SIST EN ISO 13408-1:2011/A1:2013

Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008/Amd 1:2013)

ISO 13408-1:2008 specifies the general requirements for, and offers guidance on, processes, programmes and procedures for development, validation and routine control of the manufacturing process for aseptically-processed health care products.
ISO 13408-1:2008 includes requirements and guidance relative to the overall topic of aseptic processing. Specific requirements and guidance on various specialized processes and methods related to filtration, lyophilization, clean-in place (CIP) technologies, sterilization in place (SIP) and isolator systems are given in other parts of ISO 13408.

Aseptische Herstellung von Produkten für die Gesundheitsfürsorge - Teil 1: Allgemeine Anforderungen (ISO 13408-1:2008/Amd 1:2013)

Traitement aseptique des produits de santé - Partie 1: Exigences générales (ISO 13408-1:2008/Amd 1:2013)

Aseptična proizvodnja izdelkov za zdravstveno nego - 1. del: Splošne zahteve - Dopolnilo A1 (ISO 13408-1:2008/Amd 1:2013)

Ta del ISO 13408 določa splošne zahteve in ponuja smernice za procese, programe in postopke za razvoj, validacijo in rutinsko kontrolo proizvodnega procesa za aseptično proizvedene izdelke za zdravstveno nego. Ta del ISO 13408 vključuje zahteve in smernice, ki se nanašajo na celovito temo aseptične proizvodnje. Določene zahteve in smernice za različne specializirane procese in metode, povezane s filtracijo, liofilizacijo, tehnologijami čiščenja na mestu proizvodnje (CIP), sterilizacijo na mestu proizvodnje (SIP) in sistemom izolatorjev, so podane v drugih delih ISO 13408.

General Information

• Status: Withdrawn
• Public Enquiry End Date: 19-Dec-2011
• Publication Date: 20-Aug-2013
• Withdrawal Date: 04-Aug-2015
• ICS: 11.080.01 - Sterilization and disinfection in general
• Technical Committee: VAZ - Healthcare
• Current Stage: 9900 - Withdrawal (Adopted Project)
• Start Date: 05-Aug-2015
• Due Date: 28-Aug-2015
• Completion Date: 05-Aug-2015
• Directive: 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
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Directive: 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/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: EN ISO 13408-1:2011/A1:2013 - Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008/Amd 1:2013)

Relations

• Amends: SIST EN ISO 13408-1:2011 - Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008)
• Effective Date: 01-Sep-2013
• Replaced By: SIST EN ISO 13408-1:2015 - Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013)
• Effective Date: 01-Sep-2015
• Amends: SIST EN ISO 13408-1:2011 - Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008)
• Effective Date: 08-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 13408-1:2011/A1:2013
01-september-2013
$VHSWLþQDSURL]YRGQMDL]GHONRY]D]GUDYVWYHQRQHJRGHO6SORãQH]DKWHYH
'RSROQLOR$,62$PG
Aseptic processing of health care products - Part 1: General requirements (ISO 13408-
1:2008/Amd 1:2013)
Aseptische Herstellung von Produkten für die Gesundheitsfürsorge - Teil 1: Allgemeine
Anforderungen (ISO 13408-1:2008/Amd 1:2013)
Traitement aseptique des produits de santé - Partie 1: Exigences générales (ISO 13408-
1:2008/Amd 1:2013)
Ta slovenski standard je istoveten z: EN ISO 13408-1:2011/A1:2013
ICS:
11.080.01 Sterilizacija in dezinfekcija na Sterilization and disinfection
splošno in general
SIST EN ISO 13408-1:2011/A1:2013 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 13408-1:2011/A1:2013

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SIST EN ISO 13408-1:2011/A1:2013


EUROPEAN STANDARD
EN ISO 13408-1:2011/A1

NORME EUROPÉENNE

EUROPÄISCHE NORM
May 2013
ICS 11.080.01
English Version
Aseptic processing of health care products - Part 1: General
requirements (ISO 13408-1:2008/Amd 1:2013)
Traitement aseptique des produits de santé - Partie 1: Aseptische Herstellung von Produkten für die
Exigences générales (ISO 13408-1:2008/Amd 1:2013) Gesundheitsfürsorge - Teil 1: Allgemeine Anforderungen
(ISO 13408-1:2008/Amd 1:2013)
This amendment A1 modifies the European Standard EN ISO 13408-1:2011; it was approved by CEN on 18 April 2013.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of this
amendment into the relevant 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 amendment 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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United
Kingdom.





EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2013 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 13408-1:2011/A1:2013: E
worldwide for CEN national Members.

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SIST EN ISO 13408-1:2011/A1:2013
EN ISO 13408-1:2011/A1:2013 (E)
Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 90/385/EEC on Active Implantable Medical Devices .4
Annex ZB (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on Medical Devices .5
Annex ZC (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 98/79/EC on in vitro diagnostic medical devices .6

2

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SIST EN ISO 13408-1:2011/A1:2013
EN ISO 13408-1:2011/A1:2013 (E)
Foreword
This document (EN ISO 13408-1:2011/A1:2013) 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 Amendment to the European Standard EN ISO 13408:2011 shall be given the status of a national
standard, either by publication of an identical text or by endorsement, at the latest by November 2013, and
conflicting national standards shall be withdrawn at the latest by November 2013.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EU Directives.
For relationship with EU Directives, see informative Annex ZA, B and C, which are integral parts of this
document.
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, Former Yugoslav Republic of Macedonia, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
Endorsement notice
The text of ISO 13408-1:2008/Amd 1:2013 has been approved by CEN as EN ISO 13408-1:2011/A1:2013
without any modification.
3

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SIST EN ISO 13408-1:2011/A1:2013
EN ISO 13408-1:2011/A1:2013 (E)
Annex ZA
(informative)

Relationship between this European Standard and the Essential
Requirements of EU Directive 90/385/EEC on Active Implantable Medical
Devices
This European Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association to provide a means of conforming to Essential Requirements of the
New Approach Directive 90/385/EEC on active implantable medical devices.
Once this standard is cited in the Official Journal of the European Union under that Directive and has been
implemented as a national standard in at least one Member State, compliance with the clauses of this
standard given in Table ZA.1 confers, within the limits of the scope of this standard, a presumption of
conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations.
Table ZA.1 — Correspondence between this European Standard and Directive 90/385/EEC
Clauses of this EN Essential Requirements (ERs) Qualifying remarks/Notes
of Directive 90/385/EEC
4,5,6,7,8,9,10,11 7 This relevant Essential Requirement is only partly
addressed in this European Standard. Packaging for
maintenance of sterility during transportation and
storage are not covered

WARNING — Other requirements and other EU Directives may be applicable to the
product(s) falling within the scope of this Standard.
4

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SIST EN ISO 13408-1:2011/A1:2013
EN ISO 13408-1:2011/A1:2013 (E)
Annex ZB
(informative)

Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on Medical Devices
This European Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association to provide a means of conforming to Essential Requirements of the
New Approach Directive 93/42/EEC on medical devices.
Once this standard is cited in the Official Journal of the European Union under that Directive and has been
implemented as a national standard in at least one Member State, compliance with the clauses of this
standard given in Table ZB.1 confers, within the limits of the scope of this standard, a presumption of
conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations.
Table ZB.1 — Correspondence between this European Standard and Directive 93/42/EEC
Clauses of this EN Essential Requirements (ERs) of Qualifying remarks/Notes
Directive 93/42/EEC
4,5,6,7,8,9,10,11 8.3 This relevant Essential Requirement is only partly
addressed in this European Standard. Packaging for
maintenance of sterility during transportation and
storage are not covered
4,5,6,7,8,9,10,11 8.4

WARNING — Other requirements and other EU Directives may be applicable to the
product(s) falling within the scope of this Standard.
5

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SIST EN ISO 13408-1:2011/A1:2013
EN ISO 13408-1:2011/A1:2013 (E)
Annex ZC
(informative)

Relationship between this European Standard and the Essential
Requirements of EU Directive 98/79/EC on in vitro diagnostic medical
devices
This European Standard has been prepared under a mandate
...