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    IEC 62570-2014 Standard practice for marking medical devices and other items for safety in the magnetic resonance environment《核磁共振环境中医疗设备及其他设备安全性标识的标准实施规程》.pdf

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    IEC 62570-2014 Standard practice for marking medical devices and other items for safety in the magnetic resonance environment《核磁共振环境中医疗设备及其他设备安全性标识的标准实施规程》.pdf

    1、 IEC 62570 Edition 1.0 2014-02 INTERNATIONAL STANDARD NORME INTERNATIONALE Standard practice for marking medical devices and other items for safety in the magnetic resonance environment Pratiques normalises relatives au marquage des appareils mdicaux et des lments de sret divers ddis aux environneme

    2、nts de rsonance magntique IEC 62570:2014-02(en-fr) colour inside THIS PUBLICATION IS COPYRIGHT PROTECTED Copyright 2014 IEC, Geneva, Switzerland 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 mecha

    3、nical, including photocopying and microfilm, without permission in writing from either IEC or IECs member National Committee in the country of the requester. If you have any questions about IEC copyright or have an enquiry about obtaining additional rights to this publication, please contact the add

    4、ress below or your local IEC member National Committee for further information. Droits de reproduction rservs. Sauf indication contraire, aucune partie de cette publication ne peut tre reproduite ni utilise sous quelque forme que ce soit et par aucun procd, lectronique ou mcanique, y compris la phot

    5、ocopie et les microfilms, sans laccord crit de lIEC ou du Comit national de lIEC du pays du demandeur. Si vous avez des questions sur le copyright de lIEC ou si vous dsirez obtenir des droits supplmentaires sur cette publication, utilisez les coordonnes ci-aprs ou contactez le Comit national de lIEC

    6、 de votre pays de rsidence. IEC Central Office Tel.: +41 22 919 02 11 3, rue de Varemb Fax: +41 22 919 03 00 CH-1211 Geneva 20 infoiec.ch Switzerland www.iec.ch About the IEC The International Electrotechnical Commission (IEC) is the leading global organization that prepares and publishes Internatio

    7、nal Standards for all electrical, electronic and related technologies. About IEC publications The technical content of IEC publications is kept under constant review by the IEC. Please make sure that you have the latest edition, a corrigenda or an amendment might have been published. IEC Catalogue -

    8、 webstore.iec.ch/catalogue The stand-alone application for consulting the entire bibliographical information on IEC International Standards, Technical Specifications, Technical Reports and other documents. Available for PC, Mac OS, Android Tablets and iPad. IEC publications search - www.iec.ch/searc

    9、hpub The advanced search enables to find IEC publications by a variety of criteria (reference number, text, technical committee,). It also gives information on projects, replaced and withdrawn publications. IEC Just Published - webstore.iec.ch/justpublished Stay up to date on all new IEC publication

    10、s. Just Published details all new publications released. Available online and also once a month by email. Electropedia - www.electropedia.org The worlds leading online dictionary of electronic and electrical terms containing more than 30 000 terms and definitions in English and French, with equivale

    11、nt terms in 14 additional languages. Also known as the International Electrotechnical Vocabulary (IEV) online. IEC Glossary - std.iec.ch/glossary More than 55 000 electrotechnical terminology entries in English and French extracted from the Terms and Definitions clause of IEC publications issued sin

    12、ce 2002. Some entries have been collected from earlier publications of IEC TC 37, 77, 86 and CISPR. IEC Customer Service Centre - webstore.iec.ch/csc If you wish to give us your feedback on this publication or need further assistance, please contact the Customer Service Centre: csciec.ch. A propos d

    13、e lIEC La Commission Electrotechnique Internationale (IEC) est la premire organisation mondiale qui labore et publie des Normes internationales pour tout ce qui a trait llectricit, llectronique et aux technologies apparentes. A propos des publications IEC Le contenu technique des publications IEC es

    14、t constamment revu. Veuillez vous assurer que vous possdez ldition la plus rcente, un corrigendum ou amendement peut avoir t publi. Catalogue IEC - webstore.iec.ch/catalogue Application autonome pour consulter tous les renseignements bibliographiques sur les Normes internationales, Spcifications tec

    15、hniques, Rapports techniques et autres documents de lIEC. Disponible pour PC, Mac OS, tablettes Android et iPad. Recherche de publications IEC - www.iec.ch/searchpub La recherche avance permet de trouver des publications IEC en utilisant diffrents critres (numro de rfrence, texte, comit dtudes,). El

    16、le donne aussi des informations sur les projets et les publications remplaces ou retires. IEC Just Published - webstore.iec.ch/justpublished Restez inform sur les nouvelles publications IEC. Just Published dtaille les nouvelles publications parues. Disponible en ligne et aussi une fois par mois par

    17、email. Electropedia - www.electropedia.org Le premier dictionnaire en ligne de termes lectroniques et lectriques. Il contient plus de 30 000 termes et dfinitions en anglais et en franais, ainsi que les termes quivalents dans 14 langues additionnelles. Egalement appel Vocabulaire Electrotechnique Int

    18、ernational (IEV) en ligne. Glossaire IEC - std.iec.ch/glossary Plus de 55 000 entres terminologiques lectrotechniques, en anglais et en franais, extraites des articles Termes et Dfinitions des publications IEC parues depuis 2002. Plus certaines entres antrieures extraites des publications des CE 37,

    19、 77, 86 et CISPR de lIEC. Service Clients - webstore.iec.ch/csc Si vous dsirez nous donner des commentaires sur cette publication ou si vous avez des questions contactez-nous: csciec.ch. IEC 62570 Edition 1.0 2014-02 INTERNATIONAL STANDARD NORME INTERNATIONALE Standard practice for marking medical d

    20、evices and other items for safety in the magnetic resonance environment Pratiques normalises relatives au marquage des appareils mdicaux et des lments de sret divers ddis aux environnements de rsonance magntique INTERNATIONAL ELECTROTECHNICAL COMMISSION COMMISSION ELECTROTECHNIQUE INTERNATIONALE Q I

    21、CS 11.040.50; 11.040.55 PRICE CODE CODE PRIX ISBN 978-2-8322-1443-5 Registered trademark of the International Electrotechnical Commission Marque dpose de la Commission Electrotechnique Internationale Warning! Make sure that you obtained this publication from an authorized distributor. Attention! Veu

    22、illez vous assurer que vous avez obtenu cette publication via un distributeur agr. colour inside2 CONTENTS FOREWORD 3 1 Scope 5 2 Referenced Documents 5 3 Terminology . 6 4 Significance and Use . 7 5 Requirements for assessment of potential hazards caused by interactions of an item and the MR Enviro

    23、nment 7 6 Methods of Marking 7 7 Information Included in MR Marking . 8 8 Keywords . 10 APPENDIX 13 X1. RATIONALE . 13 3 INTERNATIONAL ELECTROTECHNICAL COMMISSION _ STANDARD PRACTICE FOR MARKING MEDICAL DEVICES AND OTHER ITEMS FOR SAFETY IN THE MAGNETIC RESONANCE ENVIRONMENT FOREWORD 1) The Internat

    24、ional Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising all national electrotechnical committees (IEC National Committees). The object of IEC is to promote international co- operation on all questions concerning standardization in the electrical and electro

    25、nic fields. To this end and in addition to other activities, IEC publishes International Standards, Technical Specifications, Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC Publication(s)”). Their preparation is entrusted to technical committees;

    26、 any IEC National Committee interested in the subject dealt with may participate in this preparatory work. International, governmental and non-governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely with the International Organization for Stand

    27、ardization (ISO) in accordance with conditions determined by agreement between the two organizations. 2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international consensus of opinion on the relevant subjects since each technical committee has re

    28、presentation from all interested IEC National Committees. 3) IEC Publications have the form of recommendations for international use and are accepted by IEC National Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC Publications is accurate,

    29、IEC cannot be held responsible for the way in which they are used or for any misinterpretation by any end user. 4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications transparently to the maximum extent possible in their national and regional pub

    30、lications. Any divergence between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in the latter. 5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity assessment services and, in some ar

    31、eas, access to IEC marks of conformity. IEC is not responsible for any services carried out by independent certification bodies. 6) All users should ensure that they have the latest edition of this publication. 7) No liability shall attach to IEC or its directors, employees, servants or agents inclu

    32、ding individual experts and members of its technical committees and IEC National Committees for any personal injury, property damage or other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and expenses arising out of the publication, use of, or relia

    33、nce upon, this IEC Publication or any other IEC Publications. 8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is indispensable for the correct application of this publication. 9) Attention is drawn to the possibility that some of the el

    34、ements of this IEC Publication may be the subject of patent rights. IEC shall not be held responsible for identifying any or all such patent rights. International Standard IEC 62570, integrating the unmodified text of ASTM F2503 - 13, has been developed by subcommittee 62B: Diagnostic imaging equipm

    35、ent, of IEC technical committee 62: Medical equipment in medical practice, in collaboration with ASTM. The text of this standard is based on the following documents: FDIS Report on voting 62B/933/FDIS 62B/934/RVD Full information on the voting for the approval of this standard can be found in the re

    36、port on voting indicated in the above table. The committee has decided that the contents of this publication will remain unchanged until the stability date indicated on the IEC web site under “http:/webstore.iec.ch“ in the data related to the specific publication. At this date, the publication will

    37、be 4 reconfirmed, withdrawn, replaced by a revised edition, or amended. IMPORTANT The “colour inside” logo on the cover page of this publication indicates that it contains colours which are considered to be useful for the correct understanding of its contents. Users should therefore print this publi

    38、cation using a colour printer. F2503 - 13 5 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment 1This standard is issued under the fixed designation F2503 - 13; the number immediately following the designation indicates the year of original

    39、adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A superscript epsilon ( ) indicates an editorial change since the last revision or reapproval. 1. Scope 1.1 This international standard applies to the practice of marking o

    40、f items that might be used in the magnetic resonance (MR) environment. 1.2 The purpose of this practice is to mark items that might be brought into the MR environment and to recommend information that should be included in the marking. 1.3 The standard specifies the permanent marking of items, which

    41、 are used in an MR environment, by means of terms and icons. 1.4 MR image artifacts are not considered to be a performance issue and so are not addressed in this international standard practice (see X1.5). 1.5 The values stated in SI units are to be regarded as standard. No other units of measuremen

    42、t are included in this standard. 1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of his standard to establish appropriate safety and health practices and determine the applicability of regulatory limitati

    43、ons prior to use. 2. Referenced Documents 2.1 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. 2.2

    44、 ASTM Standards: 2F2052 Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment F2119 Test Method for Evaluation of MR Image Artifacts from Passive Implants F2182 Test Method for Measurement of Radio Frequency Induced Heating On

    45、 or Near Passive Implants During Magnetic Resonance Imaging F2213 Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment 2.3 Other Standards: IEC 60601-2-33 Medical Electrical EquipmentPart 2-33: Particular Requirements for the Safety of M

    46、agnetic Resonance Equipment for Medical Diagnosis 4ISO 14971 Medical Devices Application of Risk Management to Medical Devices ISO/IEC Guide 51 Safety Aspects Guidelines for their Inclusion in Standards ISO TS 10974 Assessment of the Safety of Magnetic Resonance Imaging for Patients with an Active I

    47、mplantable Medical Device 1 This practice is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee F04.15 on Material Test Methods. Current edition approved Oct. 1, 2008. Published November 2008. Originally approve

    48、d in 2005. Last previous edition approved in 2005 as F2503 05. DOI: 10.1520/F2503 - 08. 2 For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at serviceastm.org. For Annual Book of ASTM Standards volume information, refer to the standards Document Su

    49、mmary page on the ASTM website. F2503 - 13 6 3. Terminology 3.1 Definitions: 3.1.1 harmful interaction unintended direct or indirect interaction of items with MR equipment, especially with the static magnetic field, the gradient fields and the RF fields of the MR equipment, that can pose hazards to patients or other persons. NOTE 1- In this context, the affected image quality or image artifacts are not considered to be a harmful interaction. 3.1.2 hazar


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