1、ANSI/AAMI/ISO 14155: 2011Clinical investigation of medical devices for human subjects Good clinical practiceAmerican National StandardObjectives and uses of AAMI standards and recommended practices It is most important that the objectives and potential uses of an AAMI product standard or recommended
2、 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 technologies to patient c
3、are, 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 and restrictive uses
4、 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 techniques that can be
5、 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 characteristics, instructions for u
6、se, 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 facilitate uniformity in re
7、porting; 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 establishing the criter
8、ia 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 that a device is used sa
9、fely 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 a recommended practic
10、e 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 industrial personnel
11、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 determining whether an AAM
12、I 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 procurement authorities
13、). 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 representatives, who
14、se 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 practice is limited, however
15、, 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-making. Despite periodic r
16、eview 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 rationale for each of its
17、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 practices. While observed or
18、 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 particular product as “unsafe
19、“. 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 context of the specific ne
20、eds 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 when it is used in conj
21、unction 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, to the AAMI Vice Pre
22、sident, 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 upon exhaustion of a
23、ny 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 which has not been de
24、veloped 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/ISO 14155:2011 (Revision of ANSI/AAMI/ISO 14155-1:2003/(R)2008 and ANSI/AAMI/ISO 14155-2:2003/(R)2008) Co
25、rrected 16 December 2011: Includes change to subclause 7.3 Clinical investigation of medical devices for human subjects Good clinical practice Approved 8 December 2010 by Association for the Advancement of Medical Instrumentation Approved 30 December 2010 by American National Standards Institute Abs
26、tract: Addresses the technical aspects of clinical investigations carried out in human subjects to establish the performance and safety of medical devices for regulatory purposes by defining procedures for their design, conduct, recording and reporting. Keywords: biological evaluation, clinical inve
27、stigation AAMI Standard This Association 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 standa
28、rd or not, from manufacturing, marketing, 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 an
29、y time. AAMI procedures require that 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 by calling or writing AAMI, or by visiting the AAMI website at www.aami.org.
30、 All AAMI standards, recommended practices, technical information 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
31、are adopted by government regulatory agencies or procurement authorities, in which case the adopting agency is responsible for enforcement of its rules and regulations. Published by Association for the Advancement of Medical Instrumentation 4301 N. Fairfax Drive, Suite 301 Arlington, VA 22203-1633 w
32、ww.aami.org 2011 by the Association for the Advancement of Medical Instrumentation All Rights Reserved This publication is subject to copyright claims of ISO, ANSI, and AAMI. No part of this publication may be reproduced or distributed in any form, including an electronic retrieval system, without t
33、he prior written permission of AAMI. All requests pertaining to this document should be submitted to AAMI. It is illegal under federal 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 Associ
34、ation for the Advancement of Medical Instrumentation. Violators risk legal action, including civil and criminal penalties, and damages of $100,000 per offense. For permission regarding the use of all or any part of this document, complete the reprint request form at www.aami.org or contact AAMI at 4
35、301 N. Fairfax Drive, Suite 301, Arlington, VA 22203-1633. Phone: (703) 525-4890; Fax: (703) 525-1067. Printed in the United States of America ISBN 1-57020-409-8 Contents Page Glossary of equivalent standards v Committee representation .vii Background of ANSI/AAMI adoption of ISO 14155:2011 .ix Fore
36、wordx 1 Scope.1 2 Normative references1 3 Terms and definitions2 4 Ethical considerations.8 4.1 General8 4.2 Improper influence or inducement.8 4.3 Compensation and additional health care.8 4.4 Responsibilities8 4.5 Communication with the ethics committee (EC)9 4.5.1 General9 4.5.2 Initial EC submis
37、sion.9 4.5.3 Information to be obtained from the EC9 4.5.4 Continuing communication with the EC9 4.5.5 Continuing information to be obtained from the EC10 4.6 Vulnerable populations.10 4.7 Informed consent.10 4.7.1 General10 4.7.2 Process of obtaining informed consent11 4.7.3 Special circumstances f
38、or informed consent.11 4.7.4 Information to be provided to the subject.12 4.7.5 Informed consent signature14 4.7.6 New information.15 5 Clinical investigation planning.15 5.1 General15 5.2 Risk evaluation.15 5.3 Justification for the design of the clinical investigation15 5.4 Clinical investigation
39、plan (CIP).16 5.5 Investigators brochure (IB)16 5.6 Case report forms (CRFs).16 5.7 Monitoring plan16 5.8 Investigation site selection.16 5.9 Agreement(s)16 5.10 Labeling17 5.11 Data monitoring committee (DMC).17 6 Clinical investigation conduct17 6.1 General17 6.2 Investigation site initiation17 6.
40、3 Investigation site monitoring17 6.4 Adverse events and device deficiencies.18 6.4.1 Adverse events.18 6.4.2 Device deficiencies18 6.5 Clinical investigation documents and documentation18 6.5.1 Amendments18 6.5.2 Subject identification log18 6.5.3 Source documents.18 6.6 Additional members of the i
41、nvestigation site team19 6.7 Subject privacy and confidentiality of data.19 6.8 Document and data control19 6.8.1 Traceability of documents and data.19 6.8.2 Recording of data.19 6.8.3 Electronic clinical data systems.20 6.9 Investigational device accountability20 6.10 Accounting for subjects21 6.11
42、 Auditing.21 7 Suspension, termination and close-out of the clinical investigation.21 7.1 Suspension or premature termination of the clinical investigation.21 7.1.1 Procedure for suspension or premature termination21 7.1.2 Procedure for resuming the clinical investigation after temporary suspension2
43、2 7.2 Routine close-out.23 7.3 Clinical investigation report23 7.4 Document retention.24 8 Responsibilities of the sponsor.24 8.1 Clinical quality assurance and quality control.24 8.2 Clinical investigation planning and conduct25 8.2.1 Selection of clinical personnel.25 8.2.2 Preparation of document
44、s and materials26 8.2.3 Conduct of clinical investigation26 8.2.4 Monitoring.27 8.2.5 Safety evaluation and reporting.29 8.2.6 Clinical investigation close-out30 8.3 Outsourcing of duties and functions.30 8.4 Communication with regulatory authorities31 9 Responsibilities of the principal investigato
45、r.31 9.1 General31 9.2 Qualification of the principal investigator.31 9.3 Qualification of investigation site31 9.4 Communication with the EC.32 9.5 Informed consent process32 9.6 Compliance with the CIP.32 9.7 Medical care of subjects33 9.8 Safety reporting34 Annex A (normative) Clinical investigat
46、ion plan (CIP)35 Annex B (normative) Investigators brochure (IB).42 Annex C (informative) Case report forms (CRFs)44 Annex D (informative) Clinical investigation report.46 Annex E (informative) Essential clinical investigation documents52 Annex F (informative) Adverse event categorization.59 Bibliog
47、raphy62 2011 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 14155:2011 v Glossary of equivalent standards International Standards adopted in the United States may include normative references to other International Standards. For each International Standard that has been ad
48、opted by AAMI (and ANSI), the table below gives the corresponding U.S. designation and level of equivalency to the International Standard. NOTE: Documents are sorted by international designation. The code in the US column, “(R)20xx” indicates the year the document was officially reaffirmed by AAMI.
49、E.g., ANSI/AAMI/ISO 10993-4:2002/(R)2009 indicates that 10993-4, originally approved and published in 2002, was reaffirmed without change in 2009. Other normatively referenced International Standards may be under consideration for U.S. adoption by AAMI; therefore, this list should not be considered exhaustive. International designation U.S. designation Equivalency IEC 60601-1:2005 Technical Corrigendum 1 and 2 ANSI/AAMI ES60601-1:2005 and ANSI/AAMI ES60601-1:2005/A2:2010 ANSI/AAMI ES60601-1:2005/C1:2009 (amdt) Major technical variations C1 Identical to Corrigendum 1 b) IB or e
