ISO 10993-18:2005
Withdrawn
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
View Superseded by
Biological evaluation of medical devices Part 18: Chemical characterization of materials
Available format(s)
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
Withdrawn date
01-01-2020
Superseded by
Language(s)
English, French, Russian
Published date
06-30-2005
Important note : All end users must be registered with an Account prior to user licenses being assigned.
ISO 10993-18:2005 describes a framework for the identification of a material and the identification and quantification of its chemical constituents. The chemical characterization information generated can be used for a range of important applications, for example, as part of an assessment of the overall biological safety of a medical device (ISO 10993-1 and 14971), as a measurement of the level of a leachable substance in a medical device in order to allow the assessment of compliance with the allowable limit derived for that substance from health based risk assessment (ISO 10993-17), for judging equivalence of a proposed material to a clinically established material, for judging equivalence of a final device to a prototype device to check the relevance of data on the latter to be used to support the assessment of the former, or for screening of potential new materials for suitability in a medical device for a proposed clinical application.
ISO 10993-18:2005 does not address the identification or quantification of degradation products, which is covered in ISO 10993-9, ISO 10993-13, ISO 10993-14 and ISO 10993-15.
The ISO 10993 series of standards is applicable when the material or device comes into contact with the body directly or indirectly (see 4.2.1 of ISO 10993-1).
ISO 10993-18:2005 is intended for suppliers of materials and manufacturers of medical devices, when carrying out a biological safety assessment.
| DevelopmentNote |
Supersedes ISO/DIS 10993-18 (07/2005)
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| DocumentType |
Standard
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| Pages |
17
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| PublisherName |
International Organization for Standardization
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| Status |
Withdrawn
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| SupersededBy |
| Standards | Relationship |
| DS EN ISO 10993-18 : 2009 | Identical |
| SS-EN ISO 10993-18:2009 | Identical |
| NS EN ISO 10993-18 : 2009 | Identical |
| NF EN ISO 10993-18 : 2009 | Identical |
| DIN EN ISO 10993-18:2009-08 | Identical |
| EN ISO 10993-18:2009 | Identical |
| NBN EN ISO 10993-18 : 2009 | Identical |
| UNE-EN ISO 10993-18:2009 | Identical |
| I.S. EN ISO 10993-18:2009 | Identical |
| NEN EN ISO 10993-18 : 2009 | Identical |
| UNI EN ISO 10993-18 : 2009 | Identical |
| PN EN ISO 10993-18 : 2009 | Identical |
| SN EN ISO 10993-18 : 2009 | Identical |
| GOST ISO 10993-18 : 2011 | Identical |
| BS EN ISO 10993-18:2009 | Identical |
| ONORM EN ISO 10993-18 : 2009 | Identical |
| ANSI/AAMI BE83:2006(R2011) | Identical |
| GOST R ISO 10993-18 : 2009 | Identical |
| AAMI BE83 : 2006 | Identical |
| BS EN ISO 10993-18:2005 | Identical |
| UNE-EN ISO 10993-18:2006 | Identical |
| ANSI/AAMI/ISO 10993-3:2014 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 3: TESTS FOR GENOTOXICITY, CARCINOGENICITY, AND REPRODUCTIVE TOXICITY |
| BS ISO 18562-4:2017 | Biocompatibility evaluation of breathing gas pathways in healthcare applications Tests for leachables in condensate |
| DD ISO/TS 10993-19:2006 | Biological evaluation of medical devices Physico-chemical, morphological and topographical characterization of materials |
| 11/30212473 DC : 0 | 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 18666:2015 | Traditional Chinese medicine. General requirements of moxibustion devices |
| 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 |
| 06/30106186 DC : 0 | ISO 10993-1 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT SYSTEM |
| UNE-EN ISO 22442-1:2016 | Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2015) |
| I.S. EN ISO 10993-16:2017 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 16: TOXICOKINETIC STUDY DESIGN FOR DEGRADATION PRODUCTS AND LEACHABLES (ISO 10993-16:2010) |
| ISO 14607:2007 | Non-active surgical implants Mammary implants Particular requirements |
| ISO 7405:2008 | Dentistry Evaluation of biocompatibility of medical devices used in dentistry |
| ASTM F 2027 : 2016 : REDLINE | Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products |
| DIN EN ISO 22442-1:2016-05 | Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2015) |
| BS EN ISO 10993-1 : 2009-10 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS (ISO 10993-1:2009) |
| BS EN ISO 10993-12:2012 | Biological evaluation of medical devices Sample preparation and reference materials |
| BS EN ISO 22803:2005 | Dentistry. Membrane materials for guided tissue regeneration in oral and maxillofacial surgery. Contents of a technical file |
| BS EN ISO 10993-3:2014 | Biological evaluation of medical devices Tests for genotoxicity, carcinogenicity and reproductive toxicity |
| UNI EN ISO 10993-12 : 2012 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 12: SAMPLE PREPARATION AND REFERENCE MATERIALS |
| VDI 5703:2015-09 | Systematical development for a model-based testing of medical devices |
| ONORM EN ISO 10993-10 : 2014 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 10: TESTS FOR IRRITATION AND SKIN SENSITIZATION (ISO 10993-10:2010) |
| ONORM EN ISO 10993-1 : 2011 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS |
| UNE-EN ISO 16061:2015 | Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2015) |
| ISO 10993-16:2017 | Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables |
| PD ISO/TR 13014:2012 | Nanotechnologies. Guidance on physico-chemical characterization of engineered nanoscale materials for toxicologic assessment |
| 17/30344601 DC : 0 | BS EN ISO 10993-1 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS |
| ISO 20308:2017 | Traditional Chinese medicine — Gua Sha instruments |
| AAMI ISO 10993-16 : 2010 : R2014 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 16: TOXICOKINETIC STUDY DESIGN FOR DEGRADATION PRODUCTS AND LEACHABLES |
| DIN EN ISO 16061:2015-09 | Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2015) |
| I.S. EN ISO 14607:2009 | NON-ACTIVE SURGICAL IMPLANTS - MAMMARY IMPLANTS - PARTICULAR REQUIREMENTS (ISO 14607:2018) |
| ISO 18562-4:2017 | Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 4: Tests for leachables in condensate |
| ISO/TR 37137:2014 | Cardiovascular biological evaluation of medical devices — Guidance for absorbable implants |
| DIN EN ISO 22803:2006-01 | Dentistry - Membrane materials for guided tissue regeneration in oral and maxillofacial surgery - Contents of a technical file (ISO 22803:2004) |
| DIN EN ISO 10993-12:2012-10 | Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2012) |
| UNE-EN ISO 10993-10:2013 | Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010) |
| BS EN ISO 22442-1:2015 | Medical devices utilizing animal tissues and their derivatives Application of risk management |
| I.S. EN ISO 22442-1:2015 | MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - PART 1: APPLICATION OF RISK MANAGEMENT (ISO 22442-1:2015) |
| I.S. EN ISO 10993-3:2014 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 3: TESTS FOR GENOTOXICITY, CARCINOGENICITY AND REPRODUCTIVE TOXICITY (ISO 10993-3:2014) |
| EN ISO 22442-1:2015 | Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2015) |
| I.S. EN ISO 10993-12:2012 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 12: SAMPLE PREPARATION AND REFERENCE MATERIALS (ISO 10993-12:2012) |
| I.S. EN ISO 10993-10:2013 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 10: TESTS FOR IRRITATION AND SKIN SENSITIZATION (ISO 10993-10:2010) |
| OVE/ONORM EN 60601-1 : 2014 | MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE (IEC 60601-1:2005 + COR.:2006 + COR.:2007 + A1:2012) |
| 13/30285624 DC : 0 | BS EN ISO 16061 - INSTRUMENTATION FOR USE IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS |
| PD ISO/TR 16197:2014 | Nanotechnologies. Compilation and description of toxicological screening methods for manufactured nanomaterials |
| 17/30343686 DC : 0 | BS EN ISO 7405 - DENTISTRY - EVALUATION OF BIOCOMPATIBILITY OF MEDICAL DEVICES USED IN DENTISTRY |
| BS ISO 27427:2013 | Anaesthetic and respiratory equipment. Nebulizing systems and components |
| AAMI ISO 10993-1:2009 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS |
| ANSI/AAMI/ISO TIR10993-19:2006 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 19: PHYSICOCHEMICAL, MORPHOLOGICAL, AND TOPOGRAPHICAL CHARACTERIZATION OF MATERIALS |
| ISO/TS 20993:2006 | Biological evaluation of medical devices Guidance on a risk-management process |
| ANSI/AAMI/ISO 22442-1:2016 | MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - PART 1: APPLICATION OF RISK MANAGEMENT |
| AAMI/ISO TIR15499:2017 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - GUIDANCE ON THE CONDUCT OF BIOLOGICAL EVALUATION WITHIN A RISK MANAGEMENT PROCESS |
| AAMI ISO 10993-10 : 2010 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 10: TESTS FOR IRRITATION AND SKIN SENSITIZATION |
| BS EN ISO 10993-16:2017 | Biological evaluation of medical devices Toxicokinetic study design for degradation products and leachables |
| I.S. EN ISO 7405:2009 | DENTISTRY - EVALUATION OF BIOCOMPATIBILITY OF MEDICAL DEVICES USED IN DENTISTRY (ISO 7405:2008) |
| ISO/TR 15499:2016 | Biological evaluation of medical devices Guidance on the conduct of biological evaluation within a risk management process |
| DIN EN ISO 10993-3:2015-02 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 3: TESTS FOR GENOTOXICITY, CARCINOGENICITY AND REPRODUCTIVE TOXICITY (ISO 10993-3:2014) |
| DIN EN ISO 10993-1:2010-04 | Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management system (ISO 10993-1:2009) |
| UNE-EN ISO 10993-3:2015 | Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014) |
| ISO 10993-3:2014 | Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity |
| BS EN ISO 10993-10:2013 | Biological evaluation of medical devices Tests for irritation and skin sensitization |
| DIN EN ISO 10993-10:2014-10 | Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010) |
| UNI EN ISO 10993-10 : 2013 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 10: TESTS FOR IRRITATION AND SKIN SENSITIZATION |
| UNI EN ISO 10993-3 : 2015 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 3: TESTS FOR GENOTOXICITY, CARCINOGENICITY AND REPRODUCTIVE TOXICITY |
| BS EN ISO 7405 : 2008 | DENTISTRY - EVALUATION OF BIOCOMPATIBILITY OF MEDICAL DEVICES USED IN DENTISTRY (ISO 7405:2008) |
| UNI EN ISO 10993-1 : 2010 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS |
| ISO/TR 16196:2016 | Nanotechnologies Compilation and description of sample preparation and dosing methods for engineered and manufactured nanomaterials |
| PD ISO/TR 15499:2016 | Biological evaluation of medical devices. Guidance on the conduct of biological evaluation within a risk management process |
| 15/30281262 DC : 0 | BS ISO 18666 - TRADITIONAL CHINESE MEDICINE - GENERAL REQUIREMENTS OF MOXIBUSTION DEVICES |
| 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 |
| 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 |
| 16/30319982 DC : 0 | BS ISO 20308 - TRADITIONAL CHINESE MEDICINE - GUA SHA INSTRUMENTS |
| CSA ISO 27427 : 2014 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - NEBULIZING SYSTEMS AND COMPONENTS |
| BS EN ISO 16061:2015 | Instrumentation for use in association with non-active surgical implants. General requirements |
| AAMI ISO 10993-16:2010 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 16: TOXICOKINETIC STUDY DESIGN FOR DEGRADATION PRODUCTS AND LEACHABLES |
| 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) |
| AAMI BE78 : 2002 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 10: TESTS FOR IRRITATION AND DELAYED TYPE HYPERSENSITIVITY |
| I.S. EN ISO 25539-1:2017 | CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES (ISO 25539-1:2017) |
| ISO/TR 13014:2012 | Nanotechnologies Guidance on physico-chemical characterization of engineered nanoscale materials for toxicologic assessment |
| ISO/TR 16197:2014 | Nanotechnologies Compilation and description of toxicological screening methods for manufactured nanomaterials |
| DIN EN ISO 7405:2013-12 | DENTISTRY - EVALUATION OF BIOCOMPATIBILITY OF MEDICAL DEVICES USED IN DENTISTRY (ISO 7405:2008 + AMD. 1:2013) |
| ASTM F 3160 : 2016 | Standard Guide for Metallurgical Characterization of Absorbable Metallic Materials for Medical Implants |
| UNI EN ISO 7405 : 2013 | DENTISTRY - EVALUATION OF BIOCOMPATIBILITY OF MEDICAL DEVICES USED IN DENTISTRY |
| ISO 18666:2015 | Traditional Chinese medicine General requirements of moxibustion devices |
| EN ISO 14607:2018 | Non-active surgical implants - Mammary implants - Particular requirements (ISO 14607:2018, Corrected version 2018-08) |
| ISO/TS 10993-19:2006 | Biological evaluation of medical devices Part 19: Physico-chemical, morphological and topographical characterization of materials |
| I.S. EN ISO 16061:2015 | INSTRUMENTATION FOR USE IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS (ISO 16061:2015) |
| ISO 16061:2015 | Instrumentation for use in association with non-active surgical implants General requirements |
| ISO 22442-1:2015 | Medical devices utilizing animal tissues and their derivatives Part 1: Application of risk management |
| UNE-EN ISO 10993-12:2013 | Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2012) |
| ISO 10993-12:2012 | Biological evaluation of medical devices Part 12: Sample preparation and reference materials |
| I.S. EN ISO 10993-1:2009+AC:2010 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS (ISO 10993-1:2009) |
| ISO 10993-10:2010 | Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization |
| EN ISO 10993-10:2013 | Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010) |
| EN ISO 22803:2005 | Dentistry - Membrane materials for guided tissue regeneration in oral and maxillofacial surgery - Contents of a technical file (ISO 22803:2004) |
| EN ISO 10993-3:2014 | Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014) |
| 10/30203224 DC : 0 | BS ISO 13022 - MEDICAL PRODUCTS CONTAINING VIABLE HUMAN CELLS - APPLICATION OF RISK MANAGEMENT AND REQUIREMENTS FOR PROCESSING PRACTICES |
| ANSI/AAMI/ISO 10993-10:2010(R2014) | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 10: TESTS FOR IRRITATION AND SKIN SENSITIZATION |
| 16/30335531 DC : 0 | BS EN ISO 10993-16 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 16: TOXICOKINETIC STUDY DESIGN FOR DEGRADATION PRODUCTS AND LEACHABLES |
| PD ISO/TR 37137:2014 | Cardiovascular biological evaluation of medical devices. Guidance for absorbable implants |
| 07/30163763 DC : 0 | BS ISO 7405 - DENTISTRY - PRECLINICAL EVALUATION OF BIOCOMPATIBILITY OF MEDICAL DEVICES USED IN DENTISTRY - TEST METHODS FOR DENTAL MATERIALS |
| AAMI ISO 10993-1 : 2009 : R2013 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS |
| 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 |
| 02/560790 DC : DRAFT FEB 2002 | BS EN ISO 16671 - OPHTHALMIC IMPLANTS - IRRIGATING SOLUTIONS FOR OPHTHALMIC SURGERY |
| EN ISO 10993-12:2012 | Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2012) |
| ISO 17327-1:2018 | Non-active surgical implants — Implant coating — Part 1: General requirements |
| ANSI/AAMI/ISO 10993-12:2012 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 12: SAMPLE PREPARATION AND REFERENCE MATERIALS |
| EN ISO 10993-16:2017 | Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2017) |
| ASTM F 2848 : 2017 : REDLINE | Standard Specification for Medical-Grade Ultra-High Molecular Weight Polyethylene Yarns |
| NF EN ISO 10993-1 : 2010 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT SYSTEM PROCESS |
| ASTM F 2847 : 2017 : REDLINE | Standard Practice for Reporting and Assessment of Residues on Single-Use Implants and Single-Use Sterile Instruments |
| ISO 27427:2013 | Anaesthetic and respiratory equipment — Nebulizing systems and components |
| ISO 22803:2004 | Dentistry — Membrane materials for guided tissue regeneration in oral and maxillofacial surgery — Contents of a technical file |
| EN ISO 16061:2015 | Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2015) |
| DIN EN ISO 10993-10:2003-02 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 10: TESTS FOR IRRITATION AND SKIN SENSITIZATION (ISO 10993-10:2010) |
| EN 12442-3 : 2000 | ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 3: VALIDATION OF THE ELIMINATION AND/OR INACTIVATION OF VIRUSES AND TRANSMISSIBLE AGENTS |
| ISO 5725-1:1994 | Accuracy (trueness and precision) of measurement methods and results — Part 1: General principles and definitions |
| ISO 10993-9:1999 | Biological evaluation of medical devices Part 9: Framework for identification and quantification of potential degradation products |
| ISO 5832-1:1997 | Implants for surgery Metallic materials Part 1: Wrought stainless steel |
| ISO 10993-2:2006 | Biological evaluation of medical devices — Part 2: Animal welfare requirements |
| EN 455-3:2015 | Medical gloves for single use - Part 3: Requirements and testing for biological evaluation |
| ISO 10993-14:2001 | Biological evaluation of medical devices — Part 14: Identification and quantification of degradation products from ceramics |
| ISO 14971:2000 | Medical devices Application of risk management to medical devices |
| ISO 10993-1:2003 | Biological evaluation of medical devices Part 1: Evaluation and testing |
| ISO 10993-17:2002 | Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances |
| EN 12442-1 : 2000 | ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 1: ANALYSIS AND MANAGEMENT OF RISK |
| ISO 10993-15:2000 | Biological evaluation of medical devices Part 15: Identification and quantification of degradation products from metals and alloys |
| ISO 10993-13:1998 | Biological evaluation of medical devices Part 13: Identification and quantification of degradation products from polymeric medical devices |
| EN 12442-2 : 2000 | ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 2: CONTROLS ON SOURCING, COLLECTION AND HANDLING |
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