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1、| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | BRITISH STANDARD BS ISO 5841-2:2000 ICS 11
2、.040.40 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW Implants for surgery Cardiac pacemakers Part 2: Reporting of clinical performance of populations of pulse generators or leads Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:52:46 GMT+00:00 2006, Uncontrolled Co
3、py, (c) BSI This British Standard, having been prepared under the direction of the Health and Environment Sector Committee, was published under the authority of the Standards Committee and comes into effect on 15 February 2001 BSI 02-2001 ISBN 0 580 36652 9 BS ISO 5841-2:2000 Amendments issued since
4、 publication Amd. No.DateComments National foreword This British Standard reproduces verbatim ISO 5841-2:2000 and implements it as the UK national standard. It supersedes BS 6902-2:1987 which is withdrawn. The UK participation in its preparation was entrusted to Technical Committee CH/92, Active imp
5、lants, which has the responsibility to: aid enquirers to understand the text; present to the responsible international/European committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed; monitor related international and European developments and prom
6、ulgate them in the UK. A list of organizations represented on this committee can be obtained on request to its secretary. Cross-references The British Standards which implement international publications referred to in this document may be found in the BSI Standards Catalogue under the section entit
7、led International Standards Correspondence Index, or by using the Find facility of the BSI Standards Electronic Catalogue. A British Standard does not purport to include all the necessary provisions of a contract. Users of British Standards are responsible for their correct application. Compliance w
8、ith a British Standard does not of itself confer immunity from legal obligations. Summary of pages This document comprises a front cover, an inside front cover, the ISO title page, pages ii to v, a blank page, pages 1 to 19 and a back cover. The BSI copyright notice displayed in this document indica
9、tes when the document was last issued. Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:52:46 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Reference number ISO 5841-2:2000(E) INTERNATIONAL STANDARD ISO 5841-2 Second edition 2000-10-15 Implants for surgery Cardiac pacemakers Part 2: Reporting
10、of clinical performance of populations of pulse generators or leads Implants chirurgicaux Stimulateurs cardiaques Partie 2: tablissement dun rapport sur le fonctionnement clinique de populations de gnrateurs dimpulsions ou de fils-lectrodes Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:5
11、2:46 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ISO 5841-2:2000(E) ii Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:52:46 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ISO 5841-2:2000(E) iii Contents Page Foreword.iv Introduction.v 1 Scope 1 2 Normative reference1 3 Terms and definitions .1
12、 4 General requirements3 5 Reporting cumulative experience with devices4 6 Reporting estimated future clinical performance for devices 4 Annex A (normative) Categorization of devices 5 Annex B (informative) Statistical guidelines and discussion of application of results obtained.7 Annex C (informati
13、ve) Rationale16 Bibliography19 Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:52:46 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ISO 5841-2:2000(E) iv Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies)
14、. 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 non
15、-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, Part
16、 3. 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 a vote. Attention is drawn to the possibility that some of the elements of th
17、is part of ISO 5841 may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. International Standard ISO 5841-2 was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee SC 2, Cardiovascular implants. This second ed
18、ition cancels and replaces the first edition (ISO 5841-2:1986), which has been technically revised. ISO 5841 consists of the following parts, under the general title Implants for surgery Cardiac pacemakers: ?Part 1: Implantable pacemakers ?Part 2: Reporting of clinical performance of populations of
19、pulse generators or leads ?Part 3: Low-profile connectors (IS-1) for implantable pacemakers Annex A forms a normative part of this part of ISO 5841. Annexes B and C are for information only. Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:52:46 GMT+00:00 2006, Uncontrolled Copy, (c) BSI IS
20、O 5841-2:2000(E) v Introduction ISO 5841-1 requires the clinicians manual to contain a statement of nominal pulse-generator service life. Expectations of available power-source energy are not always fulfilled, and changes in pulse-generator components and assemblies have resulted in an actual servic
21、e life which is different from the nominal service life. Defined production groups of pulse generators or leads have required closer follow-up or replacement due to changes in performance exhibited in clinical use. This experience shows the value of maintaining an accurate and discriminating view of
22、 clinical performance of a population of pulse generators or leads, referred to in this document as devices, so as to aid patient management. In order to do this, it is necessary to collect implant and explant information. ISO 5841-1 specifies the content of forms to report implant and explant infor
23、mation for pulse generators. The primary purpose of this part of ISO 5841 is to describe the reporting responsibilities in sharing clinical performance information for patient management. When clinical performance reports discriminate by production group and focus on recent experience, they are of v
24、alue in patient management. This part of ISO 5841 concerns the clinical performance of devices, not the clinical reasons for their use. It is realized that reasons for use can be a guide in the design of future products. Reporting parties may give cumulative clinical-experience information based on
25、a variety of assumptions and statistical techniques. This part of ISO 5841 gives, in annexes, a method for categorizing devices, guidelines to the statistical techniques that should be used to obtain the most benefit from the data and a statement of the rationale for this part of ISO 5841. Clinician
26、s have emphasized that a device whose performance has changed, either expectedly or unexpectedly, is sometimes left implanted due to other medical considerations. Instances exist where the performance of a device has changed to stable but out-of-specification performance that is considered safe and
27、effective by the attending clinician. This is an important reason why the term “failure” is avoided throughout the classification. “Failure” is not sufficiently specific to express the significance of a change in performance. In addition, “failure” implies a negative connotation for pulse generators
28、 that meet all longevity claims and cease functioning due to normal power-source depletion. Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:52:46 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:52:46 GMT+00:00 2006, Uncontrolled Copy, (c
29、) BSI INTERNATIONAL STANDARD ISO 5841-2:2000(E) 1 Implants for surgery Cardiac pacemakers Part 2: Reporting of clinical performance of populations of pulse generators or leads 1 Scope This part of ISO 5841 specifies requirements for reports on the clinical performance in humans of population samples
30、 of pulse generators or leads, intended for long-term implantation as cardiac pacemakers, hereinafter referred to as devices. It includes general requirements for all reports and supplementary requirements for reports on cumulative experience with devices and estimates of future clinical performance
31、 for devices, when appropriate. Annex A provides requirements for categorizing devices. Annex B provides guidelines for statistics, including a discussion of application of the results obtained. As with other statistical methods, the benefit of the analytical methods in this part of ISO 5841 is limi
32、ted by the size of population under consideration. Annex C gives the rationale for this part of ISO 5841. 2 Normative reference The following normative document contains provisions which, through reference in this text, constitute provisions of this part of ISO 5841. For dated references, subsequent
33、 amendments to, or revisions of, any of these publications do not apply. However, parties to agreements based on this part of ISO 5841 are encouraged to investigate the possibility of applying the most recent edition of the normative document indicated below. For undated references, the latest editi
34、on of the normative document referred to applies. Members of ISO and IEC maintain registers of currently valid International Standards. ISO 5841-1, Implants for surgery Cardiac pacemakers Part 1: Implantable pacemakers. 3 Terms and definitions For the purposes of this part of ISO 5841, the terms and
35、 definitions given in ISO 5841-1 and the following apply. 3.1 advisory notification any action taken to inform the clinicians concerned by a manufacturer who has become aware that a device may fail to conform to any claims made relating to effectiveness, benefits, performance characteristics or safe
36、ty 3.2 clinical performance period calendar period, defined by the reporting party, during which the clinical performance of a specific population sample of devices is assessed 3.3 damaged, adj having characteristics which have changed outside the limits stated by the manufacturer, due to some exter
37、nal agency Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:52:46 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ISO 5841-2:2000(E) 2 3.4 dysfunctional, adj having some characteristic outside the limits specified in the technical manual, except changes to the characteristics of a pulse generato
38、r due to expected battery depletion 3.5 follow-up centre medical centre, hospital, clinic or individual responsible for the care of a patient after the implantation of a device 3.6 in service functioning in such a manner as to provide potential medical benefits to the patient NOTE This term can appl
39、y to a device that may be out of specification (see 3.10). 3.7 in specification having characteristics within the limits recommended by the manufacturer for clinical use 3.8 medical reasons reasons unrelated to the device or its operation EXAMPLES Infection, extrusion, indication for an alternative
40、medical device (e.g. the replacement of a single-chamber pacemaker in a patient with pacemaker syndrome with a dual-chamber pacemaker), etc. 3.9 out of service not providing a medical benefit to the patient NOTE A device thus described is not necessarily out of specification (see 3.10) or explanted.
41、 3.10 out of specification having one or more characteristics outside the limits established by the manufacturer for clinical use 3.11 population sample group of devices designated for the purpose of reporting performance experience that is assumed to be representative of the population 3.12 product
42、ion group population sample of devices designated by the manufacturer on the basis of a particular parameter EXAMPLE Such a parameter may be, for example, time or place of manufacture or a change in the manufacturing process or components. 3.13 prophylactic explantation explantation for reasons base
43、d on the anticipated performance of the device or other medical reasons 3.14 recommended replacement condition condition in which the device exhibits characteristic(s) identified by the manufacturer as signalling that the device should be taken out of service EXAMPLE A pulse generator that exhibits
44、the maximum allowable changes in the battery-condition indicators stated by the manufacturer is in a condition where replacement is recommended. Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:52:46 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ISO 5841-2:2000(E) 3 3.15 registered explant reg
45、istered implant for which the date of explantation is known by the reporting party 3.16 registered implant implanted device for which the date of implantation is known by the reporting party 3.17 registered implant month one month of operation by a registered implant 3.18 reporting party individual
46、or organization publishing clinical pacemaker data or the analysis thereof 4 General requirements A report on the clinical performance that conforms to this part of ISO 5841 shall contain the following information: a) model designation(s) of the devices covered by the report; b) sources of the data
47、and the methods used to collect them; c) sample size and how the population and population sample are defined; d) criteria for including and excluding data; e) time period over which the data were acquired; f) units of time of the data; g) category assigned to the device, in accordance with annex A;
48、 h) explanation of methods used to adjust for any sources of bias known to be present (see annex B); i) statement of the basis for adjusting registered implant months to compensate for unreported mortality and unreported explants. Each report shall explain the presentation of the information and any
49、 methods of analysis used to calculate numerical expressions of performance. Any generalizations or inferences from data shall be qualified as to assumptions, limitations and associated confidence levels. Devices referred to in an advisory notification shall be identified by means of the serial numbers of the devices. If the results are segregated by production group, the report shall explain the basis on which the production groups are established. It shall be stated in the report that it has been prepared in accordance with this part of ISO 5841. I