1、 Reference number ISO 14708-4:2008(E) ISO 2008INTERNATIONAL STANDARD ISO 14708-4 First edition 2008-11-15 Implants for surgery Active implantable medical devices Part 4: Implantable infusion pumps Implants chirurgicaux Dispositifs mdicaux implantables actifs Partie 4: Pompes dinfusion en implant ISO
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5、ven below. COPYRIGHT PROTECTED DOCUMENT ISO 2008 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 th
6、e 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 2008 All rights reservedISO 14708-4:2008(E) ISO 2008 All ri
7、ghts reserved iii Contents Page Foreword. v Introduction . vi 1 Scope . 1 2 Normative references . 1 3 Terms and definitions. 2 4 Symbols and abbreviated terms . 3 5 General requirements for non-implantable parts 3 6 Requirements for particular active implantable medical devices . 3 7 General arrang
8、ement of the packaging 5 8 General markings for active implantable medical devices 5 9 Markings on the sales packaging . 6 10 Construction of the sales packaging 6 11 Markings on the sterile pack . 6 12 Construction of the non-reusable pack 7 13 Markings on the active implantable medical device . 7
9、14 Protection from unintentional biological effects caused by the active implantable medical device. 7 15 Protection from harm to the patient or user caused by external physical features of the active implantable medical device 8 16 Protection from harm to the patient caused by electricity. 8 17 Pro
10、tection from harm to the patient caused by heat 9 18 Protection from ionizing radiation released or emitted from the active implantable medical device 9 19 Protection from unintended effects caused by the device. 9 20 Protection of the device from damage caused by external defibrillators. 10 21 Prot
11、ection of the device from changes caused by high-power electrical fields applied directly to the patient 10 22 Protection of the active implantable medical device from changes caused by miscellaneous medical treatments . 10 23 Protection of the active implantable medical device from mechanical force
12、s 10 24 Protection of the active implantable medical device from damage caused by electrostatic discharge . 11 25 Protection of the active implantable medical device from damage caused by atmospheric pressure changes . 11 26 Protection of the active implantable medical device from damage caused by t
13、emperature changes . 11 27 Protection of the active implantable medical device from electromagnetic non-ionizing radiation. 11 ISO 14708-4:2008(E) iv ISO 2008 All rights reserved28 Accompanying documentation 17 Annex AA (informative) Relationship between the fundamental principles in ISO/TR 14283 8a
14、nd the clauses of this part of ISO 14708 20 Annex BB (informative) Relationship between the clauses of this part of ISO 14708 and the fundamental principles listed in Annex AA 30 Annex CC (informative) Rationale. 32 Bibliography . 41 ISO 14708-4:2008(E) ISO 2008 All rights reserved v Foreword ISO (t
15、he 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 which a technical commit
16、tee 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 matters of electrotech
17、nical 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 circulated to the member
18、 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 responsible for identifying
19、 any or all such patent rights. ISO 14708-4 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 1: General requiremen
20、ts 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 ISO 14708-4:2008(E) vi ISO 2008 All rights reservedIntroduction This part of ISO 14708 specifies particular requirements fo
21、r active implantable medical devices intended to deliver a medicinal substance to site-specific locations within the human body, to provide basic assurance of safety for both patients and users. It amends and supplements ISO 14708-1:2000, hereinafter referred to as ISO 14708-1. The requirements of t
22、his part of ISO 14708 take priority over those of ISO 14708-1. An implantable infusion pump is a device that delivers either a constant flow rate or a variable flow rate from which a medicinal substance is delivered via an implanted catheter to site-specific locations within the human body. An exter
23、nal programmer might be used to adjust device parameters. This part of ISO 14708 is relevant to all parts and accessories of implantable infusion pumps, including catheters, refill kits, direct access port kits, programmers and related software. Not all parts or accessories might be intended to be t
24、otally or partially implanted, but there is a need to specify some requirements of non- implantable parts and accessories if they could affect the safety or performance intended by the manufacturer. Requirements for physiologic sensing functions of implantable infusion pumps are not included in this
25、 edition of this part of ISO 14708 but might be considered in future editions. 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”:
26、 the text of this particular part of ISO 14708 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.
27、 Subclauses, figures, 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 14708-4:2008(E) ISO 2008 All rights reserved 1 Implants for surgery Active implantable medical devices Part 4: Implantab
28、le infusion pumps 1 Scope This part of ISO 14708 is applicable to active implantable medical devices intended to deliver medicinal substances to site-specific locations within the human body. This part of ISO 14708 is also applicable to some non-implantable parts and accessories of the devices as de
29、fined in Clause 3. The tests that are specified in this part of ISO 14708 are type tests intended to be carried out on a sample of a device to show compliance, and are not intended to be used for the routine testing of manufactured products. NOTE This part of ISO 14708 is not intended to apply to no
30、n-implantable infusion systems. However, it does apply to devices intended to be used as trial systems because of their close affiliation with implantable infusion pumps. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated refer
31、ences, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 14708-1, Implants for surgery Active implantable medical devices Part 1: General requirements for safety, marking and for information to be provided by
32、 the manufacturer IEC 60601-1:2005, Medical electrical equipment Part 1: General requirements for basic safety and essential performance IEC 60601-1-2:2007, Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance Collateral standard: Electromagnetic com
33、patibility Requirements and tests IEC 61000-4-3:2002, Electromagnetic compatibility (EMC) Part 43: Testing and measurement techniques Radiated, radio-frequency, electromagnetic field immunity test ANSI/AAMI PC69:2000, Active implantable medical devices Electromagnetic compatibility EMC test protocol
34、s for implantable cardiac pacemakers and implantable cardioverter defibrillators ISO 14708-4:2008(E) 2 ISO 2008 All rights reserved3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 14708-1 and the following apply. 3.101 implantable infusion pump active
35、 implantable medical device intended for delivery of a medicinal substance to a specific location within the human body NOTE For purposes of this part of ISO 14708, an implantable infusion pump can be a single article, or a system consisting of a set of components and accessories which interact to a
36、chieve the performance intended by the manufacturer. Not all of these components or accessories might be required to be partially or totally implanted, e.g. programmers and trial systems. 3.102 pump gear implantable part of an implantable infusion pump containing the fluid reservoir, energy source a
37、nd, in some cases, control electronics 3.103 fluid path internal surfaces of the implantable infusion pump which are in direct contact with a medicinal substance 3.104 outlet port port where fluid enters the delivery catheter 3.105 refill access port port allowing access to the fluid reservoir 3.106
38、 direct access port port allowing access to the delivery catheter 3.107 internal volume fluid volume extending from the reservoir to the outlet port 3.108 reservoir volume fluid volume of the reservoir that can be discharged while maintaining infusion accuracy within specifications 3.109 residual vo
39、lume fluid volume that cannot be removed from the pump gear 3.110 projected service life period after implantation when the implantable infusion pump remains within stated specifications and characteristics 3.111 stability interval calculated maximum interval between two subsequent reservoir refills
40、 to assure stability of the medicinal substance 3.112 infusion accuracy how close the true (actual) infusion rate is to the specified rate ISO 14708-4:2008(E) ISO 2008 All rights reserved 3 3.113 repeatability value below which the absolute difference between two successive test results obtained wit
41、h the same implantable infusion pump with the same infusate under the same conditions can be expected to lie, with a probability of 95 % NOTE 1 A more qualitative way of looking at repeatability is the ability to consistently deliver the same results over time (e.g. infusion rate). Repeatability is
42、a metric independent of accuracy. NOTE 2 A method for calculating repeatability is given in Annex B of ISO 11631:1998 9 . 3.114 minimum rate lowest rate selectable by the user 3.115 intermediate rate rate specified by the manufacturer as typical for the implantable infusion pump NOTE The rate specif
43、ied might depend on the application. 3.116 maximum rate highest rate selectable by the user 3.117 bolus discrete quantity of liquid that is delivered in a short time 3.118 essential performance performance necessary to achieve freedom from unacceptable risk NOTE For guidance on essential performance
44、 concepts see IEC 60601-1. 4 Symbols and abbreviated terms This clause of ISO 14708-1 and the following applies. DUT device under test 5 General requirements for non-implantable parts This clause of ISO 14708-1 applies. 6 Requirements for particular active implantable medical devices Additional subc
45、lauses: 6.101 Implantable infusion pump characteristics The specifications and characteristics (e.g. infusion accuracy and repeatability) stated by the manufacturer in the accompanying documentation (see 28.8) shall be maintained over the projected service life and over the range of environmental co
46、nditions stated by the manufacturer. NOTE 1 Minimum environmental conditions for atmospheric pressure are specified in Clause 25. ISO 14708-4:2008(E) 4 ISO 2008 All rights reservedInfusion accuracy shall be stated for all selectable rates (including bolus rates) over a range of reservoir volumes. Co
47、nstant flow implantable infusion pump accuracy shall be stated for the specified infusion rate of the pump over a range of reservoir volumes. The manufacturer shall provide a plot of infusion accuracy versus reservoir volume. For variable rate pumps the plot shall contain curves for minimum rate, ma
48、ximum rate, and one or more intermediate rates. The method of computing and determining the infusion accuracy shall be clearly stated in the accompanying documentation. Environmental test conditions used to establish infusion accuracy shall also be stated. NOTE 2 Accuracy is a commonly used term and
49、 might include the effects of systematic and random errors. Although it is convenient to combine all these errors under the heading “accuracy”, it is still a qualitative term. For all selectable infusion rates, the repeatability of the actual rate shall also be stated. The method of computing and determining the stated repeatability shall be clearly described in the accompanying documentation. Compliance shall be confirmed by inspection of test procedures and results provided by the manufacturer, supp
