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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 2: FILTRATION
Hardcopy , PDF
30-07-2020
German, English
01-01-2011
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
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