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I.S. EN ISO 13408-6:2011

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by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 (ISO 13408-6:2005)

Available format(s)

Hardcopy , PDF

Superseded date

11-07-2020

Language(s)

English

Published date

01-01-2011

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.


Dates of withdrawal of national standards are available from NSAI.

€53.00
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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

Gives 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 I.S. EN 13824. (07/2011)
DocumentType
Standard
Pages
33
PublisherName
National Standards Authority of Ireland
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Superseded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/TS 17665-3:2013 Sterilization of health care products — Moist heat — Part 3: Guidance on the designation of a medical device to a product family and processing category for steam sterilization
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 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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