ISO 10993-6:2016
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Biological evaluation of medical devices Part 6: Tests for local effects after implantation
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English, French
Published date
28-11-2016
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ISO 10993-6:2016 specifies test methods for the assessment of the local effects after implantation of biomaterials intended for use in medical devices.
ISO 10993-6:2016 applies to materials that are
- solid and non-absorbable,
- non-solid, such as porous materials, liquids, gels, pastes, and particulates, and
- degradable and/or absorbable, which may be solid or non-solid.
The test sample is implanted into a site and animal species appropriate for the evaluation of the biological safety of the material. These implantation tests are not intended to evaluate or determine the performance of the test sample in terms of mechanical or functional loading. This part of ISO 10993 can also be applied to medical devices that are intended to be used topically in clinical indications where the surface or lining might have been breached, in order to evaluate local tissue responses.
The local effects are evaluated by a comparison of the tissue response caused by a test sample to that caused by control materials used in medical devices whose clinical acceptability and biocompatibility characteristics have been established. The objective of the test methods is to characterize the history and evolution of the tissue response after implantation of a medical device/biomaterial including final integration or absorption/degradation of the material. In particular for degradable/absorbable materials, the degradation characteristics of the material and the resulting tissue response should be determined.
ISO 10993-6:2016 does not deal with systemic toxicity, carcinogenicity, teratogenicity or mutagenicity. However, the long-term implantation studies intended for evaluation of local biological effects might provide insight into some of these properties. Systemic toxicity studies conducted by implantation might satisfy the requirements of this part of ISO 10993. When conducting combined studies for evaluating local effects and systemic effects, the requirements of both standards is to be fulfilled.
| DevelopmentNote |
Supersedes ISO/DIS 10993-6. (12/2016)
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| DocumentType |
Standard
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| Pages |
29
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| PublisherName |
International Organization for Standardization
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| Status |
Current
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| Supersedes |
| Standards | Relationship |
| DIN EN ISO 10993-6:2017-09 | Identical |
| ANSI/AAMI/ISO 10993-6:2016 | Identical |
| NEN EN ISO 10993-6 : 2016 | Identical |
| NS EN ISO 10993-6 : 2016 | Identical |
| I.S. EN ISO 10993-6:2016 | Identical |
| PN EN ISO 10993-6 : 2017 | Identical |
| SN EN ISO 10993-6 : 2017 | Identical |
| SS-EN ISO 10993-6:2017 | Identical |
| UNI EN ISO 10993-6 : 2017 | Identical |
| BS EN ISO 10993-6:2016 | Identical |
| EN ISO 10993-6:2016 | Identical |
| NF EN ISO 10993-6 : 2017 | Identical |
| UNE-EN ISO 10993-6:2017 | Identical |
| DIN EN ISO 10993-6:2009-08 | Identical |
| PNE-EN 30993-6 | Identical |
| GOST ISO 10993-6 : 2011 | Identical |
| NS ISO 10993-6 : 1ED 1995 | Identical |
| EN 30993-6 : 1994 | Identical |
| UNE-EN 30993-6:1995 | Identical |
| GOST R ISO 10993-6 : 2009 | Identical |
| CSA ISO 10993-6 : 1997(R2009) | Identical |
| SAC GB/T 16886.6 : 1997 | Identical |
| NEN ISO 10993-6 : 1995 | Identical |
| I.S. EN 30993-6:1995 | Identical |
| DIN EN 30993-6:1994-12 | Corresponds |
| DD ISO/TS 10993-20:2006 | Biological evaluation of medical devices 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 |
| 04/30103836 DC : DRAFT JUL 2004 | ISO 11979-5 - OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 5: BIOCOMPATIBILITY |
| BS ISO 18562-4:2017 | Biocompatibility evaluation of breathing gas pathways in healthcare applications Tests for leachables in condensate |
| AAMI ISO 10993-1 : 2009 : R2013 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS |
| 14/30295064 DC : 0 | BS EN ISO 16672 - OPHTHALMIC IMPLANTS - OCULAR ENDOTAMPONADES |
| ISO/TS 20993:2006 | Biological evaluation of medical devices Guidance on a risk-management process |
| 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 |
| 11/30212473 DC : 0 | BS EN ISO 10993-3 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 3: TESTS FOR GENOTOXICITY, CARCINOGENICITY AND REPRODUCTIVE TOXICITY |
| 06/30106186 DC : 0 | ISO 10993-1 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT SYSTEM |
| ANSI Z80.12 : 2007 : R2017 | OPHTHALMICS - MULTIFOCAL INTRAOCULAR LENSES |
| ANSI Z80.13 : 2007 : R2012 | OPHTHALMICS - PHAKIC INTRAOCULAR LENSES |
| UNE-EN ISO 22442-1:2016 | Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2015) |
| ISO 7405:2008 | Dentistry Evaluation of biocompatibility of medical devices used in dentistry |
| DIN EN ISO 11979-5:2010-11 | Ophthalmic implants - Intraocular lenses - Part 5: Biocompatibility (ISO 11979-5:2006) |
| 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 22803:2005 | Dentistry. Membrane materials for guided tissue regeneration in oral and maxillofacial surgery. Contents of a technical file |
| UNE-EN ISO 16672:2016 | Ophthalmic implants - Ocular endotamponades (ISO 16672:2015) |
| BS EN ISO 10993-3:2014 | Biological evaluation of medical devices Tests for genotoxicity, carcinogenicity and reproductive toxicity |
| EN 12011 : 1998 | INSTRUMENTATION TO BE USED IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS |
| ONORM EN ISO 11979-5 : 2010 | OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 5: BIOCOMPATIBILITY |
| ONORM EN ISO 10993-1 : 2011 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS |
| 14/30295067 DC : 0 | BS EN ISO 16671 - OPHTHALMIC IMPLANTS - IRRIGATING SOLUTIONS FOR OPHTHALMIC SURGERY |
| 17/30344601 DC : 0 | BS EN ISO 10993-1 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS |
| ANSI Z80.13 : 2007 | OPHTHALMICS - PHAKIC INTRAOCULAR LENSES |
| ISO/TR 10993-9:1994 | Biological evaluation of medical devices — Part 9: Degradation of materials related to biological testing |
| ASTM F 3273 : 2017 | Standard Specification for Wrought Molybdenum-47.5 Rhenium Alloy for Surgical Implants (UNS R03700) |
| ASTM F 3207 : 2017 | Standard Guide for <emph type="bdit">in vivo</emph> Evaluation of Rabbit Lumbar Intertransverse Process Spinal Fusion Model |
| 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 16672:2015-12 | Ophthalmic implants - Ocular endotamponades (ISO 16672:2015) |
| BS EN ISO 22442-1:2015 | Medical devices utilizing animal tissues and their derivatives Application of risk management |
| I.S. EN ISO 22794:2009 | DENTISTRY - IMPLANTABLE MATERIALS FOR BONE FILLING AND AUGMENTATION IN ORAL AND MAXILLOFACIAL SURGERY - CONTENTS OF A TECHNICAL FILE |
| 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 16672:2015 | OPHTHALMIC IMPLANTS - OCULAR ENDOTAMPONADES (ISO 16672:2015) |
| 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) |
| 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 |
| BS ISO 27427:2013 | Anaesthetic and respiratory equipment. Nebulizing systems and components |
| ANSI Z80.29 : 2015 | OPHTHALMICS - ACCOMODATIVE INTRAOCULAR LENSES |
| 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 |
| ANSI/AAMI/ISO 22442-1:2016 | MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - PART 1: APPLICATION OF RISK MANAGEMENT |
| ANSI/AAMI/ISO TIR10993-20:2006 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 20: PRINCIPLES AND METHODS FOR IMMUNOTOXICOLOGY TESTING OF MEDICAL DEVICES |
| 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 |
| I.S. EN ISO 16671:2015 | OPHTHALMIC IMPLANTS - IRRIGATING SOLUTIONS FOR OPHTHALMIC SURGERY (ISO 16671:2015) |
| 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 10993-3:2015-02 | 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 |
| ISO 22794:2007 | Dentistry Implantable materials for bone filling and augmentation in oral and maxillofacial surgery Contents of a technical file |
| I.S. EN ISO 11979-5:2006 | OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 5: BIOCOMPATIBILITY |
| EN ISO 11979-5:2006 | Ophthalmic implants - Intraocular lenses - Part 5: Biocompatibility (ISO 11979-5:2006) |
| ONORM EN ISO 15798 : 2013 AMD 1 2018 | OPHTHALMIC IMPLANTS - OPHTHALMIC VISCOSURGICAL DEVICES (ISO 15798:2013) |
| 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 |
| I.S. EN 12011:1998 | INSTRUMENTATION TO BE USED IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS |
| 02/560790 DC : DRAFT FEB 2002 | BS EN ISO 16671 - OPHTHALMIC IMPLANTS - IRRIGATING SOLUTIONS FOR OPHTHALMIC SURGERY |
| 08/30170164 DC : DRAFT AUG 2008 | BS EN ISO 10993-10 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 10: TESTS FOR IRRITATION AND SKIN SENSITIZATION |
| ANSI Z80.13 : 2007 : R2017 | OPHTHALMICS - PHAKIC INTRAOCULAR LENSES |
| CSA ISO 27427 : 2014 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - NEBULIZING SYSTEMS AND COMPONENTS |
| 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 |
| I.S. EN ISO 25539-1:2017 | CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES (ISO 25539-1:2017) |
| I.S. EN ISO 7405:2009 | DENTISTRY - EVALUATION OF BIOCOMPATIBILITY OF MEDICAL DEVICES USED IN DENTISTRY (ISO 7405:2008) |
| ISO 16671:2015 | Ophthalmic implants — Irrigating solutions for ophthalmic surgery |
| 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 |
| BS EN ISO 16671 : 2015 | OPHTHALMIC IMPLANTS - IRRIGATING SOLUTIONS FOR OPHTHALMIC SURGERY |
| ISO/TS 10993-20:2006 | Biological evaluation of medical devices — Part 20: Principles and methods for immunotoxicology testing of medical devices |
| BS EN ISO 11979-5:2006 | Ophthalmic implants. Intraocular lenses Biocompatibility |
| BS EN 12011:1998 | Instrumentation to be used 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 |
| ISO 16672:2015 | Ophthalmic implants Ocular endotamponades |
| ISO 11979-5:2006 | Ophthalmic implants Intraocular lenses Part 5: Biocompatibility |
| 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) |
| BS EN ISO 22794:2009 | Dentistry. Implantable materials for bone filling and augmentation in oral and maxillofacial surgery. Contents of a technical file |
| 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 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 10993-3:2014 | Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014) |
| 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 |
| 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 |
| CSA ISO 5840 : 0 | CARDIOVASCULAR IMPLANTS - CARIDAC VALVE PROSTHESES |
| ANSI Z80.30 : 2010 | OPHTHALMICS - TORIC INTRAOCULAR LENSES |
| AAMI ISO 10993-1:2009 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS |
| ANSI Z80.12 : 2007 | OPHTHALMICS - MULTIFOCAL INTRAOCULAR LENSES |
| UNE-EN ISO 16671:2016 | Ophthalmic implants - Irrigating solutions for ophthalmic surgery (ISO 16671:2015) |
| ISO/TS 22911:2016 | Dentistry Preclinical evaluation of dental implant systems Animal test methods |
| UNI EN ISO 22794 : 2009 | DENTISTRY - IMPLANTABLE MATERIALS FOR BONE FILLING AND AUGMENTATION IN ORAL AND MAXILLOFACIAL SURGERY - CONTENTS OF A TECHNICAL FILE |
| ISO 15798:2013 | Ophthalmic implants Ophthalmic viscosurgical devices |
| ONORM EN ISO 7405 : 2013 | DENTISTRY - EVALUATION OF BIOCOMPATIBILITY OF MEDICAL DEVICES USED IN DENTISTRY (ISO 7405:2008 + AMD 1:2013) |
| 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 |
| ISO 22803:2004 | Dentistry — Membrane materials for guided tissue regeneration in oral and maxillofacial surgery — Contents of a technical file |
| BS EN ISO 16672:2015 | Ophthalmic implants. Ocular endotamponades |
| EN 12442-1 : 2000 | ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 1: ANALYSIS AND MANAGEMENT OF RISK |
| ISO 5832-1:2016 | Implants for surgery — Metallic materials — Part 1: Wrought stainless steel |
| ISO 10993-4:2017 | Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood |
| ISO 10993-16:2017 | Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables |
| ASTM F 1983 : 2014 : REDLINE | Standard Practice for Assessment of Selected Tissue Effects of Absorbable Biomaterials for Implant Applications |
| ISO 5832-6:1997 | Implants for surgery Metallic materials Part 6: Wrought cobalt-nickel-chromium-molybdenum alloy |
| ISO 5832-5:2005 | Implants for surgery Metallic materials Part 5: Wrought cobalt-chromium-tungsten-nickel alloy |
| ISO 5832-3:2016 | Implants for surgery Metallic materials Part 3: Wrought titanium 6-aluminium 4-vanadium alloy |
| ISO 10993-2:2006 | Biological evaluation of medical devices — Part 2: Animal welfare requirements |
| ISO 7405:2008 | Dentistry Evaluation of biocompatibility of medical devices used in dentistry |
| ISO 5832-8:1997 | Implants for surgery Metallic materials Part 8: Wrought cobalt-nickel-chromium-molybdenum- tungsten-iron alloy |
| ISO 5832-4:2014 | Implants for surgery — Metallic materials — Part 4: Cobalt-chromium-molybdenum casting alloy |
| ISO 6474-1:2010 | Implants for surgery Ceramic materials Part 1: Ceramic materials based on high purity alumina |
| ASTM F 763 : 2004 | Standard Practice for Short-Term Screening of Implant Materials |
| ISO 10993-11:2017 | Biological evaluation of medical devices — Part 11: Tests for systemic toxicity |
| ISO 10993-12:2012 | Biological evaluation of medical devices Part 12: Sample preparation and reference materials |
| ISO 5834-2:2011 | Implants for surgery Ultra-high-molecular-weight polyethylene Part 2: Moulded forms |
| ASTM F 748 : 2016 : REDLINE | Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices |
| ISO 10993-1:2009 | Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
| ISO 5832-2:1999 | Implants for surgery Metallic materials Part 2: Unalloyed titanium |
| ISO 5832-7:2016 | Implants for surgery — Metallic materials — Part 7: Forgeable and cold-formed cobalt-chromium-nickel-molybdenum-iron alloy |
| ISO 10993-9:2009 | Biological evaluation of medical devices Part 9: Framework for identification and quantification of potential degradation products |
| ISO 11979-5:2006 | Ophthalmic implants Intraocular lenses Part 5: Biocompatibility |
| ISO 6474-2:2012 | Implants for surgery Ceramic materials Part 2: Composite materials based on a high-purity alumina matrix with zirconia reinforcement |
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