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ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 6: ISOLATOR SYSTEMS (ISO 13408-6:2005)
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Available format(s): Hardcopy, PDF
Withdrawn date: 30-11-2021
Language(s): English
Published date: 01-01-2011
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.
Foreword Introduction 1 Scope2 Normative references3 Terms and definitions4 Quality system elements5 Design of isolator systems 6 Facility requirements7 User requirements 8 Validation9 Routine monitoring and control 10 Personnel training BibliographyAnnex ZA (informative) - Relationship between this European Standard and the Essential Requirements of EU Directive 90/385/EEC on Active Implantable Medical DevicesAnnex ZB (informative) - Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on Medical DevicesAnnex ZC (informative) - Relationship between this European Standard and the Essential Requirements of EU Directive 98/79/EC on in vitro diagnostic medical devices
Gives the requirements for isolator systems used for aseptic processing and offers guidance on qualification, bio-decontamination, validation, operation and control of isolator systems used for aseptic processing of health care products.
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