DIN EN ISO 10993-7:1995-11
Superseded Standard
Historical

DIN EN ISO 10993-7:1995-11

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:1995); German version EN ISO 10993-7:1995
Most recent standard

Summary

The document 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 and guidance also is included in informative annexes.

Technical characteristics

Publisher Deutsche Institut für Normung e.V. (DIN)
Publication Date 11/01/1995
Page Count 35
EAN ---
ISBN ---
Weight (in grams) ---
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Previous versions

DIN EN ISO 10993-7:2024-08

DIN EN ISO 10993-7:2024-08

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO/DIS 10993-7:2024); German and English version prEN ISO 10993-7:2024
01/08/2024
Active
Most Recent
DIN EN ISO 10993-7:2022-09

DIN EN ISO 10993-7:2022-09

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008 + Cor 1:2009 + Amd 1:2019); German version EN ISO 10993-7:2008 + AC:2009 + A1:2022
01/09/2022
Active , Under review
Most Recent
DIN EN ISO 10993-7/A1:2018-08

DIN EN ISO 10993-7/A1:2018-08

Évaluation biologique des dispositifs médicaux - Partie 7: Résidus de stérilisation à l'oxyde d'éthylène - Amendement 1 (ISO 10993-7:2008/DAM 1:2018); Version allemande et anglaise EN ISO 10993-7:2008/prA1:2018
01/08/2018
Superseded
Historical
DIN EN ISO 10993-7 Berichtigung 1:2011-06

DIN EN ISO 10993-7 Berichtigung 1:2011-06

Évaluation biologique des dispositifs médicaux - Partie 7: Résidus de stérilisation à l'oxyde d'éthylène (ISO 10993-7:2008); Version allemande EN ISO 10993-7:2008, Corrigendum à DIN EN ISO 10993-7:2009-02, Version allemande EN ISO 10993-7:2008/AC:2009
01/06/2011
Superseded
Historical
DIN EN ISO 10993-7:2009-02

DIN EN ISO 10993-7:2009-02

Évaluation biologique des dispositifs médicaux - Partie 7: Résidus de stérilisation à l'oxyde d'éthylène (ISO 10993-7:2008); Version allemande EN ISO 10993-7:2008
01/02/2009
Superseded
Historical
DIN EN ISO 10993-7:2006-11

DIN EN ISO 10993-7:2006-11

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO/DIS 10993-7:2006); German version prEN ISO 10993-7:2006
01/11/2006
Superseded
Historical
DIN EN ISO 10993-7:1995-11

DIN EN ISO 10993-7:1995-11

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:1995); German version EN ISO 10993-7:1995
01/11/1995
Superseded
Historical
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