NF EN ISO 10993-7

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.

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Collections

National standards and national normative documents

Publication date

December 2008

Number of pages

107 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

S99-501-7

Print number

1 - 04/12/2008

International kinship

ISO 10993-7:2008

European kinship

EN ISO 10993-7:2008
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.

Replaced standards (1)
NF EN ISO 10993-7
January 1996
Standard Cancelled
Biological evaluation of medical devices. Part 7 : ethylene oxide sterilization residuals.

Table of contents
  • Avant-propos
    iv
  • Introduction
    vi
  • 1 Domaine d'application
    1
  • 2 Références normatives
    1
  • 3 Termes et définitions
    2
  • 4 Exigences
    2
  • 4.1 Généralités
    2
  • 4.2 Classification des dispositifs
    3
  • 4.3 Limites admissibles
    3
  • 4.4 Détermination des taux de résidus d'oxyde d'éthylène et de chlorhydrate d'éthylène
    5
  • 5 Libération du produit
    11
  • 5.1 Généralités
    11
  • 5.2 Libération des produits en l'absence de courbes de dissipation
    11
  • 5.3 Libération des produits en présence de courbes de dissipation
    12
  • Annexe A (normative) Évaluation des chromatogrammes en phase gazeuse
    14
  • Annexe B (informative) Détermination des taux d'oxyde d'éthylène et de chlorhydrate d'éthylène par chromatographie en phase gazeuse
    8
  • Annexe C (informative) Diagramme de flux et directives pour l'application de la série de normes de la présente partie de l'ISO 10993 afin de déterminer les taux de résidus d'oxyde d'éthylène et de chlorhydrate d'éthylène dans les dispositifs médicaux
    22
  • Annexe D (informative) Facteurs influençant les résidus de produit
    30
  • Annexe E (informative) Conditions d'extraction pour la détermination des taux résiduels d'oxyde d'éthylène
    32
  • Annexe F (informative) Justificatifon pour les dispositions de la présente partie de l'ISO 10993
    33
  • Annexe G (informative) Établissement de limites admissibles d'oxyde d'éthylène
    38
  • Annexe H (informative) Établissement de limites admissibles de chlorhydrate d'éthylène
    58
  • Annexe I (informative) Établissement de limites admissibles d'éthylène glycol
    68
  • Annexe J (informative) Préparation d'étalons d'oxyde d'éthylène et de chlorhydrate d'éthylène
    73
  • Annexe K (informative) Méthodes de mesure des résidus d'oxyde d'éthylène
    77
  • Bibliographie
    85
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