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

Standard No.

DIN EN ISO 11737-2:2010

Release Date

2010

Published By

German Institute for Standardization

Status

Be replaced

Replace By

DIN EN ISO 11737-2 E:2018

Latest

DIN EN ISO 11737-2:2020-07

Replace

DIN EN ISO 11737-2:2000 DIN EN ISO 11737-2:2008

Scope

This part of ISO 11737 specifies the general criteria for tests of sterility on medical devices that have been exposed to a treatment with the sterilizing agent reduced relative to that anticipated to be used in routine sterilization processing. These tests are intended to be performed when defining, validating or maintaining a sterilization process.

DIN EN ISO 11737-2:2010 Referenced Document

• ISO 10012 Measurement management systems - Requirements for measurement processes and measuring equipment
• ISO 11737-1:2006 Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products
• ISO 13485:2003 Medical devices - Quality management systems - Requirements for regulatory purposes
• ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories

DIN EN ISO 11737-2:2010 history

• 2020 DIN EN ISO 11737-2:2020-07 Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2019); German version EN ISO 11737-2:2020
• 2020 DIN EN ISO 11737-2:2020 Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2019)
• 1970 DIN EN ISO 11737-2 E:2018-07 Microbiological methods for sterilization of medical devices Part 2: Definition, effectiveness and maintenance of sterility tests during sterilization processes (draft)
• 2018 DIN EN ISO 11737-2 E:2018 Draft Document - Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO/DIS 11737-2:2018); German and English version prEN ISO 1173...
• 2010 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
• 0000 DIN EN ISO 11737-2:2008
• 0000 DIN EN ISO 11737-2:2000