1、ANSI/AAMI/ISO TIR17137:2014Technical Information ReportCardiovascular implants and extracorporeal systems Cardiovascular absorbable implantsAn ANSI Technical Report prepared by AAMI ANSI/AAMI/ISO TIR17137:2014 Cardiovascular implants and extracorporeal systems Cardiovascular absorbable implants Appr
2、oved 10 March 2014 by Association for the Advancement of Medical Instrumentation Registered 4 May 2014 by American National Standards Institute Abstract: Outlines design verification and validation considerations for absorbable cardiovascular implants.Applies to implants in direct contact with the c
3、ardiovascular system, where the intended action is upon the circulatory system. Keywords: biocompatibility, classification, clinical, degrade, design, leachable, riskPublished by Association for the Advancement of Medical Instrumentation 4301 N. Fairfax Drive, Suite 301 Arlington, VA 22203-1633 www.
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16、sponsible 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 TIR has been registered by the America
17、n 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 Procedures for the Registration of Technical
18、 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, Arlington, VA 22203-1633. Contents Page
19、Glossary of equivalent standards v Committee representation vi Background on ANSI/AAMI adoption of ISO/TS 17137:2014 vii Foreword . viii Introduction. xi 1 Scope . 1 2 Normative references . 1 3 Terms and definitions . 2 4 Implant considerations . 3 4.1 Classification 3 4.2 Intended clinical perform
20、ance 3 4.3 Intended clinical use . 3 4.4 Materials . 4 4.5 Packaging, labelling, and sterilization 4 4.6 Risk management 7 5 Design verification and validation Testing and analysis 8 5.1 Overview 8 5.2 Considerations in the characterization and assessment of material and implant properties . 9 5.3 i
21、n vitro procedural assessment 12 5.4 in vitro degradation assessment (post procedure) . 13 5.5 in vitro-in vivo correlation (IVIVC) 16 5.6 Biocompatibility 16 5.7 Pre-clinical in vivo evaluation . 17 5.8 Clinical considerations specific to absorbable implants . 20 5.9 Shelf life considerations . 21
22、Annex A (informative) Nomenclature of absorb, degrade and related terms . 23 Bibliography 24 Glossary of equivalent standards International Standards adopted in the United States may include normative references to other International Standards. AAMI maintains a current list of each International St
23、andard 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 Association for the Advancement of Medical Instrume
24、ntation ANSI/AAMI/ISO TIR17137:2014 v Committee representation Association for the Advancement of Medical Instrumentation Cardiovascular Absorbable Implants Committee This adoption of ISO Technical Specification (TS) 17137 as an AAMI Technical Information Report (TIR) was initiated by the AAMI Cardi
25、ovascular Absorbable Implants Committee. Approval of the TIR does not necessarily imply that all working group members voted for its approval. At the time this document was published, the AAMI Cardiovascular Absorbable Implants Committee had the following members: Chairs: Maureen Dreher, PhD, FDA/CD
26、RH Julia Fox, PhD, Abbott Vascular Members: Umang Anand, PhD, Boston Scientific Joseph Berglund, Medtronic Brian Choules, PhD, MED Institute James C. Conti, PhD, Dynatek Labs Maureen Dreher, FDA/CDRH Julia Fox, PhD, Abbott Vascular Silvia Garcia-Tunon, MS MSEM, Cordis Byron Hayes, WL Gore Anil Mahap
27、atro, PhD, Wichita State University Lito Mejia, Bose Ed Parsonage, St. Jude Medical Brenda Seidman, PhD, Seidman Regulatory Toxicology Craig Weinberg, PhD, Biomedical Device Consultants “should” indicates a recommendation; “may” is used to indicate that something is permitted; “can” is used to indic
28、ate that something is possible, for example, that an organization or individual is able to do something. 3.3.1 of the ISO/IEC Directives, Part 2 (sixth edition, 2011) defines a requirement as an “expression in the content of a document conveying criteria to be fulfilled if compliance with the docume
29、nt is to be claimed and from which no deviation is permitted.” 3.3.2 of the ISO/IEC Directives, Part 2 (sixth edition, 2011) defines a recommendation as an “expression in the content of a document conveying that among several possibilities one is recommended as particularly suitable, without mention
30、ing or excluding others, or that a certain course of action is preferred but not necessarily required, or that (in the negative form) a certain possibility or course of action is deprecated but not prohibited.” viii 2014 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO TIR171
31、37:2014 Introduction Absorbable cardiovascular implants are medical devices with various clinical indications for use in the human cardiovascular blood system. An absorbable cardiovascular implant, or at least a portion thereof, is designed to intentionally degrade over time into products that are a
32、bsorbed by the body through metabolism, assimilation, and/or excretion (elimination). Such implants can be either surgically or interventionally introduced to the site of treatment. This Technical Specification outlines requirements for intended performance, design attributes, materials, design eval
33、uation, manufacturing, sterilization, packaging, and information supplied by the manufacturer. This Technical Specification should be considered as a supplement to ISO 14630, which specifies general requirements for the performance of non-active surgical implants. This Technical Specification should
34、 also be considered as a supplement to relevant device-specific standards such as the ISO 25539 series specifying requirements for endovascular devices, which do not address degradation and other time dependent aspects of absorbable implants and coatings. This Technical Specification is not comprehe
35、nsive with respect to the pharmacological evaluation of cardiovascular absorbable implants. More detailed safety and performance requirements for pharmacological agents included in the absorbable cardiovascular implant are described in ISO/TS 12417. Only issues related to absorption combined with th
36、e cardiovascular implant are covered by this Technical Specification. NOTE For issues related to the common mechanical function of the cardiovascular implant, the reader might find it useful to consider a number of other International Standards (see Bibliography). 2014 Association for the Advancemen
37、t of Medical Instrumentation ANSI/AAMI/ISO TIR17137:2014 ix AAMI Technical Information Report AAMI/ISO TIR17137:2014 Cardiovascular implants and extracorporeal systems Cardiovascular absorbable implants 1 Scope This Technical Specification outlines design verification and validation considerations f
38、or absorbable cardiovascular implants. NOTE Due to the variations in the design of implants covered by this Technical Specification and in some cases due to the relatively recent development of some of these implants (e.g. absorbable stents), acceptable standardized in vitro tests and clinical resul
39、ts are not always available. As further scientific and clinical data become available, appropriate revision of this Technical Specification will be necessary. For the purpose of this Technical Specification the terms “vessel and/or vascular space” refer to the entire circulatory system, including th
40、e heart and all vasculature. This Technical Specification is applicable to implants in direct contact with the cardiovascular system, where the intended action is upon the circulatory system. This technical specification does not address the specific evaluation of issues associated with viable tissu
41、es, viable cells, and/or implants with non-viable biological materials and their derivatives. Additionally, procedures and devices used prior to and following the introduction of the absorbable cardiovascular implant (e.g. balloon angioplasty devices) are excluded from the scope of this Technical Sp
42、ecification if they do not affect the absorption aspects of the implant. A cardiovascular absorbable implant may incorporate substance(s) which, if used separately, can be considered to be a medicinal product (drug product) but the action of the medicinal substance is ancillary to that of the implan
43、t and supports the primary mode of action of the implant. NOTE Some aspects of absorbable components of cardiovascular device-drug combination products (e.g. coatings) in their connection with drug-related aspects of the device are addressed in ISO/TS 12417. 2 Normative references The following docu
44、ments, 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 10993 (all parts), Bi
45、ological evaluation of medical devices ISO 11135-1, Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices ISO 11137 (all parts), Sterilization of health care products Radiation ISO/TS 1
46、2417, Cardiovascular implants and extracorporeal systemsVascular device-drug combination products ISO 14155:2011, Clinical Investigation of Medical Devices for Human Subjects Good Clinical Practice ISO 14630:2012, Non-active surgical implants General requirements 2014 Association for the Advancement
47、 of Medical Instrumentation ANSI/AAMI/ISO TIR17137:2014 1 ISO 14937, Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices ISO 14971:2007, Medical devic
48、es Application of risk management to medical devices ISO/TR 15499, Biological evaluation of medical devices Guidance on the conduct of biological evaluation within a risk management process ISO 17665-1, Sterilization of health care products Moist heat Part 1: Requirements for the development, valida
49、tion and routine control of a sterilization process for medical devices ISO 25539-2:2008, Cardiovascular implants Endovascular devices Part 2: Vascular stents ISO 5840 (all parts), Cardiovascular implants Cardiac valve prostheses ISO 11607-1:2006, Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems IEC 62366, Medical devices Application of usability engineering to medical devices ASTM F2394-07(2013), Standard Guide for Measuring Securement of Bal
