Standard

SN EN ISO 10993-7:2008

Dec 2008 Current

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Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals - Applicability of allowable limits for neonates and infants (ISO 10993-7:2008/Amd 1:2019); Amendement A1 Current SN EN ISO 10993-7/A1:2022 Amendment from Publication date: Jul 2022 Pages: 14 Language: English, French, German Services: Online, Online + Pdf
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Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008/Cor 1:2009); Corrigendum AC Current SN EN ISO 10993-7/AC:2009 Corrigendum from Publication date: Nov 2009 Version: Pages: 2 Language: English, French, German Services: Online, Online + Pdf

Abstract

ISO 10993-7:2008 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 the standard is applied are also included in informative annexes.EO-sterilized devices that have no patient contact (e.g., in vitro diagnostic devices) are not covered by ISO 10993-7:2008.

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Standard from INB
Published: December 1 2008
Effective: December 1 2008
Document type: EN
Pages
ISBN:

ICS: 11.100.20
Publisher: SNV
Distributor: SNV
National Committee: INB/NK 129

Swiss Federal Authority: SWISSMEDIC
Designated under following Swiss law: 812.213
Designated under following EU law: 90/385/EWG, Council Directive 93/42/EEC

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Adopted from: ISO 10993-7:2008, IDT
Replaces: SN EN ISO 10993-7:1996

Extended editions Extended editions (0)

Version history Related Corrigenda and Amendments (2)

SN EN ISO 10993-7/A1:2022

SN EN ISO 10993-7/AC:2009

Version history History (2)