ISO 14708-2-2012 Implants for surgery - Active implantable medical devices - Part 2 Cardiac pacemakers《外科植入物 有源可植入医疗装置 第2部分 心脏起搏器》.pdf

1、 Reference number ISO 14708-2:2012(E) ISO 2012INTERNATIONAL STANDARD ISO 14708-2 Second edition 2012-08-15 Implants for surgery Active implantable medical devices Part 2: Cardiac pacemakers Implants chirurgicaux Dispositifs mdicaux implantables actifs Partie 2: Stimulateurs cardiaques ISO 14708-2:20

2、12(E) COPYRIGHT PROTECTED DOCUMENT ISO 2012 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 add

3、ress below or ISOs 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 2012 All rights reservedISO 14708-2:2012(E) ISO 2012 All rights

4、reserved iiiContents Page Foreword . v Introduction vi 1 Scope 1 2 Normative references 1 3 Terms and definitions . 2 4 Symbols and abbreviated terms 6 5 General requirements for non-implantable parts . 6 6 Measurements of implantable pulse generator and lead characteristics . 6 6.1 Measurement of i

5、mplantable pulse generator characteristics . 6 6.2 Measurement of the lead pacing impedance (Z p ) 18 7 General arrangement of the packaging . 19 8 General markings for active implantable medical devices . 20 9 Markings on the sales packaging 20 10 Construction of the sales packaging 21 11 Markings

6、on the sterile pack 21 12 Construction of the non-reusable pack 22 13 Markings on the active implantable medical device 23 14 Protection from unintentional biological effects being caused by the active implantable medical device . 24 15 Protection from harm to the patient or user caused by external

7、physical features of the active implantable medical device . 24 16 Protection from harm to the patient caused by electricity 24 17 Protection from harm to the patient caused by heat . 25 18 Protection from ionizing radiation released or emitted from the active implantable medical device . 26 19 Prot

8、ection from unintended effects caused by the device . 26 20 Protection of the device from damage caused by external defibrillators . 27 21 Protection of the device from changes caused by high power electrical fields applied directly to the patient 27 22 Protection of the active implantable medical d

9、evice from changes caused by miscellaneous medical treatments 27 23 Protection of the active implantable medical device from mechanical forces . 27 24 Protection of the active implantable medical device from damage caused by electrostatic discharge 32 25 Protection of the active implantable medical

10、device from damage caused by atmospheric pressure changes 32 26 Protection of the active implantable medical device from damage caused by temperature changes 33 ISO 14708-2:2012(E) iv ISO 2012 All rights reserved27 Protection of the active implantable medical device from electromagnetic non-ionizing

11、 radiation 33 28 Accompanying documentation 33 Annex A A (informative) Relationship between the fundamental principles in ISO/TR 14283 and the clauses of this International Standard 37 Annex B B (informative) Relationship between the clauses of this part of ISO 14708 and the fundamental principles i

12、n Annex A 51 Annex C C (informative) Rationale 52 Annex D D (informative) Code for describing modes of implantable pulse generators 61 Annex E E (informative) Symbols 64 Annex F F (normative) Pulse forms .65 Bibliography 67 ISO 14708-2:2012(E) ISO 2012 All rights reserved vForeword ISO (the Internat

13、ional 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 body interested in a subject for which a technical committee has bee

14、n 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 Electrotechnical Commission (IEC) on all matters of electrotechnical stand

15、ardization. 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 by the technical committees are circulated to the member bodies for

16、 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 rights. ISO shall not be held responsible for identifying any or all

17、 such patent rights. ISO 14708-2 was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee SC 6, Active implants. This second edition cancels and replaces the first edition (ISO 14708-2:2005), which has been technically revised. ISO 14708 consists of the following parts, und

18、er 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 neurostimulators Part 4: Implantable infusion pumps Part 5: Circulatory

19、 support devices Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators) The following parts are under preparation: Part 7: Particular requirements for cochlear implant systems ISO 14708-2:2012(E) vi ISO 2012 All

20、 rights reservedIntroduction This part of ISO 14708 specifies particular requirements for those ACTIVE IMPLANTABLE MEDICAL DEVICES intended to treat bradyarrhythmias (PACEMAKERS), to provide basic assurance of safety to both patients and users. An implantable cardiac PACEMAKER is essentially a power

21、ed electronic device within a sealed, encapsulating enclosure (an IMPLANTABLE PULSE GENERATOR). The device can stimulate heart beats by generating electrical impulses which are transmitted to the heart along implanted, insulated conductors with ELECTRODES (LEADS). The PACEMAKER may be adjusted non-i

22、nvasively by an electronic device, known as a programmer. This part of ISO 14708 is relevant to all parts of implantable PACEMAKERS, including all accessories. Typical examples are IMPLANTABLE PULSE GENERATORS, LEADS, ADAPTORS, programmers and the related software. The requirements of this part of I

23、SO 14708 supplement or modify those of ISO 14708-1, referred to as the General Standard. 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 starting from 101; additional annexes are lettered A

24、A, BB, etc. Although both this part of ISO 14708 and the Directive 90/385/EEC deal with the same products, the structure and purpose of the two documents are different. Annex AA correlates the requirements of the Directive with the subclauses of ISO 14708-1 and this part of ISO 14708. Annex BB provi

25、des reference in the other direction, from this part of ISO 14708 to the Directive. Annex CC is a rationale providing further explanation of the subclauses of this part of ISO 14708. Annex DD describes a coding system that may be used to designate bradyarrhythmia pacing modes. Annex EE provides opti

26、onal symbols that may be used to reduce the need for translation of MARKINGS and information in the accompanying documentation in multiple languages. Annex FF defines reference points for measurements of PULSE AMPLITUDE and PULSE DURATION, and the form of test signal used to determine SENSITIVITY. A

27、ll annexes except Annex FF are informative. INTERNATIONAL STANDARD ISO 14708-2:2012(E) ISO 2012 All rights reserved 1Implants for surgery Active implantable medical devices Part 2: Cardiac pacemakers 1 Scope This part of ISO 14708 specifies requirements that are applicable to those ACTIVE IMPLANTABL

28、E MEDICAL DEVICES intended to treat bradyarrhythmias. The tests that are specified in this part of 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 (se

29、e NOTE 1). The electrical characteristics of the implantable pulse generator OR LEAD are determined either by the appropriate method detailed in this particular standard or by any other method demonstrated to have an accuracy equal to, or better than, the method specified. In case of dispute, the me

30、thod detailed in this particular standard applies. Any features of an ACTIVE IMPLANTABLE MEDICAL DEVICE intended to treat tachyarrhythmias are covered by ISO 14708-6. NOTE 1 The device that is commonly referred to as an ACTIVE IMPLANTABLE MEDICAL DEVICE may in fact be a single device, a combination

31、of devices, 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 performanc

32、e of the implantable device. NOTE 2 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 qualifier in another term, it is not printed in small capital letters unless the concept thus qualified is also defined. 2 Normativ

33、e references 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 5841-3:2000, Implants for surger

34、y Cardiac pacemakers Part 3: Low-profile connectors (IS-1) for implantable pacemakers ISO 8601, Data elements and interchange formats Information interchange Representation of dates and times ISO 11318:2002, Cardiac defibrillators Connector assembly DF-1 for implantable defibrillators Dimensions and

35、 test requirements ISO 14708-2:2012(E) 2 ISO 2012 All rights reservedISO 14117, Active implantable medical devices Electromagnetic compatibility EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices ISO 14708-1:2000, Impl

36、ants for surgery Active implantable medical devices Part 1: General requirements for safety, marking and for information to be provided by the manufacturer IEC 60068-2-47, Environmental testing Part 2-47: Test Mounting of specimens for vibration, impact and similar dynamic tests IEC 60068-2-64, Envi

37、ronmental testing Part 2-64: Tests Test Fh: Vibration, broadband random and guidance 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 14708-1 and the following apply. 3.1 accessory article which, while not being a device, is intended specifically by i

38、ts manufacturer to be used together with a device in accordance with the use of the device intended by the device manufacturer 3.2 adaptor special connector used between an otherwise incompatible active implantable pulse generator and a lead 3.3 pacemaker ACTIVE IMPLANTABLE MEDICAL DEVICE intended t

39、o treat bradyarrhythmias, comprising an IMPLANTABLE PULSE GENERATOR and LEAD(S) 3.4 implantable pulse generator part of the PACEMAKER, including the power supply and electronic circuit that produces an electrical output 3.5 sensor part of a pacemaker that is designed to detect signals for the purpos

40、e of RATE MODULATION 3.6 dual-chamber condition of relating both to the atrium and ventricle 3.7 input impedance Z in implantable pulse generator electrical impedance presented at an input terminal, measured according to the procedure in 6.1.4 and taken as equal to that presented to a sensed beat 3.

41、8 sensitivity sensing threshold minimum signal required to control consistently the function of the IMPLANTABLE PULSE GENERATOR NOTE See 6.1.3. ISO 14708-2:2012(E) ISO 2012 All rights reserved 33.9 electrode electrically conducting part (usually the termination of a LEAD), which is designed to form

42、an interface with body tissue or body fluid 3.10 bipolar lead LEAD with two ELECTRODES, electrically isolated from each other 3.11 unipolar lead LEAD with one ELECTRODE 3.12 endocardial lead LEAD with an ELECTRODE designed to make contact with the endocardium, or inner surface of the heart 3.13 epic

43、ardial lead LEAD with an ELECTRODE designed to make contact with the epicardium, or outer surface of the heart 3.14 transvenous approach to the heart through the venous system 3.15 insertion diameter LEAD minimum bore of a rigid cylindrical tube into which the LEAD (not including the connector) may

44、be inserted 3.16 lead conductor resistance R cohmic resistance between the ELECTRODE and the corresponding lead connector terminal 3.17 lead pacing impedance Z pimpedance that is formed by the ratio of a voltage PULSE to the resulting current NOTE 1 The impedance is composed of the ELECTRODE/tissue

45、interface and the LEAD CONDUCTOR RESISTANCE. 3.18 lead sensing impedance Z ssource impedance of a LEAD as seen by an IMPLANTABLE PULSE GENERATOR 3.19 model designation name and/or a combination of letters and numbers used by a manufacturer to distinguish, by function or type, one device from another

46、 3.20 serial number unique combination of letters and/or numbers, selected by the manufacturer, intended to distinguish a device from other devices with the same MODEL DESIGNATION ISO 14708-2:2012(E) 4 ISO 2012 All rights reserved3.21 beat ordered spontaneous or paced activity of the heart 3.22 puls

47、e electrical output of an IMPLANTABLE PULSE GENERATOR intended to stimulate the myocardium 3.23 pulse amplitude amplitude of the PULSE measured according to the procedure in 6.1.2 3.24 pulse duration duration of the PULSE measured according to the procedure in 6.1.2 3.25 pulse interval interval betw

48、een equivalent points of two consecutive PULSES NOTE See 6.1.2. 3.26 basic pulse interval PULSE INTERVAL in absence of sensed cardiac or other electrical influence 3.27 pulse rate number of PULSES per minute NOTE See 6.1.2. 3.28 basic rate PULSE RATE of an IMPLANTABLE PULSE GENERATOR, either atrial

49、or ventricular, unmodified by sensed cardiac or other electrical influence 3.29 atrioventricular interval AV interval delay between an atrial PULSE or the sensing of an atrial depolarization and the subsequent ventricular PULSE or the sensing of a ventricular depolarization NOTE See 6.1.8. 3.30 escape interval time elapsing between the sensing of a spontaneous BEAT and the succeeding non-triggered PULSE of an IMPLANTABLE PULSE GENERATOR NOTE See 6.1.5. 3.31 hysteresis characteristic of an I