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ANSI/AAMI/ISO 13408-6:2005(R2013)&A1:2013

Current
Current

The latest, up-to-date edition.

ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 6: ISOLATOR SYSTEMS
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

26-11-2013

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

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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