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SRPS EN ISO 10993-7:2011/A1:2022

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals - Amendment 1: Applicability of allowable limits for neonates and infants (ISO 10993-7:2008/Amd 1:2019)

Jun 30, 2022

General information

60.60     Jun 30, 2022

ISS

Z076

European Norm

11.100.20  

English  

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Scope

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

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PUBLISHED
SRPS EN ISO 10993-7:2011/A1:2022
60.60 Standard published
Jun 30, 2022

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naSRPS EN 10993-7:2022

Related project

Adopted from EN ISO 10993-7:2008/A1:2022

Adopted from ISO 10993-7:2008/Amd 1:2019