DIN EN ISO 11737-1:2009 PDF

Standard No.: DIN EN ISO 11737-1:2009
Release Date: 2009
Published By: German Institute for Standardization
Status: Be replaced
Replace By: DIN EN ISO 11737-1 E:2016
Latest: DIN EN ISO 11737-1:2021; DIN EN ISO 11737-1:2018; DIN EN ISO 11737-1:2021-10

Scope: This part of ISO 11737 specifies requirements and provides guidance for the enumeration and microbial characterization of the population of viable microorganisms on or in a medical device, component, raw material or package. NOTE 1 The nature and extent of microbial characterization is dependent on the intended use of the bioburden data. This part of ISO 11737 does not specify requirements for the enumeration or identification of viral or protozoan contaminants. NOTE 2 Furthermore, the requirements specified in this part of ISO 11737 are not intended to address the removal and detection of the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease. This part of ISO 11737 does not specify requirements for the microbiological monitoring of the environment in which medical devices are manufactured.

DIN EN ISO 11737-1:2009 Referenced Document

ISO 10012 Measurement management systems - Requirements for measurement processes and measuring equipment
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

2021 DIN EN ISO 11737-1:2021 Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2018 + Amd 1:2021); German version EN ISO 11737-1:2018 + A1:2021
2019 DIN EN ISO 11737-1/A1:2019 Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products - Amendment 1 (ISO 11737-1:2018/DAM 1:2019); German and English version EN ISO 11737-1:2018/prA1:2019
2018 DIN EN ISO 11737-1:2018 Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2018)
1970 DIN EN ISO 11737-1 E:2016-11 Microbiological Methods for Disinfection of Medical Devices Part 1: Determination of Microbial Communities on Products (Draft)
2016 DIN EN ISO 11737-1 E:2016 Draft Document - Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO/DIS 11737-1:2016); German and English version prEN ISO 11737-1:2016
2009 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