I.S. EN ISO 13408-6:2021
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 6: Isolator systems
Hardcopy , PDF
07-14-2021
English
06-16-2021
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.
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Quality system elements
5 Basic principle of isolator systems
6 Isolator system specification
7 Design of isolator systems
8 Validation
9 Routine monitoring and control
10 Personnel training
Annex A (informative) Devices acting as transfer ports for portable and mobile equipment
Annex B (informative) Isolator system — Explanation of terms used and flow of air and
material
Annex C (informative) Isolator system — Direct/indirect product contact surfaces
Bibliography
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