AAMI ISO 13408-6:2005
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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
19-07-2015
English
01-01-2013
Glossary of equivalent standards
Committee representation
Background of ANSI/AAMI adoption of ISO 13408-6:2005
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Quality system elements
4.1 General
4.2 Management responsibility
4.3 Design control
4.4 Measuring instruments and measuring systems
5 Design of isolator systems
5.1 General
5.2 Types of isolators
5.3 Materials of construction
5.4 Air-handling system
5.5 Operator interface
5.6 Ancillary equipment
6 Facility requirements
6.1 Surrounding room classification
6.2 Process utilities
7 User requirements
7.1 Product/process application
7.2 Ergonomics
7.3 Cleaning
7.4 Bio-decontamination
8 Validation
8.1 General
8.2 Design qualification
8.3 Installation qualification
8.4 Operational qualification
8.5 Performance qualification
8.6 Review and approval of validation
8.7 Requalification
9 Routine monitoring and control
9.1 Procedures
9.2 System integrity
9.3 Bio-decontamination process monitoring
9.4 Environmental monitoring
9.5 Change control
9.6 Maintenance and calibration
10 Personnel training
Bibliography
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