CSA ISO 10993-7 : 1998

Withdrawn

Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 7: ETHYLENE OXIDE STERILIZATION RESIDUALS

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Withdrawn date: 31-08-2009

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Published date: 31-12-2006

Publisher: Canadian Standards Association

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

1 Scope
2 Normative references
3 Definitions
4 Requirements
   4.1 General
   4.2 Categorization of devices
   4.3 Allowable limits
   4.4 Determination of ED and ECH residuals
5 Product release
   5.1 Release of products without dissipation curve
       data
   5.2 Procedure for product release using residue
       dissipation can
Annexes
A Evaluation of gas chromatograms

Abstract - (Show below) - (Hide below)

Specifies limits allowable for residual ethylene oxide and ethylene chlorohydrin in individual sterilized medical devices, methods of determining compliance and procedures for the measurement of ethylene chlorohydrin and ethylene oxide are covered.

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Document Type	Standard
ISBN
Pages
Published
Publisher	Canadian Standards Association
Status	Withdrawn
Supersedes	CSA ISO 10993-7 : 0

International Equivalents – Equivalent Standard(s) & Relationship - (Show below) - (Hide below)

Equivalent Standard(s)	Relationship
ISO 10993-7:2008	Identical

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

CSA Z8638 : 2008	CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - EXTRACORPOREAL BLOOD CIRCUIT FOR HAEMODIALYSERS, HAEMODIAFILTERS AND HAEMOFILTERS
CSA ISO 10993-13 : 0	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 13: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM POLYMERIC MEDICAL DEVICES
CSA ISO 10993-16 : 0	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 16: TOXICOKINETIC STUDY DESIGN FOR DEGRADATION PRODUCTS AND LEACHABLES
CSA ISO 10993-9 : 0	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 9: FRAMEWORK FOR IDENTIFICATION AND QUANTIFICATION OF POTENTIAL DEGRADATION PRODUCTS
CSA Z8637 : 2008	CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS

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
EN 550 : 1994	STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF ETHYLENE OXIDE STERILIZATION
ISO 11135:2014	Sterilization of health-care products Ethylene oxide Requirements for the development, validation and routine control of a sterilization process for medical devices
AAMI ST30 : 1989	DETERMINING RESIDUAL ETHYLENE CHLOROHYDRIN AND ETHYLENE GLYCOL IN MEDICAL DEVICES
AAMI ST29 : 1988	DETERMINING RESIDUAL ETHYLENE OXIDE IN MEDICAL DEVICES
ISO 10993-10:2010	Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
ISO 10993-1:2009	Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process

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