EN ISO 10993-9:2009

Superseded

Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2009)

Available format(s):

Superseded date: 07-10-2021

Language(s):

Published date: 15-12-2009

Publisher: Comite Europeen de Normalisation

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Table of Contents - (Show below) - (Hide below)

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

Abstract - (Show below) - (Hide below)

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.

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

Committee	CEN/TC 206
Document Type	Standard
ISBN
Pages
Published
Publisher	Comite Europeen de Normalisation
Status	Superseded
Superseded By	EN ISO 10993-9:2021

National Adoptions - (Show below) - (Hide below)

Equivalent Standard(s)	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:May 2009	Identical
UNE-EN ISO 10993-9:2009	Identical
BS EN ISO 10993-9:December 2009	Identical

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

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
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
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 10993-14:2009-08	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

Standards Referencing This Book - (Show below) - (Hide below)

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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