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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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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
25、7 All rights reserved Introduction The minimum safety requirements specified in this part of ISO 81060 are considered to provide a practical degree of safety in the operation of non-automated sphygmomanometers. The requirements are followed by specifications for the relevant tests. A “rationale and
26、guidance” section giving some explanatory notes, where appropriate, about the more important requirements is included in Annex A. It is considered that knowledge of the reasons for these requirements will not only facilitate the proper application of this part of ISO 81060 but will, in due course, e
27、xpedite any revision necessitated by changes in clinical practice or as a result of developments in technology. However, Annex A does not form part of the requirements of this part of ISO 81060. Throughout this document, text for which a rationale is provided in Annex A is indicated by an asterisk (
28、*). 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 -,-,- INTERNATIONAL STANDARD ISO 81060-1:2007
29、(E) ISO 2007 All rights reserved 1 Non-invasive sphygmomanometers Part 1: Requirements and test methods for non-automated measurement type 1 * Scope This part of ISO 81060 specifies requirements for non-automated sphygmomanometers, as defined in 3.11, and their accessories, which, by means of inflat
30、able cuffs, are used for the non-invasive blood pressure measurement by operator observation. This part of ISO 81060 specifies requirements for the safety and essential performance, including effectiveness and labelling, for non-automated sphygmomanometers and their accessories, including test metho
31、ds to determine the accuracy of non-invasive blood pressure measurement. The part of ISO 81060 covers non-invasive blood pressure measurement devices with a pressure-sensing element and display used in conjunction with means of detecting blood flow. EXAMPLE 1 A stethoscope for detecting Korotkoff so
32、unds, Doppler ultrasound or other manual methods. Requirements for non-invasive blood pressure measurement equipment with electrically-powered pressure sensing elements and/or displays used in conjunction with other automatic methods determining blood pressure are specified in IEC 60601-2-30 7. Requ
33、irements for invasive blood pressure measurement equipment that directly measure blood pressure are specified in document IEC 60601-2-34 8. EXAMPLE 2 Measuring equipment, including associated transducers, that is used for the invasive measurement of circulatory system pressures. 2 Normative referenc
34、es 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 any amendments) applies. ISO 594-1, Conical fittings with a 6 % (Luer)
35、taper for syringes, needles and certain other medical equipment Part 1: General requirements ISO 594-2, Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 2: Lock fittings ISO 7010:2003, Graphical symbols Safety colours and safety signs Safety signs
36、 used in workplaces and public areas 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 81
37、060-1:2007(E) 2 ISO 2007 All rights reserved ISO 10993-11), Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management system ISO 14937, Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, v
38、alidation and routine control of a sterilization process for medical devices ISO 15223-1:2007, Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements IEC 60601-1, Medical electrical equipment Part 1: General requirements f
39、or basic safety and essential performance 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. For convenience, an alphabetized list of the sources of all defined terms used in this document is given in Annex E. 3.1 accompanying document document acco
40、mpanying a non-automated sphygmomanometer or accessory and containing information for those accountable for the installation, use and maintenance of the non-automated sphygmomanometer or accessory, the operator or the responsible organization, particularly regarding safety Modified from ISO 14971:20
41、07, definition 2.1 3.2 bladder that part of the cuff that is inflatable 3.3 blood pressure pressure in the systemic arterial system of the body 3.4 clearly legible capable of being read by a person with normal vision IEC 60601-1:2005, definition 3.15 3.5 cuff part of the non-automated sphygmomanomet
42、er that is wrapped around the limb of the patient NOTE A cuff might comprise a bladder and an inelastic part that encloses the bladder, or have an integral bladder (i.e., the cuff including the bladder are fixed together or are one piece). 3.6 expected service life maximum period of useful life as d
43、efined by the manufacturer IEC 60601-1:2005, definition 3.28 1) To be published. (Revision of ISO 10993-1:2003) 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
44、 reproduction or networking permitted without license from IHS -,-,- ISO 81060-1:2007(E) ISO 2007 All rights reserved 3 3.7 intended use use of a product, process or service in accordance with the specifications, instructions and information provided by the manufacturer NOTE Intended use should not
45、be confused with normal use. While both include the concept of use as intended by the manufacturer, intended use focuses on the medical purpose while normal use incorporates not only the medical purpose, but also maintenance, service, transport, etc. IEC 60601-1:2005, definition 3.44 3.8 manufacture
46、r natural or legal person with responsibility for the design, manufacture, packaging or labelling of non-automated sphygmomanometers, or adapting non-automated sphygmomanometers, regardless of whether these operations are performed by that person or on that persons behalf by a third party NOTE 1 ISO
47、 13485 2 defines “labelling” as written, printed or graphic matter affixed to a medical device or any of its containers or wrappers or accompanying a medical device, related to identification, technical description, and use of the medical device, but excluding shipping documents. In this part of ISO
48、 81060, that material is described as markings and the accompanying document. NOTE 2 “Adapting” includes making substantial modifications to a non-automated sphygmomanometer already in use. NOTE 3 In some jurisdictions, the responsible organization can be considered a manufacturer when involved in the activities described. Modified from IEC 60601-1:2005, definition 3.55 3.9 * model or type reference combination of figures, letters or both used to identi