EN ISO 13408-6:2021

SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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.

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

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 and the
European Free Trade Association, and supports essential requirements of EU Directive(s).
For the relationship with EU Directive(s) see informative Annex ZA and ZB which are an integral parts
of this document.
This document is an adoption of an International Standard. As the scope of the applicable regulatory
requirements differ from nation to nation and region to region, the scope of this document can differ
from the scope of the European Regulations that it supports. This document supports European
regulatory requirements only to the extent of the scope of the European regulations for medical devices
and in vitro diagnostic medical devices. For relationship with EU Regulations, see informative Annex ZA
and ZB, which are an integral part of this document.
The following referenced documents are indispensable for the application of this document. For
undated references, the latest edition of the referenced document (including any amendments) applies.
For dated references, only the edition cited applies. However, for any use of this standard ‘within the
meaning of Annexes ZA and ZB, the user should always check that any referenced document has not
been superseded and that its relevant contents can still be considered the generally acknowledged
state-of-art.
When an IEC or ISO standard is referred to in the ISO standard text, this should be understood as a
normative reference to the corresponding EN standard, if available, and otherwise to the dated version
of the ISO or IEC standard as listed below.
NOTE The way in which these referenced documents are cited in normative requirements determines the
extent (in whole or in part) to which they apply.
Table – Correlation between normative references and dated EN and ISO standards
Normative references Equivalent dated standard
as listed in Clause 2 of the ISO
EN ISO
standard
ISO 11139 EN ISO 11139:2018 ISO 11139:2018
ISO 13408-1:2008 EN ISO 13408-1:2015 ISO 13408-1:2008
ISO 13408-4 EN ISO 13408-4:2011 ISO 13408-4:2005
ISO 13408-7 EN ISO 13408-7:2015 ISO 13408-7:2012
ISO 14644-1:2015 EN ISO 14644-1:2015 ISO 14644-1:2015
ISO 14644-7 EN ISO 14644-7:2004 ISO 14644-7:2004
ISO 18362:2016 No equivalent ISO 18362:2016
ISO/IEC/IEEE 90003 No equivalent ISO/IEC/IEEE 90003:2018
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, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 13408-6:2021 has been approved by CEN as EN ISO 13408-6:2021 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 a Commission’s standardisation request 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].
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 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.
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 This Annex ZA is based on normative references according to the table of references in the European
Foreword, replacing the references in the core text.
NOTE 4 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]
General Safety and Performance Clause(s)/sub-clause(s) Remarks/Notes
Requirements of Regulation (EU) of this EN
2017/745
11.3 4,5,6,7,8,9,10 This standard provides requirements for
the specification, selection, qualification,
bio-decontamination, validation, operation
and control of isolator systems related to
aseptic processing.
This General Safety and Performance
Requirement is addressed only with
regard to devices for which use of isolators
for aseptic processing is appropriate.
In conjunction with EN ISO 13408-1, this
relevant 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 within an isolator are not
covered.
11.4 first sentence only 4,5,6,7,8,9,10 This standard provides requirements for
the specification, selection, qualification,
bio-decontamination, validation, operation
and control of isolator systems related to
aseptic processing.
This General Safety and Performance
Requirement is addressed only with
regard to devices for which use of isolators
for aseptic processing is appropriate.
In conjunction with EN ISO 13408-1, this
relevant 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 within
an isolator are not covered.
11.5 4,5,6,7,8,9,10 This standard provides requirements for
the specification, selection, qualification,
bio-decontamination, validation, operation
and control of isolator systems related to
aseptic processing.
This General Safety and Performance
Requirement is addressed only with
regard to devices for which use of isolators
for aseptic processing is appropriate.
In conjunction with EN ISO 13408-1, this
relevant General Safety and Performance
Requirement is only partly addressed in
this European Standard. Design and
packaging for maintenance of sterility is
not covered. Aspects of manufacture other
than those related to maintenance of
sterility during aseptic processing within
an isolator are not covered.
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 a Commission’s standardisation request 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].
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 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.
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) 2017/746. This means that risks have to be
‘reduced as far as possible’, ‘reduced to a level as low as reasonably practicable’, ‘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’, ‘prevented’ 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, 10, 11, 13, 15, 16, 17, 18 and 19 of the Regulation.
NOTE 3 This Annex ZB is based on normative refe
...