EN ISO 11137-2:2015
(Main)Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)
ISO 11137-2:2013 specifies methods for determining the minimum dose needed to achieve a specified requirement for sterility and methods to substantiate the use of 25 kGy or 15 kGy as the sterilization dose to achieve a sterility assurance level, SAL, of 10−6. ISO 11137-2:2013 also specifies methods of sterilization dose audit used to demonstrate the continued effectiveness of the sterilization dose.
ISO 11137-2:2013 defines product families for sterilization dose establishment and sterilization dose audit.
Sterilisation von Produkten für die Gesundheitsfürsorge - Strahlen - Teil 2: Festlegung der Sterilisationsdosis
Im vorliegenden Teil von ISO 11137 werden Verfahren zur Ermittlung der Mindestdosis, die zur Erfüllung einer festgelegten Anforderung an die Sterilität erforderlich ist, sowie Verfahren zur Bestätigung der Anwendung von 25 kGy oder 15 kGy als Sterilisationsdosis zur Erzielung eines Sterilitätssicherheitsniveaus, SAL, von 106 festgelegt. Dieser Teil von ISO 11137 legt auch Überprüfungsverfahren für die Sterilisationsdosis zum Nachweis der fortgesetzten Wirksamkeit der Sterilisationsdosis fest.
Dieser Teil von ISO 11137 definiert Produktfamilien für die Festlegung der Sterilisationsdosis und die Überprüfungen der Sterilisationsdosis.
Stérilisation des produits de santé - Irradiation - Partie 2: Établissement de la dose stérilisante (ISO 11137-2:2013)
L'ISO 11137-2:2013 spécifie des méthodes de détermination de la dose minimale nécessaire pour satisfaire à une exigence spécifiée de stérilité, ainsi que des méthodes pour justifier l'utilisation de la dose stérilisante de 25 kGy ou 15 kGy, pour obtenir un niveau d'assurance de la stérilité (NAS) de 10−6. Elle spécifie également des méthodes d'audit de la dose stérilisante utilisées pour démontrer l'efficacité continue de la dose stérilisante.
L'ISO 11137-2:2013 définit des familles de produits pour l'établissement de la dose stérilisante et l'audit de la dose stérilisante.
Sterilizacija izdelkov za zdravstveno nego - Sevanje - 2. del: Določanje odmerka sterilizacije (ISO 11137-2:2013)
Ta del standarda ISO 11137 določa metode za določanje minimalnega odmerka, ki je potreben za doseganje določene zahteve glede sterilnosti, in metode za utemeljitev uporabe 25 kGy ali 15 kGy kot odmerka sterilizacije za doseganje ravni zagotavljanja sterilnosti (SAL) 10–6. Ta del standarda ISO 11137 določa tudi metode za revizijo odmerka sterilizacije, ki se uporabljajo za dokaz stalne učinkovitosti odmerka sterilizacije. Ta del standarda ISO 11137 določa skupine izdelkov za določanje odmerka sterilizacije in revizijo odmerka sterilizacije.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-september-2015
1DGRPHãþD
SIST EN ISO 11137-2:2013
6WHULOL]DFLMDL]GHONRY]D]GUDYVWYHQRQHJR6HYDQMHGHO 'RORþDQMHRGPHUND
VWHULOL]DFLMH ,62
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization
dose (ISO 11137-2:2013)
Sterilisation von Produkten für die Gesundheitsfürsorge - Strahlen - Teil 2: Festlegung
der Sterilisationsdosis
Stérilisation des produits de santé - Irradiation - Partie 2: Établissement de la dose
stérilisante (ISO 11137-2:2013)
Ta slovenski standard je istoveten z: EN ISO 11137-2:2015
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.
EUROPEAN STANDARD
EN ISO 11137-2
NORME EUROPÉENNE
EUROPÄISCHE NORM
June 2015
ICS 11.080.01 Supersedes EN ISO 11137-2:2013
English Version
Sterilization of health care products - Radiation - Part 2:
Establishing the sterilization dose (ISO 11137-2:2013)
Stérilisation des produits de santé - Irradiation - Partie 2: Sterilisation von Produkten für die Gesundheitsfürsorge -
Établissement de la dose stérilisante (ISO 11137-2:2013) Strahlen - Teil 2: Festlegung der Sterilisationsdosis (ISO
11137-2:2013)
This European Standard was approved by CEN on 20 May 2015.
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, 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
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2015 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11137-2:2015 E
worldwide for CEN national Members.
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
Foreword
The text of ISO 11137-2:2013 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 11137-2:2015 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 2015, and conflicting national standards shall be withdrawn
at the latest by December 2015.
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 ISO 11137-2:2013.
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 Directives.
For relationship with EU Directives, see informative Annexes ZA, ZB and ZC, which are integral parts of this
document.
The following referenced documents are indispensable for the application of this document. For undated
references, the edition of the referenced document (including any amendments) listed below 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 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 11137 EN ISO 11137-1:2006/A1:2013 ISO 11137-1:2006/A1:2013
ISO 11737-1 EN ISO 11737-1:2006 + AC:2009 ISO 11737-1:2006 + Cor 1:2007
ISO 11737-2 EN ISO 11737-2:2009 ISO 11737-2:2009
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 11137-2:2013 has been approved by CEN as EN ISO 11137-2:2015 without any modification.
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/CENELEC 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 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 90/385/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, 4, 5, 8, 9 and 10 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 Directive 90/385/EEC
Clauses of this European Essential Requirements (ERs) of Qualifying remarks/Notes
Standard EU Directive 90/385/EEC
4, 5, 6, 7, 8, 9, 10 7 Only a sterilization process using
ionizing radiation is considered by
this standard.
This relevant Essential
Requirement is only partly
addressed in this European
Standard. Design and packaging
for maintenance of sterility during
transportation and storage are not
covered. Aspects of manufacture
other than those related to
sterilization are not covered.
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within
the scope of this standard.
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/CENELC 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 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 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 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 ZB.1 — Correspondence between this European Standard and EU Directive 93/42/EEC
Clauses of this European Essential Requirements (ERs) Qualifying remarks/Notes
Standard of EU Directive 93/42/EEC
4, 5, 6, 7, 8, 9, 10 8.3 Only a sterilization process using
inoizing radiation is considered by this
standard.
This relevant ER is only partly
addressed in this International
Standard and only in conjunction with
ISO 11137-1. Design and packaging
for maintenance of sterility during
transportation and storage are not
covered. Aspects of manufacture
other than those related to sterilization
are not covered.
4, 5, 6, 7, 8, 9, 10 8.4 This relevant ER is only partly
addressed in this International
Standard and only in conjunction with
ISO 11137-1. Aspects of manufacture
other than those related to sterilization
are not covered.
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within
the scope of this standard.
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/CENELEC 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 normative 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.
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 98/79/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
Part A: 1, 2 and 5; Part B: 1.2, 2, 3, 5, 6, and 7 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 ZC.1 — Correspondence between this European Standard and Directive 98/79/EC
Clauses of this European Essential Requirements (ERs) of Qualifying remarks/Notes
Standard EU Directive 98/79/EC
4, 5, 6, 7, 8, 9, 10 B.2.3 Only a sterilization process using
inoizing radiation is considered by
this standard.
This relevant ER is only partly
addressed in this International
Standard and only in conjunction
with ISO 11137-1. Design and
packaging for maintenance of
sterility during transportation and
storage are not covered. Aspects
of manufacture other than those
related to sterilization are not
...
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