1、 Reference number ISO 14708-5:2010(E) ISO 2010INTERNATIONAL STANDARD ISO 14708-5 First edition 2010-02-01 Implants for surgery Active implantable medical devices Part 5: Circulatory support devices Implants chirurgicaux Dispositifs mdicaux implantables actifs Partie 5: Appareils annexes circulatoire
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5、ss given below. COPYRIGHT PROTECTED DOCUMENT ISO 2010 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
6、at the address 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 2010 All rights reservedISO 14708-5:2010(E) ISO 2010 A
7、ll rights reserved iiiContents Page Foreword .v Introductionvi 1 Scope1 2 Normative references1 3 Terms and definitions .2 4 Symbols and abbreviated terms 6 5 General requirements for non-implantable parts.6 6 Requirements for particular active implantable medical devices 6 7 General arrangement of
8、the packaging.19 8 General markings for active implantable medical devices .19 9 Markings on the sales packaging 19 10 Construction of the sales packaging 20 11 Markings on the sterile pack 20 12 Construction of the non-reusable pack 20 13 Markings on the active implantable medical device21 14 Prote
9、ction from unintentional biological effects caused by the active implantable medical device21 15 Protection from harm to the patient or user caused by external physical features of the active implantable medical device.21 16 Protection from harm to the patient caused by electricity21 17 Protection f
10、rom harm to the patient caused by heat .21 18 Protection from ionizing radiation released or emitted from the active implantable medical device .21 19 Protection from unintended effects caused by the device .21 20 Protection of the device from damage caused by external defibrillators .23 21 Protecti
11、on of the device from changes caused by high-power electrical fields applied directly to the patient 23 22 Protection of the active implantable medical device from changes caused by miscellaneous medical treatments23 23 Protection of the active implantable medical device from mechanical forces .23 2
12、4 Protection of the active implantable medical device from damage caused by electrostatic discharge23 25 Protection of the active implantable medical device from damage caused by atmospheric pressure changes23 26 Protection of the active implantable medical device from damage caused by temperature c
13、hanges 23 27 Protection of the active implantable medical device from electromagnetic non-ionizing radiation23 ISO 14708-5:2010(E) iv ISO 2010 All rights reserved28 Accompanying documentation 23 Annex AA (informative) Relationship between the fundamental principles in ISO/TR 14283 and the clauses of
14、 this part of ISO 14708 .26 Annex BB (informative) Relationship between the clauses of this part of ISO 14708 and the fundamental principles listed in Annex AA 35 Annex CC (informative) Rationale .37 Annex DD (informative) In vitro test 42 Bibliography 46 ISO 14708-5:2010(E) ISO 2010 All rights rese
15、rved vForeword ISO (the International 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 whi
16、ch a technical committee has been 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 m
17、atters of electrotechnical standardization. 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 cir
18、culated to the member bodies for 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 respon
19、sible for identifying any or all such patent rights. ISO 14708-5 was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee SC 6, Active implants. ISO 14708 consists of the following parts, under the general title Implants for surgery Active implantable medical devices: Part
20、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 support devices Part 6: Particular requirements for active implantable medical dev
21、ices intended to treat tachyarrhythmia (including implantable defibrillators) ISO 14708-5:2010(E) vi ISO 2010 All rights reservedIntroduction This part of ISO 14708 specifies requirements for safety and performance of active implantable circulatory support devices. It is not intended to be used for
22、extracorporeal perfusion devices, cardiomyoplasty, heart restraint devices, and counter-pulsation devices such as extra- or intra-aortic balloon pumps. It amends and supplements ISO 14708-1:2000, hereinafter referred to as ISO 14708-1. The requirements of this part of ISO 14708 take priority over th
23、ose of ISO 14708-1. Heart failure (HF) is a major public health problem. It is estimated that worldwide more than 5 million people die per year due to heart failure. The number of newly diagnosed cases is more than 550 000 per year in the USA alone (AHA 13 ). In 2001, nearly 53 000 patients in the U
24、nited States died of HF as a primary cause. Further, heart failure is implicated as a contributing factor in more than 250 000 deaths each year in the USA alone (Yusuf 29 ). Particularly at a higher risk for heart failure are the elderly ( 60 years), who account for 70 % of heart failure patients (H
25、aldeman et al 18 ), and for whom congestive heart failure is the leading cause of hospitalization. From 1990 to 1999, the annual number of hospitalizations has increased from approximately 810 000 to over 1 million for HF as a primary diagnosis and from 2,4 million to 3,6 million for HF as a primary
26、 or secondary diagnosis (Koelling TM et al, 30 ). The economic costs are enormous. It has been estimated that in 2005, the total direct and indirect cost of HF in the United States is equal to $27,9 billion (AHA 13 ). Worldwide, it is estimated that over $900 billion per year is spent and almost one
27、 third of patients are younger than 60. Heart transplantation in recent years has become an effective treatment for end-stage heart failure. Unfortunately the number of donor hearts is limited to just about 3 000 worldwide, available only to a small fraction of patients who need heart transplants. F
28、uture drug discoveries and/or biological therapies such as cell regeneration and gene therapy hold promise for the future in the treatment of chronic heart failure. However, as of today, mechanical circulatory devices remain the only alternative to heart transplantation and will continue to be a via
29、ble treatment for end-stage heart failure for the foreseeable future. Within this part of ISO 14708, the following terms are used to amend and supplement ISO 14708-1: “Replacement”: the clause of ISO 14708-1 is replaced completely by the text of this particular part of ISO 14708. “Addition”: the tex
30、t of this particular part is additional to the requirements of ISO 14708-1. “Amendment”: the clause of ISO 14708-1 is amended as indicated by the text of this particular part of ISO 14708. “Not used”: the clause of ISO 14708-1 is not applied in this particular part of ISO 14708. Subclauses, figures,
31、 or tables that are additional to those of ISO 14708-1 are numbered starting from 101; additional annexes are lettered AA, BB, etc. INTERNATIONAL STANDARD ISO 14708-5:2010(E) ISO 2010 All rights reserved 1Implants for surgery Active implantable medical devices Part 5: Circulatory support devices 1 S
32、cope This part of ISO 14708 specifies requirements for safety and performance of active implantable circulatory support devices. It is not applicable to extracorporeal perfusion devices, cardiomyoplasty, heart restraint devices and counter-pulsation devices, such as extra- or intra-aortic balloon pu
33、mps. This part of ISO 14708 specifies type tests, animal studies and clinical evaluation requirements. NOTE The device that is commonly referred to as an active implantable medical device can in fact be a single device, a combination of devices, or a combination of a device or devices and one or mor
34、e accessories. Not all of these parts are required to be either partially or totally implantable, but there is a need to specify main requirements of non- implantable parts and accessories if they could affect the safety or performance of the implantable device. 2 Normative references The following
35、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 5198, Centrifugal, mixed flow and axial pumps Code for hydr
36、aulic performance tests Precision grade ISO 5840, Cardiovascular implants Cardiac valve prostheses ISO 7198, Cardiovascular implants Tubular vascular prostheses ISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process ISO 14155 1) , Clinic
37、al investigation of medical devices for human subjects Good clinical practice 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 14971, Medical devices Application of risk ma
38、nagement to medical devices IEC 60601-1, Medical electrical equipment Part 1: General requirements for basic safety and essential performance IEC 60601-1-1, Medical electrical equipment Part 1-1: General requirements for safety Collateral standard: Safety requirements for medical electrical systems
39、1) To be published. (Revision of ISO 14155-1 and ISO 14155-2) ISO 14708-5:2010(E) 2 ISO 2010 All rights reservedIEC 60601-1-2, Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance Collateral standard: Electromagnetic compatibility Requirements and te
40、sts IEC 60601-1-8, Medical electrical equipment Part 1-8: General requirements for basic safety and essential performance Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems IEC 62304, Medical device software
41、Software life cycle processes 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 14708-1 and ISO 14971 and the following apply. 3.101 accessory device separate part of a circulatory support system that is not essential to the primary function of the cir
42、culatory support system NOTE Examples are programming units, monitoring units and alternative power supply units. 3.102 artificial valve prosthetic valve component of the circulatory support system that directs the unidirectional flow of the blood into and out of the pump 3.103 atrial cuff connector
43、 between the right or left atrial ring after resection of the natural ventricle and the inlet of the right or left blood pump in total artificial heart replacement 3.104 cavitation sudden formation and collapse of low pressure bubbles in the blood by means of mechanical forces 3.105 clinical study e
44、valuation of a device in humans 3.106 conduit component of the circulatory support system that connects the pump to the patients circulation 3.107 controller component of the circulatory support system that contains the logic, circuitry and/or software to control the driving mechanism that enables t
45、he system to perform its primary function 3.108 diastolic pressure arithmetic average of diastolic blood pressure (when the left ventricle is not contracting), over a sufficient number of cycles to filter out cyclic variation, of the minimum aortic pressures in a pulsatile pressure waveform 3.109 dp
46、/dt time derivative of pressure giving the rate of change of pressure with respect to time NOTE dp/dt is expressed in millimetres of mercury per second, mmHg/s (kiloPascal per second kPa/s in SI units). ISO 14708-5:2010(E) ISO 2010 All rights reserved 33.110 dQ/dt time derivative of flow giving the
47、rate of change of flow with respect to time NOTE dQ/dt is expressed in units of litres per minute per second. 3.111 drive line tube and/or cable that connects a driver or energy source to the pump EXAMPLE The tube that connects a pneumatic console to a pneumatically driven pump. 3.112 durability abi
48、lity of an item to perform a required function under given conditions of use and maintenance, until a limiting state is reached NOTE A limiting state of an item should be characterized by the end of the useful life, unsuitability for any economic or technological reasons, or other relevant factors.
49、3.113 ejection/fill E/F ratio between the ejection time period and the filling time period of the blood pump cycle NOTE E/F is identical to S/D (systolic/diastolic) when related to the natural heart. 3.114 extracorporeal component component or subsystem of the circulatory support system that is kept external to the patient (outside of the body) 3.115 failure termination of the ability of an item to perform a required function NOTE 1 After failure, the item has a fault. NOTE 2 “Fa
