PR NF EN ISO 10993-7

PR NF EN ISO 10993-7

July 2024
Standard Project

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals

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.

Main informations

Collections

National standards and national normative documents

Publication date

July 2024

Number of pages

283 p.

Reference

PR NF EN ISO 10993-7

ICS Codes

11.040.01   Medical equipment in general
11.080.01   Sterilization and disinfection in general
11.100.20   Biological evaluation of medical devices

Classification index

S99-501-7PR

Print number

1

International kinship

ISO/DIS 10993-7

European kinship

PR EN ISO 10993-7
Sumary
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals

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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