DIN EN ISO 14937:2010 PDF

Standard No.: DIN EN ISO 14937:2010
Release Date: 2010
Published By: German Institute for Standardization
Status: Be replaced
Replace By: DIN EN ISO 14937:2010-03
Latest: DIN EN ISO 14937:2010-03
Replace: DIN EN ISO 14937:2008 DIN EN ISO 14937 Berichtigung 1:2005 DIN EN ISO 14937:2001

Scope: This Standard specifies general requirements for the characterization of a sterilizing agent, and for the development, validation, and routine monitoring and control of a sterilization process for medical devices.Note Although the scope of this International Standard is limited to medical devices, the requirements specified herein can also be applied to sterilization processes for other health care products.This Standard applies to sterilization processes in which microorganisms are inactivated by physical and/or chemical means.

DIN EN ISO 14937:2010 Referenced Document

ISO 10012 Measurement management systems - Requirements for measurement processes and measuring equipment
ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process*， 2018-08-01 Update
ISO 11138-1:2006 Sterilization of health care products - Biological indicators - Part 1: General requirements
ISO 11140-1 Sterilization of health care products - Chemical indicators - Part 1: General requirements*， 2014-11-01 Update
ISO 11737-1 Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on products — Amendment 1*， 2021-05-19 Update
ISO 11737-2 Sterilization of health care products — Microbiological methods — Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process*， 2019-12-02 Update
ISO 13485:2003 Medical devices - Quality management systems - Requirements for regulatory purposes

2010 DIN EN ISO 14937:2010-03 Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009); German version EN ISO 14937:2009
2010 DIN EN ISO 14937:2010 Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009); German version EN ISO 14937:2009
0000 DIN EN ISO 14937:2008
0000 DIN EN ISO 14937 Berichtigung 1:2005
0000 DIN EN ISO 14937:2001