EN ISO 13408-6:2011/A1:2013
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 6: ISOLATOR SYSTEMS (ISO 13408-6:2005/AMD 1:2013)
29-05-2021
12-01-2013
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Quality system elements
5 Design of isolator systems
6 Facility requirements
7 User requirements
8 Validation
9 Routine monitoring and control
10 Personnel training
Bibliography
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
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