ANSI CI86-2017 Cochlear implant systems Requirements for safety functional verification labeling and reliability reporting.pdf

1、ANSI/AAMI CI86:2017Cochlear implant systems: Requirements for safety, functional verification, labeling and reliability reportingAmerican National StandardObjectives and uses of AAMI standards and recommended practices It is most important that the objectives and potential uses of an AAMI product st

2、andard or recommended practice are clearly understood. The objectives of AAMIs technical development program derive from AAMIs overall mission: the advancement of medical instrumentation. Essential to such advancement are (1) a continued increase in the safe and effective application of current tech

3、nologies to patient care, and (2) the encouragement of new technologies. It is AAMIs view that standards and recommended practices can contribute significantly to the advancement of medical instrumentation, provided that they are drafted with attention to these objectives and provided that arbitrary

4、 and restrictive uses are avoided. A voluntary standard for a medical device recommends to the manufacturer the information that should be provided with or on the product, basic safety and performance criteria that should be considered in qualifying the device for clinical use, and the measurement t

5、echniques that can be used to determine whether the device conforms with the safety and performance criteria and/or to compare the performance characteristics of different products. Some standards emphasize the information that should be provided with the device, including performance characteristic

6、s, instructions for use, warnings and precautions, and other data considered important in ensuring the safe and effective use of the device in the clinical environment. Recommending the disclosure of performance characteristics often necessitates the development of specialized test methods to facili

7、tate uniformity in reporting; reaching consensus on these tests can represent a considerable part of committee work. When a drafting committee determines that clinical concerns warrant the establishment of minimum safety and performance criteria, referee tests must be provided and the reasons for es

8、tablishing the criteria must be documented in the rationale. A recommended practice provides guidelines for the use, care, and/or processing of a medical device or system. A recommended practice does not address device performance per se, but rather procedures and practices that will help ensure tha

9、t a device is used safely and effectively and that its performance will be maintained. Although a device standard is primarily directed to the manufacturer, it may also be of value to the potential purchaser or user of the device as a frame of reference for device evaluation. Similarly, even though

10、a recommended practice is usually oriented towards healthcare professionals, it may be useful to the manufacturer in better understanding the environment in which a medical device will be used. Also, some recommended practices, while not addressing device performance criteria, provide guidelines to

11、industrial personnel on such subjects as sterilization processing, methods of collecting data to establish safety and efficacy, human engineering, and other processing or evaluation techniques; such guidelines may be useful to health care professionals in understanding industrial practices. In deter

12、mining whether an AAMI standard or recommended practice is relevant to the specific needs of a potential user of the document, several important concepts must be recognized: All AAMI standards and recommended practices are voluntary (unless, of course, they are adopted by government regulatory or pr

13、ocurement authorities). The application of a standard or recommended practice is solely within the discretion and professional judgment of the user of the document. Each AAMI standard or recommended practice reflects the collective expertise of a committee of health care professionals and industrial

14、 representatives, whose work has been reviewed nationally (and sometimes internationally). As such, the consensus recommendations embodied in a standard or recommended practice are intended to respond to clinical needs and, ultimately, to help ensure patient safety. A standard or recommended practic

15、e is limited, however, in the sense that it responds generally to perceived risks and conditions that may not always be relevant to specific situations. A standard or recommended practice is an important reference in responsible decision-making, but it should never replace responsible decision-makin

16、g. Despite periodic review and revision (at least once every five years), a standard or recommended practice is necessarily a static document applied to a dynamic technology. Therefore, a standards user must carefully review the reasons why the document was initially developed and the specific ratio

17、nale for each of its provisions. This review will reveal whether the document remains relevant to the specific needs of the user. Particular care should be taken in applying a product standard to existing devices and equipment, and in applying a recommended practice to current procedures and practic

18、es. While observed or potential risks with existing equipment typically form the basis for the safety and performance criteria defined in a standard, professional judgment must be used in applying these criteria to existing equipment. No single source of information will serve to identify a particul

19、ar product as “unsafe“. A voluntary standard can be used as one resource, but the ultimate decision as to product safety and efficacy must take into account the specifics of its utilization and, of course, cost-benefit considerations. Similarly, a recommended practice should be analyzed in the conte

20、xt of the specific needs and resources of the individual institution or firm. Again, the rationale accompanying each AAMI standard and recommended practice is an excellent guide to the reasoning and data underlying its provision. In summary, a standard or recommended practice is truly useful only wh

21、en it is used in conjunction with other sources of information and policy guidance and in the context of professional experience and judgment. INTERPRETATIONS OF AAMI STANDARDS AND RECOMMENDED PRACTICES Requests for interpretations of AAMI standards and recommended practices must be made in writing,

22、 to the AAMI Vice President, Standards Policy and Programs. An official interpretation must be approved by letter ballot of the originating committee and subsequently reviewed and approved by the AAMI Standards Board. The interpretation will become official and representation of the Association only

23、 upon exhaustion of any appeals and upon publication of notice of interpretation in the “Standards Monitor“ section of the AAMI News. The Association for the Advancement of Medical Instrumentation disclaims responsibility for any characterization or explanation of a standard or recommended practice

24、which has not been developed and communicated in accordance with this procedure and which is not published, by appropriate notice, as an official interpretation in the AAMI News. American National Standard ANSI/AAMI CI86:2017 Cochlear implant systems: Requirements for safety, functional verification

25、, labeling and reliability reporting Approved 15 December 2016 by AAMI Approved 6 January 2017 by American National Standards Institute, Inc. Abstract: This standard establishes minimum requirements for those active implantable medical devices known as cochlear implants or cochlear prostheses, which

26、 are intended to treat hearing impairment by means of electrical stimulation of the cochlea. Devices that treat hearing impairment other than by including electrical stimulation of the cochlea are not covered by this standard. This standard applies to the electrical stimulation component(s) of combi

27、nation devices that treat hearing impairment using multiple means, including electrical stimulation. The tests specified in this standard are industry-accepted tests and are to be carried out on samples of devices to show compliance. This standard is also applicable to non-implantable parts and acce

28、ssories of the devices, including fitting and diagnostic components. General and specific requirements are provided with regard to design verification, post-implantation device testing, reliability assessment and reporting, packaging and labeling, protections of the patient associated with design is

29、sues and device malfunctions, and protections of the device associated with environmental challenges arising from transport, storage, handling during implantation, unrelated-medical treatments, and normal use. Keywords: cochlear implants, cochlear prosthesis, medical deviceAAMI Standard This Associa

30、tion for the Advancement of Medical Instrumentation (AAMI) standard implies a consensus of those substantially concerned with its scope and provisions. The existence of an AAMI standard does not in any respect preclude anyone, whether they have approved the standard or not, from manufacturing, marke

31、ting, purchasing, or using products, processes, or procedures not conforming to the standard. AAMI standards are subject to periodic review, and users are cautioned to obtain the latest editions. CAUTION NOTICE: This AAMI standard may be revised or withdrawn at any time. AAMI procedures require that

32、 action be taken to reaffirm, revise, or withdraw this standard no later than 5 years from the date of publication. Interested parties may obtain current information on all AAMI standards and recommended practices by calling or writing AAMI. All AAMI standards, recommended practices, technical infor

33、mation reports, and other types of technical documents developed by AAMI are voluntary, and their application is solely within the discretion and professional judgment of the user of the document. Occasionally, voluntary technical documents are adopted by government regulatory agencies or procuremen

34、t authorities, in which case the adopting agency is responsible for enforcement of its rules and regulations. The transition period for voluntary compliance with this standard is indicated below. o Design and test requirements (transition period is 2 years): For devices or changes to devices approve

35、d prior to publication of standard, conformance tothis standard is optional. For devices or changes approved during the transition period, conformance will be negotiatedbetween each manufacturer and the regulatory agency. For new devices or designs marketed after the transition period, conformance t

36、o this standardis mandatory if a cochlear manufacturer intends to claim compliance to this standard.o Reliability reporting: For all implantable components (both currently marketed and no longer distributed devices),the transition period for reporting as specified in this standard is 2 years from pu

37、blication. For implantable components that will be introduced after publication, the transition period forreporting as specified in this standard is 1 year. For all sound processors (reporting as specified in Section 11), the transition period forreporting as specified in this standard is 2 years fr

38、om publication.NOTEThis document contains active links. To return to your previous location after following an active link, use Alt (left arrow). Published by AAMI 4301 N. Fairfax Dr., Suite 301 Arlington, VA 22203-1633 2017 by the Association for the Advancement of Medical Instrumentation All Right

39、s Reserved Publication, reproduction, photocopying, storage, or transmission, electronically or otherwise, of all or any part of this document without the prior written permission of the Association for the Advancement of Medical Instrumentation is strictly prohibited by law. It is illegal under fed

40、eral law (17 U.S.C. 101, et seq.) to make copies of all or any part of this document (whether internally or externally) without the prior written permission of the Association for the Advancement of Medical Instrumentation. Violators risk legal action, including civil and criminal penalties, and dam

41、ages of $100,000 per offense. For permission regarding the use of all or any part of this document, contact AAMI, 1110 N. Glebe Road, Suite 220, Arlington, VA 22201-4795. Phone: (703) 525-4890; Fax: (703) 525-1067. Printed in the United States of America ISBN 978-1-57020-662-7 Contents Page Glossary

42、 of equivalent standards . v Committee representation vi Acknowledgments vi Foreword . vii 1 Scope 1 2 Normative references 2 3 Definitions 4 4 Units, abbreviations, and symbols 12 5 General requirements for characterizing a cochlear implant system . 14 6 General requirements for implantable parts .

43、 27 7 General requirements for non-implantable parts . 29 8 System-level inspection, characterization, and measurement 31 9 Implantation support (RESERVED FOR FUTURE VERSIONS) 42 10 Post-implantation testing, in vivo assessment, and analysis of failed devices . 42 11 Reliability monitoring and repor

44、ting 45 12 Information on use, warnings, and hazards 64 13 General arrangement of the packaging system 70 14 Markings on the packaging system and the cochlear implant device 70 15 Safety from unintentional biological effects of the cochlear implant system 76 16 Safety of secondary features of the co

45、chlear implant system 76 17 Safety of electrical stimulation . 77 18 Safety of implantable energy sources . 82 19 Safety from heat sources 83 20 Safety from unintended effects caused by the device . 85 21 Safety and device immunity during magnetic resonance imaging . 87 22 Device immunity to externa

46、l stresses caused by medical treatment and procedures . 92 23 Device immunity to stresses of mechanical forces 97 24 Device immunity to stresses caused by atmospheric pressure changes 107 25 Device immunity to stresses caused by temperature changes . 109 26 Non-implantable device immunity to stresse

47、s caused by environment and usage 110 Annex A (informative) Clinical identification and management of cochlear implant device failures 123 Annex B (informative) Clinical checklist prior to explantation Signs and symptoms checklist 125 Annex C (informative) Returned implant analysis . 129 Annex D (in

48、formative) Indications of performance decline . 135 Annex E (informative) Reliability reporting to regulatory bodies . 136 Annex F (informative) Pareto analysis 145 Annex G (informative) Failed component return rate (FCRR) graphic and table 147 Annex H (informative) Reliability reporting template fo

49、r the public and clinical community . 149 Annex I (informative) Product specification data sheets 152 Annex J (informative) Mechanical testing of leads and interfaces to case bodies . 158 Annex K (informative) Logic flow diagram of the relationships between the required testing, explant category classification, and reliability reporting to both regulatory bodies and the public . 161 Bibliography . 167 2017 Association for the Advancement of Medical Instrumentation AAMI CI86:2017 v Glossary of equivalent standards International Standards adopted in the United States may inclu