EN ISO 13408-1:2024
(Main)Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2023)
Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2023)
This document specifies the general requirements for, and offers guidance on, processes, programs and procedures for development, validation and routine control of aseptic processing of health care products.
This document includes requirements and guidance relative to the overall topic of aseptic processing.
Specific requirements and guidance on various specialized processes and methods related to sterilizing filtration, lyophilization, clean-in place (CIP) technologies, sterilization in place (SIP) and isolator systems are given in the other parts of the ISO 13408 series.
Aseptische Herstellung von Produkten für die Gesundheitsfürsorge - Teil 1: Allgemeine Anforderungen (ISO 13408-1:2023)
Dieses Dokument legt die allgemeinen Anforderungen an Verfahren, Programme und Verfahrensweisen zur Entwicklung, Validierung und routinemäßigen Kontrolle der aseptischen Herstellung von Produkten für die Gesundheitsfürsorge fest und stellt einen Leitfaden dafür zur Verfügung.
Dieses Dokument umfasst Anforderungen und einen Leitfaden in Bezug auf das Gesamtthema der aseptischen Herstellung.
Besondere Anforderungen und ein Leitfaden für verschiedene spezielle Prozesse und Verfahren in Bezug auf Sterilfiltration, Lyophilisierung, Technologien der Reinigung vor Ort (en: cleaning in place, CIP), Sterilisation vor Ort (en: sterilization in place, SIP) und Isolatorensysteme sind in den anderen Teilen der Normenreihe ISO 13408 angeführt.
Traitement aseptique des produits de santé - Partie 1: Exigences générales (ISO 13408-1:2023)
Le présent document spécifie des exigences générales et propose des recommandations en matière de procédés, de programmes et de modes opératoires pour le développement, la validation et le contrôle de routine du traitement aseptique des produits de santé.
Le présent document spécifie comprend des exigences et des recommandations relatives à la thématique générale du traitement aseptique.
Des exigences et des recommandations spécifiques relatives aux divers procédés et méthodes spécialisés de filtration stérilisante, de lyophilisation, de nettoyage in situ (CIP), de stérilisation in situ (SIP) et de systèmes isolateurs sont indiquées dans les autres parties de la série ISO 13408.
Aseptična proizvodnja izdelkov za zdravstveno nego - 1. del: Splošne zahteve (ISO 13408-1:2023)
Ta dokument določa splošne zahteve ter ponuja smernice za procese, programe in postopke za razvoj, validacijo in rutinsko kontrolo aseptične proizvodnje izdelkov za zdravstveno nego.
Ta dokument vključuje zahteve in smernice v povezavi z aseptično proizvodnjo na splošno.
Posebne zahteve in smernice glede različnih specializiranih postopkov in metod, povezanih s sterilizacijsko filtracijo, liofilizacijo, tehnologijami čiščenja v zaprtih sistemih (CIP), sistemi za sterilizacijo (SIP) in izolatorskimi sistemi, so podane v drugih delih skupine standardov ISO 13408.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-julij-2024
Aseptična proizvodnja izdelkov za zdravstveno nego - 1. del: Splošne zahteve (ISO
13408-1:2023)
Aseptic processing of health care products - Part 1: General requirements (ISO 13408-
1:2023)
Aseptische Herstellung von Produkten für die Gesundheitsfürsorge - Teil 1: Allgemeine
Anforderungen (ISO 13408-1:2023)
Traitement aseptique des produits de santé - Partie 1 : Exigences générales (ISO 13408
-1:2023)
Ta slovenski standard je istoveten z: EN ISO 13408-1:2024
ICS:
11.080.01 Sterilizacija in dezinfekcija na Sterilization and disinfection
splošno in general
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 13408-1
EUROPEAN STANDARD
NORME EUROPÉENNE
April 2024
EUROPÄISCHE NORM
ICS 11.080.01 Supersedes EN ISO 13408-1:2015
English Version
Aseptic processing of health care products - Part 1:
General requirements (ISO 13408-1:2023)
Traitement aseptique des produits de santé - Partie 1: Aseptische Herstellung von Produkten für die
Exigences générales (ISO 13408-1:2023) Gesundheitsfürsorge - Teil 1: Allgemeine
Anforderungen (ISO 13408-1:2023)
This European Standard was approved by CEN on 2 July 2023.
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, Türkiye and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2024 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 13408-1:2024 E
worldwide for CEN national Members.
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. 4
Annex ZB (informative) Relationship between this European Standard and the General
Safety and Performance Requirements of Regulation (EU) 2017/746 aimed to be
covered. 8
European foreword
This document (EN ISO 13408-1:2024) 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 October 2024, and conflicting national standards shall
be withdrawn at the latest by October 2024.
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 13408-1:2015.
This document has been prepared under a standardization request addressed to CEN by the European
Commission. The Standing Committee of the EFTA States subsequently approves these requests for its
Member States.
For the relationship with EU Legislation, see informative Annex ZA and ZB, which is an integral part of
this document.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: 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, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 13408-1:2023 has been approved by CEN as EN ISO 13408-1:2024 without any
modification.
Annex ZA
(informative)
Relationship between this European Standard and the General Safety and
Performance requirements of Regulation (EU) 2017/745 aimed to be
covered
This European standard has been prepared under M/575 to provide one voluntary means of
conforming to the General Safety and Performance Requirements of Regulation (EU) 2017/745 of 5
April 2017 concerning medical devices [OJ L 117] and to system or process requirements including
those relating to quality management systems, risk management, post-market surveillance systems,
clinical investigations, clinical evaluation or post-market clinical follow-up.
Once this standard is cited in the Official Journal of the European Union under that Regulation,
compliance with the normative clauses of this standard given in Table ZA.1 and application of the
edition of the normatively referenced standards as given in Table ZA.2 confers, within the limits of the
scope of this standard, a presumption of conformity with the corresponding General Safety and
Performance Requirements of that Regulation, and associated EFTA Regulations.
Where a definition in this standard differs from a definition of the same term set out in Regulation (EU)
2017/745, the differences shall be indicated in this Annex Z. For the purpose of using this standard in
support of the requirements set out in Regulation (EU) 2017/745, the definitions set out in this
Regulation prevail.
Where the European standard is an adoption of an International Standard, the scope of this standard
can differ from the scope of the European Regulation that it supports. As the scope of the applicable
regulatory requirements differ from nation to nation and region to region, the standard can only
support European regulatory requirements to the extent of the scope of the European regulation for
medical devices (EU) 2017/745).
NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk
management process needs to be in compliance with Regulation (EU) 2017/745. This means that risks have to be
‘reduced as far as possible’, ‘reduced to the lowest possible level’, ‘reduced as far as possible and appropriate’,
‘removed or reduced as far as possible’, ‘eliminated or reduced as far as possible’, ’removed or minimized as far as
possible’, or ‘minimized’, according to the wording of the corresponding General Safety and Performance
Requirement.
NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with General Safety
and Performance Requirements 1, 2, 3, 4, 5, 8, 9, 10, 11, 14, 16, 17, 18, 19, 20, 21 and 22 of the Regulation.
NOTE 3 When a General Safety and Performance Requirement does not appear in Table ZA.1, it means that it is
not addressed by this European Standard.
Table ZA.1 — Correspondence between this European Standard and Annex I of
Regulation (EU) 2017/745 [OJ L 117] and to system or process requirements including those
relating to quality management systems, risk management, post-market surveillance systems,
clinical investigations, clinical evaluation or post-market clinical follow-up
General Safety and
Performance Requirements Clause(s)/sub-clause(s) of
Remarks/Notes
of Regulation (EU) this EN
2017/745
11.3 4,5,6,7,8,9 This standard provides general
requirements for processes, programs and
procedures for development, validation
and routine control of aseptic processing.
This General Safety and Performance
Requirement is addressed only with regard
to devices for which use of aseptic
processing is appropriate.
This General Safety and Performance
Requirement is only partly addressed in
this European Standard. Design and
packaging for maintenance of sterility are
not covered. Aspects of manufacture other
than those related to maintenance of a
specific microbial state by aseptic
processing are not covered.
11.4 first sentence only 4,5,6,7,8,9 This standard provides general
requirements for processes, programs and
procedures for development, validation
and routine control of aseptic processing.
This General Safety and Performance
Requirement is addressed only with regard
to devices for which use of aseptic
processing is appropriate.
This General Safety and Performance
Requirement is only partly addressed in
this European Standard. Design and
packaging for maintenance of sterility are
not covered. Evidence that the integrity of
the packaging is maintained to the point of
use is not covered. Aspects of manufacture
other than those related to maintenance of
sterility during aseptic processing are not
covered. Transport and storage conditions
are not covered.
11.5 4,5,6,7,8,9 This standard provides general
requirements for processes, programs and
procedures for development, validation
and routine control of aseptic processing.
This General Safety and Performance
Requirement is addressed only with regard
General Safety and
Performance Requirements Clause(s)/sub-clause(s) of
Remarks/Notes
of Regulation (EU) this EN
2017/745
to devices for which use of aseptic
processing is appropriate.
This General Safety and Performance
Requirement is only partly addressed in
this European Standard. Design and
packaging for maintenance of sterility are
not covered. Aspects of manufacture other
than those related to maintenance of
sterility during aseptic processing are not
covered.
Table ZA.2 — Applicable Standards to confer presumption of conformity as described in this
Annex ZA
Column 1 Column 2 Column 3 Column 4
Reference in International Title Corresponding European
Clause 2 Standard Edition Standard Edition
ISO 13408-2 ISO 13408-2:2018 Aseptic processing of health care EN ISO 13408-2:2018
products — Part 2: Sterilizing
filtration
ISO 13408-6 ISO 13408-6:2021 Aseptic processing of health care EN ISO 13408-6:2021
products — Part 6: Isolator
systems
ISO 14644- ISO 14644-1:2015 Cleanrooms and associated EN ISO 14644-1:2015
1:2015 controlled environments —
Part 1: Classification of air
cleanliness by particle
concentration
ISO 14644-2 ISO 14644-2:2015 Cleanrooms and associated EN ISO 14644-2:2015
controlled environments —
Part 2: Monitoring to provide
evidence of cleanroom
performance related to air
cleanliness by particle
concentration
ISO 14664-4 ISO 14664-4:2001 Cleanrooms and associated EN ISO 14664-4:2001
controlled environments —
Part 4: Design, construction and
start-up
ISO 14644-7 ISO 14644-7:2004 Cleanrooms and associated EN ISO 14644-7:2004
controlled environments —
Part 7: Separative devices (clean
air hoods, gloveboxes, isolators
and mini-environments)
The documents listed in the Column 1 of Table ZA.2, in whole or in part, are normatively referenced in
this document and are indispensable for its application. The achievement of the presumption of
conformity is subject to the application of the edition of Standards as listed in Column 4 or, if no
European Standard Edition exists, the International Standard Edition given in Column 2 of Table ZA.2.
WARNING 1 Presumption of conformity stays valid only as long as a reference to this European
Standard is maintained in the list published in the Official Journal of the European Union. Users of this
standard should consult frequently the latest list published in the Official Journal of the European
Union.
WARNING 2 Other Union legislation may be applicable to the product(s) falling within the scope of this
standard.
Annex ZB
(informative)
Relationship between this European Standard and the General Safety and
Performance Requirements of Regulation (EU) 2017/746 aimed to be
covered
This European standard has been prepared under M/575 to provide one voluntary means of
conforming to the General Safety and Performance Requirements of Regulation (EU) 2017/746 of 5
April 2017 concerning in vitro diagnostic medical devices [OJ L 117] and to system or process
requirements including those relating to quality management systems, risk management, post-market
surveillance systems, performance studies, clinical evidence or post-market performance follow-up.
Once this standard is cited in the Official Journal of the European Union under that Regulation,
compliance with the normative clauses of this standard given in Table ZB.1 and application of the
edition of the normatively referenced standards as given in Table ZA.2 confers, within the limits of the
scope of this standard, a presumption of conformity with the corresponding Gene
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