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

Standard No.

DIN EN ISO 11137-2:2015

Release Date

2015

Published By

German Institute for Standardization

Status

Be replaced

Replace By

DIN EN ISO 11137-2:2015-11

Latest

DIN EN ISO 11137-2:2023-08

Replace

DIN EN ISO 11137-2:2013

DIN EN ISO 11137-2:2015 Referenced Document

• DIN EN ISO 11137-1:2015 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013); German version EN ISO 11137-1:2015
• DIN EN ISO 11737-1:2009 Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2006) (includes Corrigendum AC:2009); English version of DIN EN ISO 11737-1:2009-09
• DIN EN ISO 11737-2:2010 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2009); German version EN ISO 11737-2:2009
• DIN EN ISO 14971:2013 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01); German version EN ISO 14971:2012
• ISO 11137-1:2006 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
• ISO 11137-3:2006 Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects
• ISO 11137:1995 Sterilization of health care products - Requirements for validation and routine control - Radiation sterilization
• ISO 11737 Sterilization of health care products — Microbiological methods — Part 3: Bacterial endotoxin testing*， 2023-06-01 Update
• ISO 11737-1:2006 Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products
• ISO/TS 11139:2006 Sterilization of health care products - Vocabulary

DIN EN ISO 11137-2:2015 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
• 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