DIN EN ISO 13408-2:2011-09
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 2: FILTRATION
Hardcopy , PDF
30-07-2020
German, English
01-01-2011
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National foreword
National Annex NA (informative) - Bibliography
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Selection of filters and filter assemblies based
on filter manufacturer's data
6 Fluid-specific selection criteria based on filter
user's data
7 Filtration process
8 Filtration system design
9 Routine process
10 Process documentation
11 Maintenance and change control
12 Operator training
Annex A (informative) - Basic information and quality
certificates for filter cartridges
Annex 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
Bibliography
This standard is included in DIN Handbook 406.
| DevelopmentNote |
Supersedes DIN EN 13824. (09/2011) DRAFT 2017 issued in April 2017. (04/2017)
|
| DocumentType |
Standard
|
| Pages |
22
|
| PublisherName |
German Institute for Standardisation (Deutsches Institut für Normung)
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| ISO 13408-2:2003 | Identical |
| EN ISO 13408-2:2018 | Identical |
| DIN HDBK 406 : 2ED 2016 | |
| DIN EN ISO 13408-1:2015-12 | Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013) |
| DIN EN ISO 14534:2015-08 | Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011) |
| DIN EN ISO 14644-1:2016-06 | CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 1: CLASSIFICATION OF AIR CLEANLINESS BY PARTICLE CONCENTRATION (ISO 14644-1:2015) |
| DIN EN ISO 13408-1:2015-12 | Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013) |
| ISO 13408-1:2008 | Aseptic processing of health care products — Part 1: General requirements |
| ISO/TS 11139:2006 | Sterilization of health care products Vocabulary |
| ISO 14644-1:2015 | Cleanrooms and associated controlled environments Part 1: Classification of air cleanliness by particle concentration |
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