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EN ISO 13408-6:2021

(Main)

Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2021)

Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2021)

This document specifies the requirements for and provides guidance on the specification, selection, qualification, bio-decontamination, validation, operation and control of isolator systems related to aseptic processing of health care products and processing of cell-based health care products.
This document does not specify requirements for restricted access barrier systems (RABS).
This document does not supersede or replace national regulatory requirements such as Good Manufacturing Practices (GMPs) and/or compendia requirements that pertain in particular to national or regional jurisdictions.
This document does not specify requirements for isolators used for sterility testing; however, some of the principles and information in this document could be applicable to this application.
This document does not define biosafety containment requirements.

Aseptische Herstellung von Produkten für die Gesundheitsfürsorge - Teil 6: Isolatorensysteme (ISO 13408-6:2021)

Dieses Dokument legt die Anforderungen für Isolatorensysteme fest und stellt einen Leitfaden zur Spezifikation, Auswahl, Qualifizierung, Biodekontamination, Validierung, zum Betrieb und zur Kontrolle von Isolatorensystemen im Zusammenhang mit der aseptischen Herstellung von Produkten für die Gesundheitsfürsorge und der Herstellung von zellbasierten Produkten für die Gesundheitsfürsorge zur Verfügung.
Dieses Dokument legt keine Anforderungen für Barrieresysteme mit beschränktem Zugang (RABS, en: restricted access barrier system) fest.
Dieses Dokument ersetzt keine nationalen behördlichen Anforderungen, wie z. B. Gute Herstellungspraktiken (GMP, en: Good Manufacturing Practices) und/oder Anforderungen von Arzneibüchern, die insbesondere nationale oder regionale Zuständigkeiten betreffen.
Dieses Dokument legt keine Anforderungen für Isolatoren fest, die für Sterilitätsprüfungen verwendet werden, jedoch könnten einige der Grundsätze und Angaben in diesem Dokument auf diese Anwendung anwendbar sein.
Dieses Dokument legt keine Eindämmungsanforderungen für die Biosicherheit fest.

Traitement aseptique des produits de santé - Partie 6: Systèmes isolateurs (ISO 13408-6:2021)

Le présent document spécifie les exigences et fournit les recommandations relatives à la spécification, la sélection, la qualification, la bio-décontamination, la validation, au fonctionnement et au contrôle des systèmes isolateurs utilisés pour le traitement aseptique des produits de santé et le traitement des produits de santé à base de cellules.
Le présent document ne spécifie aucune exigence concernant les systèmes de barrière à accès restreint (RABS).
Le présent document n’a pas pour vocation de remplacer ou d’annuler des exigences réglementaires nationales, telles que les bonnes pratiques de fabrication (BPF) et/ou les exigences officielles, qui relèvent des juridictions nationales ou régionales particulières.
Le présent document ne spécifie aucune exigence pour les isolateurs utilisés dans le cadre d’essais de stérilité ; cependant, certains principes et informations contenus dans le présent document peuvent s’appliquer à cette application.
Le présent document ne définit pas d’exigences de confinement de biosécurité.

Aseptična proizvodnja izdelkov za zdravstveno nego - 6. del: Sistemi izolatorjev (ISO 13408-6:2021)

General Information

Status
Published
Publication Date
18-May-2021
Withdrawal Date
29-Nov-2021
ICS
11.080.01 - Sterilization and disinfection in general
Technical Committee
CEN/TC 204 - Sterilization of medical devices
Drafting Committee
CEN/TC 204 - Sterilization of medical devices
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Start Date
19-May-2021
Completion Date
19-May-2021
Directive
2017/745 - Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
2017/746 - Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU
90/385/EEC - Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices
93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
98/79/EC - Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices
Mandate
M/565 - Medical devices and in vitro diagnostic medical devices in support of Regulation (EU) 2017/745 of the European Parliament and of the Council and Regulation (EU) 2017/746
M/575 - Medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746
M/BC/CEN/89/9 - Joint Standardization request to CEN/CENELEC concerning harmonized standards relating to horizontal aspects in the field of medical devices
Ref Project
SIST EN ISO 13408-6:2021 - Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2021)

Relations

Replaces
EN ISO 13408-6:2011/A1:2013 - Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005/Amd 1:2013)
Effective Date
26-May-2021
Replaces
EN ISO 13408-6:2011 - Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005)
Effective Date
31-May-2017

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SLOVENSKI STANDARD
SIST EN ISO 13408-6:2021
01-september-2021
Nadomešča:
SIST EN ISO 13408-6:2011
SIST EN ISO 13408-6:2011/A1:2013
Aseptična proizvodnja izdelkov za zdravstveno nego - 6. del: Sistemi izolatorjev
(ISO 13408-6:2021)
Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2021)
Aseptische Herstellung von Produkten für die Gesundheitsfürsorge - Teil 6:
Isolatorensysteme (ISO 13408-6:2021)
Traitement aseptique des produits de santé - Partie 6: Systèmes isolateurs (ISO 13408-
6:2021)
Ta slovenski standard je istoveten z: EN ISO 13408-6:2021
ICS:
11.080.01 Sterilizacija in dezinfekcija na Sterilization and disinfection
splošno in general
SIST EN ISO 13408-6:2021 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN ISO 13408-6:2021

---------------------- Page: 2 ----------------------
SIST EN ISO 13408-6:2021


EN ISO 13408-6
EUROPEAN STANDARD

NORME EUROPÉENNE

May 2021
EUROPÄISCHE NORM
ICS 11.080.01 Supersedes EN ISO 13408-6:2011
English Version

Aseptic processing of health care products - Part 6:
Isolator systems (ISO 13408-6:2021)
Traitement aseptique des produits de santé - Partie 6: Aseptische Herstellung von Produkten für die
Systèmes isolateurs (ISO 13408-6:2021) Gesundheitsfürsorge - Teil 6: Isolatorensysteme (ISO
13408-6:2021)
This European Standard was approved by CEN on 7 June 2020.

This European Standard was corrected and reissued by the CEN-CENELEC Management Centre on 9 June 2021.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.





EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATIO N

EUROPÄISCHES KOMITEE FÜR NORMUN G

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2021 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 13408-6:2021 E
worldwide for CEN national Members.

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SIST EN ISO 13408-6:2021
EN ISO 13408-6:2021 (E)
Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this European Standard and the General
Safety and Performance requirements of Regulation (EU) 2017/745 aimed to be
covered. 5
Annex ZB (informative) Relationship between this European Standard and the General
Safety and Performance Requirements of Regulation (EU) 2017/746 aimed to be
covered. 7

2

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SIST EN ISO 13408-6:2021
EN ISO 13408-6:2021 (E)
European foreword
This document (EN ISO 13408-6:2021) has been prepared by Technical Committee ISO/TC 198
"Sterilization of health care products" in collaboration with Technical Committee CEN/TC 204
“Sterilization of medical devices” the secretariat of which is held by BSI.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by November 2021, and conflicting national standards
shall be withdrawn at the latest by November 2021.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 13408-6:2011 + A1:2013.
This document has been prepared under a mandate given to CEN by the European Commission a
...

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1.2.4    This document does not specify requirements for occupational safety associated with the design and operation of LTSF sterilization facilities.
NOTE 1    Safety requirements for sterilizers are specified in IEC 61010‑2‑040.
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1.2.6    This document does not cover preparatory measures that might be necessary before sterilization such as cleaning, disinfection and packing.
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