EN ISO 10993-7:2008/FprA1

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals - Amendment 1 (ISO 10993-7/FDAM 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however since these legilsations have been repealed, the link has been removed and the EN is to proceed to publication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/FDAM 1:2019)

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

Biološko ovrednotenje medicinskih pripomočkov - 7. del: Ostanki po sterilizaciji z etilenoksidom - Dopolnilo A1 (ISO 10993-7/DAM 1:2018)

General Information

• Status: Not Published
• ICS: 11.100.20 - Biological evaluation of medical devices
• Technical Committee: CEN/TC 206 - Biocompatibility of medical and dental materials and devices
• Drafting Committee: CEN/TC 206 - Biocompatibility of medical and dental materials and devices
• Current Stage: 5060 - Closure of Vote - Formal Approval
• Due Date: 04-Oct-2019
• Completion Date: 04-Oct-2019
• 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: SIST EN ISO 10993-7:2009/oprA1:2018 - Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals - Amendment 1 (ISO 10993-7/DAM 1:2018)

RELATIONS

• Amends: EN ISO 10993-7:2008 - Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008)
• Effective Date: 14-Dec-2016

Standards Content (sample)

SLOVENSKI STANDARD
SIST EN ISO 10993-7:2009/oprA1:2018
01-oktober-2018

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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

(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

(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

(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
...