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STERILIZATION OF HEALTH CARE PRODUCTS - MICROBIOLOGICAL METHODS - PART 1: DETERMINATION OF A POPULATION OF MICROORGANISMS ON PRODUCTS (ISO 11737-1:2018)
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Available format(s): Hardcopy, PDF
Superseded date: 21-07-2021
Language(s): English
Published date: 01-01-2018
Publisher: National Standards Authority of Ireland
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.Only cited Standards give presumption of conformance to New Approach Directives/Regulations.Dates of withdrawal of national standards are available from NSAI.
National ForewordEuropean forewordEndorsement noticeForewordIntroduction1 Scope2 Normative references3 Terms and definitions4 General requirements5 Selection of products6 Methods of determination and microbial characterization of bioburden7 Validation of the method for determining bioburden8 Routine determination of bioburden and interpretation of data9 Maintenance of the method for determining bioburdenAnnex A (informative) - Guidance on the determination of a population of microorganisms on productsAnnex B (informative) - Guidance on methods to determine bioburdenAnnex C (informative) - Validation of bioburden recovery efficiencyAnnex D (informative) - Typical assignment of responsibilitiesBibliographyAnnex 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
Gives requirements and provides guidance for the enumeration and microbial characterization of the population of viable micro-organisms on or in a medical device, component, raw material or package.
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