ANSI/AAMI/ISO 13408-6:2005(R2013)&A1:2013
Current
The latest, up-to-date edition.
ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 6: ISOLATOR SYSTEMS
Hardcopy , PDF
English
11-26-2013
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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
Describes 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 |
WG 09
|
| DocumentType |
Standard
|
| ISBN |
978-1-57020-812-6
|
| Pages |
44
|
| ProductNote |
Reconfirmed 201300
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| ISO 13408-6:2005 | Identical |
| ISO 13408-4:2005 | Aseptic processing of health care products — Part 4: Clean-in-place technologies |
| IEST RP CC006.2 : 1997 | TESTING CLEANROOMS |
| ISO 10648-1:1997 | Containment enclosures — Part 1: Design principles |
| ISO/TS 17665-2:2009 | Sterilization of health care products — Moist heat — Part 2: Guidance on the application of ISO 17665-1 |
| ISO 13408-1:2008 | Aseptic processing of health care products — Part 1: General requirements |
| ISO/TS 11139:2006 | Sterilization of health care products Vocabulary |
| ISO 14644-7:2004 | Cleanrooms and associated controlled environments — Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments) |
| ISO 14644-1:2015 | Cleanrooms and associated controlled environments Part 1: Classification of air cleanliness by particle concentration |
| ISO 9001:2015 | Quality management systems — Requirements |
| ISO 10648-2:1994 | Containment enclosures — Part 2: Classification according to leak tightness and associated checking methods |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
| ISO/IEC 90003:2014 | Software engineering Guidelines for the application of ISO 9001:2008 to computer software |
| ISO 17665-1:2006 | Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices |
| ISO 13408-5:2006 | Aseptic processing of health care products Part 5: Sterilization in place |
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