EN ISO 10993-9:2009
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2009)
07-10-2021
15-12-2009
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Principles for design of degradation studies
5 Study report
Annex A (normative) - Consideration of the need for
degradation studies
Annex B (informative) - Biodegradation study considerations
Annex ZA (informative) - Relationship between this European
Standard and the Essential Requirements
of EU Directive 93/42/EEC on Medical
devices
Annex ZB (informative) - Relationship between this European
Standard and the Essential Requirements
of EU Directive 90/385/EEC on Active
Implantable Medical Devices
Bibliography
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.
| Committee |
CEN/TC 206
|
| DocumentType |
Standard
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| UNE-EN ISO 10993-9:2010 | Identical |
| UNI EN ISO 10993-9 : 2010 | Identical |
| NS EN ISO 10993-9 : 2009 | Identical |
| PN EN ISO 10993-9 : 2010 | Identical |
| SN EN ISO 10993-9 : 2010 | Identical |
| SS-EN ISO 10993-9:2009 | Identical |
| I.S. EN ISO 10993-9:2009 (APRIL 2010) | Identical |
| NBN EN ISO 10993-9 : 2010 | Identical |
| ISO 10993-9:2009 | Identical |
| BS EN ISO 10993-9 : 2009-12 | Identical |
| NEN EN ISO 10993-9 : 2010 | Identical |
| DIN EN ISO 10993-9:2010-04 | Identical |
| NF EN ISO 10993-9 : 2010 | Identical |
| I.S. EN ISO 10993-9:2009-12 | Identical |
| ONORM EN ISO 10993-9 : 2010 | Identical |
| BS EN ISO 10993-9:2009 | Identical |
| BS EN ISO 10993-9:May 2009 | Identical |
| UNE-EN ISO 10993-9:2009 | Identical |
| BS EN ISO 10993-9:December 2009 | Identical |
| BS EN 16105:2011 | Paints and varnishes. Laboratory method for determination of release of substances from coatings in intermittent contact with water |
| I.S. EN ISO 7198:2017 | CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR PROSTHESES - TUBULAR VASCULAR GRAFTS AND VASCULAR PATCHES (ISO 7198:2016) |
| 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 7198:2017 | Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches (ISO 7198:2016) |
| 10/30218101 DC : 0 | BS EN 16105 - PAINTS AND VARNISHES - LEACHING OF SUBSTANCES FROM COATINGS - LABORATORY IMMERSION METHOD |
| 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 |
| DIN EN 13503-6:2003-03 | OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 6: SHELF-LIFE AND TRANSPORT STABILITY |
| 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 12442-1:2000 | ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 1: ANALYSIS AND MANAGEMENT OF RISK |
| I.S. EN 13503-6:2002 | OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 6: SHELF-LIFE AND TRANSPORT STABILITY |
| BS EN 12442-1:2000 | Animal tissues and their derivatives utilized in the manufacture of medical devices Analysis and management of risk |
| 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 |
| BS EN ISO 25539-1:2017 | Cardiovascular implants. Endovascular devices Endovascular prostheses |
| I.S. EN ISO 15798:2013 | OPHTHALMIC IMPLANTS - OPHTHALMIC VISCOSURGICAL DEVICES (ISO 15798:2013) |
| I.S. EN ISO 25539-1:2017 | CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES (ISO 25539-1:2017) |
| EN 16105:2011 | Paints and varnishes - Laboratory method for determination of release of substances from coatings in intermittent contact with water |
| EN ISO 7198:2017 | Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches (ISO 7198:2016) |
| BS EN ISO 7198:2017 | Cardiovascular implants and extracorporeal systems. Vascular prostheses. Tubular vascular grafts and vascular patches |
| DIN EN 16105:2011-12 | Paints and varnishes - Laboratory method for determination of release of substances from coatings in intermittent contact with water |
| UNI EN 16105 : 2011 | PAINTS AND VARNISHES - LABORATORY METHOD FOR DETERMINATION OF RELEASE OF SUBSTANCES FROM COATINGS IN INTERMITTENT CONTACT WITH WATER |
| UNE-EN 16105:2012 | Paints and varnishes - Laboratory method for determination of release of substances from coatings in intermittent contact with water |
| 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) |
| 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 |
| 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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