BS EN ISO 10993-7:2008:2010 Edition

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Biological evaluation of medical devices – Ethylene oxide sterilization residuals

Published By	Publication Date	Number of Pages
BSI	2010	98

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Categories: 11.100.20 - Biological evaluation of medical devices, BSI

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Description

This part of ISO 10993 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 ISO 10993.

NOTE This part of ISO 10993 does not specify limits for ethylene glycol (EG).

Additional information

Status	Withdrawn
Title	Biological evaluation of medical devices – Ethylene oxide sterilization residuals
Corrects	BS EN ISO 10993-7:2008
Publisher	BSI
Committee	CH/194
Pages	98
Publication Date	2010-07-31
Withdrawn Date	2022-01-26
ISBN	978 0 580 70145 0
Standard Number	BS EN ISO 10993-7:2008
Identical National Standard Of	ISO 10993-7:2008/Cor 1:2009, EN ISO 10993-7:2008/AC:2009
Descriptors	Chemical analysis and testing, Extraction methods of analysis, Temperature, Standard solutions, Biological analysis and testing, Dose (drug), Conformity, Chemical hazards, Ethylene oxide, Solvent extraction methods, Precision, Safety measures, Factor of safety, Aqueous extraction methods, Sterile equipment, Determination of content, Testing conditions, Biological hazards, Calibration, Medical equipment, Formulae (mathematics), Sampling methods, Sterilization (hygiene), Gas chromatography
ICS Codes	11.100.20 - Biological evaluation of medical devices

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BS EN ISO 10993-7:2008:2010 Edition

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