BS EN ISO 11737-1:2006

BS EN ISO 11737-1:2006 specifies requirements and provides guidance for the enumeration and microbialcharacterization 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.

BS EN ISO 11737-1:2006 does not specify requirements for the enumeration or identification of viral or protozoan contaminants.

NOTE 2 Furthermore, the requirements specified in BS EN ISO 11737-1:2006 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.

BS EN ISO 11737-1:2006 does not specify requirements for the microbiological monitoring of the environment in which medical devices are manufactured.



Cross References:
ISO 10012
ISO 13485:2003
ISO/IEC 17025:2005
ISO/TR 7871:1997
ISO 8258:1991
ISO 9000:2005
ISO 17665-1
ISO 11137-1
ISO 11137-2
ISO 11137-3
ISO 11138-2
ISO/TS 11139:2006
ISO 11737-2
ISO 14160:1998
ISO 14937:2000
ISO 90003:2004
ISO 9001:2000
ASTM D4855:1997
90/385/EEC
93/42/EEC
98/79/EC




Keywords: Sterile equipment; Sterilization (hygiene); Medical equipment; Medical instruments; Microbiological analysis; Count methods (microbiology) ; Biological analysis and testing; Packaging; Microbiology; Quality management

Product Code(s): 30245504,30245504

This product references:ISO 13485:2003 - Medical devices - Quality management systems - Requirements for regulatory purposes
ISO 8258:1991 - Shewhart control charts
ISO 14160:1998 - Sterilization of single-use medical devices incorporating materials of animal origin -- Validation and routine control of sterilization by liquid chemical sterilants
ISO 9001:2000 - Quality management systems -- Requirements
ISO 14937:2000 - 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/IEC 17025:2005 - General requirements for the competence of testing and calibration laboratories
ISO 9000:2005 - Quality management systems - Fundamentals and vocabulary
This product referenced by:BS 09/30190221 DC - Sterilization of medical devices. Microbiological methods. Determination of a population of microorganisms on products
BS EN 13795:2011 - Sterilization of medical devices. Microbiological methods. Determination of a population of microorganisms on products
This product replaces:BS EN 1174-1:1996 - Sterilization of medical devices. Estimation of the population of micro-organisms on product. Requirements
BS EN 1174-2:1997 - Sterilization of medical devices. Estimation of the population of micro-organisms on product. Guidance
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

Browse Product Family:

BS EN ISO 11737-1:2006
BS EN 1174-3:1997
BS EN 1174-2:1997
BS EN 1174-1:1996

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