DIN EN ISO 10993-7 Berichtigung 1:2011-06
Superseded Standard Corrigendum
Historical

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

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008); German version EN ISO 10993-7:2008, Corrigendum to DIN EN ISO 10993-7:2009-02, German version EN ISO 10993-7:2008/AC:2009
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.

Technical characteristics

Publisher Deutsche Institut für Normung e.V. (DIN)
Publication Date 06/01/2011
Page Count 3
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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Superseded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

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008); German version EN ISO 10993-7:2008, Corrigendum to DIN EN ISO 10993-7:2009-02, German version 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Superseded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

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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