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    ANSI TIR15499-2012 Biological evaluation of medical devices CGuidance on the conduct of biological evaluation within a risk management process.pdf

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    ANSI TIR15499-2012 Biological evaluation of medical devices CGuidance on the conduct of biological evaluation within a risk management process.pdf

    1、ANSI/AAMI/ ISO TIR 15499:2012Technical Information ReportBiological evaluation of medical devicesGuidance on the conduct of biological evaluation within a risk management processAn ANSI Technical Report prepared by AAMI ANSI/AAMI/ISO TIR15499:2012 Biological evaluation of medical devicesGuidance on

    2、the conduct of biological evaluation within a risk management process Approved 3 December 2012 by Association for the Advancement of Medical Instrumentation Registered 10 August 2012 by American National Standards Institute, Inc. Abstract: This guidance is applicable to the conduct of biological eva

    3、luation of medical devices according to the requirements of ISO 10993-1. It does not add to, or otherwise change, the requirements of ISO 10993-1. This guidance does not include requirements to be used as the basis of regulatory inspection or certification assessment activities. This guidance is app

    4、licable to all biological evaluation of all types of medical devices including active, non-active, implantable and non-implantable medical devices. Keywords: biological evaluation, risk management Published by Association for the Advancement of Medical Instrumentation 4301 N. Fairfax Drive, Suite 30

    5、1 Arlington, VA 22203-1633 www.aami.org 2013 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

    6、 retrieval system, without the 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 writ

    7、ten permission of the Association 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.a

    8、ami.org or contact AAMI at 4301 N. Fairfax Drive, Suite 301, Arlington, VA 22203-1633. Phone: +1-703-525-4890; Fax: +1-703-525-1067. Printed in the United States of America ISBN 1-57020-474-8 AAMI Technical Information Report A technical information report (TIR) is a publication of the Association f

    9、or the Advancement of Medical Instrumentation (AAMI) Standards Board that addresses a particular aspect of medical technology. Although the material presented in a TIR may need further evaluation by experts, releasing the information is valuable because the industry and the professions have an immed

    10、iate need for it. A TIR differs markedly from a standard or recommended practice, and readers should understand the differences between these documents. Standards and recommended practices are subject to a formal process of committee approval, public review, and resolution of all comments. This proc

    11、ess of consensus is supervised by the AAMI Standards Board and, in the case of American National Standards, by the American National Standards Institute. A TIR is not subject to the same formal approval process as a standard. However, a TIR is approved for distribution by a technical committee and t

    12、he AAMI Standards Board. Another difference is that, although both standards and TIRs are periodically reviewed, a standard must be acted onreaffirmed, revised, or withdrawnand the action formally approved usually every five years but at least every 10 years. For a TIR, AAMI consults with a technica

    13、l committee about five years after the publication date (and periodically thereafter) for guidance on whether the document is still usefulthat is, to check that the information is relevant or of historical value. If the information is not useful, the TIR is removed from circulation. A TIR may be dev

    14、eloped because it is more responsive to underlying safety or performance issues than a standard or recommended practice, or because achieving consensus is extremely difficult or unlikely. Unlike a standard, a TIR permits the inclusion of differing viewpoints on technical issues. CAUTION NOTICE: This

    15、 AAMI TIR may be revised or withdrawn at any time. Because it addresses a rapidly evolving field or technology, readers are cautioned to ensure that they have also considered information that may be more recent than this document. All standards, recommended practices, technical information reports,

    16、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 procurement authorities, i

    17、n which case the adopting agency is responsible for enforcement of its rules and regulations. Comments on this technical information report are invited and should be sent to AAMI, Attn: Standards Department, 4301 N. Fairfax Drive, Suite 301, Arlington, VA 22203-1633. ANSI Technical Report This AAMI

    18、TIR has been registered by the American National Standards Institute as an ANSI Technical Report. Publication of this ANSI Technical Report has been approved by the accredited standards developer (AAMI). This document is registered as a Technical Report series of publications according to the Proced

    19、ures for the Registration of Technical Reports with ANSI. This document is not an American National Standard and the material contained herein is not normative in nature. Comments on the content of this document should be sent to AAMI, Attn: Standards Department, 4301 N. Fairfax Drive, Suite 301, Ar

    20、lington, VA 22203-1633. Contents Page Glossary of equivalent standards v Committee representation . viii Background of AAMI adoption of ISO TR 15499:2012 . x FOREWORD . xi INTRODUCTION xii 1 Scope 1 2 Normative references 1 3 Terms and definitions 1 4 Biological evaluation as a risk management pract

    21、ice . 2 4.1 General . 2 4.2 The biological evaluation plan 4 5 Guidance on risk management . 6 5.1 Risk assessment . 6 5.2 Risk control . 8 5.3 Evaluation of residual risk acceptability 8 5.4 Post production monitoring . 8 6 Guidance on specific aspects of biological evaluation . 9 6.1 Material char

    22、acterization . 9 6.2 Biological evaluation . 10 6.3 Device testing considerations . 10 6.4 Biological safety assessment 11 6.5 General guidance 13 Bibliography 15 2013 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO TIR15499:2012 v Glossary of equivalent standards Internatio

    23、nal Standards adopted in the United States may include normative references to other International Standards. For each International Standard that has been adopted by AAMI (and ANSI), the table below gives the corresponding U.S. designation and level of equivalency to the International Standard. NOT

    24、E: Documents are sorted by international designation. The code in the U.S. column, “(R)20xx” indicates the year the document was officially reaffirmed by AAMI. For example, ANSI/AAMI/ISO 10993-4:2002/(R)2009 indicates that 10993-4, originally approved and published in 2002, was reaffirmed without ch

    25、ange 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 ANSI/AAMI ES60601-1:2005/(R)2012 Major technical

    26、variations IEC 60601-1:2005/A1:2012 ANSI/AAMI ES60601-1:2005/A1:2012 A1 identical IEC Technical Corrigendum 1 and 2 ANSI/AAMI ES60601-1:2005/C1:2009/(R)2012 (amdt) C1 identical to Corrigendum 1 biological evaluation is a component of risk management and this Technical Report includes guidance on the

    27、 application of ISO 14971 to the conduct of biological evaluation. 2013 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO TIR15499:2012 1 AAMI Technical Information Report ANSI/AAMI/ISO TIR15499:2012Biological evaluation of medical devices Guidance on the conduct of biological

    28、 evaluation within a risk management process 1 Scope This Technical Report is applicable to the conduct of biological evaluation of medical devices according to the requirements of ISO 10993-1. It does not add to, or otherwise change, the requirements of ISO 10993-1. This Technical Report does not i

    29、nclude requirements to be used as the basis of regulatory inspection or certification assessment activities. This guidance is applicable to all biological evaluation of all types of medical devices including active, non-active, implantable and non-implantable medical devices. 2 Normative references

    30、The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 109

    31、93-1:2009, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 10993-1 and the following apply. 3.1 biocompatibility ability of a material to perform

    32、 with an appropriate host response in a specific application 3.2 biological risk potential for a substance to cause harm to health by virtue of its toxicity 3.3 biological safety freedom from unacceptable biological risk 2 2013 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO

    33、 TIR15499:2012 3.4 risk assessment overall process comprising a risk analysis and a risk evaluation SOURCE: ISO/IEC Guide 51:1999, 3.12 3.5 risk evaluation process of comparing the estimated risk against given risk criteria to determine the acceptability of the risk SOURCE: ISO 14971:2007, 2.21 3.6

    34、risk management systematic application of management policies, procedures and practices to the tasks of analyzing, evaluating, controlling and monitoring risk SOURCE: ISO 14971:2007, 2.22 3.7 toxicological hazard potential for a compound or material to cause an adverse biological reaction, taking in

    35、to account the nature of the reaction and the dose required to elicit it 3.8 toxicological risk probability of a specified degree of an adverse reaction occurring in response to a specified level of exposure 3.9 risk analysis systematic use of available information to identify hazards and to estimat

    36、e the risk SOURCE: ISO 14971:2007, 2.17, modified 4 Biological evaluation as a risk management practice 4.1 General ISO 10993-1:2009, B.2.2.2 describes a continuous process by which a manufacturer can identify the biological hazards associated with medical devices, estimate and evaluate the risks, c

    37、ontrol these risks, and monitor the effectiveness of the control. Appropriate protection of the patient by weighing risks and benefits of medical devices is an essential element of this biological evaluation plan. Benefit to the patient from the use of medical devices entails the acceptance of poten

    38、tial risks. These risks will vary depending on the nature and intended use of the specific medical device. The level of risk which is acceptable for a specific device will depend upon the expected benefit provided by its use. Consideration of biological (toxicological) risk is only one aspect of the

    39、 risk assessment of a medical device, which should consider all aspects of risk. In some cases it can be specifically necessary to consider the relative benefits of materials of different biological safety profiles in the context of some other characteristic. For example it can be possible that the

    40、most biologically safe material available can have 2013 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO TIR15499:2012 3 unacceptable mechanical strength, in which case it would be necessary to consider if an alternate stronger material is of acceptable biological safety. It

    41、is fundamental to the conduct of biological evaluation that it be undertaken as part of the overall risk management process required in the design and development of the medical device. Material selection and risk analysis are integral components of the design process for medical devices. The select

    42、ion of materials plays a crucial role in evaluating the biological safety and, when approached in a systematic way, allows the collection of relevant data. In line with ISO 9001 and ISO 14971, criteria to define the acceptable biological (toxicological) risk should be established at the start of the

    43、 design process. Because starting material, formulation and processing variations could impact final product biocompatibility, these considerations should also be incorporated into the risk assessment. The biological safety evaluation should be designed and performed to demonstrate the achievement o

    44、f specified criteria for safety. This evaluation is a component of the risk management plan encompassing identification of all hazards and the estimation of associated risks. Adequate risk assessment requires characterization of toxicological hazards and exposures. A major component in hazard identi

    45、fication is material characterization. The following steps can be identified: define and characterize each material, including suitable alternative materials; identify hazards in materials, additives, processing aids, etc.; identify the potential effect of downstream processing (e.g. chemical intera

    46、ctions between material components, or final product sterilization) on chemicals present in final product; identify the chemicals that could be released during product use (e.g. intermediate or final degradation products from a degradable implant); estimate exposure (total or clinically available am

    47、ounts); review toxicology and other biological safety data (published/available). Information on biological safety to be reviewed can include: toxicology data on relevant component materials/compounds; information on prior use of relevant component materials/compounds; data from biological safety te

    48、sts. The risks posed by the identified hazards should then be evaluated. At this stage it should be possible to determine whether there is an undue toxicological risk from the material. If it can be concluded from existing data that risks are acceptable then no additional toxicity testing is needed.

    49、 Testing is also unwarranted if risks are found to be unacceptable. When existing data are insufficient, additional information should be obtained. The purpose of testing is to obtain additional data which can assist in reaching a conclusion. A rationale for testing should therefore be based on an analysis of the relevant risks which are indicated from the existing data. The results of any tests should be assessed. Test reports should include descriptive evidence, an assessment of the findings and qualitative assessment of their acceptab


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