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UNI EN ISO 13408-6 : 2013

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by

ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 6: ISOLATOR SYSTEMS

Superseded date

31-08-2022

Superseded by

UNI EN ISO 13408-6:2021

Published date

01-01-2013

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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
Annex ZA (informative) - Relationship between this
         European Standard and the Essential Requirements
         of EU Directive 90/385/EEC on Active Implantable
         Medical Devices
Annex ZB (informative) - Relationship between this
         European Standard and the Essential Requirements
         of EU Directive 93/42/EEC on Medical Devices
Annex ZC (informative) - Relationship between this
         European Standard and the Essential Requirements
         of EU Directive 98/79/EC on in vitro diagnostic
         medical devices

Defines 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.

DevelopmentNote
Supersedes UNI EN 13824. (10/2011) Supersedes UNI EN ISO 13408-1. (05/2013)
DocumentType
Standard
PublisherName
Ente Nazionale Italiano di Unificazione (UNI)
Status
Superseded
SupersededBy
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 13408-5:2006 Aseptic processing of health care products Part 5: Sterilization in place

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