NF EN ISO 10993-7
NF EN ISO 10993-7

NF EN ISO 10993-7

January 1996
Standard Cancelled

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

January 1996

Release date

novembre 2008

Number of pages

55 p.

Reference

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

Print number

1 - février 1996

International kinship

ISO 10993-7:1995

European kinship

EN ISO 10993-7:1995
Standard replaced by (1)
NF EN ISO 10993-7
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.

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