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EN ISO 13408-6:2011/A1:2013

EN ISO 13408-6:2011/A1:2013

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 6: ISOLATOR SYSTEMS (ISO 13408-6:2005/AMD 1:2013)

Amendment of

EN ISO 13408-6:2011

Superseded date

05-29-2021

Published date

01-12-2013

Publisher

Comite Europeen de Normalisation

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.

Committee
TC 204
DevelopmentNote
Supersedes EN 13824. (07/2011)
DocumentType
Standard
PublisherName
Comite Europeen de Normalisation
Status
Superseded
SupersededBy
Supersedes

ISO 13408-1:2008 Aseptic processing of health care products — Part 1: General requirements
DIN EN ISO 13408-1:2015-12 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS (ISO 13408-1:2008, INCLUDING AMD 1:2013)
PD CEN/TS 16244:2018 Ventilation in hospitals. Coherent hierarchic structure and common terms and definitions for a standard related to ventilation in hospitals
BS EN ISO 13408-1:2015 Aseptic processing of health care products General requirements
DIN EN 556-2:2015-11 STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR MEDICAL DEVICES TO BE DESIGNATED 'STERILE' - PART 2: REQUIREMENTS FOR ASEPTICALLY PROCESSED MEDICAL DEVICES
BS EN 556-2:2015 Sterilization of medical devices. Requirements for medical devices to be designated \'STERILE\' Requirements for aseptically processed medical devices
PREN 556-2 : DRAFT 2014 STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR MEDICAL DEVICES TO BE DESIGNATED 'STERILE' - PART 2: REQUIREMENTS FOR ASEPTICALLY PROCESSED MEDICAL DEVICES
I.S. EN 556-2:2015 STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR MEDICAL DEVICES TO BE DESIGNATED 'STERILE' - PART 2: REQUIREMENTS FOR ASEPTICALLY PROCESSED MEDICAL DEVICES
S.R. CEN/TS 16244:2018 VENTILATION IN HOSPITALS - COHERENT HIERARCHIC STRUCTURE AND COMMON TERMS AND DEFINITIONS FOR A STANDARD RELATED TO VENTILATION IN HOSPITALS
I.S. EN ISO 13408-1:2015 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS (ISO 13408-1:2008, INCLUDING AMD 1:2013)
EN ISO 13408-1:2015 Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013)
EN 556-2:2015 Sterilization of medical devices - Requirements for medical devices to be designated 'STERILE" - Part 2: Requirements for aseptically processed medical devices
14/30273161 DC : 0 BS EN 556-2 - STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR MEDICAL DEVICES TO BE DESIGNATED ''STERILE'' - PART 2: REQUIREMENTS FOR ASEPTICALLY PROCESSED MEDICAL DEVICES
CEN/TS 16244:2018 Ventilation in hospitals - Coherent hierarchic structure and common terms and definitions for a standard related to ventilation in hospitals
UNE-EN 556-2:2016 Sterilization of medical devices - Requirements for medical devices to be designated 'STERILE" - Part 2: Requirements for aseptically processed medical devices

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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