Sky Bear Technical Standards - Home
Search
×
FR

Placeholder headline

This is just a placeholder headline

B51-14 (R2019) – Boiler, pressure vessel, and pressure piping code

$

362

BUY NOW

ISO 10993:2008

ISO 10993:2008 Biological evaluation of medical devices – Part 7: Ethylene oxide sterilization residuals

CDN $435.00

SKU: 308adaed8144 Categories: ,

Description

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.

Edition

2

Published Date

2008-10-13

Status

PUBLISHED

Pages

86

Language Detail Icon

English

Format Secure Icon

Secure 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.

Previous Editions

Can’t find what you are looking for?

Please contact us at: