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Superseded

Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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

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Superseded date: 30-08-2022

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Published date: 31-12-2012

Publisher: Ente Nazionale Italiano di Unificazione (UNI)

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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

Abstract - (Show below) - (Hide below)

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.

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Development Note	Supersedes UNI EN 13824. (10/2011) Supersedes UNI EN ISO 13408-1. (05/2013)
Document Type	Standard
ISBN
Pages
Published
Publisher	Ente Nazionale Italiano di Unificazione (UNI)
Status	Superseded
Superseded By	UNI EN ISO 13408-6:2021
Supersedes	UNI EN ISO 13408-6 : 2011 UNI EN 13824 : 2005

International Equivalents – Equivalent Standard(s) & Relationship - (Show below) - (Hide below)

Equivalent Standard(s)	Relationship
ISO 13408-6:2005	Identical
EN ISO 13408-6:2011/A1:2013	Identical

Standards Referencing This Book - (Show below) - (Hide below)

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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