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

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

Classification index

S99-507

Print number

1 - 01/02/1996

International kinship

ISO 10993-7:1995

European kinship

EN ISO 10993-7:1995

Standard replaced by (1)

NF EN ISO 10993-7

December 2008

Standard Current

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.

Table of contents

1
Domaine d'application 1
2
Références normatives 1
3 Définitions
1
4 Prescriptions
2
4.1 Généralités
2
4.2
Classification des dispositifs 2
4.3
Limites admissibles 2
4.4
Détermination des taux de résidus d'oxyde d'éthylène et de chlorhydrate d'éthylène 3
5
Commercialisation du produit 8
5.1
Commercialisation des produits en l'absence de courbes de dissipation 8
5.2
Commercialisation des produits en présence de courbes de dissipation 9
A
Évaluation des résultats de la chromatographie en phase gazeuse (chromatogrammes) 11
B
Détermination des taux d'oxyde d'éthylène et de chlorhydrate d'éthylène par chromatographie en phase gazeuse 14
C
Facteurs influençant les résidus de produit 24
D
Conditions d'extraction pour la détermination des taux résiduels d'oxyde d'éthylène 26
E Justificatifs
27
F Bibliographie
40

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