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

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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

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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