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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Withdrawn
Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.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Withdrawn date

09-01-2009

Published date

01-01-2007

Publisher

Canadian Standards Association

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

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.

DocumentType
Standard
PublisherName
Canadian Standards Association
Status
Withdrawn
Supersedes

Standards Relationship
ISO 10993-7:2008 Identical

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

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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