EN ISO 13408-2:2018
Current
The latest, up-to-date edition.
Aseptic processing of health care products - Part 2: Sterilizing filtration (ISO 13408-2:2018)
21-03-2018
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 |
Standards | Relationship |
I.S. EN ISO 13408-2:2018 | Identical |
ISO 13408-2:2018 | Identical |
ONORM EN ISO 13408-2 : 2011 | Identical |
NS EN ISO 13408-2 : 2018 | Identical |
NEN EN ISO 13408-2 : 2011 | Identical |
ONORM EN ISO 13408-2:2018 | Identical |
UNE-EN ISO 13408-2:2018 | Identical |
I.S. EN ISO 13408-2:2011 | Identical |
SS-EN ISO 13408-2:2018 | Identical |
SN EN ISO 13408-2:2018 | Identical |
BS EN ISO 13408-2:2011 | Identical |
DIN EN ISO 13408-2:2011-09 | Identical |
NF EN ISO 13408-2 : 2018 | Identical |
UNE-EN ISO 13408-2:2011 | Identical |
NF EN ISO 13408-2 : 2011 | Identical |
SN EN ISO 13408-2 : 2011 | Identical |
NBN EN ISO 13408-2 : 2011 | Identical |
PN EN ISO 13408-2 : 2012 | Identical |
NEN-EN-ISO 13408-2:2018 | Identical |
UNI EN ISO 13408-2:2018 | Identical |
UNI EN ISO 13408-2 : 2011 | Identical |
DIN EN ISO 13408-2:2018-06 | Identical |
PN-EN ISO 13408-2:2018-05 | Identical |
BS EN ISO 13408-2:2018 | Identical |
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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