ISO 10993-1 : 2009

Withdrawn

Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

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

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Published date: 01-01-2009

Publisher: International Organization for Standardization

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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Status	Withdrawn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Superseded By	ISO 10993-1:2018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
GOST R ISO 10993-1 : 2009	Identical
DIN EN 30993-1:1994-12	Similar to
UNE-EN 30993-1:1994	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
NS EN ISO 10993-1 : 2009 COR 2010	Identical
SANS 10993-1 : 2ED 2010	Identical
SS-EN ISO 10993-1:2009	Identical
GOST ISO 10993-1 : 2011	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
AAMI ISO 10993-1 : 2009 : R2013	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 : 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 16061:2015-09	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 28399:2011-05	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 20072:2013-10	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 11135-1:2007-08	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 18397:2016-09	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 3826-4:2015-12	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 5840-3:2013-06	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 8637:2014-03	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 868-10:2009-09	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 10873:2010-12	Dentistry - Denture adhesives (ISO 10873:2010)
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 9693-1:2012-06	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 12417-1:2016-02	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 11607-1:2014-11	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 26782:2010-02	Anaesthetic and respiratory equipment - Spirometers intended for the measurement of time forced expired volumes in humans (ISO 26782:2009 + Cor. 1:2009) (includes Corrigendum AC:2009)
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 1135-5:2016-06	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 13017:2016-05	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 7197:2009-08	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 14683:2014-07	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 27020:2011-04	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 8638:2014-03	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
(Inactive record) 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 5832-14:2009-12	IMPLANTS FOR SURGERY - METALLIC MATERIALS - PART 14: WROUGHT TITANIUM 15-MOLYBDENUM 5-ZIRCONIUM 3-ALUMINIUM ALLOY
DIN EN ISO 13688:2013-12	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 8536-12:2013-04	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
S.R. 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 5832-14:2009-12	IMPLANTS FOR SURGERY - METALLIC MATERIALS - PART 14: WROUGHT TITANIUM 15-MOLYBDENUM 5-ZIRCONIUM 3-ALUMINIUM ALLOY
DIN EN ISO 8836:2015-02	Suction catheters for use in the respiratory tract (ISO 8836:2014); German version EN 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 5367:2015-02	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
(INACTIVE RECORD)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 868-9:2009-09	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
(INACTIVE RECORD) DIN EN ISO 28158:2010-12	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 10555-6:2017-11	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 21563:2013-12	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 3630-5:2012-01	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 25539-2:2013-05	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 20857:2013-08	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 5840-2:2016-05	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