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Superseded

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BS EN ISO 11737-1 - STERILIZATION OF HEALTH CARE PRODUCTS - MICROBIOLOGICAL METHODS - PART 1: DETERMINATION OF A POPULATION OF MICROORGANISMS ON PRODUCT

Available format(s)

Hardcopy , PDF

Superseded date

21-02-2018

Language(s)

English

Publisher

British Standards Institution

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Quality management system elements
5 Selection of product
6 Methods of determination and microbial
  characterization of bioburden
7 Validation of method for determining
  bioburden
8 Routine determination of bioburden and
  interpretation of data
9 Maintenance of the method of determination
  of bioburden
Annex A (informative) - Guidance on determination
        of a population of microorganisms on product
Annex B (informative) - Guidance on methods of
        determination of bioburden
Annex C (informative) - Validation of bioburden
        recovery efficiency
Annex D (informative) - Typical assignment of responsibilities
Annex ZA (informative) - Relationship between this
         European Standard and the Essential Requirements of
         EU Directive 90/385/EEC on active implantable medical
         devices
Annex ZB (informative) - Relationship between this European
         Standard and the Essential Requirements of EU Directive
         93/42/EEC on medical devices
Annex ZC (informative) - Relationship between this European
         Standard and the Essential Requirements of EU Directive
         98/79/EC on in vitro diagnostic medical devices
Bibliography

BS EN ISO 11737-1.

Committee	CH/198
DocumentType	Draft
Pages	70
PublisherName	British Standards Institution
Status	Superseded
SupersededBy	BS EN ISO 11737-1:2006

ISO/IEC 17025:2005	General requirements for the competence of testing and calibration laboratories
ISO 11137-1:2006	Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
ISO 14160:2011	Sterilization of health care products Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives Requirements for characterization, development, validation and routine control of a sterilization process for medical devices
ISO 11737-2:2009	Sterilization of medical devices Microbiological methods Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
ISO 13485:2016	Medical devices Quality management systems Requirements for regulatory purposes
ISO 14937:2009	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 11138-2:2017	Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes
ISO/TS 11139:2006	Sterilization of health care products Vocabulary
ISO 11137-3:2017	Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects of development, validation and routine control
ISO 10012:2003	Measurement management systems — Requirements for measurement processes and measuring equipment
ISO 9000:2015	Quality management systems — Fundamentals and vocabulary
ISO/IEC 90003:2014	Software engineering Guidelines for the application of ISO 9001:2008 to computer software
ISO/TR 7871:1997	Cumulative sum charts Guidance on quality control and data analysis using CUSUM techniques
ISO 17665-1:2006	Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices