|
SLOVENSKI STANDARD
01-september-2022
Embalaža za končno sterilizirane medicinske pripomočke - 1. del: Zahteve za
materiale, sterilne pregradne sisteme in sisteme embalaže - Dopolnilo A11 (ISO
11607-1:2019)
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials,
sterile barrier systems and packaging systems (ISO 11607-1:2019)
Verpackungen für in der Endverpackung zu sterilisierende Medizinprodukte - Teil 1:
Anforderungen an Materialien, Sterilbarrieresysteme und Verpackungssysteme (ISO
11607-1:2019/A11:2020)
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials,
sterile barrier systems and packaging systems (ISO 11607-1:2019)
Ta slovenski standard je istoveten z: EN ISO 11607-1:2020/A11:2022
ICS:
11.080.30 Sterilizirana embalaža Sterilized packaging
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 11607-
EUROPEAN STANDARD
1:2020/A11
NORME EUROPÉENNE
EUROPÄISCHE NORM
June 2022
ICS 11.080.30
English Version
Packaging for terminally sterilized medical devices - Part
1: Requirements for materials, sterile barrier systems and
packaging systems (ISO 11607-1:2019)
Emballages des dispositifs médicaux stérilisés au stade Verpackungen für in der Endverpackung zu
terminal - Partie 1: Exigences relatives aux matériaux, sterilisierende Medizinprodukte - Teil 1:
aux systèmes de barrière stérile et aux systèmes Anforderungen an Materialien, Sterilbarrieresysteme
d'emballage (ISO 11607-1:2019) und Verpackungssysteme (ISO 11607-1:2019)
This amendment A11 modifies the European Standard EN ISO 11607-1:2020; it was approved by CEN on 13 April 2022.
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, 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 NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2022 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11607-1:2020/A11:2022 E
worldwide for CEN national Members.
Contents
Page
European foreword . 3
Annex ZA (informative) Relationship between this European Standard and the essential
requirements of Directive 93/42/EEC [OJ L 169] (as amended) aimed to be covered . 5
Annex ZB (informative) Relationship between this European Standard and the essential
requirements of Directive 90/385/EEC [OJ L 189] (as amended) aimed to be covered . 8
Annex ZC (informative) Relationship between this European Standard and the essential
requirements of Directive 98/79/EC [OJ L 331] (as amended) aimed to be covered . 10
European foreword
This document (EN ISO 11607-1:2020/A11:2022) has been prepared by Technical Committee CEN/TC
102 “Sterilizers and associated equipment for processing of medical devices”, the secretariat of which is
held by DIN.
This Amendment to the European Standard EN ISO 11607-1:2020 shall be given the status of a national
standard, either by publication of an identical text or by endorsement, at the latest by December 2022,
and conflicting national standards shall be withdrawn at the latest by December 2022.
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 amends EN ISO 11607-1:2020 with a revised European Foreword and European Annexes
ZA, ZB and ZC.
This Amendment to the European Standard EN ISO 11607-1:2020 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 relationship with EU Directive(s), see informative Annexes ZA, ZB and ZC, which are 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 websites.
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
Annex ZA, ZB or ZC', 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 shall 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 as Equivalent dated standard
listed in Clause 2 of the ISO
standard EN ISO or IEC
ISO 5636-5 ISO 5636-5:2013
ISO 11607-2 EN ISO 11607-2:2020 ISO 11607-2:2019
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, Republic of North Macedonia, France, Germany,
Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United
Kingdom.
Annex ZA
(informative)
Relationship between this European Standard and the essential
requirements of Directive 93/42/EEC [OJ L 169] (as amended) aimed to be
covered
This European Standard has been prepared under a Commission’s standardization mandate
BC/CEN/CENELEC/09/89 "Standardization mandate jointly to CEN and CENELEC concerning the
preparation of European standards relating to Horizontal aspects in the field of medical devices" referred
to in the mandate M/023, concerning the development of European standards relating to medical devices
to provide one voluntary means of conforming to essential requirements of Council Directive 93/42/EEC
of 14 June 1993 concerning medical devices [OJ L 169].
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 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 essential requirements of that Directive 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 Directive 93/42/EEC as amended by 2007/47/EC. This means
that risks have to be reduced ‘as far as possible’, ‘to a minimum’, ‘to the lowest possible level’, ‘minimized’ or
‘removed’, according to the wording of the corresponding essential requirement.
NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with Essential
Requirements 1, 2, 5, 6, 7, 8, 9, 11 and 12 of the Directive.
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 an Essential 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 requirements of Annex I of
Directive 93/42/EEC [OJ L 169]
Essential Requirements of Clause(s)/sub-clause(s) of Remarks/Notes
Annex I of Directive this EN
93/42/EEC
8.1 6.1.1, 6.1.2, 6.1.3, 6.1.6, 6.1.8, 7 Partially covered. E.R. is covered
only in respect of the function of
the sterile barrier system(s) to
protect the sterility of the device
from the point of sterilisation to
the point of use and to allow for
aseptic presentation. The
standard includes a way to
evaluate the packaging design in
terms of usability to provide
supportive evidence for easy
Essential Requirements of Clause(s)/sub-clause(s) of Remarks/Notes
Annex I of Directive this EN
93/42/EEC
handling covering the aspect of
...