SIST EN ISO 13408-2:2011

Aseptic processing of health care products - Part 2: Filtration (ISO 13408-2:2003)

This part of ISO 13408 specifies requirements for sterilizing filtration as part of aseptic processing of health care products. It also offers guidance to filter users concerning general requirements for set-up, validation and routine operation of a sterilizing filtration process, to be used for aseptic processing of health care products. This part of ISO 13408 is not applicable to removal of viruses. Sterilizing filtration is not applicable to fluids containing particles as effective ingredient larger than the pore size of a filter (e.g. bacterial whole-cell vaccines).

Aseptische Herstellung von Produkten für die Gesundheitsfürsorge - Teil 2: Filtration (ISO 13408-2:2003)

Der vorliegende Teil von ISO 13408 legt die Anforderung an die Sterilfiltration als Teil der aseptischen Herstellung von Produkten für die Gesundheitsfürsorge fest. Er stellt auch einen Leitfaden für die Anwender der Filter hinsichtlich der allgemeinen Anforderungen an Einrichtung, Validierung und routinemäßigen Betrieb eines Prozesses der Sterilfiltration zur Verfügung, der bei der aseptischen Herstellung von Produkten für die Gesundheitsfürsorge anzuwenden ist.
Der vorliegende Teil von ISO 13408 gilt nicht für das Entfernen von Viren. Sterilfiltration ist nicht bei Fluiden anwendbar, die als wirksamen Inhaltsstoff Partikel enthalten, deren Größe die Porengröße eines Filters überschreitet (z. B. bakterielle Ganzzellimpfstoffe).

Traitement aseptique des produits de santé - Partie 2: Filtration (ISO 13408-2:2003)

L'ISO 13408-2:2003 spécifie les exigences de filtration stérilisante dans le cadre du traitement aseptique des produits de santé. Elle propose également des directives aux utilisateurs de filtre concernant les exigences générales de configuration, de validation et d'opération de routine d'un processus de filtration stérilisante à utiliser pour le traitement aseptique des produits de santé.
L'ISO 13408-2:2003 ne concerne pas l'élimination des virus. La filtration stérilisante ne s'applique pas aux fluides contenant des particules dont les principes actifs sont de taille supérieure à la dimension des pores d'un filtre (par exemple vaccins bactériens sur des cellules entières).

Aseptična proizvodnja izdelkov za zdravstveno nego - 2. del: Filtracija (ISO 13408-2:2003)

Ta del ISO 13408 določa zahteve za sterilizacijsko filtracijo kot del aseptične proizvodnje izdelkov za zdravstveno nego. Prav tako ponuja smernice za uporabnike filtrov glede splošnih zahtev za postavitev, validacijo in rutinsko delovanje procesa sterilizacijske filtracije za uporabo v aseptični proizvodnji izdelkov za zdravstveno nego. Ta del ISO 13408 ne velja za odstranjevanje virusov. Sterilizacijska filtracija se ne uporablja za tekočine, ki kot učinkovito sestavino vsebujejo delce, večje od velikosti pore filtra (npr. cepiva iz celih bakterijskih celic).

General Information

• Status: Withdrawn
• Public Enquiry End Date: 14-Apr-2011
• Publication Date: 15-Sep-2011
• Withdrawal Date: 17-Apr-2018
• ICS: 11.080.01 - Sterilization and disinfection in general
• Technical Committee: VAZ - Healthcare
• Current Stage: 9900 - Withdrawal (Adopted Project)
• Start Date: 17-Apr-2018
• Due Date: 10-May-2018
• Completion Date: 18-Apr-2018
• 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 13408-2:2011 - Aseptic processing of health care products - Part 2: Filtration (ISO 13408-2:2003)

Relations

• Replaced By: SIST EN ISO 13408-2:2018 - Aseptic processing of health care products - Part 2: Sterilizing filtration (ISO 13408-2:2018)
• Effective Date: 01-Jul-2018
• Replaced By: SIST EN ISO 13408-2:2018 - Aseptic processing of health care products - Part 2: Sterilizing filtration (ISO 13408-2:2018)
• Effective Date: 08-Jun-2022
• Replaces: SIST EN 13824:2005 - Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements
• Effective Date: 01-Oct-2011
• Replaces: SIST EN 13824:2005 - Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements
• Effective Date: 08-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 13408-2:2011
01-oktober-2011
1DGRPHãþD
SIST EN 13824:2005
$VHSWLþQDSURL]YRGQMDL]GHONRY]D]GUDYVWYHQRQHJRGHO)LOWUDFLMD,62

Aseptic processing of health care products - Part 2: Filtration (ISO 13408-2:2003)
Aseptische Herstellung von Produkten für die Gesundheitsfürsorge - Teil 2: Filtration
(ISO 13408-2:2003)
Traitement aseptique des produits de santé - Partie 2: Filtration (ISO 13408-2:2003)
Ta slovenski standard je istoveten z: EN ISO 13408-2:2011
ICS:
11.080.01 Sterilizacija in dezinfekcija na Sterilization and disinfection
splošno in general
SIST EN ISO 13408-2:2011 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 13408-2:2011

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SIST EN ISO 13408-2:2011


EUROPEAN STANDARD
EN ISO 13408-2

NORME EUROPÉENNE

EUROPÄISCHE NORM
June 2011
ICS 11.080.01 Supersedes EN 13824:2004
English Version
Aseptic processing of health care products - Part 2: Filtration
(ISO 13408-2:2003)
Traitement aseptique des produits de santé - Partie 2: Aseptische Herstellung von Produkten für die
Filtration (ISO 13408-2:2003) Gesundheitsfürsorge - Teil 2: Filtration (ISO 13408-2:2003)
This European Standard was approved by CEN on 10 June 2011.

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, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.





EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2011 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 13408-2:2011: E
worldwide for CEN national Members.

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SIST EN ISO 13408-2:2011
EN ISO 13408-2:2011 (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 13408-2:2011
EN ISO 13408-2:2011 (E)
Foreword
The text of ISO 13408-2:2003 has been prepared by Technical Committee ISO/TC 198 “Sterilization of health
care products” of the International Organization for Standardization (ISO) and has been taken over as
EN ISO 13408-2:2011 by 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 December 2011, and conflicting national standards shall be withdrawn
at the latest by December 2011.
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 supersedes EN 13824:2004.
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 Annexes ZA, ZB, or ZC, 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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO 13408-2:2003 has been approved by CEN as a EN ISO 13408-2:2011 without any
modification.
3

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SIST EN ISO 13408-2:2011
EN ISO 13408-2:2011 (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) of Qualifying remarks/Notes
Directive 90/385/EEC
4,5,6,7,8,9,10,11,12 7 This relevant Essential Requirement is
only partly addressed in this European
Standard and only in conjunction with
EN ISO 13408-1
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 13408-2:2011
EN ISO 13408-2:2011 (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
4,5,6,7,8,9,10,11,12 8.3 This relevant Essential Requirement is
only partly addressed in this European
Standard and only in conjunction with
EN ISO 13408-1
4,5,6,7,8,9,10,11,12 8.4 This relevant Essential Requirement is
addressed in this European standard
only in conjunction with
EN ISO 13408-1
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 13408-2:2011
EN ISO 13408-2:2011 (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 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 98/79/EC on in vitro diagnostic 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 ZC.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 ZC.1 — Correspondence between this European Standard and Directive 98/79/EC
Clauses of this EN Essential Requirements (ERs) of Qualifying remarks/Notes
Directive 98/79/EC
4,5,6,7,8,9,10,11,12 B.2.3 This relevant Essential Requirement is
only partly addressed in this European
Standard and only in conjunction with
EN ISO 13408-1
4,5,6,7,8,9,10,11,12 B.2.4 This relevant Essential Requirement is
addressed in this European standard
only in conjunction with
EN ISO 13408-1
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling
within the scope of this Standard.

6

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SIST EN ISO 13408-2:2011

INTERNATIONAL ISO
STANDARD 13408-2
First edition
2003-03-15


Aseptic processing of health care
products —
Part 2:
Filtration
Traitement aseptique des produits de santé —
Partie 2: Filtration





Reference number
ISO 13408-2:2003(E)
©
ISO 2003

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SIST EN ISO 13408-2:2011
ISO 13408-2:2003(E)
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ii © ISO 2003 — All rights reserved

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SIST EN ISO 13408-2:2011
ISO 13408-2:2003(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope. 1
2 Normative references. 1
3 Terms and definitions. 1
4 General requirements. 3
5 Selection of filters and filter assemblies based on filter manufacturer's data. 3
6 Fluid-specific selection criteria based on filter user's data. 3
7 Filtration process. 4
7.1 Process parameters. 4
7.2 Validation of fluid-specific microbial retention by filters. 5
8 Filtration system design. 7
9 Routine process. 8
10 Process documentation. 8
11 Maintenance and change control . 9
12 Operator training. 9
Annex A (informative) Basic information and quality certificates for filter cartridges. 10
Bibliography . 11

© ISO 2003 — All rights reserved iii

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SIST EN ISO 13408-2:2011
ISO 13408-2:2003(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 13408-2 was prepared by Technical Committee ISO/TC 198, Sterilization of health care products.
ISO 13408 consists of the following parts, under the general title Aseptic processing of health care products:
 Part 1: General requirements
 Part 2: Filtration
The following parts are under preparation:
 Part 3: Freeze-drying
 Part 4: Sterilization in place
 Part 5: Cleaning in place
 Part 6: Isolator/barrier technology

iv © ISO 2003 — All rights reserved

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SIST EN ISO 13408-2:2011
ISO 13408-2:2003(E)
Introduction
During the process of preparing ISO 13408-1:1998, which addresses general requirements, several items, e.g.
filtration, freeze-drying and steam-in-place, were found to be in need of supplementary information which was
too large to be given in corresponding Annexes. This part of ISO 13408 includes requirements and guidance
that are to be observed when aseptically manufacturing health care products by filtration.
ISO 13408-1:1998 will be revised soon after the publication of this part of ISO 13408, as clause 20 of
ISO 13408-1:1998 is replaced by this part of ISO 13408.

© ISO 2003 — All rights reserved v

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SIST EN ISO 13408-2:2011

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SIST EN ISO 13408-2:2011
INTERNATIONAL STANDARD ISO 13408-2:2003(E)

Aseptic processing of health care products —
Part 2:
Filtration
1 Scope
This part of ISO 13408 specifies requirements for sterilizing filtration as part of aseptic processing of health
care products. It also offers guidance to filter users concerning general requirements for set-up, validation and
routine operation of a sterilizing filtration process, to be used for aseptic processing of health care products.
This part of ISO 13408 is not applicable to removal of viruses. Sterilizing filtration is not applicable to fluids
containing particles as effective ingredient larger than the pore size of a filter (e.g. bacterial whole-cell
vaccines).
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
ISO 13408-1:1998, Aseptic processing of health care products — Part 1: General requirements
ISO/TS 11139:2001, Sterilization of health care products — Vocabulary
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 13408-1, ISO/TS 11139 and the
following apply.
3.1
bacterial challenge test
test to evaluate the capability of a filter to retain organisms from a bacterial suspension under defined
conditions
3.2
bioburden
population of viable microorganisms in a fluid prior to sterilizing filtration
NOTE For the purposes of this part of ISO 13408, the definition of bioburden is narrower than that in ISO/TS 11139.
3.3
chemical compatibility
ability of the process fluids not to adversely affect the properties of filter materials and/or filter assembly
components and vice versa
3.4
fibre
particle having an aspect (length-to-width) ratio of 10 or more
[ISO 14644-1:1999, 2.2.7]
© ISO 2003 — All rights reserved 1

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SIST EN ISO 13408-2:2011
ISO 13408-2:2003(E)
3.5
fibre-releasing filter
filter which, even after
...