EN ISO 10993-18:2020/prA1

SLOVENSKI STANDARD
SIST EN ISO 10993-18:2020/oprA1:2021
01-oktober-2021
Biološko ovrednotenje medicinskih pripomočkov - 18. del: Kemična opredelitev
lastnosti materialov za medicinske pripomočke znotraj procesov obvladovanja
tveganja - Dopolnilo 1: Določitev faktorja negotovosti (ISO 10993-18:2020/DAM
1:2021)

Biological evaluation of medical devices - Part 18: Chemical characterization of medical

device materials within a risk management process - Amendment 1: Determination of the

Biologische Beurteilung von Medizinprodukten - Teil 18: Chemische Charakterisierung

Évaluation biologique des dispositifs médicaux - Partie 18: Caractérisation chimique des

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

Partie 18: Caractérisation chimique des matériaux des dispositifs médicaux au sein d'un processus de

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

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

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

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

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 the following

This document was prepared by Technical Committee ISO/TC 194, Biological and clinical evaluation of

In the columns “Qualitative” and “Quantitative” for the example methods “HPLC, with UV, CAD, ELSD and/or

In the column “Anti-solvents” for “Polymer” Polystyrene and Styrenics (ABS), replace “can” by “ACN”

Quantification in extractables profiling is achieved by various means which differ with respect to

the accuracy of the estimated and reported concentration, where the accuracy can vary significantly

depending on the quantification means employed. For example, quantification could involve the use

of an internal standard to normalize the responses obtained for all relevant analytes. In such an

approach, one estimates the concentration of each analyte based on the simplifying assumption that

all analytes respond similarly, among themselves and with respect to the internal standard (i.e. all

substances have the same response factor). Depending on the validity of this simplifying assumption,

the concentration estimates thus obtained can have widely differing uncertainties and degrees of