ISO 10993-9:2009
Withdrawn
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
View Superseded by
withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
Biological evaluation of medical devices Part 9: Framework for identification and quantification of potential degradation products
Available format(s)
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
Withdrawn date
11-28-2019
Language(s)
English, French
Published date
11-30-2009
ISO 10993-9:2008 provides general principles for the systematic evaluation of the potential and observed biodegradation of medical devices and for the design and performance of biodegradation studies. Information obtained from these studies can be used in the biological evaluation described in the ISO 10993 series. ISO 10993-9:2008 considers both non-resorbable and resorbable materials.
| DevelopmentNote |
Supersedes ISO TR 10993-9 (03/2001) DRAFT ISO/DIS 10993-9 is also available for this standard. (03/2018)
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| DocumentType |
Standard
|
| Pages |
9
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| PublisherName |
International Organization for Standardization
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| Status |
Withdrawn
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| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| GOST ISO 10993-9 : 2015 | Identical |
| NBN EN ISO 10993-9 : 2010 | Identical |
| NEN EN ISO 10993-9 : 2010 | Identical |
| I.S. EN ISO 10993-9:2009-12 | Identical |
| PN EN ISO 10993-9 : 2010 | Identical |
| SN EN ISO 10993-9 : 2010 | Identical |
| UNI EN ISO 10993-9 : 2010 | Identical |
| SS-EN ISO 10993-9:2009 | Identical |
| BS EN ISO 10993-9 : 2009-12 | Identical |
| EN ISO 10993-9:2009 | Identical |
| NF EN ISO 10993-9 : 2010 | Identical |
| UNE-EN ISO 10993-9:2010 | Identical |
| DIN EN ISO 10993-9:2010-04 | Identical |
| I.S. EN ISO 10993-9:2009 (APRIL 2010) | Identical |
| ONORM EN ISO 10993-9 : 2010 | Identical |
| GOST R ISO 10993-9 : 2009 | Identical |
| NS EN ISO 10993-9 : 2009 | Identical |
| SAC GB/T 16886.9 : 2001 | Identical |
| CSA ISO 10993-9 : 0 | Identical |
| ANSI/AAMI/ISO 10993-9:2009(R2014) | Identical |
| BS EN ISO 10993-9:December 2009 | Identical |
| AAMI ISO 10993-9 : 2009 | Identical |
| 16/30332223 DC : 0 | BS ISO 6474-1 - IMPLANTS FOR SURGERY - CERAMIC MATERIALS - PART 1: CERAMIC MATERIALS BASED ON HIGH PURITY ALUMINA |
| 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 |
| ISO 6474-1:2010 | Implants for surgery Ceramic materials Part 1: Ceramic materials based on high purity alumina |
| BS ISO 18562-1:2017 | Biocompatibility evaluation of breathing gas pathways in healthcare applications Evaluation and testing within a risk management process |
| BS ISO 18562-4:2017 | Biocompatibility evaluation of breathing gas pathways in healthcare applications Tests for leachables in condensate |
| UNI EN ISO 10271 : 2011 | DENTISTRY - CORROSION TEST METHODS FOR METALLIC MATERIALS |
| AAMI ISO 10993-1 : 2009 : R2013 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS |
| 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 16105:2011 | Paints and varnishes. Laboratory method for determination of release of substances from coatings in intermittent contact with water |
| 06/30106186 DC : 0 | ISO 10993-1 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT SYSTEM |
| DD ISO/TS 10993-19:2006 | Biological evaluation of medical devices Physico-chemical, morphological and topographical characterization of materials |
| ISO/TR 13329:2012 | Nanomaterials Preparation of material safety data sheet (MSDS) |
| I.S. EN 16105:2011 | PAINTS AND VARNISHES - LABORATORY METHOD FOR DETERMINATION OF RELEASE OF SUBSTANCES FROM COATINGS IN INTERMITTENT CONTACT WITH WATER |
| UNE-EN ISO 22442-1:2016 | Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2015) |
| 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 |
| ISO 15798:2013 | Ophthalmic implants Ophthalmic viscosurgical devices |
| ISO 7405:2008 | Dentistry Evaluation of biocompatibility of medical devices used in dentistry |
| ASTM F 3036 : 2013 | Standard Guide for Testing Absorbable Stents |
| 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) |
| DIN EN ISO 10993-10 E : 2003 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 10: TESTS FOR IRRITATION AND SKIN SENSITIZATION (ISO 10993-10:2010) |
| DIN EN ISO 10993-15 E : 2009 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 15: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM METALS AND ALLOYS |
| DIN EN ISO 10993-13 E : 2010 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 13: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM POLYMERIC MEDICAL DEVICES |
| 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 22803:2005 | Dentistry. Membrane materials for guided tissue regeneration in oral and maxillofacial surgery. Contents of a technical file |
| BS EN ISO 10271:2011 | Dentistry. Corrosion test methods for metallic materials |
| BS EN ISO 14534:2015 | Ophthalmic optics. Contact lenses and contact lens care products. Fundamental requirements |
| 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 |
| BS ISO 6474-1:2010 | Implants for surgery. Ceramic materials Ceramic materials based on high purity alumina |
| 17/30344601 DC : 0 | BS EN ISO 10993-1 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS |
| PD ISO/TR 13329:2012 | Nanomaterials. Preparation of Material Safety Data Sheet (MSDS) |
| 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 |
| AAMI BE83 : 2006 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 18: CHEMICAL CHARACTERIZATION OF MATERIALS |
| ISO 18562-1:2017 | Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 1: Evaluation and testing within a risk management process |
| CSA ISO 10993-13 : 0 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 13: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM POLYMERIC MEDICAL DEVICES |
| ASTM F 2150 : 2013 : REDLINE | Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Tissue-Engineered Medical Products |
| ASTM F 2027 : 2016 : REDLINE | Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products |
| ASTM F 3089 : 2014 | Standard Guide for Characterization and Standardization of Polymerizable Collagen-Based Products and Associated Collagen-Cell Interactions |
| DIN EN ISO 10271:2011-10 | DENTISTRY - CORROSION TEST METHODS FOR METALLIC MATERIALS |
| 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 10993-18:2009-08 | Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 10993-18:2005); German version EN ISO 10993-18:2009 |
| 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/COR 1:2010) |
| BS EN ISO 10993-15:2009 | Biological evaluation of medical devices Identification and quantification of degradation products from metals and alloys |
| BS EN 45502-1:2015 | Implants for surgery. Active implantable medical devices General requirements for safety, marking and for information to be provided by the manufacturer |
| BS EN ISO 10993-6:2016 | Biological evaluation of medical devices Tests for local effects after implantation |
| 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 10993-6:2016 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 6: TESTS FOR LOCAL EFFECTS AFTER IMPLANTATION (ISO 10993-6:2016) |
| I.S. EN ISO 14534:2015 | OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - FUNDAMENTAL REQUIREMENTS (ISO 14534:2011) |
| I.S. EN ISO 22794:2009 | DENTISTRY - IMPLANTABLE MATERIALS FOR BONE FILLING AND AUGMENTATION IN ORAL AND MAXILLOFACIAL SURGERY - CONTENTS OF A TECHNICAL FILE |
| UNI EN ISO 10993-18 : 2009 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 18: CHEMICAL CHARACTERIZATION OF MATERIALS |
| 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) |
| 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 10451:2010 | DENTISTRY - CONTENTS OF TECHNICAL FILE FOR DENTAL IMPLANT SYSTEMS |
| I.S. EN 45502-1:2015 | IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND FOR INFORMATION TO BE PROVIDED BY THE MANUFACTURER |
| I.S. EN ISO 10993-10:2013 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 10: TESTS FOR IRRITATION AND SKIN SENSITIZATION (ISO 10993-10:2010) |
| I.S. EN ISO 10993-14:2009 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 14: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM CERAMICS (ISO 10993-14:2001) |
| I.S. EN ISO 10993-13:2010 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 13: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM POLYMERIC MEDICAL DEVICES (ISO 10993-13:2010) |
| 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) |
| CSA Z13329 : 2015 | NANOMATERIALS - PREPARATION OF SAFETY DATA SHEETS (SDSS) |
| I.S. EN 12442-1:2000 | ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 1: ANALYSIS AND MANAGEMENT OF RISK |
| 17/30343686 DC : 0 | BS EN ISO 7405 - DENTISTRY - EVALUATION OF BIOCOMPATIBILITY OF MEDICAL DEVICES USED IN DENTISTRY |
| 09/30075204 DC : 0 | BS EN ISO 10271 - DENTAL METALLIC MATERIALS - CORROSION TEST METHODS |
| 09/30207531 DC : 0 | BS EN ISO 14534 - OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - FUNDAMENTAL REQUIREMENTS |
| ANSI/AAMI/ISO TIR10993-19:2006 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 19: PHYSICOCHEMICAL, MORPHOLOGICAL, AND TOPOGRAPHICAL CHARACTERIZATION OF MATERIALS |
| 08/30178723 DC : DRAFT AUG 2008 | BS ISO 15798 - OPHTHALMIC IMPLANTS - OPHTHALMIC VISCOSURGICAL DEVICES |
| 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 |
| 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 |
| ANSI/AAMI/ISO 10993-6:2016 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 6: TESTS FOR LOCAL EFFECTS AFTER IMPLANTATION |
| AAMI ISO 10993-14 : 2001 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 14: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM CERAMICS |
| AAMI ISO 10993-15 : 2000 : R2011 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 15: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM METALS AND ALLOYS |
| 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 |
| ASTM F 2103 : 2011-03 | GUIDE FOR CHARACTERIZATION AND TESTING OF CHITOSAN SALTS AS STARTING MATERIALS INTENDED FOR USE IN BIOMEDICAL AND TISSUE-ENGINEERED MEDICAL PRODUCT APPLICATIONS |
| ASTM F 2212 : 2011 : REDLINE | Standard Guide for Characterization of Type I Collagen as Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs) |
| ISO/TR 15499:2016 | Biological evaluation of medical devices Guidance on the conduct of biological evaluation within a risk management process |
| DIN EN ISO 22794:2009-11 | Dentistry - Implantable materials for bone filling and augmentation in oral and maxillofacial surgery - Contents of a technical file (ISO 22794:2007, corrected version 2009-01-15) |
| 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) |
| ISO 10271:2011 | Dentistry Corrosion test methods for metallic materials |
| BS EN ISO 10993-18:2009 | Biological evaluation of medical devices Chemical characterization of materials |
| 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) |
| ISO 22794:2007 | Dentistry Implantable materials for bone filling and augmentation in oral and maxillofacial surgery Contents of a technical file |
| DIN EN ISO 10993-15:2009-10 | Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2000) |
| I.S. EN ISO 10993-18:2009 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 18: CHEMICAL CHARACTERIZATION OF MATERIALS (ISO 10993-18:2005) |
| I.S. EN ISO 10271:2011 | DENTISTRY - CORROSION TEST METHODS FOR METALLIC MATERIALS |
| EN ISO 10993-18:2009 | Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 10993-18:2005) |
| EN ISO 10271:2011 | Dentistry - Corrosion test methods for metallic materials (ISO 10271:2011) |
| UNI EN ISO 10993-10 : 2013 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 10: TESTS FOR IRRITATION AND SKIN SENSITIZATION |
| ONORM EN ISO 15798 : 2013 AMD 1 2018 | OPHTHALMIC IMPLANTS - OPHTHALMIC VISCOSURGICAL DEVICES (ISO 15798:2013) |
| UNI EN ISO 10993-15 : 2009 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 15: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM METALS AND ALLOYS |
| UNI EN ISO 10451 : 2010 | DENTISTRY - CONTENTS OF TECHNICAL FILE FOR DENTAL IMPLANT SYSTEMS |
| EN 45502-1:2015 | IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND FOR INFORMATION TO BE PROVIDED BY THE MANUFACTURER |
| UNI EN ISO 10993-14 : 2009 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 14: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM CERAMICS |
| UNI EN ISO 10993-13 : 2010 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 13: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM POLYMERIC MEDICAL DEVICES |
| BS EN ISO 7405 : 2008 | DENTISTRY - EVALUATION OF BIOCOMPATIBILITY OF MEDICAL DEVICES USED IN DENTISTRY (ISO 7405:2008) |
| ASTM F 1635 : 2016 : REDLINE | Standard Test Method for <emph type="bdit">in vitro</emph> Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants |
| UNI EN ISO 10993-1 : 2010 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS |
| PD ISO/TR 15499:2016 | Biological evaluation of medical devices. Guidance on the conduct of biological evaluation within a risk management process |
| 10/30196848 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 |
| 14/30261590 DC : 0 | BS EN ISO 10993-6 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 6: TESTS FOR LOCAL EFFECTS AFTER IMPLANTATION |
| 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 |
| 08/30170164 DC : DRAFT AUG 2008 | BS EN ISO 10993-10 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 10: TESTS FOR IRRITATION AND SKIN SENSITIZATION |
| 03/305222 DC : DRAFT MAR 2003 | BS ISO 6474 - IMPLANTS FOR SURGERY - CERAMIC MATERIALS BASED ON HIGH PURITY ALUMINA |
| CSA ISO 27427 : 2014 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - NEBULIZING SYSTEMS AND COMPONENTS |
| AAMI ISO 10993-13:2010 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 13: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM POLYMERIC MEDICAL DEVICES |
| I.S. EN ISO 15798:2013 | OPHTHALMIC IMPLANTS - OPHTHALMIC VISCOSURGICAL DEVICES (ISO 15798:2013) |
| AAMI BE78 : 2002 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 10: TESTS FOR IRRITATION AND DELAYED TYPE HYPERSENSITIVITY |
| ANSI/AAMI/ISO 10993-14:2001(R2011) | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 14: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM CERAMICS |
| I.S. EN ISO 25539-1:2017 | CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES (ISO 25539-1:2017) |
| ANSI/AAMI/ISO 14708-1:2014 | IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND FOR INFORMATION TO BE PROVIDED BY THE MANUFACTURER |
| I.S. EN ISO 7405:2009 | DENTISTRY - EVALUATION OF BIOCOMPATIBILITY OF MEDICAL DEVICES USED IN DENTISTRY (ISO 7405:2008) |
| DIN EN ISO 7405:2013-12 | DENTISTRY - EVALUATION OF BIOCOMPATIBILITY OF MEDICAL DEVICES USED IN DENTISTRY (ISO 7405:2008 + AMD. 1:2013) |
| ASTM F 2695 : 2012 : REDLINE | Standard Specification for Ultra-High Molecular Weight Polyethylene Powder Blended With Alpha-Tocopherol (Vitamin E) and Fabricated Forms for Surgical Implant Applications |
| UNI EN ISO 7405 : 2013 | DENTISTRY - EVALUATION OF BIOCOMPATIBILITY OF MEDICAL DEVICES USED IN DENTISTRY |
| ISO/TS 10993-19:2006 | Biological evaluation of medical devices Part 19: Physico-chemical, morphological and topographical characterization of materials |
| DIN EN ISO 14534:2015-08 | Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011) |
| BS EN ISO 10993-14:2009 | Biological evaluation of medical devices Identification and quantification of degradation products from ceramics |
| ISO 10993-13:2010 | Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices |
| BS EN 12011:1998 | Instrumentation to be used in association with non-active surgical implants. General requirements |
| UNE-EN ISO 10271:2012 | Dental metallic materials - Corrosion test methods (ISO 10271:2011) |
| ISO 22442-1:2015 | Medical devices utilizing animal tissues and their derivatives Part 1: Application of risk management |
| ISO 10993-14:2001 | Biological evaluation of medical devices — Part 14: Identification and quantification of degradation products from ceramics |
| ISO 14534:2011 | Ophthalmic optics Contact lenses and contact lens care products Fundamental requirements |
| DIN EN ISO 10993-13:2010-11 | Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010) |
| 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) |
| UNE-EN ISO 14534:2015 | Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011) |
| ISO 10993-10:2010 | Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization |
| BS EN ISO 10451:2010 | Dentistry. Contents of technical file for dental implant systems |
| BS EN ISO 10993-13:2010 | Biological evaluation of medical devices Identification and quantification of degradation products from polymeric medical devices |
| ISO 10451:2010 | Dentistry — Contents of technical file for dental implant systems |
| BS EN ISO 22794:2009 | Dentistry. Implantable materials for bone filling and augmentation in oral and maxillofacial surgery. Contents of a technical file |
| UNE-EN ISO 10993-13:2010 | Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010) |
| I.S. EN ISO 10993-15:2009 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 15: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM METALS AND ALLOYS (ISO 10993-15:2000) |
| EN ISO 10993-6:2016 | Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2016) |
| EN 16105:2011 | Paints and varnishes - Laboratory method for determination of release of substances from coatings in intermittent contact with water |
| EN ISO 10993-10:2013 | Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010) |
| EN ISO 10993-15:2009 | Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2000) |
| 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 10993-14:2009 | Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics (ISO 10993-14:2001) |
| EN ISO 10451:2010 | Dentistry - Contents of technical file for dental implant systems (ISO 10451:2010) |
| EN ISO 22794:2009 | Dentistry - Implantable materials for bone filling and augmentation in oral and maxillofacial surgery - Contents of a technical file (ISO 22794:2007, corrected version 2009-01-15) |
| EN ISO 14534:2015 | Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011) |
| EN ISO 10993-13:2010 | Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010) |
| BS ISO 27427:2013 | Anaesthetic and respiratory equipment. Nebulizing systems and components |
| AAMI ISO 10993-15 : 2000 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 15: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM METALS AND ALLOYS |
| DIN EN 16105:2011-12 | Paints and varnishes - Laboratory method for determination of release of substances from coatings in intermittent contact with water |
| ANSI/AAMI/ISO 10993-10:2010(R2014) | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 10: TESTS FOR IRRITATION AND SKIN SENSITIZATION |
| 03/100426 DC : DRAFT JAN 2003 | BS EN ISO 10993-18 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 18: CHEMICAL CHARACTERIZATION OF MATERIALS |
| PD ISO/TR 37137:2014 | Cardiovascular biological evaluation of medical devices. Guidance for absorbable implants |
| ANSI/AAMI BE83:2006(R2011) | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 18: CHEMICAL CHARACTERIZATION OF MATERIALS |
| 07/30163763 DC : 0 | BS ISO 7405 - DENTISTRY - PRECLINICAL EVALUATION OF BIOCOMPATIBILITY OF MEDICAL DEVICES USED IN DENTISTRY - TEST METHODS FOR DENTAL MATERIALS |
| UNI EN 16105 : 2011 | PAINTS AND VARNISHES - LABORATORY METHOD FOR DETERMINATION OF RELEASE OF SUBSTANCES FROM COATINGS IN INTERMITTENT CONTACT WITH WATER |
| AAMI ISO 10993-1:2009 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS |
| EN ISO 15798:2013/A1:2017 | OPHTHALMIC IMPLANTS - OPHTHALMIC VISCOSURGICAL DEVICES (ISO 15798:2013/AMD 1:2017) |
| UNE-EN 16105:2012 | Paints and varnishes - Laboratory method for determination of release of substances from coatings in intermittent contact with water |
| UNI EN ISO 22794 : 2009 | DENTISTRY - IMPLANTABLE MATERIALS FOR BONE FILLING AND AUGMENTATION IN ORAL AND MAXILLOFACIAL SURGERY - CONTENTS OF A TECHNICAL FILE |
| EN ISO 7405:2008/A1:2013 | DENTISTRY - EVALUATION OF BIOCOMPATIBILITY OF MEDICAL DEVICES USED IN DENTISTRY (ISO 7405:2008) |
| NF EN ISO 10993-1 : 2010 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT SYSTEM PROCESS |
| ISO 27427:2013 | Anaesthetic and respiratory equipment — Nebulizing systems and components |
| DIN EN ISO 10993-14 E : 2009 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 14: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM CERAMICS |
| DIN EN ISO 10993-18 E : 2009 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 18: CHEMICAL CHARACTERIZATION OF MATERIALS |
| DIN EN ISO 10451:2010-11 | Dentistry - Contents of technical file for dental implant systems (ISO 10451:2010) |
| DIN EN ISO 10993-6:2009-08 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 6: TESTS FOR LOCAL EFFECTS AFTER IMPLANTATION (ISO 10993-6:2016) |
| DIN EN ISO 10993-14:2009-08 | Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics (ISO 10993-14:2001) |
| ISO 10993-6:2016 | Biological evaluation of medical devices Part 6: Tests for local effects after implantation |
| ISO 22803:2004 | Dentistry — Membrane materials for guided tissue regeneration in oral and maxillofacial surgery — Contents of a technical file |
| BS EN 13503-6:2002 | Ophthalmic implants. Intraocular lenses Shelf-life and transport stability |
| EN 13503-6 : 2002 | OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 6: SHELF-LIFE AND TRANSPORT STABILITY |
| EN 45502-1 : 2015 | IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND FOR INFORMATION TO BE PROVIDED BY THE MANUFACTURER |
| EN 12442-1 : 2000 | ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 1: ANALYSIS AND MANAGEMENT OF RISK |
| DIN EN ISO 10993-6:2017-09 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 6: TESTS FOR LOCAL EFFECTS AFTER IMPLANTATION (ISO 10993-6:2016) |
| DIN EN ISO 10993-10:2003-02 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 10: TESTS FOR IRRITATION AND SKIN SENSITIZATION (ISO 10993-10:2010) |
| ISO/IEC 17025:2005 | General requirements for the competence of testing and calibration laboratories |
| ISO 10993-13:2010 | Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices |
| ISO 10271:2011 | Dentistry Corrosion test methods for metallic materials |
| ISO 10993-2:2006 | Biological evaluation of medical devices — Part 2: Animal welfare requirements |
| ISO 10993-14:2001 | Biological evaluation of medical devices — Part 14: Identification and quantification of degradation products from ceramics |
| ISO 13781:2017 | Implants for surgery — Homopolymers, copolymers and blends on poly(lactide) — In vitro degradation testing |
| ISO 10993-1:2009 | Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
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