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1、a Date: 19 December 2006 Origin: International Latest date for receipt of comments: 31 March 2007 Project no.: 2006/03511 Responsible committee: CH/121/3 Lung ventilators and related equipment Interested committees: Title: Draft BS EN 80100 ISO 80100 (Ed.1): Basic safety and essential performance re
2、quirements of clinical thermometer for body temperature measurement Supersession information: If this document is published as a standard, the UK implementation of it will supersede NONE and partially supersede NONE . If you are aware of a current national standard which may be affected, please noti
3、fy the secretary (contact details below). WARNING: THIS IS A DRAFT AND MUST NOT BE REGARDED OR USED AS A BRITISH STANDARD. THIS DRAFT IS NOT CURRENT BEYOND 31 March 2007. This draft is issued to allow comments from interested parties; all comments will be given consideration prior to publication. No
4、 acknowledgement will normally be sent. See overleaf for information on commenting. No copying is allowed, in any form, without prior written permission from BSI except as permitted under the Copyright, Designs and Patent Act 1988 or for circulation within a nominating organization for briefing purp
5、oses. Electronic circulation is limited to dissemination by e-mail within such an organization by committee members. Further copies of this draft may be purchased from BSI Customer Services, Tel: +44(0) 20 8996 9001 or email ordersbsi-. British, International and foreign standards are also available
6、 from BSI Customer Services. British Standards on CD or Online are available from British Standards Publishing Sales Limited. Tel: 01344 404409 or email bsonlinetechindex.co.uk. Information on the co-operating organizations represented on the committees referenced above may be obtained from the resp
7、onsible committee secretary. Cross-references The British Standards which implement International or European publications referred to in this draft may be found via the British Standards Online Service on the BSI web site http:/www.bsi-. Direct tel: 020 8996 7298 Responsible Committee Secretary: Mr
8、 Ciaran Molloy (BSI) E-mail: ciaran.molloybsi- Draft for Public Comment Head Office 389 Chiswick High Road London W4 4AL Telephone: +44(0)20 8996 9000 Fax: +44(0)20 8996 7001 www.bsi Form 36 Version 6.1 DPC: 06/30160368 DC Licensed Copy: London South Bank University, London South Bank University, S
9、at Dec 30 06:07:53 GMT+00:00 2006, Uncontrolled Copy, (c) BSI b Introduction This draft standard is based on international discussions in which the UK has taken an active part. Your comments on this draft are welcome and will assist in the preparation of the consequent standard. If no comments are r
10、eceived to the contrary, then the UK will approve this draft. There is a high probability that this text could be adopted by CENELEC as a reference document for harmonization or as a European Standard. Recipients of this draft are requested to comment on the text bearing in mind this possibility. UK
11、 Vote Please indicate whether you consider the UK should submit a negative (with reasons) or positive vote on this draft. Submission The guidance given below is intended to ensure that all comments receive efficient and appropriate attention by the responsible BSI committee. Annotated drafts are not
12、 acceptable and will be rejected. All comments must be submitted, preferably electronically, to the Responsible Committee Secretary at the address given on the front cover. Comments should be compatible with Version 6.0 or Version 97 of Microsoft Word for Windows, if possible; otherwise comments in
13、ASCII text format are acceptable. Any comments not submitted electronically should still adhere to these format requirements. All comments submitted should be presented as given in the example below. Further information on submitting comments and how to obtain a blank electronic version of a comment
14、 form are available from the BSI web site at:http:/www.bsi- Template for comments and secretariat observations Date: xx/xx/200x Document: ISO/DIS xxxxx 1 2 (3) 4 5 (6) (7) MB Clause No./ Subclause No./ Annex (e.g. 3.1) Paragraph/ Figure/Table/ Note (e.g. Table 1) Type of com- ment Comment (justifica
15、tion for change) by the MB Proposed change by the MB Secretariat observations on each comment submitted 3.1 Definition 1 ed Definition is ambiguous and needs clarifying. Amend to read . so that the mains connector to which no connection . 6.4 Paragraph 2 te The use of the UV photometer as an alterna
16、tive cannot be supported as serious problems have been encountered in its use in the UK. Delete reference to UV photometer. Microsoft and MS-DOS are registered trademarks, and Windows is a trademark of Microsoft Corporation. Licensed Copy: London South Bank University, London South Bank University,
17、Sat Dec 30 06:07:53 GMT+00:00 2006, Uncontrolled Copy, (c) BSI FORM CD (IEC) 2002-08-08 62D/588/CD COMMITTEE DRAFT (CD) IEC/TC or SC: 62D Project number ISO 80100/Ed.1 Title of TC/SC: Electromedical equipment Date of circulation 2006-12-08 Closing date for comments 2007-03-09 Also of interest to the
18、 following committees ISO/TC 121/SC 3 Supersedes document 62D/528/NP, 62D/539/RVN Functions concerned: Safety EMC Environment Quality assurance Secretary: Mr. M.W. Schmidt c/o AAMI, 1110 North Glebe Road, Suite 220 Arlington, Virginia 22201, USA THIS DOCUMENT IS STILL UNDER STUDY AND SUBJECT TO CHAN
19、GE. IT SHOULD NOT BE USED FOR REFERENCE PURPOSES. RECIPIENTS OF THIS DOCUMENT ARE INVITED TO SUBMIT, WITH THEIR COMMENTS, NOTIFICATION OF ANY RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE AND TO PROVIDE SUPPORTING DOCUMENTATION. Title: ISO 80100 (Ed.1): Basic safety and essential performance requir
20、ements of clinical thermometer for body temperature measurement (Titre) : Introductory note This first edition of IEC 80100 was prepared by a Joint Working Group (JWG 8) of IEC subcommittee 62D: Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical practice, and IS
21、O subcommittee SC3: Lung ventilators and related equipment, of ISO technical committee 121: Anaesthetic and respiratory equipment with ISO lead. National Committee experts are requested to use the line numbering in the document when submitting comments. Comments on this draft will be discussed at a
22、meeting of ISO/TC 121/SC 3 JWG8 in Frankfurt, DE in April 2007. Copyright 2006 International Electrotechnical Commission, IEC. All rights reserved. It is permitted to download this electronic file, to make a copy and to print out the content for the sole purpose of preparing National Committee posit
23、ions. You may not copy or “mirror“ the file or printed version of the document, or any part of it, for any other purpose without permission in writing from IEC. Licensed Copy: London South Bank University, London South Bank University, Sat Dec 30 06:07:53 GMT+00:00 2006, Uncontrolled Copy, (c) BSI C
24、OMMITTEE DRAFT ISO/CD 80100 Date 2006-12-01 Reference number ISO/TC 121 / SC 3 N 1289 (62D/588/CD) Supersedes document N1201_NP, N1216_RVN_NWIP, N8_WD1_80100, N18_WD2_80100 62D/528/NP, 62D/539/RVN WARNING: This document is not an International Standard. It is distributed for review and comment. It i
25、s subject to change without notice and may not be referred to as an International Standard. ISO/TC 121 / SC 3 Title Lung ventilators and related equipment Circulated to P- and O- members, and to technical committees and organizations in liaison for: discussion at Frankfurt, DE on Monday, 2007- 04-02
26、 through Wednesday 2007-04-04 venue/date of meeting comments by 2007-03-09 date approval for registration as a DIS in accordance with 2.5.6 of part 1 of the ISO/IEC Directives, by 2007-10-01 date (P- members vote only: ballot form attached) Secretariat ANSI c/o D Osborn d.g.osbornieee.org P-members
27、of the technical committee or subcommittee concerned have an obligation to vote. English title IEC ISO 80100 (Ed.1): Basic safety and essential performance requirements of clinical thermometer for body temperature measurement French title Reference language version: English French Russian Introducto
28、ry note This first edition of IEC 80100 was prepared by a Joint Working Group 8 of IEC subcommittee 62D: Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical practice, and ISO subcommittee SC3: Lung ventilators and related equipment, of ISO technical committee 121
29、: Anaesthetic and respiratory equipment with ISO lead. Member Body experts are requested to use the line numbering in the document when submitting comments. Licensed Copy: London South Bank University, London South Bank University, Sat Dec 30 06:07:53 GMT+00:00 2006, Uncontrolled Copy, (c) BSI IEC I
30、SO 2006 All rights reserved Document type: International Standard Document subtype: Document stage: (30) Committee Document language: E I:doc62Dcd62D- 588- annexe- cd.doc STD Version 2.2 IEC ISO TC 121/SC 3 Date: 2006- 11- 20 IEC ISO/CD 80100-1 IEC ISO TC 121/SC 3/ JWG 8 Secretariat: ANSI Basic safe
31、ty and essential performance requirements of clinical thermometer for body temperature measurement Warning This document is not an ISO International Standard. It is distributed for review and comment. It is subject to change without notice and may not be referred to as an International Standard. Rec
32、ipients 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. Licensed Copy: London South Bank University, London South Bank University, Sat Dec 30 06:07:53 GMT+00:00 2006, Uncontrolled Co
33、py, (c) BSI IEC ISO/CD 80100-1 iv IEC ISO 2006 All rights reserved Copyright notice This ISO document is a working draft or committee draft and is copyright- protected by ISO. While the reproduction of working drafts or committee drafts in any form for use by participants in the ISO standards develo
34、pment process is permitted without prior permission from ISO, neither this document nor any extract from it may be reproduced, stored or transmitted in any form for any other purpose without prior written permission from ISO. Requests for permission to reproduce this document for the purpose of sell
35、ing it should be addressed as shown below or to ISOs member body in the country of the requester: Indicate the full address, telephone number, fax number, telex number, and electronic mail address, as appropriate, of the Copyright Manager of the ISO member body responsible for the secretariat of the
36、 TC or SC within the framework of which the working document has been prepared. Reproduction for sales purposes may be subject to royalty payments or a licensing agreement. Violators may be prosecuted. Licensed Copy: London South Bank University, London South Bank University, Sat Dec 30 06:07:53 GMT
37、+00:00 2006, Uncontrolled Copy, (c) BSI IEC ISO/CD 80100-1 IEC ISO 2006 All rights reserved v Contents Page Foreword .vii Introductionviii 1 * Scope1 2 Normative references1 3 Terms, definitions, symbols and abbreviated terms .1 4 Unit of measure .4 5 Basic safety and essential performance.4 6 Labor
38、atory performance requirements.4 6.1 * General.4 6.1.1 Minimum environmental conditions4 6.1.2 Minimum rated output range5 6.2 Maximum permissible error5 6.2.1 * Testing for compliance of maximum permissible error within the environmental conditions.5 6.2.2 Testing for compliance of maximum permissi
39、ble error within the minimum rated output range and/or extended rated output range.6 6.2.3 Testing for compliance of maximum permissible error within changing environmental conditions.6 6.3 * Time response for continuous clinical thermometer6 6.3.1 Requirements.6 6.3.2 Testing7 6.4 * Indicating unit
40、7 7 * Clinical accuracy evaluation7 7.1 General .7 7.2 Testing7 7.3 * Patient population 3 .8 7.4 * Clinical Bias.8 7.5 * Limit of agreement9 7.6 * Clinical Repeatability9 8 Identification, marking and documents 10 8.1 Marking of the clinical thermometer10 8.2 Marking of the clinical thermometer pac
41、kaging.10 8.3 Marking of the probe cover packaging .11 8.4 Information provided by the manufacturer.Error! Bookmark not defined. Annex A (informative) Rationale12 Annex B (informative) Reference source21 B.1 Type of clinical thermometer .21 B.1.1 For contact clinical thermometer.21 B.1.2 For non-con
42、tact clinical thermometer.21 Annex C (informative) Environmental aspects 22 Annex D (informative) Reference to the essential principles of safety and performance of medical devices in accordance with ISO/TR 1614223 Annex ZA (informative) Clauses of this European Standard addressing Essential Require
43、ments or other provisions of EU Directives27 Bibliography28 Licensed Copy: London South Bank University, London South Bank University, Sat Dec 30 06:07:53 GMT+00:00 2006, Uncontrolled Copy, (c) BSI IEC ISO/CD 80100-1 IEC ISO 2006 All rights reserved vii Foreword 1 ISO (the International Organization
44、 for Standardization) is a worldwide federation of national standards bodies 2 (ISO member bodies). The work of preparing International Standards is normally carried out through ISO 3 technical committees. Each member body interested in a subject for which a technical committee has been 4 establishe
45、d has the right to be represented on that committee. International organizations, governmental and 5 non- governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the 6 International Electrotechnical Commission (IEC) on all matters of electrotechnical standardizat
46、ion. 7 International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. 8 The main task of technical committees is to prepare International Standards. Draft International Standards 9 adopted by the technical committees are circulated to the member bodies for
47、voting. Publication as an 10 International Standard requires approval by at least 75 % of the member bodies casting a vote. 11 Attention is drawn to the possibility that some of the elements of this document may be the subject of patent 12 rights. ISO shall not be held responsible for identifying an
48、y or all such patent rights. 13 ISO/IEC 80100- 1 was prepared by a Joint Working Group of Technical Committee ISO/TC 121, Anaesthetic 14 and respiratory equipment, Subcommittee SC 3, Lung ventilators and related equipment and IEC 15 subcommittee 62D: Electrical equipment, of IEC technical committee
49、62: Electrical equipment in medical 16 practice. 17 ISO/IEC 80100 consists of the following parts, under the general title Basic safety and essential performance 18 requirements of clinical thermometer for body temperature measurement: 19 Licensed Copy: London South Bank University, London South Bank University, Sat Dec 30 06:07:53 GMT+00:00 2006, Uncontrolled Copy, (c) BSI IEC ISO/CD 80100-1 viii