NF EN ISO 10993-7

May 2026

Standard Current

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

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Main informations

Collections

National standards and national normative documents

Publication date

May 2026

Number of pages

139 p.

Reference

NF EN ISO 10993-7

ICS Codes

11.080.01 Sterilization and disinfection in general

11.100.20 Biological evaluation of medical devices

11.040.01 Medical equipment in general

International kinship

ISO 10993-7:2026

European kinship

EN ISO 10993-7:2026

Replaced standards (2)

NF EN ISO 10993-7

December 2008

Standard Cancelled

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

La présente partie de l''ISO 10993 spécifie les limites admissibles des résidus d''oxyde d''éthylène (OIE) et de chlorhydrate d''éthylène (ECH) pour des dispositifs médicaux individuels stérilisés à l''oxyde d''éthylène, les modes opératoires pour le mesurage de l''oxyde d''éthylène et du chlorhydrate d''éthylène et les méthodes de mesure en vue de déterminer leur conformité et de procéder à leur libération. Une documentation supplémentaire, y compris des directives et un diagramme de flux sont également inclus dans les annexes informatives. Les dispositifs stérilisés à l''oxyde d''éthylène ne présentant pas de contact avec le patient (par exemple les dispositifs de diagnostic in vitro) ne sont pas couverts par la présente partie de l''ISO 10993.

NF EN ISO 10993-7/A1

January 2022

Standard Cancelled

Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals — Amendment 1: Applicability of allowable limits for neonates and infants

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