UNI EN ISO 13408-2 : 2011
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by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
23-07-2013
01-01-2011
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
Describes requirements for sterilizing filtration as part of aseptic processing of health care products. Also provides guidance to filter users concerning general requirements for set-up, validation and routine operation of a sterilizing filtration process, to be used for aseptic processing of health care products.
| DevelopmentNote |
Supersedes UNI EN 13824. (10/2011)
|
| DocumentType |
Standard
|
| PublisherName |
Ente Nazionale Italiano di Unificazione (UNI)
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| ISO 13408-2:2003 | Identical |
| EN ISO 13408-2:2018 | Identical |
| 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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