ISO 14708-6-2010 Implants for surgery - Active implantable medical devices - Part 6 Particular requirements for active implantable medical devices intended to t.pdf

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1、 Reference number ISO 14708-6:2010(E) ISO 2010INTERNATIONAL STANDARD ISO 14708-6 First edition 2010-03-01 Implants for surgery Active implantable medical devices Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrilla

2、tors) Implants chirurgicaux Dispositifs mdicaux implantables actifs Partie 6: Exigences particulires pour les dispositifs mdicaux implantables actifs destins traiter la tachyarythmie (y compris les dfibrillateurs implantables) ISO 14708-6:2010(E) PDF disclaimer This PDF file may contain embedded typ

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5、imized 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 PROTECTED DOCUMENT ISO 2010 All rights reserved.

6、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 ISOs member body in the country of the requester. I

7、SO 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 2010 All rights reservedISO 14708-6:2010(E) ISO 2010 All rights reserved iiiContents Page Foreword .v Introduction.vii 1 Scope1 2

8、 Normative references1 3 Terms and definitions .2 4 Symbols and abbreviated terms (optional).6 5 General requirements for non-implantable parts.6 6 Measurement of implantable pulse generator and lead characteristics .6 6.1 Measurement of IMPLANTABLE PULSE GENERATOR characteristics .6 6.2 Measurement

9、 of the electrical characteristic of a sensing/pacing LEAD9 7 General arrangement of the packaging.9 8 General markings for active implantable medical devices .9 9 Markings on the sales packaging 9 10 Construction of the SALES PACKAGING 10 11 Markings on the STERILE PACK.10 12 Construction of the NO

10、N-REUSABLE PACK11 13 Markings on the ACTIVE IMPLANTABLE MEDICAL DEVICE 11 14 Protection from unintended biological effects being caused by the ACTIVE IMPLANTABLE MEDICAL DEVICE 12 15 Protection from HARM to the patient or user caused by external physical features of the ACTIVE IMPLANTABLE MEDICAL DE

11、VICE .12 16 Protection from HARM to the patient caused by electricity12 17 Protection from HARM to the patient caused by heat .15 18 Protection from ionizing radiation released or emitted from the ACTIVE IMPLANTABLE MEDICAL DEVICE 15 19 Protection from unintended effects caused by the device .15 20

12、Protection of the device from damage caused by external defibrillators .17 21 Protection of the device from changes caused by high power electrical fields applied directly to the patient 21 21.2 Protection of the device from damage caused by HF surgical exposure .21 22 Protection of the ACTIVE IMPLA

13、NTABLE MEDICAL DEVICE from changes caused by miscellaneous medical instruments22 23 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from mechanical forces22 24 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from damage caused by electrostatic discharge27 25 Protection of the ACTIVE IMPLANTA

14、BLE MEDICAL DEVICE from damage caused by atmospheric pressure changes27 ISO 14708-6:2010(E) iv ISO 2010 All rights reserved26 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from changes caused by temperature changes 27 27 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from electromagnetic

15、non-ionizing radiation27 28 Accompanying documentation 49 Annex A (informative) Relationship between the fundamental principles in ISO/TR 14283 and the clauses of this standard55 Annex B (informative) Relationship between the clauses of this standard and the fundamental principles listed in Annex A7

16、7 Annex C (informative) Notes on ISO 14708-6 .79 Annex D (informative) Code for describing modes of IMPLANTABLE PULSE GENERATORS 99 Annex E (normative) Interface circuits .101 Annex F (informative) Selection of capacitor C x 105 Annex G (normative) Calibration of injection network (Figure E.105); Te

17、st signal of inhibition generator (Figure G.101) .106 Annex H (informative) Defined terms 108 Bibliography 110 ISO 14708-6:2010(E) ISO 2010 All rights reserved vForeword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies

18、). The work of preparing International Standards is normally carried out through ISO technical committees. Each member 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 no

19、n-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Par

20、t 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted 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

21、 a vote. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 14708-6 was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommitt

22、ee SC 6, Active implants. ISO 14708 consists of the following parts, under the general title Implants for surgery Active implantable medical devices: Part 1: General requirements for safety, marking and for information to be provided by the manufacturer Part 2: Cardiac pacemakers Part 3: Implantable

23、 neurostimulators Part 4: Implantable infusion pumps Part 5: Circulatory support devices Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators) In this International Standard, the following print types are used:

24、 Requirements and definitions: roman type. Test specifications: italic type. Informative material appearing outside of tables, such as notes, examples and references: smaller type. Normative text of tables is also in a smaller type. T ERMS DEFINED IN CLAUSE 3 OF ISO 14708-1, IN THIS PART OF ISO 1470

25、8 OR AS NOTED: SMALL CAPITALS In referring to the structure of this standard, the term “clause” means one of the seventeen numbered divisions within the table of contents, inclusive of all subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.); “subclause” means a numbered subdivision of a

26、clause (e.g. 7.1, 7.2 and 7.2.1 are all subclauses of Clause 7). ISO 14708-6:2010(E) vi ISO 2010 All rights reservedReferences to clauses within this standard are preceded by the term “Clause” followed by the clause number. References to subclauses within this collateral standard are by number only.

27、 In this International Standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any combination of the conditions is true. The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC Directives, Part 2. For the purposes of this standard, t

28、he auxiliary verb: “shall” means that compliance with a requirement or a test is mandatory for compliance with this standard; “should” means that compliance with a requirement or a test is recommended but is not mandatory for compliance with this standard; “may” is used to describe a permissible way

29、 to achieve compliance with a requirement or test. ISO 14708-6:2010(E) ISO 2010 All rights reserved viiIntroduction This part of ISO 14708 specifies particular requirements for IMPLANTABLE CARDIOVERTER DEFIBRILLATORS and the functions of ACTIVE IMPLANTABLE MEDICAL DEVICES intended to treat tachyarrh

30、ythmia, to provide basic assurance of safety for both patients and users. An external defibrillator is a MEDICAL DEVICE used, in the emergency setting, to deliver a high-energy shock to the heart, by means of ELECTRODES applied to the external chest wall, in patients suffering ventricular fibrillati

31、on (a rapid, disorganized and potentially lethal heart rhythm abnormality), to restore normal heart action. External defibrillators may also be used, in emergency or elective settings, to terminate other ventricular or atrial tachyarrhythmias by delivery of a high-energy shock, synchronized to the i

32、ntrinsic cardiac rhythm, a procedure known as CARDIOVERSION. In patients known to be at risk of such arrhythmias, due to the occurrence of previous episodes or the presence of specific predisposing cardiac conditions, an IMPLANTABLE CARDIOVERTER DEFIBRILLATOR may be implanted to perform similar func

33、tions. The implantable device, which is much smaller than an external defibrillator, is contained within a sealed, encapsulating enclosure. It generates high voltage PULSES from an enclosed, miniature, electrical battery. The PULSES are transmitted to the heart by means of implanted, insulated condu

34、ctors with ELECTRODES ( LEADS). The IMPLANTABLE CARDIOVERTER DEFIBRILLATOR may also incorporate other sensing and pacing functions, such as rate support for bradycardia and ANTITACHYCARDIA PACING (ATP) to terminate certain tachyarrhythmias without the need of a high-energy shock. The defibrillator m

35、ay be adjusted non-invasively by means of an electronic device, known as a programmer. This part of ISO 14708 is relevant to all parts of ACTIVE IMPLANTABLE MEDICAL DEVICES intended to treat tachyarrhythmia other than pacing functions to control bradyarrhythmia. Typical examples are IMPLANTABLE PULS

36、E GENERATORS, LEADS, ADAPTORS, ACCESSORIES, programmers and the related software (bradyarrhythmia pacing functions are dealt with in ISO 14708-2). The requirements of this part of ISO 14708 supplement or modify those of ISO 14708-1, Implants for surgery Active implantable medical devices Part 1: Gen

37、eral requirements for safety, marking and for information to be provided by the manufacturer, hereinafter referred to as ISO 14708-1. The requirements of this part of ISO 14708 take priority over those of ISO 14708-1. Figures or tables that are additional to those of ISO 14708-1 are numbered startin

38、g from 101. Annex D describes a coding system that may be used to designate tachyarrhythmia therapy modes. Annex E defines the tissue equivalent interface circuits and low-pass filter required for some compliance tests. Annex F describes a method for selecting the filter capacitor used in the tissue

39、 equivalent interface circuits defined by Annex E. Annex G defines the method of calibrating the injection network defined by Annex E. All annexes except Annex E and Annex G are informative. INTERNATIONAL STANDARD ISO 14708-6:2010(E) ISO 2010 All rights reserved 1Implants for surgery Active implanta

40、ble medical devices Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators) 1 Scope This part of ISO 14708 specifies requirements that are applicable to IMPLANTABLE CARDIOVERTER DEFIBRILLATORS and the functions o

41、f ACTIVE IMPLANTABLE MEDICAL DEVICES intended to treat tachyarrhythmia. The tests that are specified in ISO 14708 are type tests and are to be carried out on samples of a device to show compliance. This part of ISO 14708 is also applicable to some non-implantable parts and accessories of the devices

42、 (see Note 1). The characteristics of the IMPLANTABLE PULSE GENERATOR or LEAD shall be determined by either the appropriate method detailed in this part of ISO 14708 or by any other method demonstrated to have accuracy equal to, or better than, the method specified. In the case of dispute, the metho

43、d detailed in this part of ISO 14708 shall apply. Any aspect of an ACTIVE IMPLANTABLE MEDICAL DEVICE intended to treat bradyarrhythmias is covered by ISO 14708-2. NOTE 1 The device that is commonly referred to as an ACTIVE IMPLANTABLE MEDICAL DEVICE may in fact be a single device, a combination of d

44、evices, or a combination of a device or devices and one or more accessories. Not all of these parts are required to be either partially or totally implantable, but there is a need to specify some requirements of non- implantable parts and accessories if they could affect the safety or performance of

45、 the implantable device. NOTE 2 The terminology used in this European Standard is intended to be consistent with the terminology of Directive 90/385/EEC. NOTE 3 In this part of ISO 14708, terms printed in small capital letters are used as defined in Clause 3. Where a defined term is used as a qualif

46、ier in another term, it is not printed in small capital letters unless the concept thus qualified is also defined. NOTE 4 Particular requirements for congestive heart failure devices are under consideration. These types of devices are not covered by this part of ISO 14708. 2 Normative references The

47、 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. This clause of ISO 14708-1 applies except as follows

48、: Additional references: ISO 14708-6:2010(E) 2 ISO 2010 All rights reservedISO 5841-3 + corr. 1, Implants for surgery Cardiac pacemakers Part 3: Low-profile connectors (IS-1) for implantable pacemakers ISO 8601, Data elements and interchange formats Information interchange Representation of dates an

49、d times ISO 11318, Cardiac defibrillators Connector assembly DF-1 for implantable defibrillators Dimensions and test requirements ISO 14708-1, Implants for surgery Active implantable medical devices Part 1: General requirements for safety, marking and for information to be provided by the manufacturer ISO 14708-2, Implants for surgery Active implantable medical devices Part 2: Cardiac pacemakers ISO 15223-1, Medical devices Symbols to be used with medical device labels, labelli