EN ISO 10993-7 : 2008 COR 2009

Superseded

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BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 7: ETHYLENE OXIDE STERILIZATION RESIDUALS (ISO 10993-7:2008/COR 1:2009)

Available format(s):

Superseded date: 21-01-2022

Language(s):

Published date: 15-11-2009

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 Requirements
  4.1 General
  4.2 Categorization of devices
  4.3 Allowable limits
  4.4 Determination of EO and ECH residuals
5 Product release
  5.1 General
  5.2 Release of products without dissipation curve data
  5.3 Procedure for product release using residue dissipation
      curves
Annex A (normative) - Evaluation of gas chromatograms
Annex B (informative) - Gas chromatographic determination
                        for EO and ECH
Annex C (informative) - Flowchart and guidance for the
                        application of this part of ISO
                        10993 series of standards to the
                        determination of EO and ECH residuals
                        in medical devices
Annex D (informative) - Factors influencing product residual
Annex E (informative) - Extraction conditions for
                        determination of residual EO
Annex F (informative) - Rationale for the provisions of this
                        part of ISO 10993
Annex G (informative) - Establishment of allowable limits for
                        EO
Annex H (informative) - Establishment of allowable limits for
                        ECH
Annex I (informative) - Establishment of allowable limits for
                        EG
Annex J (informative) - Preparation of EO and ECH standards
Annex K (informative) - Ethylene oxide residue measuring
                        methods
Bibliography
Annex ZA (informative) - Relationship between this International
                         Standard and the Essential Requirements
                         of EU Directive 93/42/EEC Medical
                         devices
Annex ZB (informative) - Relationship between this International
                         Standard and the Essential Requirements
                         of EU Directive 90/385/EEC on Active
                         Implantable Medical Devices

Abstract - (Show below) - (Hide below)

Describes allowable limits for residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) in individual EO-sterilized medical devices, procedures for the measurement of EO and ECH, and methods for determining compliance so that devices may be released.

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

Committee	TC 206
Document Type	Standard
ISBN
Pages
Published
Publisher	Comite Europeen de Normalisation
Status	Superseded
Superseded By	EN ISO 10993-7:2008+A1:2022
Supersedes	EN ISO 10993-7:2008

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

Equivalent Standard(s)	Relationship
ONORM EN ISO 10993-7 : 2010	Identical
NBN EN ISO 10993-7 : 2008 COR 2009	Identical
PN EN ISO 10993-7 : 2009 AC 2010	Identical
UNE-EN ISO 10993-7:2009	Identical
SN EN ISO 10993-7 : 2008 CORR 2009	Identical
BS EN ISO 10993-7:2008 (published 2010-07)	Identical
UNI EN ISO 10993-7 : 2009	Identical
NF EN ISO 10993-7 : 2008	Identical
I.S. EN ISO 10993-7:2008+AC:2009	Identical
DIN EN ISO 10993-7:2009-02	Identical
NEN EN ISO 10993-7 : 2008 C1 2009	Identical
I.S. EN ISO 10993-7:2008	Identical
ISO 10993-7:2008	Identical
NS EN ISO 10993-7 : 2008 AC 2009	Identical

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

I.S. EN 12022:1999	BLOOD GAS EXCHANGERS
I.S. EN 13503-8:2000	OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 8: FUNDAMENTAL REQUIREMENTS
DIN EN ISO 7199:2015-06 (Draft)	CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - BLOOD-GAS EXCHANGERS (OXYGENATORS) (ISO 7199:2016)
I.S. EN ISO 7198:2017	CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR PROSTHESES - TUBULAR VASCULAR GRAFTS AND VASCULAR PATCHES (ISO 7198:2016)
UNE-EN ISO 7198:2017	Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches (ISO 7198:2016)
DIN EN 1422:2014-08	STERILIZERS FOR MEDICAL PURPOSES - ETHYLENE OXIDE STERILIZERS - REQUIREMENTS AND TEST METHODS
BS EN 12006-2 : 1998	NON-ACTIVE SURGICAL IMPLANTS - PARTICULAR REQUIREMENTS FOR CARDIAC AND VASCULAR IMPLANTS - PART 2: VASCULAR PROSTHESES INCLUDING CARDIAC VALVE CONDUITS
EN 12011 : 1998	INSTRUMENTATION TO BE USED IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS
EN 13503-8 : 2000	OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 8: FUNDAMENTAL REQUIREMENTS
EN 12022 : 1999	BLOOD GAS EXCHANGERS
PREN 1422 : DRAFT 2011	STERILIZERS FOR MEDICAL PURPOSES - ETHYLENE OXIDE STERILIZERS - REQUIREMENTS AND TEST METHODS
11/30252448 DC : 0	BS EN 1422 - STERILIZERS FOR MEDICAL PURPOSES - ETHYLENE OXIDE STERILIZERS - REQUIREMENTS AND TEST METHODS
BS EN ISO 7199:2017	CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - BLOOD-GAS EXCHANGERS (OXYGENATORS) (ISO 7199:2016)
I.S. EN 1422:2014	STERILIZERS FOR MEDICAL PURPOSES - ETHYLENE OXIDE STERILIZERS - REQUIREMENTS AND TEST METHODS
DIN EN 1422:1997-11	STERILIZERS FOR MEDICAL PURPOSES - ETHYLENE OXIDE STERILIZERS - REQUIREMENTS AND TEST METHODS
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
DIN EN ISO 7199 E : 2017	CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - BLOOD-GAS EXCHANGERS (OXYGENATORS) (ISO 7199:2016)
BS EN 12022:1999	BLOOD-GAS EXCHANGERS
BS 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 12006-2:1998	NON ACTIVE SURGICAL IMPLANTS - PARTICULAR REQUIREMENTS FOR CARDIAC AND VASCULAR IMPLANTS - PART 2: VASCULAR PROSTHESES INCLUDING CARDIAC VALVE CONDUITS
UNI EN 12006-2 : 2009	NON ACTIVE SURGICAL IMPLANTS - PARTICULAR REQUIREMENTS FOR CARDIAC AND VASCULAR IMPLANTS - PART 2: VASCULAR PROSTHESES INCLUDING CARDIAC VALVE CONDUITS
UNI EN 1422 : 2014	STERILIZERS FOR MEDICAL PURPOSES - ETHYLENE OXIDE STERILIZERS - REQUIREMENTS AND TEST METHODS
BS EN ISO 25539-1:2017	Cardiovascular implants. Endovascular devices Endovascular prostheses
I.S. EN 12011:1998	INSTRUMENTATION TO BE USED IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS
I.S. EN ISO 25539-1:2017	CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES (ISO 25539-1:2017)
BS EN 13503-8:2000	OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 8: FUNDAMENTAL REQUIREMENTS
EN ISO 7198:2017	Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches (ISO 7198:2016)
EN 12006-2:1998+A1:2009	Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 2: Vascular prostheses including cardiac valve conduits
EN 1422:2014	Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
BS EN ISO 7198:2017	Cardiovascular implants and extracorporeal systems. Vascular prostheses. Tubular vascular grafts and vascular patches
I.S. EN ISO 7199:2017	CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - BLOOD-GAS EXCHANGERS (OXYGENATORS) (ISO 7199:2016)
DIN EN 12006-2:2009-08	NON ACTIVE SURGICAL IMPLANTS - PARTICULAR REQUIREMENTS FOR CARDIAC AND VASCULAR IMPLANTS - PART 2: VASCULAR PROSTHESES INCLUDING CARDIAC VALVE CONDUITS
BS EN 1422:2014	STERILIZERS FOR MEDICAL PURPOSES - ETHYLENE OXIDE STERILIZERS - REQUIREMENTS AND TEST METHODS
EN ISO 7199:2017	Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) (ISO 7199:2016)
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 10993-3:2014	Biological evaluation of medical devices Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
AAMI ST30 : 1989	DETERMINING RESIDUAL ETHYLENE CHLOROHYDRIN AND ETHYLENE GLYCOL IN MEDICAL DEVICES
AAMI ST29 : 1988	DETERMINING RESIDUAL ETHYLENE OXIDE IN MEDICAL DEVICES
ISO 11135-1:2007	Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
ISO 10993-10:2010	Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
AAMI ST43 : 3ED 93	GOOD HOSPITAL PRACTICE: ETHYLENE OXIDE GAS - VENTILATION RECOMMENDATIONS AND SAFE USE
ISO 10993-12:2012	Biological evaluation of medical devices Part 12: Sample preparation and reference materials
ISO 10993-17:2002	Biological evaluation of medical devices Part 17: Establishment of allowable limits for leachable substances
ISO 10993-1:2009	Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process

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