I.S. 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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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
Hardcopy , PDF
26-06-2021
English
01-01-2013
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
Dates of withdrawal of national standards are available from NSAI.
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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
This part of ISO 13408 specifies the requirements for isolator systems used for aseptic processing and offers guidance on qualification, bio-decontamination, validation, operation and control of isolator systems used for aseptic processing of health care products.
| Committee |
TC 198
|
| DocumentType |
Standard
|
| Pages |
49
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| ISO 13408-6:2005/Amd 1:2013 | Identical |
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