES
CSA ISO 5840 : 0	CARDIOVASCULAR IMPLANTS - CARIDAC VALVE PROSTHESES
04/30048301 DC : DRAFT MAY 2004	BS EN ISO 11137-1 - STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 1: REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
CSA ISO 8637: 2012	CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS
BS ISO 16038 : 2017	MALE CONDOMS - GUIDANCE ON THE USE OF ISO 4074 AND ISO 23409 IN THE QUALITY MANAGEMENT OF CONDOMS
09/30157765 DC : 0	BS EN ISO 14160 REV - STERILIZATION OF HEALTH CARE PRODUCTS - LIQUID CHEMICAL STERILIZING AGENTS FOR SINGLE-USE MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - REQUIREMENTS FOR CHARACTERIZATION, DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
BS 7208-17(1998) : 1998	OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - FUNDAMENTAL REQUIREMENTS
AAMI TIR41 : 2011	ACTIVE IMPLANTABLE MEDICAL DEVICES - GUIDANCE FOR DESIGNATION OF LEFT VENTRICLE AND IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LEAD CONNECTORS AND PULSE GENERATOR CONNECTOR CAVITIES FOR IMPLANTABLE PACEMAKERS AND IMPLANTABLE CARDIOVERTER DEFIBRILLATORS
DIN EN ISO 25424 E : 2011	STERILIZATION OF MEDICAL DEVICES - LOW TEMPERATURE STEAM AND FORMALDEHYDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES (ISO 25424:2009)
15/30266276 DC : 0	BS ISO 18189 - OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - CYTOTOXICITY TESTING OF CONTACT LENSES AND CONTACT LENS CARE SOLUTIONS
14/30261590 DC : 0	BS EN ISO 10993-6 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 6: TESTS FOR LOCAL EFFECTS AFTER IMPLANTATION
DIN ISO 5832-14 : 2009	IMPLANTS FOR SURGERY - METALLIC MATERIALS - PART 14: WROUGHT TITANIUM 15-MOLYBDENUM 5-ZIRCONIUM 3-ALUMINIUM ALLOY
DIN EN ISO 13688 : 2013	PROTECTIVE CLOTHING - GENERAL REQUIREMENTS (ISO 13688:2013)
BS EN ISO 5361 : 2016	ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEAL TUBES AND CONNECTORS (ISO 5361:2016)
BS EN 30993-5 : 1994	BIOLOGICAL EXAMINATION OF MEDICAL DEVICES - TESTS FOR CYTOTOXICITY, IN VITRO METHODS
15/30278530 DC : 0	BS ISO 18562-1 - BIOCOMPATIBILITY EVALUATION OF BREATHING GAS PATHWAYS IN HEALTHCARE APPLICATIONS - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS
BS ISO 23409 : 2011	MALE CONDOMS - REQUIREMENTS AND TEST METHODS FOR CONDOMS MADE FROM SYNTHETIC MATERIALS
CSA ISO 11712 : 2014	ANAESTHETIC AND RESPIRATORY EQUIPMENT - SUPRALARYNGEAL AIRWAYS AND CONNECTORS
BS EN ISO 17254 : 2016	DENTISTRY - COILED SPRINGS FOR USE IN ORTHODONTICS (ISO 17254:2016)
DIN EN ISO 28319 E : 2010	DENTISTRY - LASER WELDING
AAMI ISO TIR 37137 : 2015	CARDIOVASCULAR BIOLOGICAL EVALUATION OF MEDICAL DEVICES - GUIDANCE FOR ABSORBABLE IMPLANTS
DIN EN ISO 1135-5 E : 2016	TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 5: TRANSFUSION SETS FOR SINGLE USE WITH PRESSURE INFUSION APPARATUS (ISO 1135-5:2015)
15/30330548 DC : 0	BS EN ISO 10993-11 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 11: TESTS FOR SYSTEMIC TOXICITY
09/30207531 DC : 0	BS EN ISO 14534 - OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - FUNDAMENTAL REQUIREMENTS
ISO 18242 : 2016	CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - CENTRIFUGAL BLOOD PUMPS
BS EN ISO 7199 : 2017	CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - BLOOD-GAS EXCHANGERS (OXYGENATORS) (ISO 7199:2016)
BS ISO 13179-1 : 2014	IMPLANTS FOR SURGERY - PLASMA-SPRAYED UNALLOYED TITANIUM COATINGS ON METALLIC SURGICAL IMPLANTS - PART 1: GENERAL REQUIREMENTS
06/30145887 DC : DRAFT FEB 2006	EN ISO 10993-12 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 12: SAMPLE PREPARATION AND REFERENCE MATERIALS
11/30212235 DC : 0	BS EN ISO 13504 - DENTISTRY - GENERAL REQUIREMENTS FOR INSTRUMENTS AND RELATED ACCESSORIES USED IN DENTAL IMPLANT PLACEMENT AND TREATMENT
04/19976241 DC : DRAFT AUG 2004
13/30281504 DC : 0	BS EN 455-3 - MEDICAL GLOVES FOR SINGLE USE - PART 3: REQUIREMENTS AND TESTING FOR BIOLOGICAL EVALUATION
15/30321712 DC : 0	BS ISO 15674 - CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - HARD-SHELL CARDIOTOMY/VENOUS RESERVOIR SYSTEMS (WITH/WITHOUT FILTER) AND SOFT VENOUS RESERVOIR BAGS
15/30321957 DC : 0	BS EN ISO 7199 - CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS BLOOD-GAS EXCHANGERS (OXYGENATORS)
ISO 18189 : 2016	OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - CYTOTOXICITY TESTING OF CONTACT LENSES IN COMBINATION WITH LENS CARE SOLUTION TO EVALUATE LENS/SOLUTION INTERACTIONS
15/30280904 DC : 0	BS ISO 18190 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - GENERAL REQUIREMENTS FOR AIRWAYS AND RELATED EQUIPMENT
02/563622 DC : DRAFT AUG 2002	BS EN ISO 1562 - DENTISTRY - CASTING GOLD ALLOYS
DIN EN ISO 13688 E : 2013	PROTECTIVE CLOTHING - GENERAL REQUIREMENTS (ISO 13688:2013)
17/30323851 DC : 0	BS ISO 19894 - WALKING TROLLEYS - REQUIREMENTS AND TEST METHODS
BS EN ISO 15798 : 2013	OPHTHALMIC IMPLANTS - OPHTHALMIC VISCOSURGICAL DEVICES
BS EN ISO 9693-2 : 2016	DENTISTRY - COMPATIBILITY TESTING - PART 2: CERAMIC-CERAMIC SYSTEMS
BS EN 868-9 : 2009	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 9: UNCOATED NONWOVEN MATERIALS OF POLYOLEFINES - REQUIREMENTS AND TEST METHODS
14/30297754 DC : 0	BS EN ISO 16408 - DENTISTRY - ORAL HYGIENE PRODUCTS - ORAL RINSES
BS ISO 18666 : 2015	TRADITIONAL CHINESE MEDICINE - GENERAL REQUIREMENTS OF MOXIBUSTION DEVICES
17/30357486 DC : 0	BS EN ISO 15747 - PLASTIC CONTAINERS FOR INTRAVENOUS INJECTIONS
BS ISO 11040-3 : 2012	PREFILLED SYRINGES - PART 3: SEALS FOR DENTAL LOCAL ANAESTHETIC CARTRIDGES
BS EN ISO 16671 : 2015	OPHTHALMIC IMPLANTS - IRRIGATING SOLUTIONS FOR OPHTHALMIC SURGERY
15/30278540 DC : 0	BS ISO 18562-4 - BIOCOMPATIBILITY EVALUATION OF BREATHING GAS PATHWAYS IN HEALTHCARE APPLICATIONS - PART 4: TESTS FOR LEACHABLES IN CONDENSATE
15/30314608 DC : 0	BS EN ISO 7153-1 - SURGICAL INSTRUMENTS - MATERIALS - PART 1: METALS
14/30263393 DC : 0	BS EN ISO 9693-2 - DENTISTRY - COMPATIBILITY TESTING - PART 2: CERAMIC-CERAMIC SYSTEMS
DIN ISO 8536-12 : 2013	INFUSION EQUIPMENT FOR MEDICAL USE - PART 12: CHECK VALVES (ISO 8536-12:2007 + AMD. 1:2012)
15/30314236 DC : 0	BS ISO 15676 - CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - REQUIREMENTS FOR SINGLE-USE TUBING PACKS FOR CARDIOPULMONARY BYPASS AND EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO)
CSA Z17665-2 : 2009 : R2014	STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ISO 17665-1
SR CEN ISO/TS 17665-2:2009	STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ISO 17665-1
CSA ISO 8638 : 2012	CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - EXTRACORPOREAL BLOOD CIRCUIT FOR HAEMODIALYSERS, HAEMODIAFILTERS AND HAEMOFILTERS
04/19975667 DC : 0	BS ISO 15676 - CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - SINGLE - USE TUBING PACKS FOR CARDIOPULMONARY BYPASS AND EXTRACORPOREAL MEMBRANCE OXYGENATION
07/30162839 DC : 0	BS EN ISO 10993-9 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 9: FRAMEWORK FOR IDENTIFICATION AND QUANTIFICATION OF POTENTIAL DEGRADATION PRODUCTS
DIN ISO 5832-14 E : 2009	IMPLANTS FOR SURGERY - METALLIC MATERIALS - PART 14: WROUGHT TITANIUM 15-MOLYBDENUM 5-ZIRCONIUM 3-ALUMINIUM ALLOY
DIN EN ISO 8836 : 2015	SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT (ISO 8836:2014
07/30164697 DC : 0	ISO 20857 - STERILIZATION OF HEALTH CARE PRODUCTS - DRY HEAT - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF AN INDUSTRIAL STERILIZATION PROCESS FOR MEDICAL DEVICES
13/30279967 DC : 0	BS EN ISO 6872 - DENTISTRY - CERAMIC MATERIALS
BS ISO 18189 : 2016	OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - CYTOTOXICITY TESTING OF CONTACT LENSES IN COMBINATION WITH LENS CARE SOLUTION TO EVALUATE LENS/SOLUTION INTERACTIONS
08/30170164 DC : DRAFT AUG 2008	BS EN ISO 10993-10 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 10: TESTS FOR IRRITATION AND SKIN SENSITIZATION
BS ISO 20308 : 2017	TRADITIONAL CHINESE MEDICINE - GUA SHA INSTRUMENTS
12/30244415 DC : DRAFT APR 2012	BS ISO 27427 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - NEBULIZING SYSTEMS AND COMPONENTS
13/30263389 DC : 0	BS EN ISO 4823 - DENTISTRY - ELASTOMERIC IMPRESSION MATERIALS
17/30338806 DC : 0	BS EN ISO 25424 - STERILIZATION OF HEALTH CARE PRODUCTS - LOW TEMPERATURE STEAM AND FORMALDEHYDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
10/30169478 DC : 0	BS EN ISO 9693-1 - DENTISTRY - COMPATIBILITY TESTING - PART 1: METAL-CERAMIC SYSTEMS
BS EN ISO 7494-1 : 2011	DENTISTRY - DENTAL UNITS - PART 1: GENERAL REQUIREMENTS AND TEST METHODS
10/30208977 DC : 0	BS EN ISO 11608-1 - NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 1: NEEDLE-BASED INJECTION SYSTEMS
AAMI ISO 81060-1 : 2007 : R2013	NON INVASIVE SPHYGMOMANOMETERS - PART 1: REQUIREMENTS AND TEST METHODS FOR NON-AUTOMATED MEASUREMENT TYPE
AAMI ISO TIR 10993-19 : 2006	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 19: PHYSICOCHEMICAL, MORPHOLOGICAL, AND TOPOGRAPHICAL CHARACTERIZATION OF MATERIALS
AAMI TIR 11 : 2005	SELECTION AND USE OF PROTECTIVE APPAREL AND SURGICAL DRAPES IN HEALTH CARE FACILITIES
15/30275221 DC : 0	BS ISO 18241 - CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - CARDIOPULMONARY BYPASS SYSTEMS - VENOUS BUBBLE TRAPS
BS ISO 18241 : 2016	CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - CARDIOPULMONARY BYPASS SYSTEMS - VENOUS BUBBLE TRAPS
06/30097290 DC : DRAFT FEB 2006	ISO 10993-7 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 7: ETHYLENE OXIDE STERILIZATION RESIDUALS
NBR 15723-4 : 2010	IMPLANTS FOR SURGERY - POLYMERIC MATERIALS - PART 4: SPECIFICATION FOR POROUS POLYETHYLENE POLYMERS
17/30286363 DC : 0	BS EN ISO 19023 - DENTISTRY - ORTHODONTIC ANCHOR SCREWS
14/30294895 DC : 0	BS EN ISO 8537 - STERILE SINGLE-USE SYRINGES, WITH OR WITHOUT NEEDLE, FOR INSULIN
14/30281863 DC : 0	BS EN ISO 5364 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - OROPHARYNGEAL AIRWAYS
BS EN 45502-2-3 : 2010	ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 2-3: PARTICULAR REQUIREMENTS FOR COCHLEAR AND AUDITORY BRAINSTEM IMPLANT SYSTEMS
04/30048205 DC : DRAFT JUL 2004	BS EN ISO 17665 - STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
06/30160368 DC : 0	BS EN 80100 - BASIC SAFETY AND ESSENTIAL PERFORMANCE REQUIREMENTS OF CLINICAL THERMOMETER FOR BODY TEMPERATURE MEASUREMENT
09/30168835 DC : 0	BS EN ISO 7885 - STERILE DENTAL INJECTION NEEDLES FOR SINGLE USE
03/103026 DC : DRAFT JAN 2003	BS EN ISO 5840 - CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES
10/30205392 DC : 0	BS ISO 7494-1 - DENTISTRY - DENTAL UNITS - PART 1: GENERAL REQUIREMENTS AND TEST METHODS
16/30282706 DC : 0	BS ISO 11608-6 - NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 6: ON-BODY DELIVERY SYSTEMS
BS EN ISO 8638 : 2014	CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - EXTRACORPOREAL BLOOD CIRCUIT FOR HAEMODIALYSERS, HAEMODIAFILTERS AND HAEMOFILTERS
BS EN ISO 13688 : 2013	PROTECTIVE CLOTHING - GENERAL REQUIREMENTS (ISO 13688:2013)
PREN ISO 24234 : DRAFT 2013	DENTISTRY - DENTAL AMALGAM (ISO/DIS 24234:2013)
17/30351717 DC : 0	BS EN ISO 11607-1 - PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS
12/30266398 DC : 0	BS EN ISO 20795-2 - DENTISTRY - BASE POLYMERS - PART 2: ORTHODONTIC BASE POLYMERS
DIN EN ISO 8638 E : 2014	CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - EXTRACORPOREAL BLOOD CIRCUIT FOR HAEMODIALYSERS, HAEMODIAFILTERS AND HAEMOFILTERS (ISO 8638:2010)
AAMI ISO 25539-2 : 2012	CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 2: VASCULAR STENTS
12/30266392 DC : 0	BS EN ISO 20795-1 - DENTISTRY - BASE POLYMERS - PART 1: DENTURE BASE POLYMERS
03/103025 DC : DRAFT JAN 2003	BS EN ISO 11199-2 - WALKING AIDS MANIPULATED BY BOTH ARMS - REQUIREMENTS AND TEST METHODS - PART 2: ROLLATORS
09/30168805 DC : 0	BS EN ISO 3107 - DENTISTRY - ZINC OXIDE/EUGENOL CEMENTS AND ZINC OXIDE/NON-EUGENOL CEMENTS
13/30283694 DC : 0	BS EN ISO 1135-5 - TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 5: TRANSFUSION SETS FOR SINGLE USE WITH PRESSURE INFUSION APPARATUS
BS ISO 7197 : 1997	NEUROSURGICAL IMPLANTS - STERILE, SINGLE-USE HYDROCEPHALUS SHUNTS AND COMPONENTS
11/30227618 DC : 0	BS ISO 11658 - CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - BLOOD/TISSUE CONTACT SURFACE MODIFICATIONS FOR EXTRACORPOREAL PERFUSION SYSTEMS
DIN EN ISO 5367 : 2015	ANAESTHETIC AND RESPIRATORY EQUIPMENT - BREATHING SETS AND CONNECTORS (ISO 5367:2014)
08/30168864 DC : DRAFT MAY 2008	BS ISO 20795-2 - DENTISTRY - BASE POLYMERS - PART 2: ORTHODONTIC BASE POLYMERS
15/30283697 DC : 0	BS EN ISO 8536-13 - INFUSION EQUIPMENT FOR MEDICAL USE - PART 13: GRADUATED FLOW REGULATORS FOR SINGLE USE WITH FLUID CONTACT
07/30167333 DC : DRAFT AUG 2007	BS EN 868-9 - PACKAGING MATERIALS FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 9: UNCOATED NONWOVEN MATERIALS OF POLYOLEFINES FOR USE IN THE MANUFACTURE OF SEALABLE POUCHES, REELS AND LIDS - REQUIREMENTS AND TEST METHODS
02/560790 DC : DRAFT FEB 2002	BS EN ISO 16671 - OPHTHALMIC IMPLANTS - IRRIGATING SOLUTIONS FOR OPHTHALMIC SURGERY
ASTM F 2887 : 2017 : REDLINE	Standard Specification for Total Elbow Prostheses
16/30331653 DC : 0	BS EN ISO 8637-2 - EXTRACORPOREAL SYSTEMS FOR BLOOD PURIFICATION - PART 2: EXTRACORPOREAL BLOOD CIRCUIT FOR HAEMODIALYSERS, HAEMODIAFILTERS AND HAEMOFILTERS
UNI EN ISO 7197 : 2009	NEUROSURGICAL IMPLANTS - STERILE, SINGLE-USE HYDROCEPHALUS SHUNTS AND COMPONENTS
16/30319982 DC : 0	BS ISO 20308 - TRADITIONAL CHINESE MEDICINE - GUA SHA INSTRUMENTS
DIN EN ISO 11607-1 E : 2017	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS (ISO 11607-1:2006 + AMD 1:2014)
EN ISO 11070:2014	STERILE SINGLE-USE INTRAVASCULAR INTRODUCERS, DILATORS AND GUIDEWIRES (ISO 11070:2014)
10/30209603 DC : 0	BS EN ISO 11608-2 - NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 2: NEEDLES
UNI CEI EN ISO 14971 : 2012	MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES
02/565260 DC : DRAFT DEC 2002	ISO 8638 - CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - EXTRACORPOREAL BLOOD CIRCUIT FOR HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS
16/30346835 DC : 0	BS ISO 20789 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - PASSIVE HUMIDIFIERS
11/30228364 DC : 0	BS EN ISO 10555-1 - INTRAVASCULAR CATHETERS - STERILE AND SINGLE-USE CATHETERS - PART 1: GENERAL REQUIREMENTS
BS EN ISO 17730 : 2014	DENTISTRY - FLUORIDE VARNISHES
03/317861 DC : DRAFT OCT 2003	EN ISO 22523 - EXTERNAL LIMB PROSTHESES AND EXTERNAL ORTHOSES - REQUIREMENTS AND TEST METHODS
17/30332217 DC : 0	BS EN ISO 28158 - DENTISTRY - INTEGRATED DENTAL FLOSS AND HANDLES
ASTM F 623 : 1999 : EDT 1	Standard Performance Specification for Foley Catheter
CSA Z8836 : 2011 : FR	SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT
UNI EN ISO 20072 : 2013	AEROSOL DRUG DELIVERY DEVICE DESIGN VERIFICATION - REQUIREMENTS AND TEST METHODS
I.S. EN ISO 28158:2010	DENTISTRY - INTEGRATED DENTAL FLOSS AND HANDLES
UNI EN ISO 21563 : 2013	DENTISTRY - HYDROCOLLOID IMPRESSION MATERIALS
UNI EN ISO 3630-5 : 2012	DENTISTRY - ENDODONTIC INSTRUMENTS - PART 5: SHAPING AND CLEANING INSTRUMENTS
AAMI ISO 5840 : 2005 : R2010	CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES
BS ISO 15674 : 2009	CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - HARD-SHELL CARDIOTOMY/VENOUS RESERVOIR SYSTEMS (WITH/WITHOUT FILTER) AND SOFT VENOUS RESERVOIR BAGS
15/30303073 DC : 0	BS ISO 25841 - FEMALE CONDOMS - REQUIREMENTS AND TEST METHODS
09/30168908 DC : DRAFT FEB 2009	BS ISO 28319 - DENTISTRY - SUITABILITY OF METALLIC MATERIALS FOR LASER WELDING
15/30290736 DC : 0	BS EN ISO 10993-4 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 4: SELECTION OF TESTS FOR INTERACTIONS WITH BLOOD
08/30179592 DC : DRAFT MAR 2008	BS ISO 15675 - CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - CARDIOPULMONARY BYPASS SYSTEMS - ARTERIAL BLOOD LINE FILTERS
CSA ISO 8637:2012	CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS
BS ISO 81060-1 : 2007 COR 2012	NON-INVASIVE SPHYGMOMANOMETERS - PART 1: REQUIREMENTS AND TEST METHODS FOR NON-AUTOMATED MEASUREMENT TYPE
16/30302520 DC : 0	BS ISO 19611 - TRADITIONAL CHINESE MEDICINE - AIR EXHAUST CUPPING APPARATUS FOR MEDICAL USE
AAMI ISO 17665-1 : 2006	STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
CSA Z11135-1 : 2009	STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 1: REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
02/565247 DC : DRAFT DEC 2002	ISO 8637 - CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS
ISO/TS 17137 : 2014	CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - CARDIOVASCULAR ABSORBABLE IMPLANTS
CSA ISO 14937 : 2011	STERILIZATION OF HEALTH CARE PRODUCTS - GENERAL REQUIREMENTS FOR CHARACTERIZATION OF A STERILIZING AGENT AND THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
DIN EN 868-9 : 2009	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 9: UNCOATED NONWOVEN MATERIALS OF POLYOLEFINES - REQUIREMENTS AND TEST METHODS
ASTM F 1441 : 2003	SPECIFICATION FOR SOFT-TISSUE EXPANDER DEVICES
I.S. EN ISO 3826-4:2015	PLASTICS COLLAPSIBLE CONTAINERS FOR HUMAN BLOOD AND BLOOD COMPONENTS - PART 4: APHAERESIS BLOOD BAG SYSTEMS WITH INTEGRATED FEATURES (ISO 3826-4:2015)
ISO 11040-4 : 2015	PREFILLED SYRINGES - PART 4: GLASS BARRELS FOR INJECTABLES AND STERILIZED SUBASSEMBLED SYRINGES READY FOR FILLING
05/30060678 DC : DRAFT SEP 2005	BS EN ISO 22794 - DENTISTRY - IMPLANTABLE MATERIALS FOR BONE FILLING AND AUGMENTATION IN ORAL AND MAXILLOFACIAL SURGERY - CONTENTS OF A TECHNICAL FILE
CSA ISO 14971 : 2007 :R2012	MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES
BS EN 14683 : 2014	MEDICAL FACE MASKS - REQUIREMENTS AND TEST METHODS
NF ISO 18562-1 : 2017	BIOCOMPATIBILITY EVALUATION OF BREATHING GAS PATHWAYS IN HEALTHCARE APPLICATIONS - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS
AAMI ISO 10993-13:2010	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 13: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM POLYMERIC MEDICAL DEVICES
DIN EN ISO 28158 : 2010	DENTISTRY - INTEGRATED DENTAL FLOSS AND HANDLES
CSA Z7376: 2012	ANAESTHETIC AND RESPIRATORY EQUIPMENT - LARYNGOSCOPES FOR TRACHEAL INTUBATION
UNI EN ISO 8836 : 2015	A SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT
CSA ISO 10993-5 : 0	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 5: TESTS FOR IN VITRO CYTOTOXICITY
UNE EN ISO 8836 : 2015	SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT (ISO 8836:2014)
08/30178723 DC : DRAFT AUG 2008	BS ISO 15798 - OPHTHALMIC IMPLANTS - OPHTHALMIC VISCOSURGICAL DEVICES
CSA ISO 8638 : 2012 : R2017	CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - EXTRACORPOREAL BLOOD CIRCUIT FOR HAEMODIALYSERS, HAEMODIAFILTERS AND HAEMOFILTERS
BS EN ISO 5840-3 : 2013	CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 3: HEART VALVE SUBSTITUTES IMPLANTED BY TRANSCATHETER TECHNIQUES
BS EN ISO 8637 : 2014	CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS (ISO 8637:2010, INCLUDING AMENDMENT 1 2013-04-01)
03/101659 DC : DRAFT JAN 2003	ISO 22803 - DENTISTRY - MEMBRANE MATERIALS FOR GUIDED TISSUE REGENERATION IN ORAL AND MAXILLOFACIAL SURGERY - CONTENTS OF A TECHNICAL FILE
CSA Z7376 :2012	ANAESTHETIC AND RESPIRATORY EQUIPMENT - LARYNGOSCOPES FOR TRACHEAL INTUBATION
CSA Z11135-1 : 2009 : R2014	STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 1: REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
AAMI ISO 5840 : 2005	CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES
BS EN ISO 20795-1 : 2013	DENTISTRY - BASE POLYMERS - PART 1: DENTURE BASE POLYMERS
DIN EN ISO 10555-6 : 2017	INTRAVASCULAR CATHETERS - STERILE AND SINGLE-USE CATHETERS - PART 6: SUBCUTANEOUS IMPLANTED PORTS (ISO 10555-6:2015)
ASTM F 3087 : 2015	Standard Specification for Acrylic Molding Resins for Medical Implant Applications
09/30173553 DC : 0	BS ISO 10873 - DENTISTRY - DENTURE ADHESIVES
BS 5081-2(1993) : 1993 AMD 9104	STERILE HYPODERMIC SYRINGES AND NEEDLES - SPECIFICATION FOR STERILE HYPODERMIC NEEDLES FOR SINGLE USE
NBR ISO 11193-2 : 2013	SINGLE-USE MEDICAL EXAMINATION GLOVES - PART 2: SPECIFICATION FOR GLOVES MADE FROM POLY (VINYL CHLORIDE)
BS ISO 14972 : 1998	STERILE OBTURATORS FOR SINGLE USE WITH OVER-NEEDLE PERIPHERAL INTRAVASCULAR CATHETERS
ASTM F 623 : 1999	PERFORMANCE SPECIFICATION FOR FOLEY CATHETER
CSA ISO 8637 : 2012	CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS
08/30133979 DC : DRAFT MAY 2008	BS ISO 23409 - MALE CONDOMS - REQUIREMENTS AND TEST METHODS FOR CONDOMS MADE FROM SYNTHETIC MATERIALS
ASTM F 2560 : 2006	Standard Specification for Supralaryngeal Airways and Connectors
CSA ISO 14937 : 2011	STERILIZATION OF HEALTH CARE PRODUCTS - GENERAL REQUIREMENTS FOR CHARACTERIZATION OF A STERILIZING AGENT AND THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
AAMI ISO 10993-16 : 2010 : R2014	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 16: TOXICOKINETIC STUDY DESIGN FOR DEGRADATION PRODUCTS AND LEACHABLES
CSA ISO 5367 : 2014	BREATHING TUBES INTENDED FOR USE WITH ANAESTHETIC APPARATUS AND VENTILATORS
I.S. EN ISO 1135-3:2017	TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 3: BLOOD-TAKING SETS FOR SINGLE USE (ISO 1135-3:2016)
AAMI ISO TIR 17665-3 : 2014	STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - GUIDANCE ON THE DESIGNATION OF A MEDICAL PRODUCT TO A PRODUCT FAMILY AND PROCESSING CATEGORY FOR STEAM STERILIZATION
AAMI ISO 14708-4 : 2008 : R2011	IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 4: IMPLANTABLE INFUSION PUMPS
CSA ISO 8638:2012	CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - EXTRACORPOREAL BLOOD CIRCUIT FOR HAEMODIALYSERS, HAEMODIAFILTERS AND HAEMOFILTERS
CSA Z7376 : 2012 :R2017	ANAESTHETIC AND RESPIRATORY EQUIPMENT - LARYNGOSCOPES FOR TRACHEAL INTUBATION
BS EN ISO 16061 : 2015	INSTRUMENTATION FOR USE IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS
16/30328610 DC : 0	BS ISO 20749 - DENTISTRY - PRE-CAPSULATED DENTAL AMALGAM
AAMI ISO 14708-4 : 2008	IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 4: IMPLANTABLE INFUSION PUMPS
17/30357890 DC : 0	BS ISO 20495 - TRADITIONAL CHINESE MEDICINE - SKIN ELECTRICAL RESISTANCE MEASUREMENT DEVICE
AAMI ISO 10993-5 : 2009 : R2014	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 5: TESTS FOR IN VITRO CYTOTOXICITY
CSA ISO 14937 : 2011 :R2016	STERILIZATION OF HEALTH CARE PRODUCTS - GENERAL REQUIREMENTS FOR CHARACTERIZATION OF A STERILIZING AGENT AND THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
AAMI ISO 14160 : 2011 : R2016	STERILIZATION OF HEALTH CARE PRODUCTS - LIQUID CHEMICAL STERILIZING AGENTS FOR SINGLE-USE MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - REQUIREMENTS FOR CHARACTERIZATION, DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
UNE EN ISO 12417-1 : 2016	CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS - PART 1: GENERAL REQUIREMENTS (ISO 12417-1:2015)
ASTM F 1635 : 2016 : REDLINE	Standard Test Method for in vitro Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants
UNI EN ISO 25539-2 : 2013	CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 2: VASCULAR STENTS
ISO 13175-3 : 2012	IMPLANTS FOR SURGERY - CALCIUM PHOSPHATES - PART 3: HYDROXYAPATITE AND BETA-TRICALCIUM PHOSPHATE BONE SUBSTITUTES
CSA ISO 14937 : 2011 : R2016	STERILIZATION OF HEALTH CARE PRODUCTS - GENERAL REQUIREMENTS FOR CHARACTERIZATION OF A STERILIZING AGENT AND THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
CSA ISO 8637 : 2012 : INC : AMD 1 : 2015	CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS
AAMI ISO 22442-1 : 2016	MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - PART 1: APPLICATION OF RISK MANAGEMENT
CSA Z7376 : 2012 : R2017	ANAESTHETIC AND RESPIRATORY EQUIPMENT - LARYNGOSCOPES FOR TRACHEAL INTUBATION
CSA ISO 8638 : 2012:R2017	CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - EXTRACORPOREAL BLOOD CIRCUIT FOR HAEMODIALYSERS, HAEMODIAFILTERS AND HAEMOFILTERS
UNI EN ISO 20795-1 : 2013	DENTISTRY - BASE POLYMERS - PART 1: DENTURE BASE POLYMERS
CSA Z8836 : 2011	SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT
AAMI ISO 20857 : 2010	STERILIZATION OF HEALTH CARE PRODUCTS - DRY HEAT - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
AAMI ISO TIR 17665-3 : 2014 : R2016	STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - GUIDANCE ON THE DESIGNATION OF A MEDICAL PRODUCT TO A PRODUCT FAMILY AND PROCESSING CATEGORY FOR STEAM STERILIZATION
CSA Z8836 : 2011 : R2015	SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT
ISO TR 11991 : 1995(R2000)	GUIDANCE ON AIRWAY MANAGEMENT DURING LASER SURGERY OF UPPER AIRWAY
UNI CEN ISO/TS 17665-2 : 2009	STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ISO 17665-1
BS EN ISO 10555-1 : 2013	INTRAVASCULAR CATHETERS - STERILE AND SINGLE-USE CATHETERS - PART 1: GENERAL REQUIREMENTS
I.S. EN ISO 5361:2016	ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEAL TUBES AND CONNECTORS (ISO/DIS 5361:2014)
CSA ISO 8637 : 2012 : R2017	CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS
I.S. EN ISO 14607:2009	NON-ACTIVE SURGICAL IMPLANTS - MAMMARY IMPLANTS - PARTICULAR REQUIREMENTS (ISO 14607:2018)
DIN EN ISO 21563 : 2013	DENTISTRY - HYDROCOLLOID IMPRESSION MATERIALS (ISO 21563:2013)
ISO 23409 : 2011(R2015)	MALE CONDOMS - REQUIREMENTS AND TEST METHODS FOR CONDOMS MADE FROM SYNTHETIC MATERIALS
CSA ISO 14971 : 2007	MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES
DIN EN ISO 3630-5 : 2012	DENTISTRY - ENDODONTIC INSTRUMENTS - PART 5: SHAPING AND CLEANING INSTRUMENTS (ISO 3630-5:2011)
CSA Z17665-1 : 2009(R 2019)	STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
DIN EN ISO 20072 E : 2013	AEROSOL DRUG DELIVERY DEVICE DESIGN VERIFICATION - REQUIREMENTS AND TEST METHODS (ISO 20072:2009)
DIN EN ISO 16061 E : 2015	INSTRUMENTATION FOR USE IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS (ISO 16061:2015)
CSA ISO 14971 : 2007 : R2017	MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES
CSA ISO 14971 : 2007 : R2012	MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES
CSA ISO 8637 : 2012 : INC : AMD 1 : 2015 : R2017	CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS
UNI EN ISO 4049 : 2009	DENTISTRY - POLYMER-BASED RESTORATIVE MATERIALS
UNI EN ISO 20857 : 2013	STERILIZATION OF HEALTH CARE PRODUCTS - DRY HEAT - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
UNE EN ISO 11070 : 2015	Sterile single-use intravascular introducers, dilators and guidewires (ISO 11070:2014)
DIN EN ISO 25539-2 : 2013	CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 2: VASCULAR STENTS (ISO 25539-2:2012)
DIN EN ISO 21563 E : 2013	DENTISTRY - HYDROCOLLOID IMPRESSION MATERIALS (ISO 21563:2013)
CSA ISO 14937 :2011	STERILIZATION OF HEALTH CARE PRODUCTS - GENERAL REQUIREMENTS FOR CHARACTERIZATION OF A STERILIZING AGENT AND THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
AAMI ISO 12417-1 : 2015	CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS - PART 1: GENERAL REQUIREMENTS
AAMI ISO 10993-16 : 2010	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 16: TOXICOKINETIC STUDY DESIGN FOR DEGRADATION PRODUCTS AND LEACHABLES
CSA Z11135-1 : 2009 : FR	STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 1: REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
CSA ISO 14971 : 2007:R2017	MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES
ASTM F 2726 : 2008	Standard specification for fixation devices for tracheal tubes and other airway devices
DIN EN ISO 20857 : 2013	STERILIZATION OF HEALTH CARE PRODUCTS - DRY HEAT - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES (ISO 20857:2010)
15/30278537 DC : 0	BS ISO 18562-3 - BIOCOMPATIBILITY EVALUATION OF BREATHING GAS PATHWAYS IN HEALTHCARE APPLICATIONS - PART 3: TESTS FOR EMISSIONS OF VOLATILE ORGANIC COMPOUNDS (VOCS)
UNE EN ISO 21563 : 2014	DENTISTRY - HYDROCOLLOID IMPRESSION MATERIALS (ISO 21563:2013)
DIN EN ISO 7197 E : 2009	NEUROSURGICAL IMPLANTS - STERILE, SINGLE-USE HYDROCEPHALUS SHUNTS AND COMPONENTS
NBR 13850 : 1997	ELETRODOS DESCARTAVEIS PARA USO MEDICO - DETERMINACAO DAS CARACTERISTICAS ELETRICAS
DIN EN ISO 5840-2 : 2016	CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 2: SURGICALLY IMPLANTED HEART VALVE SUBSTITUTES (ISO 5840-2:2015)
I.S. EN ISO 28319:2010	DENTISTRY - LASER WELDING AND FILLER MATERIALS (ISO 28319:2018)
ISO 18241 : 2016	CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - CARDIOPULMONARY BYPASS SYSTEMS - VENOUS BUBBLE TRAPS
UNI EN ISO 5840-3 : 2013	CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 3: HEART VALVE SUBSTITUTES IMPLANTED BY TRANSCATHETER TECHNIQUES
CSA Z17665-1 : 2009 : R2014	STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
ASTM F 2064 : 2017 : REDLINE	Standard Guide for Characterization and Testing of Alginates as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications
ISO 11712 : 2009(R2015)	ANAESTHETIC AND RESPIRATORY EQUIPMENT - SUPRALARYNGEAL AIRWAYS AND CONNECTORS
EN ISO 8536-14 : 2018	INFUSION EQUIPMENT FOR MEDICAL USE - PART 14: CLAMPS AND FLOW REGULATORS FOR TRANSFUSION AND INFUSION EQUIPMENT WITHOUT FLUID CONTACT (ISO 8536-14:2016)
ISO 11607-1 : 2006	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS
AAMI ISO 11607-1 : 2006	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS, AND PACKAGING SYSTEMS
ISO 5910 : 2018	CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - CARDIAC VALVE REPAIR DEVICES
DIN EN ISO 7199 : 2015	CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - BLOOD-GAS EXCHANGERS (OXYGENATORS) (ISO 7199:2016)
ISO 19227 : 2018	IMPLANTS FOR SURGERY - CLEANLINESS OF ORTHOPEDIC IMPLANTS - GENERAL REQUIREMENTS
BS EN ISO 10993-16 : 2017	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 16: TOXICOKINETIC STUDY DESIGN FOR DEGRADATION PRODUCTS AND LEACHABLES
AAMI ISO 5840-3 : 2013	CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 3: HEART VALVE SUBSTITUTES IMPLANTED BY TRANSCATHETER TECHNIQUES
CSA Z7376:2012	ANAESTHETIC AND RESPIRATORY EQUIPMENT - LARYNGOSCOPES FOR TRACHEAL INTUBATION
DIN EN ISO 4049 E : 2010	DENTISTRY - POLYMER-BASED RESTORATIVE MATERIALS
I.S. EN ISO 28399:2011	DENTISTRY - PRODUCTS FOR EXTERNAL TOOTH BLEACHING
PREN ISO 11608-1 : DRAFT 2010	NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 1: NEEDLE-BASED INJECTION SYSTEMS
PREN 13795-2 : DRAFT 2017	SURGICAL CLOTHING AND DRAPES - REQUIREMENTS AND TEST METHODS - PART 2: CLEAN AIR SUITS
BS EN ISO 11607-1 : 2009	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS
PREN ISO 20795-1 : DRAFT 2012	DENTISTRY - BASE POLYMERS - PART 1: DENTURE BASE POLYMERS (ISO/FDIS 20795-1:2012)
PREN ISO 20795-2 : DRAFT 2012	DENTISTRY - BASE POLYMERS - PART 2: ORTHODONTIC BASE POLYMERS (ISO/FDIS 20795-2:2012)
UNI EN ISO 27020 : 2011	DENTISTRY - BRACKETS AND TUBES FOR USE IN ORTHODONTICS
AAMI ISO 14971 : 2007 : R2010	MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES
UNI EN ISO 8638 : 2014	CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - EXTRACORPOREAL BLOOD CIRCUIT FOR HAEMODIALYSERS, HAEMODIAFILTERS AND HAEMOFILTERS
ASTM F 2103 : 2011-03	GUIDE FOR CHARACTERIZATION AND TESTING OF CHITOSAN SALTS AS STARTING MATERIALS INTENDED FOR USE IN BIOMEDICAL AND TISSUE-ENGINEERED MEDICAL PRODUCT APPLICATIONS
CSA ISO 10993-9 : 0	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 9: FRAMEWORK FOR IDENTIFICATION AND QUANTIFICATION OF POTENTIAL DEGRADATION PRODUCTS
AAMI ISO TIR 17665-2 : 2009	STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ANSI/AAMI/ISO 17665-1
CSA Z17665-2 : 2009(R2019)	Sterilization of health care products — Moist heat — Part 2: Guidance on the application of ISO 17665-1 (ISO/TS 17665-2:2009, IDT)
BS ISO 7199 : 2009	CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - BLOOD-GAS EXCHANGERS (OXYGENATORS)
UNE EN ISO 20072 : 2013	AEROSOL DRUG DELIVERY DEVICE DESIGN VERIFICATION - REQUIREMENTS AND TEST METHODS (ISO 20072:2009)
BS EN ISO 11070 : 2014	STERILE SINGLE-USE INTRAVASCULAR INTRODUCERS, DILATORS AND GUIDEWIRES
ISO/TR 37137 : 2014	CARDIOVASCULAR BIOLOGICAL EVALUATION OF MEDICAL DEVICES - GUIDANCE FOR ABSORBABLE IMPLANTS
ASTM F 2475 : 2011 : REDLINE	Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials
I.S. EN ISO 27020:2010	DENTISTRY - BRACKETS AND TUBES FOR USE IN ORTHODONTICS
UNE EN ISO 20795-2 : 2013	DENTISTRY - BASE POLYMERS - PART 2: ORTHODONTIC BASE POLYMERS (ISO 20795-2:2013)
BS EN ISO 10993-11 : 2009	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 11: TESTS FOR SYSTEMIC TOXICITY
AAMI ISO 5367 : 2015	ANAESTHETIC AND RESPIRATORY EQUIPMENT - BREATHING SETS AND CONNECTORS
ISO 4049 : 2009(R2014)	DENTISTRY - POLYMER-BASED RESTORATIVE MATERIALS
CSA ISO 7199 : 0	CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - BLOOD-GAS EXCHANGERS (OXYGENATORS)
ISO 18397 : 2016	DENTISTRY - POWERED SCALER
SR CEN ISO/TS 16775:2014	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - GUIDANCE ON THE APPLICATION OF ISO 11607-1 AND ISO 11607-2 (ISO/TS 16775:2014)
AAMI ISO 10993-14 : 2001 : R2011	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 14: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM CERAMICS
AAMI ISO 11137-1 : 2006 : R2010	STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
IEEE 2010 : 2012	RECOMMENDED PRACTICE FOR NEUROFEEDBACK SYSTEMS
AAMI ISO 5366-3 : 2001	ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEOSTOMY TUBES - PART 3: PAEDIATRIC TRACHEOSTOMY TUBES
I.S. EN ISO 20608:2018	DENTISTRY - POWDER JET HANDPIECES AND POWDERS (ISO 20608:2018)
AAMI ISO 14160 : 2011	STERILIZATION OF HEALTH CARE PRODUCTS - LIQUID CHEMICAL STERILIZING AGENTS FOR SINGLE-USE MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - REQUIREMENTS FOR CHARACTERIZATION, DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
AAMI ISO 10993-2 : 2006 : R2010	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 2: ANIMAL WELFARE REQUIREMENTS
AAMI ISO 10993-12 : 2012	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 12: SAMPLE PREPARATION AND REFERENCE MATERIALS
AAMI ISO 18242 : 2016	CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - CENTRIFUGAL BLOOD PUMPS
I.S. EN ISO 15798:2013	OPHTHALMIC IMPLANTS - OPHTHALMIC VISCOSURGICAL DEVICES (ISO 15798:2013)
I.S. EN ISO 13017:2012	DENTISTRY - MAGNETIC ATTACHMENTS (ISO 13017:2012)
ISO 25841 : 2017	FEMALE CONDOMS - REQUIREMENTS AND TEST METHODS
AAMI BE78 : 2002	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 10: TESTS FOR IRRITATION AND DELAYED TYPE HYPERSENSITIVITY
I.S. EN ISO 7494-1:2011	DENTISTRY - DENTAL UNITS - PART 1: GENERAL REQUIREMENTS AND TEST METHODS
I.S. EN ISO 7886-1:1998	STERILE HYPODERMIC SYRINGES FOR SINGLE USE - PART 1: SYRINGES FOR MANUAL USE (ISO 7886-1:2017)
UNE EN ISO 20795-1 : 2013	DENTISTRY - BASE POLYMERS - PART 1: DENTURE BASE POLYMERS (ISO 20795-1:2013)
CSA ISO 10993-6 : 1997	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 6: TESTS FOR LOCAL EFFECTS AFTER IMPLANTATION
UNE EN ISO 17254 : 2017	DENTISTRY - COILED SPRINGS FOR USE IN ORTHODONTICS (ISO 17254:2016)
UNI EN ISO 9693-1 : 2012	DENTISTRY - COMPATIBILITY TESTING - PART 1: METAL-CERAMIC SYSTEMS
AAMI ISO 10993-9 : 2009 : R2014	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 9: FRAMEWORK FOR IDENTIFICATION AND QUANTIFICATION OF POTENTIAL DEGRADATION PRODUCTS
I.S. EN ISO 25539-1:2017	CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES (ISO 25539-1:2017)
AAMI ISO 10993-5 : 2009	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 5: TESTS FOR IN VITRO CYTOTOXICITY
AAMI ISO 10993-15 : 2000	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 15: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM METALS AND ALLOYS
AAMI ISO 14160 : 2011	STERILIZATION OF HEALTH CARE PRODUCTS - LIQUID CHEMICAL STERILIZING AGENTS FOR SINGLE-USE MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - REQUIREMENTS FOR CHARACTERIZATION, DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
AAMI ISO TIR 16775 : 2014	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - GUIDANCE ON THE APPLICATION OF ISO 11607-1 AND ISO 11607-2
AAMI ISO TIR 17665-2 : 2009 : R2016	STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ANSI/AAMI/ISO 17665-1
I.S. EN ISO 9917-2:2017	DENTISTRY - WATER-BASED CEMENTS - PART 2: RESIN-MODIFIED CEMENTS (ISO 9917-2:2017)
AAMI ISO 10993-10 : 2010	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 10: TESTS FOR IRRITATION AND SKIN SENSITIZATION
AAMI ISO 14708-1 : 2014	IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND FOR INFORMATION TO BE PROVIDED BY THE MANUFACTURER
AAMI ISO 10993-10 : 2010	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 10: TESTS FOR IRRITATION AND SKIN SENSITIZATION
AAMI ISO 10993-6 : 2016	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 6: TESTS FOR LOCAL EFFECTS AFTER IMPLANTATION
AAMI ISO 10993-11 : 2006	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 11: TESTS FOR SYSTEMIC TOXICITY
AAMI ISO 14937 : 2009	STERILIZATION OF HEALTH CARE PRODUCTS - GENERAL REQUIREMENTS FOR CHARACTERIZATION OF A STERILIZING AGENT AND THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
AAMI ISO 10993-7 : 2008	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 7: ETHYLENE OXIDE STERILIZATION RESIDUALS
AAMI ISO TIR 17665-3 : 2014	STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - GUIDANCE ON THE DESIGNATION OF A MEDICAL PRODUCT TO A PRODUCT FAMILY AND PROCESSING CATEGORY FOR STEAM STERILIZATION
I.S. EN ISO 5840-2:2015	CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 2: SURGICALLY IMPLANTED HEART VALVE SUBSTITUTES (ISO 5840-2:2015)
AAMI ISO 11658 : 2012	CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - BLOOD/TISSUE CONTACT SURFACE MODIFICATIONS FOR EXTRACORPOREAL PERFUSION SYSTEMS
AAMI ISO 17665-1 : 2006	STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
AAMI ISO 14937 : 2009	STERILIZATION OF HEALTH CARE PRODUCTS - GENERAL REQUIREMENTS FOR CHARACTERIZATION OF A STERILIZING AGENT AND THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
AAMI ISO 17665-1 : 2006 : R2013	STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
AAMI ISO 10993-14 : 2001	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 14: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM CERAMICS
AAMI ISO TIR 10993-20 : 2006	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 20: PRINCIPLES AND METHODS FOR IMMUNOTOXICOLOGY TESTING OF MEDICAL DEVICES
AAMI ISO 10993-7 : 2008	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 7: ETHYLENE OXIDE STERILIZATION RESIDUALS
AAMI ISO 18241 : 2016	CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - CARDIOPULMONARY BYPASS SYSTEMS - VENOUS BUBBLE TRAPS
AAMI ISO 10993-2 : 2006 : R2014	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 2: ANIMAL WELFARE REQUIREMENTS
AAMI ISO 10993-15 : 2000 : R2011	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 15: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM METALS AND ALLOYS
AAMI ISO 14708-5 : 2010	IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 5: CIRCULATORY SUPPORT DEVICES
I.S. EN ISO 8637:2014	CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS (ISO 8637:2010, INCLUDING AMENDMENT 1 2013-04-01)
NF EN ISO 7197 : 2009	NEUROSURGICAL IMPLANTS - STERILE, SINGLE-USE HYDROCEPHALUS SHUNTS AND COMPONENTS
UNE EN ISO 7494-1 : 2012	DENTISTRY - DENTAL UNITS - PART 1: GENERAL REQUIREMENTS AND TEST METHODS (ISO 7494-1:2011)
17/30360918 DC : 0	BS EN 868-9 - PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 9: UNCOATED NONWOVEN MATERIALS OF POLYOLEFINES - REQUIREMENTS AND TEST METHODS
I.S. EN ISO 14457:2017	DENTISTRY - HANDPIECES AND MOTORS (ISO 14457:2017)
I.S. EN ISO 25424:2011	STERILIZATION OF MEDICAL DEVICES - LOW TEMPERATURE STEAM AND FORMALDEHYDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
AAMI ISO 15676 : 2016	CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - REQUIREMENTS FOR SINGLE-USE TUBING PACKS FOR CARDIOPULMONARY BYPASS AND EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO)
AAMI BE83 : 2006	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 18: CHEMICAL CHARACTERIZATION OF MATERIALS
BS EN ISO 13017 : 2012	DENTISTRY - MAGNETIC ATTACHMENTS
AAMI ISO 8638 : 2010	CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - EXTRACORPOREAL BLOOD CIRCUIT FOR HEMODIALYZERS, HEMODIAFILTERS AND HEMOFILTERS
I.S. EN ISO 12417-1:2015	CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS - PART 1: GENERAL REQUIREMENTS (ISO 12417-1:2015)
AAMI ISO 10993-2 : 2006	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 2: ANIMAL WELFARE REQUIREMENTS
AAMI ISO TIR 17137 : 2014	CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - CARDIOVASCULAR ABSORBABLE IMPLANTS
AAMI ISO 8836 : 2015	SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT
AAMI ISO 5840-2 : 2016	CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 2: SURGICALLY IMPLANTED HEART VALVE SUBSTITUTES
AAMI ISO 8638 : 2010 : R2015	CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - EXTRACORPOREAL BLOOD CIRCUIT FOR HEMODIALYZERS, HEMODIAFILTERS AND HEMOFILTERS
DIN EN ISO 14607 : 2009	NON-ACTIVE SURGICAL IMPLANTS - MAMMARY IMPLANTS - PARTICULAR REQUIREMENTS
AAMI ISO 15674 : 2016	CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - HARD-SHELL CARDIOTOMY/VENOUS RESERVOIR SYSTEMS (WITH/WITHOUT FILTER) AND SOFT VENOUS RESERVOIR BAGS
AAMI ISO 10993-2 : 2006	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 2: ANIMAL WELFARE REQUIREMENTS
AAMI ISO 10993-5 : 2009	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 5: TESTS FOR IN VITRO CYTOTOXICITY
AAMI AT6 : 2013	AUTOLOGOUS TRANSFUSION DEVICES
AAMI ISO 10993-17 : 2002	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 17: ESTABLISHMENT OF ALLOWABLE LIMITS FOR LEACHABLE SUBSTANCES
I.S. EN ISO 16061:2015	INSTRUMENTATION FOR USE IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS (ISO 16061:2015)
I.S. EN ISO 20795-1:2013	DENTISTRY - BASE POLYMERS - PART 1: DENTURE BASE POLYMERS (ISO 20795-1:2013)
DIN EN ISO 10993-11 : 2015	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 11: TESTS FOR SYSTEMIC TOXICITY
I.S. EN ISO 19023:2018	DENTISTRY - ORTHODONTIC ANCHOR SCREWS (ISO 19023:2018)
ISO 10555-1 : 2013(R2018)	INTRAVASCULAR CATHETERS - STERILE AND SINGLE-USE CATHETERS - PART 1: GENERAL REQUIREMENTS
I.S. EN 45502-2-3:2010	ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 2-3: PARTICULAR REQUIREMENTS FOR COCHLEAR AND AUDITORY BRAINSTEM IMPLANT SYSTEMS