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BS EN ISO 10993-7:2008

Withdrawn
Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.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 Ethylene oxide sterilization residuals
Available format(s)

Hardcopy , PDF

Withdrawn date

26-01-2022

Language(s)

English

Published date

31-07-2010

This part of ISO10993 specifies 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. Additional background, including guidance and a flowchart showing how this document is applied, are also included in the informative annexes.

EO-sterilized devices that have no patient contact (e.g., in vitro diagnostic devices) are not covered by this part of ISO10993.

NOTE This part of ISO10993 does not specify limits for ethylene glycol (EG).

Committee
CH/194
DevelopmentNote
Supersedes 93/500349 DC. (11/2005) Supersedes 06/30097290 DC. (12/2008)
DocumentType
Standard
Pages
98
PublisherName
British Standards Institution
Status
Withdrawn
Supersedes

BS EN 1283:1996 Haemodialysers, haemodiafilters, haemofilters, haemoconcentrators and their extracorporeal circuits

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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