SIST EN ISO 11137-2:2015/oprA1:2021

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose - Amendment 1 (ISO 11137-2:2013/DAmd 1:2021)

Sterilisation von Produkten für die Gesundheitsfürsorge - Strahlen - Teil 2: Festlegung der Sterilisationsdosis - ÄNDERUNG 1 (ISO 11137 2:2013/DAM 1:2021)

Stérilisation des produits de santé - Irradiation - Partie 2: Établissement de la dose stérilisante - Amendement 1 (ISO 11137-2:2013/DAmd 1:2021)

Sterilizacija izdelkov za zdravstveno nego - Sevanje - 2. del: Določanje odmerka sterilizacije - Dopolnilo A1 (ISO 11137-2:2013/DAmd 1:2021)

General Information

• Status: Not Published
• Public Enquiry End Date: 24-Mar-2021
• ICS: 11.080.01 - Sterilization and disinfection in general
• ICS: 11.080.99 - Other standards related to sterilization and disinfection
• Technical Committee: VAZ - Healthcare
• Current Stage: 4020 - Public enquire (PE) (Adopted Project)
• Start Date: 10-Feb-2021
• Due Date: 30-Jun-2021
• Completion Date: 23-Mar-2021
• Directive: 2017/745 - Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
• Directive: 2017/746 - Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU
• 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/565 - Medical devices and in vitro diagnostic medical devices in support of Regulation (EU) 2017/745 of the European Parliament and of the Council and Regulation (EU) 2017/746
• Mandate: M/571 - COMMISSION IMPLEMENTING DECISION of 19.11.2020 on a standardisation request to the European Committee for Standardization and the European Committee for Electrotechnical Standardization as regards personal protective equipment in support of Regulation (EU) 2016/425 of the European Parliament and of the Council
• 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 11137-2:2015/prA1 - Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose - Amendment 1 (ISO 11137-2:2013/DAmd 1:2021)

RELATIONS

• Amends: SIST EN ISO 11137-2:2015 - Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)
• Effective Date: 01-Mar-2021

Standards Content (sample)

SLOVENSKI STANDARD
SIST EN ISO 11137-2:2015/oprA1:2021
01-marec-2021
Sterilizacija izdelkov za zdravstveno nego - Sevanje - 2. del: Določanje odmerka
sterilizacije - Dopolnilo A1 (ISO 11137-2:2013/DAmd 1:2021)

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization

dose - Amendment 1 (ISO 11137-2:2013/DAmd 1:2021)

Sterilisation von Produkten für die Gesundheitsfürsorge - Strahlen - Teil 2: Festlegung

der Sterilisationsdosis - ÄNDERUNG 1 (ISO 11137 2:2013/DAM 1:2021)

Stérilisation des produits de santé - Irradiation - Partie 2: Établissement de la dose

stérilisante - Amendement 1 (ISO 11137-2:2013/DAmd 1:2021)
Ta slovenski standard je istoveten z: EN ISO 11137-2:2015/prA1
ICS:
11.080.01 Sterilizacija in dezinfekcija na Sterilization and disinfection
splošno in general
SIST EN ISO 11137-2:2015/oprA1:2021 en,fr,de

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

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SIST EN ISO 11137-2:2015/oprA1:2021
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SIST EN ISO 11137-2:2015/oprA1:2021
DRAFT AMENDMENT
ISO 11137-2:2013/DAM 1
ISO/TC 198 Secretariat: ANSI
Voting begins on: Voting terminates on:
2021-02-01 2021-04-26
Sterilization of health care products — Radiation —
Part 2:
Establishing the sterilization dose
AMENDMENT 1
Stérilisation des produits de santé — Irradiation —
Partie 2: Établissement de la dose stérilisante
AMENDEMENT 1
ICS: 11.080.01
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
ISO/CEN PARALLEL PROCESSING
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO 11137-2:2013/DAM 1:2021(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION. ISO 2021
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SIST EN ISO 11137-2:2015/oprA1:2021
ISO 11137-2:2013/DAM 1:2021(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2021

All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may

be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting

on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address

below or ISO’s member body in the country of the requester.
ISO copyright office
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Phone: [phone]
Email: [e-mail]
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Published in Switzerland
ii © ISO 2021 – All rights reserved
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SIST EN ISO 11137-2:2015/oprA1:2021
ISO 11137-2:2013/DAM 1:2021(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.

The procedures used to develop this document and those intended for its further maintenance are

described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the

different types of ISO documents should be noted. This document was drafted in accordance with the

editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).

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. Details of

any patent rights identified during the development of the document will be in the Introduction and/or

on the ISO list of patent declarations received (see www .iso .org/ patents).

Any trade name used in this document is information given for the convenience of users and does not

constitute an endorsement.

For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and

expressions related to conformity assessment, as well as information about ISO's adherence to the

World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www .iso .org/

iso/ foreword .html.

Amendment 1 to ISO 11137-2:2013 was prepared by Technical Committee ISO/TC 198, Sterilization of

health care products.

Any feedback or questions on this document should be directed to the user’s national standards body. A

complete listing of these bodies can be found at www .iso .org/ members .html.
© ISO 2021 – All rights reserved iii
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SIST EN ISO 11137-2:2015/oprA1:2021
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SIST EN ISO 11137-2:2015/oprA1:2021
ISO 11137-2:2013/DAM 1:2021(E)
Sterilization of health care products — Radiation —
Part 2:
Establishing the sterilization dose
AMENDMENT 1
Add a new 6.4:

6.4 If a sterilization dose of 17,5, 20, 22,5, 27,5, 30, 32,5 or 35 kGy is established in accordance with

ISO/TS 13004, it shall be substantiated by one of the following methods:
a) Method VD of ISO/TS 13004;
max

b) Method 1 (see Clause 7), subject to the derived sterilization dose taking a value less than or equal

to the selected sterilization dose and achieving maximally an SAL of 10 ;

c) Method 2 (see Clause 8), subject to the derived sterilization dose taking a value less than or equal

to the selected sterilization dose and achieving an SAL of 10 ; or

d) a method providing equivalent assurance to that of a), b) or c) above in achieving maximally an SAL

of 10 .
Add related content under Clause 9 so that it reads:
9 Method VDmax — Substantiation of 25 kGy or 15 kGy as the sterilization dose

Rationale and methods for substantiation of sterilization doses of 15 and 25 kGy using Method VD

max

are provided below. Rationale and methods for substantiation of sterilization doses of 17,5, 20, 22,5,

27,5, 30, 32,5 or 35 kGy using Method VD are provided in ISO/TS 13004.
max
© ISO 2021 – All rights reserved 1
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SIST EN ISO 11137-2:2015/oprA1:2021
ISO 11137-2:2013/DAM 1:2021(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/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

Essential Requirements (ERs)
Clauses of this EN Qualifying remarks/Notes
of Directive 90/385/EEC
7 4,5,6,7,8,9,10,11,12 This standard provides require-
ments for the development,
validation and routine control of a
sterilization process using ionising
radiation. This Essential Require-
ment is addressed only with regard
to devices for which sterilization
by ionising radiation is appropri-
ate and only in conjunction with
EN ISO 11137-1.
This relevant Essential Require-
ment 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 by ionising
radiation are not covered.
2 © ISO 2021 – All rights reserved
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SIST EN ISO 11137-2:2015/oprA1:2021
ISO 11137-2:2013/DAM 1:2021(E)

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 products falling within the scope

of this standard.
© ISO 2021 – All rights reserved 3
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SIST EN ISO 11137-2:2015/oprA1:2021
ISO 11137-2:2013/DAM 1:2021(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/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

Essential Requirements (ERs)
Clauses of this EN Qualifying remarks/Notes
of Directive 93/42/EEC
8.3 4,5,6,7,8,9,10 This standard provides require-
ments for the development, val-
idation and routine control of a ster-
ilization process ionising radiation
for medical devices . This Essential
Requirement is addressed only
with regard to devices for which
sterilization by ionising radiation is
appropriate and only in conjunction
with EN ISO 11137-1.
This relevant Essential Require-
ment 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 by ioni
...