ANSI TIR37137-2014 Cardiovascular biological evaluation of medical devices - Guidance for absorbable implants.pdf

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1、ANSI/AAMI/ISO TIR37137:2014Technical Information ReportCardiovascular biological evaluation of medical devices Guidance for absorbable implantsAn ANSI Technical Report prepared by AAMI ANSI/AAMI/ISO TIR37137:2014 Cardiovascular biological evaluation of medical devices Guidance for absorbable implant

2、s Approved 24 September 2014 by Association for the Advancement of Medical Instrumentation Registered 28 November 2014 by American National Standards Institute Abstract: provide interim part-by-part guidance on potential adjustments to various test methods within the10993 series to account for the i

3、ntentional release of soluble components or degradation products from absorbable medical devices. Keywords: biological evaluation, absorbable implants, cardiovascularPublished by Association for the Advancement of Medical Instrumentation 4301 N. Fairfax Dr., Ste. 301 Arlington, VA 22203-1633 www.aam

4、i.org 2014 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 the pri

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7、703) 525-4890; Fax: (703) 525-1067. Printed in the United States of America ISBN 1-57020-575-2 AAMI Technical Information Report A technical information report (TIR) is a publication of the Association for the Advancement of Medical Instrumentation (AAMI) Standards Board that addresses a particular

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17、ublication 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 Procedures for the Registration of ANSI Technical Reports. This document is not an American National Stan

18、dard and the material contained herein is not normative in nature. Contents Page Glossary of equivalent standards . v Committee representation . vi Background of AAMI adoption of ISO/TR 37137:2014 . vii 1 Scope. 1 2 Terms and definitions. 1 3 General considerations 1 4 Sterilization considerations 2

19、 5 Drug-device combination product considerations 3 6 Part listing and description of absorbable related issues in addition to the relevant parts of ISO 10993 series “Biological evaluation of medical devices” . 3 6.1 ISO 10993-1:2009, Evaluation and testing within a risk management process . 3 6.2 I

20、SO 10993-2:2006, Animal welfare requirements 4 6.3 ISO 10993-3:2003, Tests for genotoxicity, carcinogenicity and reproductive toxicity . 4 6.4 ISO 10993-4:2002, Selection of tests for interactions with blood . 4 6.5 ISO 10993-5:2009, Tests for in vitro cytotoxicity 5 6.6 ISO 10993-6:2007, Tests for

21、local effects after implantation . 6 6.7 ISO 10993-7:2008, Ethylene oxide sterilization residuals 7 6.8 ISO 10993-9:2009, Framework for identification and quantification of potential degradation products 8 6.9 ISO 10993-10:2010, Tests for irritation and delayed-type hypersensitivity 8 6.10 ISO 10993

22、-11:2006, Biological evaluation of medical devices Part 11: Tests for systemic toxicity . 8 6.11 ISO 10993-12:2012, Sample preparation and reference materials 9 6.12 ISO 10993-13:2010, Identification and quantification of degradation products from polymeric medical devices . 12 6.13 ISO 10993-14:200

23、1, Identification and quantification of degradation products from ceramics. 12 6.14 ISO 10993-15:2000, Identification and quantification of degradation products from metals and alloys . 12 6.15 ISO 10993-16:2010, Toxicokinetic study design for degradation products and leachables . 12 6.16 ISO 10993-

24、17:2002, Establishment of allowable limits for leachable substances 12 6.17 ISO 10993-18:2005, Chemical characterization of materials . 12 6.18 ISO/TS 10993-19:2006, Physico-chemical, morphological and topographical characterization of materials 13 6.19 ISO/TS 10993-20:2006, Principles and methods f

25、or immunotoxicology testing of medical devices 13 Annex A (informative) Nomenclature of absorb, degrade and related terms . 14 Bibliography . 15 Glossary of equivalent standards International Standards adopted in the United States may include normative references to other International Standards. AA

26、MI maintains a current list of each International Standard that has been adopted by AAMI (and ANSI). Available on the AAMI website at the address below, this list gives the corresponding U.S. designation and level of equivalency to the International Standard. www.aami.org/standards/glossary.pdf 2014

27、 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO TIR37137:2014 v Committee representation Association for the Advancement of Medical Instrumentation Biological Evaluation Committee The adoption of ISO/TR 37137:2014 as an AAMI Techinical Information Report was initiated by th

28、e AAMI Biological Evaluation Committee, which also functions as a U.S. Technical Advisory Group to the relevant work in the International Organization for Standardization (ISO) and the AAMI Strategic Approach to Biological Assessment Working Group. At the time this document was published, the AAMI B

29、iological Evaluation Committee had the following members: Co-chairs Ronald P. Brown, FDA/CDRH Jon Cammack, PhD DABT, Medimmune LLC Members James M. Anderson, MD PhD, Case Western Reserve Univ Joseph Carraway, DVM, NAMSA Philippe Hasgall, Zimmer Inc Richard W. Hutchinson, DVM PhD DABT, Johnson 2 2014

30、 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO TIR37137:2014 b) data that demonstrates that all differences between the test article and the final device do not impact theirchemistry or degradation kinetics.NOTE If potentially significant differences exist between the test

31、 article and final device (e.g. surface properties or device geometry when hemocompatibility testing), some test end points can be affected. In such situations, use of a test article cannot be representative of a final device. 5 Drug-device combination product considerations For devices that include

32、 an active pharmaceutical ingredient (API), the presence of a pharmaceutical can affect the biological response. As such, separate testing of both the finished device including the API and devices constructed excluding any drug component should be considered. In addition, any potential for interacti

33、on between the pharmaceutical ingredient(s) and the as-manufactured or degrading absorbable component(s) should be both understood and assessed for its impact on device biocompatibility and the drug component itself. Any pH or osmolality adjustment shall be justified. If under standard test conditio

34、ns an adverse result is obtained, one should consider the cell type, cell media, culture conditions, and degradation products when determining the amount of osmolality adjustment to be used, if any. For example, with magnesium alloys evaluated with a human osteoblast cell type, it may not be appropr

35、iate to dilute the culture medium to less than 105 % of normal osmolality. NOTE 1 Minimum value of 105 % derived from review of experimental results obtained from 10993 to 12 extraction of magnesium and magnesium alloy samples see Reference.23NOTE 2 Additional guidance regarding evaluation of drug-d

36、evice combination products can be obtained in ISO/TS 12417, which was developed for vascular medical devices. Biological evaluation of identifiable and already previously well characterized chemical components, such as degradation products from some intentionally absorbable materials or APIs in drug

37、-device combination products, may be optionally substituted with an appropriate toxicological evaluation. Such a justification might be generated through a chemical characterization of device extracts in conjunction with a biological risk assessment for the specifically identified chemicals, if the

38、risk assessment considers: a) How in vitro chemical extraction studies reasonably characterize the degradation and accumulation of chemicalsin vivo;b) Whether toxicity data are available from the literature to explore the biological response to multiple chemicalspresent from the same device;c) Resul

39、ts from a subset of final product testing where surface properties and geometry may impact thetoxicological profile of an absorbable device. For example, hemocompatibility testing might be needed if thesurface properties and/or device geometry could impact the test results.Devices that include APIs

40、can potentially impact the results with misleading positives when extracted at the recommended extraction ratio detailed in ISO 10993-12. Use of a direct dilution of the sample or a partition of the overall device evaluation may be considered. 6 Part listing and description of absorbable related iss

41、ues in addition to the relevant parts of ISO 10993 series “Biological evaluation of medical devices” 6.1 ISO 10993-1:2009, Evaluation and testing within a risk management process a) 5.3 c) and throughout ISO 10993 series1) Supplemental Information:i) Within the ISO 10993 series, the term PERMANENT i

42、s perceived as including CHRONIC orPERSISTENT implants that are physically present longer than 30 d. Since typically at least a limitedamount of an absorbable material and/or its degradation byproducts can be expected to persist in thebody past 30 d, such devices should be evaluated using the PERMAN

43、ENT implant test criteria. 2014 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO TIR37137:2014 3 6.2 ISO 10993-2:2006, Animal welfare requirements a) No identified adjustments/allowances/compensation for absorbable devices6.3 ISO 10993-3:2003, Tests for genotoxicity, carcinog

44、enicity and reproductive toxicity a) Clause 4 Genotoxicity Tests1) 4.4 Test Methodsi) Supplemental information to 4.4.1:I) When evaluating absorbable materials using in vitro genotoxicity methods, the potential ispresent for artefactual positive results due to inadequately controlled pH, osmolality,

45、 or highlevels of cytotoxicity within the culture media see OECD Guideline 473(1997), Clauses 4, 14 and38 and OECD Guideline 476(1997), Clauses 3, 14 and 36. Since absorbable materials carrypotential for at least partial dissolution during extraction, the test samples mass may bemonitored to ensure

46、that sample concentration within the extract not does not exceed either the5 mg/ml or 0.01M OECD limits for the chromosome aberration or mouse lymphoma test or the5 mg/plate limit for the bacterial reverse mutation test. If extraction results in a higherconcentration, dilution of the test liquid to

47、no less than 80 % of the respective concentration limitis acceptable. Lower concentrations may be utilized if evaluated as part of a range ofconcentrations per OECD guidelines. The samples cell culture may then be monitored for thepresence of abnormal pH and/or osmolality for later consideration in

48、the event of a positive result.NOTE Significant discussion regarding the effects of abnormal pH and osmolality ongenotoxocity testing is available in the ICPEMC report “Genotoxicity under extreme cultureconditions,” which provides a table showing the chemical-dependent nature of the impact of highos

49、molality on mammalian cell toxicity and chromosomal aberrations see Reference.21Additionalguidance regarding appropriate follow-up to a positive in vitro genotoxicity test can be found inthe internationally authored review article in Reference:226.4 ISO 10993-4:2002, Selection of tests for interactions with blood a) Annex C.6 Hemolysis Testing General Considerations1) Supplemental Information:i) This subclause provides a brief description of direct and indirect hemolysis methods. In indirectmethods, such as ASTM F756, extracts from absorbable material