BS EN ISO 11737-1:2006
Sterilization of medical devices - Microbiological methods - Determination of a population of microorganisms on products

Standard No.

BS EN ISO 11737-1:2006

Release Date

2006

Published By

British Standards Institution (BSI)

Status

Be replaced 2018-02

Replace By

BS EN ISO 11737-1:2018

Latest

BS EN ISO 11737-1:2018+A1:2021

Replace

BS EN 1174-1:1996 BS EN 1174-3:1997 BS EN 1174-2:1997 04/30081258 DC:2004

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.

BS EN ISO 11737-1:2006 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

BS EN ISO 11737-1:2006 history

• 1970 BS EN ISO 11737-1:2018+A1:2021 Sterilization of medical devices. Microbiological methods. Tests of sterility performed in the definition, validation and maintenance of a sterilization process
• 2018 BS EN ISO 11737-1:2018 Sterilization of health care products. Microbiological methods. Determination of a population of microorganisms on products
• 2006 BS EN ISO 11737-1:2006 Sterilization of medical devices - Microbiological methods - Determination of a population of microorganisms on products
• 1997 BS EN 1174-2:1997 Sterilization of medical devices - Estimation of the population of micro-organisms on product - Guidance
• 1996 BS EN 1174-1:1996 Sterilization of medical devices - Estimation of the population of micro-organisms on product - Requirements

BS EN ISO 11737-1:2006 Sterilization of medical devices - Microbiological methods - Determination of a population of microorganisms on products has been changed from BS EN 1174-1:1996 Sterilization of medical devices - Estimation of the population of micro-organisms on product - Requirements.

BS EN ISO 11737-1:2006 Sterilization of medical devices - Microbiological methods - Determination of a population of microorganisms on products has been changed from BS EN 1174-3:1997 Sterilization of medical devices - Estimation of the population of micro-organisms on product - Guide to the methods for validation of microbiological techniques.

BS EN ISO 11737-1:2006 Sterilization of medical devices - Microbiological methods - Determination of a population of microorganisms on products has been changed from BS EN 1174-2:1997 Sterilization of medical devices - Estimation of the population of micro-organisms on product - Guidance.