SIST EN ISO 10993-7:2009/A1:2022

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals - Amendment 1: Applicability of allowable limits for neonates and infants (ISO 10993-7:2008/Amd 1:2019)

2021-12-09- JO-  the EN was submitted to FV wiith the link to the legislation (90/385/EEC, 93/42/EEC)
however since these legilsations have been repealed, the link has been removed and the EN is to proceed to publication

Biologische Beurteilung von Medizinprodukten - Teil 7: Ethylenoxid-Sterilisationsrückstände - Änderung 1 (ISO 10993-7:2008/Amd 1:2019)

Évaluation biologique des dispositifs médicaux - Partie 7: Résidus de stérilisation à l'oxyde d'éthylène - Amendement 1 (ISO 10993-7:2008/Amd 1:2019)

Biološko ovrednotenje medicinskih pripomočkov - 7. del: Ostanki po sterilizaciji z etilenoksidom - Dopolnilo A1: Uporaba dovoljenih mejnih vrednosti za novorojenčke in dojenčke (ISO 10993-7:2008/Amd 1:2019)

General Information

• Status: Published
• Public Enquiry End Date: 24-Oct-2018
• Publication Date: 14-Feb-2022
• ICS: 11.100.20 - Biological evaluation of medical devices
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 31-Jan-2022
• Due Date: 07-Apr-2022
• Completion Date: 15-Feb-2022
• 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
• 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 10993-7:2008/A1:2022 - Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals - Amendment 1: Applicability of allowable limits for neonates and infants (ISO 10993-7:2008/Amd 1:2019)

Relations

• Amends: SIST EN ISO 10993-7:2009 - Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008)
• Effective Date: 01-Oct-2018

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 10993-7:2009/A1:2022
01-marec-2022
Biološko ovrednotenje medicinskih pripomočkov - 7. del: Ostanki po sterilizaciji z
etilenoksidom - Dopolnilo A1: Uporaba dovoljenih mejnih vrednosti za
novorojenčke in dojenčke (ISO 10993-7:2008/Amd 1:2019)
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals -
Amendment 1: Applicability of allowable limits for neonates and infants (ISO 10993-
7:2008/Amd 1:2019)
Biologische Beurteilung von Medizinprodukten - Teil 7: Ethylenoxid-
Sterilisationsrückstände - Änderung 1 (ISO 10993-7:2008/Amd 1:2019)
Évaluation biologique des dispositifs médicaux - Partie 7: Résidus de stérilisation à
l'oxyde d'éthylène - Amendement 1 (ISO 10993-7:2008/Amd 1:2019)
Ta slovenski standard je istoveten z: EN ISO 10993-7:2008/A1:2022
ICS:
11.100.20 Biološko ovrednotenje Biological evaluation of
medicinskih pripomočkov medical devices
SIST EN ISO 10993-7:2009/A1:2022 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 10993-7:2009/A1:2022

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SIST EN ISO 10993-7:2009/A1:2022


EN ISO 10993-7:2008/A1
EUROPEAN STANDARD

NORME EUROPÉENNE

January 2022
EUROPÄISCHE NORM
ICS 11.100.20
English Version

Biological evaluation of medical devices - Part 7: Ethylene
oxide sterilization residuals - Amendment 1: Applicability
of allowable limits for neonates and infants (ISO 10993-
7:2008/Amd 1:2019)
Évaluation biologique des dispositifs médicaux - Partie Biologische Beurteilung von Medizinprodukten - Teil 7:
7: Résidus de stérilisation à l'oxyde d'éthylène - Ethylenoxid-Sterilisationsrückstände - Änderung 1
Amendement 1 (ISO 10993-7:2008/Amd 1:2019) (ISO 10993-7:2008/Amd 1:2019)
This amendment A1 modifies the European Standard EN ISO 10993-7:2008; it was approved by CEN on 5 November 2019.

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 10993-7:2008/A1:2022 E
worldwide for CEN national Members.

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SIST EN ISO 10993-7:2009/A1:2022
EN ISO 10993-7:2008/A1:2022 (E)
Contents Page
European foreword . 3

2

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SIST EN ISO 10993-7:2009/A1:2022
EN ISO 10993-7:2008/A1:2022 (E)
European foreword
This document (EN ISO 10993-7:2008/A1:2022) has been prepared by Technical Committee ISO/TC
194 "Biological and clinical evaluation of medical devices" in collaboration with Technical Committee
CEN/TC 206 “Biological and clinical evaluation of medical devices” the secretariat of which is held by
DIN.
This Amendment to the European Standard EN ISO 10993-7:2008 shall be given the status of a national
standard, either by publication of an identical text or by endorsement, at the latest by July 2022, and
conflicting national standards shall be withdrawn at the latest by July 2022.
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.
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 website.
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 10993-7:2008/Amd 1:2019 has been approved by CEN as EN ISO 10993-
7:2008/A1:2022 without any modification.


3

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SIST EN ISO 10993-7:2009/A1:2022

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SIST EN ISO 10993-7:2009/A1:2022
INTERNATIONAL ISO
STANDARD 10993-7
Second edition
2008-10-15
AMENDMENT 1
2019-12
Biological evaluation of medical
devices —
Part 7:
Ethylene oxide sterilization residuals
AMENDMENT 1: Applicability of
allowable limits for neonates and infants
Reference number
ISO 10993-7:2008/Amd.1:2019(E)
©
ISO 2019

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SIST EN ISO 10993-7:2009/A1:2022
ISO 10993-7:2008/Amd.1:2019(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2019
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
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Fax: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii © ISO 2019 – All rights reserved

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SIST EN ISO 10993-7:2009/A1:2022
ISO 10993-7:2008/Amd.1:2019(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.
This document was prepared by Technical Committee ISO/TC 194, Biological and clinical evaluation of
medical devices.
A list of all parts in the ISO 10993 series can be found on the ISO website.
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 2019 – All rights reserved iii

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SIST EN ISO 10993-7:2009/A1:2022

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SIST EN ISO 10993
...

SLOVENSKI STANDARD
SIST EN ISO 10993-7:2009/oprA1:2018
01-oktober-2018
%LRORãNRRYUHGQRWHQMHPHGLFLQVNLKSULSRPRþNRYGHO2VWDQNLSRVWHULOL]DFLML]
HWLOHQRNVLGRP'RSROQLOR$,62'$0
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals -
Amendment 1 (ISO 10993-7/DAM 1:2018)
Biologische Beurteilung von Medizinprodukten - Teil 7: Ethylenoxid-
Sterilisationsrückstände - Änderung 1 (ISO 10993-7:2008/DAM 1:2018)
Évaluation biologique des dispositifs médicaux - Partie 7: Résidus de stérilisation à
l'oxyde d'éthylène - Amendement 1 (ISO 10993-7:2008/DAM 1:2018)
Ta slovenski standard je istoveten z: EN ISO 10993-7:2008/prA1
ICS:
11.100.20 %LRORãNRRYUHGQRWHQMH Biological evaluation of
PHGLFLQVNLKSULSRPRþNRY medical devices
SIST EN ISO 10993-7:2009/oprA1:2018 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 10993-7:2009/oprA1:2018

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SIST EN ISO 10993-7:2009/oprA1:2018
DRAFT AMENDMENT
ISO 10993-7:2008/DAM 1
ISO/TC 194 Secretariat: DIN
Voting begins on: Voting terminates on:
2018-08-09 2018-11-01
Biological evaluation of medical devices —
Part 7:
Ethylene oxide sterilization residuals
AMENDMENT 1
Évaluation biologique des dispositifs médicaux —
Partie 7: Résidus de stérilisation à l'oxyde d'éthylène
AMENDEMENT 1
ICS: 11.100.20
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 10993-7:2008/DAM 1:2018(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 2018

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SIST EN ISO 10993-7:2009/oprA1:2018
ISO 10993-7:2008/DAM 1:2018(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2018
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
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Fax: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii © ISO 2018 – All rights reserved

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SIST EN ISO 10993-7:2009/oprA1:2018
ISO 10993-7:2008/DAM 1:2018(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 on 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 the following
URL: www .iso .org/iso/foreword .html.
This document was prepared by Technical Committee ISO/TC 194, Biological and clinical evaluation of
medical devices.
A list of all parts in the ISO 10993- series can be found on the ISO website.
© ISO 2018 – All rights reserved iii

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SIST EN ISO 10993-7:2009/oprA1:2018

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SIST EN ISO 10993-7:2009/oprA1:2018
ISO 10993-7:2008/DAM 1:2018(E)
Biological evaluation of medical devices —
Part 7:
Ethylene oxide sterilization residuals
AMENDMENT 1
Normative references
Replace the reference to ISO 10993-1:— (including the footnote) with the following:
ISO 10993-1:2018, Biological evaluation of medical devices — Part 1: Evaluation and testing within
a risk management process
Renumber subsequent footnotes.
Delete ISO 10993-12 and move to Bibliography
Renumber subsequent biblio entries.
4.1, first paragraph to third paragraph
Delete all except the NOTE.
4.2, second paragraph
Replace the reference "ISO 10993-1:—, 5.3:" with "ISO 10993-1:2018, 5.3:
4.2, a) to c)
Relace the text by the following:
a) Limited exposure (A) – medical devices whose cumulative sum of single, multiple or repeated
duration of contact is up to 24 h.
b) Prolonged exposure (B) – medical devices whose cumulative sum of single, multiple or repeated
contact time is likely to exceed 24 h but not exceed 30 d.
c) Long-term exposure (C) – medical devices whose cumulative sum of single, multiple or repeated
contact time exceeds 30 d.
4.3.1, first paragraph
Replace the paragraph with the following:
The use of materials that can be sterilized by methods other than EO and the sterilization process
shall be considered during product design and development, so that EO sterilization shall be used
only when justified. Therefore, when EO is used for sterilization, elements leading to this choice shall
be documented. The allowable limits, presented below, shall be regarded as maximum allowable
amount on the device and an additional goal of the manufacturer applying this standard should be
to reduce the residues levels of EO sterilization by e.g. other method(s), improved process(es), other
material(s), design. As far as possible, given the generally recognized state of the art and given that
the risk-benefit ratio is not adversely affected.
4.3.1, third paragraph
Replace the paragraph with the following:
© ISO 2018 – All rights reserved 1

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SIST EN ISO 10993-7:2009/oprA1:2018
ISO 10993-7:2008/DAM 1:2018(E)

The limits for permanent contact and prolonged exposure devices are expressed as maximum
average daily doses. These limits carry additional constraints for the first 24 h of the exposure
period and, in the case of the permanent contact devices, for the first 30 days, whichever extraction
method is used. These constraints place limitations on the amount of EO and ECH that can be
delivered to the patient during these early time periods.
4.3.1, fourth paragraph
Replace the paragraph with the following:
If data are available, consideration should be given for proportioning the limits downward if
multiple devices with the residue of concern are used at one time, or proportioning the limits
upward when device use is only for a part of the exposure period of concern. These concomitant
exposure factors (CEF) and proportional exposure factors (PEF) are given in ISO 10993-17. A
default value of 0,2 for CEF have been given for 5 medical devices used and contributing to the
patient residues daily exposure. When the device risk analysis shows that more than five medical
devices sterilized by EO can contribute to the total daily exposure, then the allowable limits shall
be adjusted accordingly.
4.3.2, first paragraph
Replace the paragraph with the following:
In the case of a device used in an adult of body mass = 70 kg, and with CEF = 0,2 and PEF = 1,0
mb
(default factors), the average daily dose of EO to patient shall not exceed 0,1 mg/d. In addition, the
maximum EO dose shall not exceed:
4.3.2, last paragraph
Replace the paragraph with the following:
When the risk analysis indicates that the device may be used in special populations, the appropriate
patient body mass shall be used for the derivation of the allowable limits. For example, if the device
is intended to be used in premature neonates, neonates or children, the allowable limits shall be
derived using the abovementioned limits and diminished by the pro rata of the appropriate body
mass. The appropriate default body mass used for each category of special patient population
should be justified and documented.
4.3.3, first paragraph
Replace the paragraph with the following:
In the case of a device used in an adult of body mass = 70 kg, and with CEF = 0,2 and PEF = 1,0
mb
(default factors), the average daily dose of EO to patient shall not exceed 0,2 mg/d. In addition, the
maximum EO dose shall not exceed:
4.3.3, last paragraph
Replace the paragraph with the following:
When the risk analysis indicates that the device may be used in special populations, the appropriate
patient body mass shall be used for the derivation of the allowable limits. For example, if the device
is intended to be used in premature neonates, neonates or children, the allowable limits shall be
derived using the abovementioned limits and diminished by the pro rata of the appropriate body
mass. The appropriate default body mass used for each category of special patient population
should be justified and documented.
4.3.4
Replace the text with the following:
2 © ISO 2018 – All rights reserved

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SIST EN ISO 10993-7:2009/oprA1:2018
ISO 10993-7:2008/DAM 1:2018(E)

In the case of a device used in an adult of body mass = 70 kg, and with CEF = 0,2 and PEF = 1,0
mb
(default factors), the average daily dose of EO to patient shall not exceed 4 mg. The average daily
dose of ECH to patient shall not exceed 9 mg.
When the risk analysis indicates that the device may be used in special populations, the appropriate
patient body mass shall be used for the derivation of the allowable limits. For example, if the device is
intended to be used in premature neonates, neonates or children, the allowable limits shall be derived
using the abovementioned limits and diminished by the pro rata of the appropriate body mass.
4.4.2, last paragr
...