ISO-81060-1-2007.pdf
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1、 Reference number ISO 81060-1:2007(E) ISO 2007 INTERNATIONAL STANDARD ISO 81060-1 First edition 2007-12-01 Non-invasive sphygmomanometers Part 1: Requirements and test methods for non-automated measurement type Sphygmomanomtres non invasifs Partie 1: Exigences et mthodes dessai pour type mesurage no
2、n automatique Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=IHS Employees/1111111001, User=Japan, IHS Not for Resale, 12/18/2007 00:53:17 MSTNo reproduction or networking permitted without license from IHS -,-,- ISO 81060-1:2007(E) PDF discl
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4、ccept therein the responsibility of not infringing Adobes licensing policy. The ISO Central Secretariat accepts no liability in this area. Adobe is a trademark of Adobe Systems Incorporated. Details of the software products used to create this PDF file can be found in the General Info relative to th
5、e file; the PDF-creation parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below. COPYRIGHT PROTE
6、CTED DOCUMENT ISO/IEC 2007 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISO
7、s member body in the country of the requester. ISO copyright office 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 ii ISO 2007 All rights reserved Copyright International Organization for Standardization
8、 Provided by IHS under license with ISO Licensee=IHS Employees/1111111001, User=Japan, IHS Not for Resale, 12/18/2007 00:53:17 MSTNo reproduction or networking permitted without license from IHS -,-,- ISO 81060-1:2007(E) ISO 2007 All rights reserved iii Contents Page Foreword. v Introduction. vi 1 *
9、 Scope. 1 2 Normative references. 1 3 Terms and definitions. 2 4 Identification and marking. 5 4.1 * Units of measurement 5 4.2 * Legibility of markings 5 4.3 * Durability of markings 5 4.4 * Marking of non-automated sphygmomanometer 5 4.5 * Usability of reading 6 4.6 Marking of the cuff 6 4.7 Marki
10、ng of the non-automated sphygmomanometer packaging. 6 5 General requirements for testing non-automated sphygmomanometers 7 5.1 * Type tests 7 5.2 * Representative sample 7 5.3 Environmental conditions 7 5.4 Repairs and modifications. 7 5.5 * Humidity preconditioning treatment 7 6 General requirement
11、s. 8 6.1 General. 8 6.2 Electrical safety. 8 6.3 Mechanical safety. 8 6.4 Mechanical strength. 8 7 Requirements 10 7.1 Pressure indicating means 10 7.2 Pneumatic system 11 7.3 * Tamper proofing or unauthorized access . 14 7.4 Dynamic response in normal use . 14 8 Additional requirements for non-auto
12、mated sphygmomanometer with mercury manometer. 15 8.1 * Internal diameter of the tube containing mercury 15 8.2 * Portable non-automated sphygmomanometer . 15 8.3 * Prevention of mercury spillage during transport 15 8.4 * Prevention of mercury spillage in normal use 15 8.5 Quality of the mercury 16
13、9 Non-automated sphygmomanometers with aneroid manometer 16 9.1 * Scale mark at zero 16 9.2 * Zero 16 9.3 Hysteresis error 16 9.4 * Construction and materials. 17 10 Cleaning, sterilization and disinfection 17 10.1 Reusable non-automated sphygmomanometer and parts. 17 10.2 Non-automated sphygmomanom
14、eter and parts requiring processing before use . 17 10.3 Non-automated sphygmomanometer and parts delivered sterile. 18 11 Biocompatibility 18 Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=IHS Employees/1111111001, User=Japan, IHS Not for Re
15、sale, 12/18/2007 00:53:17 MSTNo reproduction or networking permitted without license from IHS -,-,- ISO 81060-1:2007(E) iv ISO 2007 All rights reserved 12 Information supplied by the manufacturer.18 12.1 Accompanying document18 12.2 Instructions for use.18 12.3 Technical description .21 Annex A (inf
16、ormative) Rationale and guidance.23 Annex B (informative) Advice regarding non-automated sphygmomanometers with a mercury manometer.31 Annex C (informative) Environmental aspects32 Annex D (informative) Reference to the essential principals.33 Annex E (informative) Terminology Alphabetized index of
17、defined terms 35 Bibliography .36 Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=IHS Employees/1111111001, User=Japan, IHS Not for Resale, 12/18/2007 00:53:17 MSTNo reproduction or networking permitted without license from IHS -,-,- ISO 81060
18、-1:2007(E) ISO 2007 All rights reserved v 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
19、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 Electr
20、otechnical 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 International Standards. Draft International Standards adopted
21、 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. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
22、rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 81060-1 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment, Subcommittee SC 3, Lung ventilators and related equipment. ISO 81060 consists of the following parts, under the
23、general title Non-invasive sphygmomanometers: Part 1: Requirements and test methods for non-automated measurement type The preparation of a second part covering clinical evaluation for the automated measurement type is planned. For automated measurement type non-invasive sphygmomanometers, see IEC 6
24、0601-2-30 7. Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=IHS Employees/1111111001, User=Japan, IHS Not for Resale, 12/18/2007 00:53:17 MSTNo reproduction or networking permitted without license from IHS -,-,- ISO 81060-1:2007(E) vi ISO 200
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