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Withdrawn

Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.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

Available format(s): Hardcopy, PDF, PDF 3 Users, PDF 5 Users, PDF 9 Users

Withdrawn date: 05-03-2019

Language(s):

Published date: 13-10-2009

Publisher: International Organization for Standardization

Abstract - (Show below) - (Hide below)

ISO 10993-1:2009 describes:

the general principles governing the biological evaluation of medical devices within a risk management process;
the general categorization of devices based on the nature and duration of their contact with the body;
the evaluation of existing relevant data from all sources;
the identification of gaps in the available data set on the basis of a risk analysis;
the identification of additional data sets necessary to analyse the biological safety of the medical device;
the assessment of the biological safety of the medical device.

General Product Information - (Show below) - (Hide below)

Committee	ISO/TC 194
Document Type	Standard
ISBN
Pages
Published
Publisher	International Organization for Standardization
Status	Withdrawn
Superseded By	ISO 10993-1:2018
Supersedes	ISO 10993-1:2003

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
AAMI ISO 10993-1:2009	Identical
GOST R ISO 10993-1 : 2009	Identical
DIN EN 30993-1:1994-12	Similar to
NF EN ISO 10993-1 : 2010	Identical
UNE-EN 30993-1:1994	Identical
EN ISO 10993-1:2009	Identical
UNI EN ISO 10993-1 : 2010	Identical
PN EN ISO 10993-1 : 2010 AC 2010	Identical
BS EN ISO 10993-1:2009	Identical
NS EN ISO 10993-1 : 2009 COR 2010	Identical
SANS 10993-1 : 2ED 2010	Identical
GOST ISO 10993-1 : 2011	Identical
NEN ISO 10993-1 : 1994	Similar to
UNE-EN ISO 10993-1:2010	Identical
BS EN 30993-1:1994	Similar to
BS EN ISO 10993-1 : 2009-10	Identical
ONORM EN ISO 10993-1 : 2011	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/AC:2010	Identical
EN 30993-1 : 1994	Similar to

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

I.S. EN ISO 4049:2009	DENTISTRY - POLYMER-BASED RESTORATIVE MATERIALS
ONORM EN ISO 10993-11 : 2009	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 11: TESTS FOR SYSTEMIC TOXICITY
DIN EN ISO 12417-1 E : 2016	CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS - PART 1: GENERAL REQUIREMENTS (ISO 12417-1:2015)
DIN EN ISO 25424:2011-09	STERILIZATION OF MEDICAL DEVICES - LOW TEMPERATURE STEAM AND FORMALDEHYDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
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
03/108761 DC : DRAFT MAY 2003	EN ISO 10477 - DENTISTRY - POLYMER-BASED CROWN AND BRIDGE MATERIALS
UNE-EN ISO 25539-2:2013	Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2012)
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
CSA ISO 10993-10 : 0	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 10: TESTS FOR IRRITATION AND SENSITIZATION
CSA Z23747 : 2008 : R2013	ANAESTHETIC AND RESPIRATORY EQUIPMENT - PEAK EXPIRATORY FLOW METERS FOR THE ASSESSMENT OF PULMONARY FUNCTION IN SPONTANEOUSLY BREATHING HUMANS
13/30263420 DC : 0	BS EN ISO 17730 - DENTISTRY - FLUORIDE VARNISHES
BS ISO 16840-2:2018	Wheelchair seating 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
AAMI RD17 : 2007	CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - EXTRACORPOREAL BLOOD CIRCUIT FOR HEMODIALYZERS, HEMODIAFILTERS AND HEMOFILTERS
I.S. EN ISO 5840:2009	CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES
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
I.S. EN 12180:2000	NON-ACTIVE SURGICAL IMPLANTS - BODY CONTOURING IMPLANTS - SPECIFIC REQUIREMENTS FOR MAMMARY IMPLANTS
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
ANSI/AAMI/ISO 10993-3:2014	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 3: TESTS FOR GENOTOXICITY, CARCINOGENICITY, AND REPRODUCTIVE TOXICITY
BS ISO 18562-1 : 2017	BIOCOMPATIBILITY EVALUATION OF BREATHING GAS PATHWAYS IN HEALTHCARE APPLICATIONS - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS
DIN EN ISO 20795-2:2013-06	DENTISTRY - BASE POLYMERS - PART 2: ORTHODONTIC BASE POLYMERS (ISO 20795-2:2013)
I.S. EN 15424:2007	STERILIZATION OF MEDICAL DEVICES - LOW TEMPERATURE STEAM AND FORMALDEHYDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
07/30160957 DC : 0	EN ISO 10993-5 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 5: TESTS FOR IN VITRO CYTOTOXICITY
16/30333382 DC : 0	BS EN ISO 22112 - DENTISTRY - ARTIFICIAL TEETH FOR DENTAL PROSTHESES
BS EN ISO 1135-5:2015	Transfusion equipment for medical use Transfusion sets for single use with pressure infusion apparatus
I.S. EN ISO 22523:2006	EXTERNAL LIMB PROSTHESES AND EXTERNAL ORTHOSES - REQUIREMENTS AND TEST METHODS
DIN EN 868-10:2009-09	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 10: ADHESIVE COATED NONWOVEN MATERIALS OF POLYOLEFINES - REQUIREMENTS AND TEST METHODS
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
PD ISO/TS 17665-3:2013	Sterilization of health care products. Moist heat 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 13824:2005	STERILIZATION OF MEDICAL DEVICES - ASEPTIC PROCESSING OF LIQUID MEDICAL DEVICES - REQUIREMENTS
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)
I.S. EN 12022:1999	BLOOD GAS EXCHANGERS
I.S. EN ISO 16744:2004	DENTISTRY - BASE METAL MATERIALS FOR FIXED DENTAL RESTORATIONS
04/30103836 DC : DRAFT JUL 2004	ISO 11979-5 - OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 5: BIOCOMPATIBILITY
16/30331650 DC : 0	BS EN ISO 8637-1 - EXTRACORPOREAL SYSTEMS FOR BLOOD PURIFICATION - PART 1: HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS
I.S. EN 13503-8:2000	OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 8: FUNDAMENTAL REQUIREMENTS
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
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
UNI EN ISO 10271 : 2011	DENTISTRY - CORROSION TEST METHODS FOR METALLIC MATERIALS
BS ISO 18562-4:2017	Biocompatibility evaluation of breathing gas pathways in healthcare applications Tests for leachables in condensate
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
14/30295067 DC : 0	BS EN ISO 16671 - OPHTHALMIC IMPLANTS - IRRIGATING SOLUTIONS FOR OPHTHALMIC SURGERY
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
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
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)
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)
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 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
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 (published 2013-07)	Protective clothing. General requirements
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