ISO PAS 18761-2013 Use and handling of medical devices covered by the scope of ISO TC 84 - Risk assessment on mucocutaneous blood exposure《被ISO TC 84范围覆盖医疗器械的使用.pdf

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1、 ISO 2013 Use and handling of medical devices covered by the scope of ISO/TC 84 Risk assessment on mucocutaneous blood exposure Utilisation et manipulation des dispositifs mdicaux couverts par le domaine dapplication du ISO/TC 84 valuation du risque concernant lexposition au sang mucocutan PUBLICLY

2、AVAILABLE SPECIFICATION ISO/PAS 18761 First edition 2013-03-01 Reference number ISO/PAS 18761:2013(E) ISO/PAS 18761:2013(E)ii ISO 2013 All rights reserved COPYRIGHT PROTECTED DOCUMENT ISO 2013 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized

3、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 ISOs member body in the country of the requester. ISO copyright of

4、fice Case postale 56 CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyrightiso.org Web www.iso.org Published in Switzerland ISO/PAS 18761:2013(E) ISO 2013 All rights reserved iii Contents Page Foreword iv Introduction v 1 Scope . 1 2 Normative references 1 3 General requirem

5、ents . 1 4 Information and educational materials provided by suppliers 1 ISO/PAS 18761:2013(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 carri

6、ed 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. I

7、SO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare Internati

8、onal Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. In other circumstances, particularly when there is an urg

9、ent market requirement for such documents, a technical committee may decide to publish other types of normative document: an ISO Publicly Available Specification (ISO/PAS) represents an agreement between technical experts in an ISO working group and is accepted for publication if it is approved by m

10、ore than 50 % of the members of the parent committee casting a vote; an ISO Technical Specification (ISO/TS) represents an agreement between the members of a technical committee and is accepted for publication if it is approved by 2/3 of the members of the committee casting a vote. An ISO/PAS or ISO

11、/TS is reviewed after three years in order to decide whether it will be confirmed for a further three years, revised to become an International Standard, or withdrawn. If the ISO/PAS or ISO/TS is confirmed, it is reviewed again after a further three years, at which time it must either be transformed

12、 into an International Standard or be withdrawn. 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. ISO/PAS 18761 was prepared by Technical Committee IS

13、O/TC 84, Devices for administration of medicinal products and intravascular catheters.iv ISO 2013 All rights reserved ISO/PAS 18761:2013(E) Introduction Use and handling of medical devices covered by ISO/TC 84 might expose mucocutaneous membranes to blood or bodily fluids. Although exposure of mucou

14、s membranes to blood and bodily fluids may present a risk for infection, the pathogenesis is unknown. This exposure risk is to be included in the risk assessment taking into account that the exposure should be minimized as far as possible. ISO 2013 All rights reserved v Use and handling of medical d

15、evices covered by the scope of ISO/TC 84 Risk assessment on mucocutaneous blood exposure 1 Scope This Publicly Available Specification covers requirements for risk assessment on mucocutaneous blood and bodily fluid exposure in relation to the handling of medical devices for the administration of med

16、icinal products covered by the scope of ISO/TC 84. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including

17、any amendments) applies. ISO 14971, Medical devices Application of risk management to medical devices 3 General requirements The risks in relation to the possible exposure of mucous membranes to blood and bodily fluids from the medical device shall be assessed in accordance with the risk assessment

18、specified in ISO 14971, as exposure of those membranes to these fluids might pose a risk of infection. The output of the risk assessment shall be part of the input into the development of new devices, including possible complementary personal protective equipment, and labelling (including marking, s

19、ales and education materials) in order to minimize the risk of infection due to exposure of mucous membranes, specifically eyes, mouth and nose, to blood and bodily fluids. 4 Information and educational materials provided by suppliers The device shall be accompanied by sufficient information to use

20、it safely in relation to the possible exposure of mucous membranes to blood and bodily fluids from the medical device, taking into account the training and knowledge of the potential users. Where needed on the basis of the risk assessment, the information shall contain the following particulars: any

21、 warnings in relation to the risks associated with the possible exposure of mucous membranes to blood and bodily fluids from the medical device; any precautions to be taken in relation to the possible exposure of mucous membranes to blood and bodily fluids from the medical device. Further recommenda

22、tions and useful information to minimize the risk of infection due to exposure of mucous membranes (e.g. possible recommendations in relation to the use of personal protective equipment during handling of the device) can be provided by various means, such as training and educational documentation, sales materials, websites and other types of media. PUBLICLY AVAILABLE SPECIFICATION ISO/PAS 18761:2013(E) ISO 2013 All rights reserved 1 ISO/PAS 18761:2013(E) ISO 2013 All rights reserved IC S 11.040.01 Price based on 1 page