DIN EN ISO 10993-7:2009-02
Superseded Standard
Historical

DIN EN ISO 10993-7:2009-02

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008); German version EN ISO 10993-7:2008
Most recent standard

Summary

This part of ISO 10993 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 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 this standard.

Notes

Amendement prévu par DIN EN ISO 10993-7/A1 (2018-08).

Technical characteristics

Publisher Deutsche Institut für Normung e.V. (DIN)
Publication Date 02/01/2009
Page Count 108
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Superseded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Superseded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

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008); German version 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

Evaluation biologiques des dispositifs médicaux - Partie 7: Résidus de stérilisation à l'oxyde d'éthylène (ISO 10993-7:1995); version allemande EN ISO 10993-7:1995
01/11/1995
Superseded
Historical
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