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EN ISO 13408-2:2018

Current

Current

The latest, up-to-date edition.

Aseptic processing of health care products - Part 2: Sterilizing filtration (ISO 13408-2:2018)

Published date

21-03-2018

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European foreword
Endorsement notice
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Quality system elements
5 Sterilizing filter characterization
6 Process and equipment characterization
7 Fluid definition
8 Process definition
9 Validation
10 Routine monitoring and control
11 Product release from sterilizing filtration
12 Maintaining process effectiveness
Annex A (informative) - Guidance on the application
        of this document
Bibliography
Annex ZA (informative) - Relationship between
         this European Standard and the Essential
         Requirements of EU Directive 90/385/EEC
         on active implantable medical devices
         [OJ L 189] aimed to be covered
Annex ZB (informative) - Relationship between this
         European Standard and the Essential
         Requirements of EU Directive 93/42/EEC on
         medical devices [OJ L 169] aimed to be covered
Annex ZC (informative) - Relationship between this
         European Standard and the Essential Requirements
         of EU Directive 98/79/EC on in vitro diagnostic
         medical devices [OJ L 331] aimed to be covered

ISO 13408-2:2018 specifies requirements for sterilizing filtration as part of aseptic processing of health care products conducted in accordance with ISO 13408‑1. It also offers guidance to filter users concerning general requirements for set-up, validation and routine operation of a sterilizing filtration process.ISO 13408-2:2018 is not applicable to removal of viruses.Sterilizing filtration is not applicable to fluids that intentionally contain particles larger than the pore size of the filter (e.g. bacterial whole-cell vaccines).ISO 13408-2:2018 is not applicable to high efficiency particulate air (HEPA) filters.ISO 13408-2:2018 does not specify requirements for the development, validation and routine control of a process for removing the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease. Specific recommendations have been produced in particular countries for the processing of materials potentially contaminated with these agents.

Committee
CEN/TC 204
DevelopmentNote
Supersedes EN 13824. (07/2011)
DocumentType
Standard
PublisherName
Comite Europeen de Normalisation
Status
Current
SupersededBy
Supersedes

ISO 13408-4:2005 Aseptic processing of health care products — Part 4: Clean-in-place technologies
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 13408-7:2012 Aseptic processing of health care products — Part 7: Alternative processes for medical devices and combination products
ISO 11135:2014 Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO 11737-1:2006 Sterilization of medical devices Microbiological methods Part 1: Determination of a population of microorganisms on products
ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
ISO 13408-3:2006 Aseptic processing of health care products Part 3: Lyophilization
ISO 13408-1:2008 Aseptic processing of health care products — Part 1: General requirements
ISO 10993-12:2012 Biological evaluation of medical devices Part 12: Sample preparation and reference materials
ISO/IEC 90003:2014 Software engineering Guidelines for the application of ISO 9001:2008 to computer software
ISO 13408-6:2005 Aseptic processing of health care products Part 6: Isolator systems
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
ISO 13408-5:2006 Aseptic processing of health care products Part 5: Sterilization in place

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