DIN EN ISO 11137-2:2007
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2006, corrected version 2006-08-01); English version of DIN EN ISO 11137-2:2007-09

Standard No.

DIN EN ISO 11137-2:2007

Release Date

2007

Published By

German Institute for Standardization

Status

Withdraw

Replace By

DIN EN ISO 11137-2:2012

Latest

DIN EN ISO 11137-2:2023-08

Scope

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 ISO 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.

DIN EN ISO 11137-2:2007 history

• 2023 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
• 2023 DIN EN ISO 11137-2:2023 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013 + Amd 1:2022) (includes Amendment A1:2023)
• 2021 DIN EN ISO 11137-2/A1:2021-02 Potentiometers for use in electronic equipment - Part 3: Sectional specification: Rotary precision potentiometers (IEC 40/2760/CD:2020); Text in German and English / Note: Date of issue 2021-01-29
• 2021 DIN EN ISO 11137-2/A1:2021 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
• 2015 DIN EN ISO 11137-2:2015-11 Dentistry - Test methods for dental unit waterline biofilm treatment (ISO 16954:2015); German version EN ISO 16954:2015
• 2015 DIN EN ISO 11137-2:2015 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013); German version EN ISO 11137-2:2015
• 2013 DIN EN ISO 11137-2:2013 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013); German version EN ISO 11137-2:2013
• 2012 DIN EN ISO 11137-2:2012 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2012); German version EN ISO 11137-2:2012
• 2007 DIN EN ISO 11137-2:2007 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2006, corrected version 2006-08-01); English version of DIN EN ISO 11137-2:2007-09