I.S. 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)
Hardcopy , PDF
English
01-01-2018
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National Foreword
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
Defines requirements for sterilizing filtration as part of aseptic processing of health care products conducted in accordance with ISO 13408-1.
| DevelopmentNote |
Supersedes I.S. EN 13824. (07/2011)
|
| DocumentType |
Standard
|
| Pages |
56
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| ISO 13408-2:2018 | Identical |
| 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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