DIN EN ISO 11137-2:2013-09
Superseded Standard
Historical

DIN EN ISO 11137-2:2013-09

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013); German version EN ISO 11137-2:2013
Most recent standard

Summary

This part of ISO 11137 specifies methods of determining the minimum dose needed to achieve a specified requirement for sterility and methods to substantiate the use of 25 kGy or 15 kGy as the sterilization dose to achieve a sterility assurance level (SAL) of 10-6. This part of IS 11137 also specifies methods of dose auditing to demonstrate the continued effectiveness of the sterilization dose. This part of ISO 11137 defines product families for dose establishment and dose auditing.

Technical characteristics

Publisher Deutsche Institut für Normung e.V. (DIN)
Publication Date 09/01/2013
Cancellation Date 11/01/2015
Page Count 86
EAN ---
ISBN ---
Weight (in grams) ---
No products.

Previous versions

DIN EN ISO 11137-2:2023-08

DIN EN ISO 11137-2:2023-08

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013 + Amd 1:2022); German version EN ISO 11137-2:2015 + A1:2023

Traduction automatique de l'anglais :
Stérilisation des produits de santé - Rayonnement - Partie 2 : Établissement de la dose stérilisante (ISO 11137-2:2013 + Amd 1:2022) ; Version allemande EN ISO 11137-2:2015 + A1:2023
01/08/2023
Active
Most Recent
DIN EN ISO 11137-2/A1:2021-02

DIN EN ISO 11137-2/A1:2021-02

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose - AMENDMENT 1 (ISO 11137-2:2013/DAM 1:2021); German and English version EN ISO 11137-2:2015/prA1:2021
01/02/2021
Superseded
Historical
DIN EN ISO 11137-2:2015-11

DIN EN ISO 11137-2:2015-11

Stérilisation des produits de santé - Irradiation - Partie 2: Établissement de la dose stérilisante (ISO 11137-2:2013); Version allemande EN ISO 11137-2:2015
01/11/2015
Superseded
Historical
DIN EN ISO 11137-2:2013-09

DIN EN ISO 11137-2:2013-09

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013); German version EN ISO 11137-2:2013
01/09/2013
Superseded
Historical
DIN EN ISO 11137-2:2012-10

DIN EN ISO 11137-2:2012-10

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO/FDIS 11137-2:2012); German version FprEN ISO 11137-2:2012
01/10/2012
Superseded
Historical
DIN EN ISO 11137-2:2012-07

DIN EN ISO 11137-2:2012-07

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2012); German version EN ISO 11137-2:2012
01/07/2012
Superseded
Historical
DIN EN ISO 11137-2:2010-07

DIN EN ISO 11137-2:2010-07

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO/DIS 11137-2:2010); German version prEN ISO 11137-2:2010
01/07/2010
Superseded
Historical
DIN EN ISO 11137-2 Berichtigung 1:2009-09

DIN EN ISO 11137-2 Berichtigung 1:2009-09

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2006, corrected version 2006-08-01); German version EN ISO 11137-2:2007, Corrigendum to DIN EN ISO 11137-2:2007-09; German version EN ISO 11137-2:2007/AC:2009
01/09/2009
Superseded
Historical
DIN EN ISO 11137-2:2009-06

DIN EN ISO 11137-2:2009-06

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO/DIS 11137-2:2009); German version prEN ISO 11137-2:2009
01/06/2009
Superseded
Historical
DIN EN ISO 11137-2:2007-09

DIN EN ISO 11137-2:2007-09

Stérilisation des produits de santé - Irradiation - Partie 2: Établissement de la dose stérilisante (ISO 11137-2:2006, version corrigée 2006-08-01); Version allemande EN ISO 11137-2:2007
01/09/2007
Superseded
Historical
DIN EN ISO 11137-2:2007-04

DIN EN ISO 11137-2:2007-04

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2006, corrected version 2006-08-01); German version prEN ISO 11137-2:2007
01/04/2007
Superseded
Historical
DIN EN ISO 11137-2:2006-07

DIN EN ISO 11137-2:2006-07

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2006); German version EN ISO 11137-2:2006
01/07/2006
Superseded
Historical
DIN EN ISO 11137-2:2004-08

DIN EN ISO 11137-2:2004-08

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO/DIS 11137-2:2004); German version prEN ISO 11137-2:2004
01/08/2004
Superseded
Historical
Contact us