1、ANSI/AAMI/ISO 17664: 2017Processing of health care productsInformation to be provided by the medical device manufacturer for the processing of medical devicesAmerican National StandardObjectives and uses of AAMI standards and recommended practices It is most important that the objectives and potenti
2、al uses of an AAMI product standard 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 effectiv
3、e application of current technologies 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 objective
4、s and provided that arbitrary 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 clinic
5、al use, and the measurement techniques 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, includi
6、ng performance characteristics, 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 speci
7、alized test methods to facilitate 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 pr
8、ovided and the reasons for establishing 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 practi
9、ces that will help ensure that 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 evalua
10、tion. Similarly, even though 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 cri
11、teria, provide guidelines to 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 i
12、ndustrial practices. In determining 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 b
13、y government regulatory or procurement 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
14、 professionals and industrial 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 st
15、andard or recommended practice 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 repla
16、ce responsible decision-making. 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 dev
17、eloped and the specific rationale 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 c
18、urrent procedures and practices. 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
19、 serve to identify a particular 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 sh
20、ould be analyzed in the context 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 pra
21、ctice is truly useful only when 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 pract
22、ices must be made in writing, 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 represent
23、ation of the Association only 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 stan
24、dard or recommended practice 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/ISO 17664:2017 Processing of health care productsInform
25、ation to be provided by the medical device manufacturer for the processing of medical devices Approved 11 August 2017 by AAMI Approved 18 August 2017 by American National Standards Institute Abstract: Specifies requirements for the information to be provided by the medical device manufacturer for th
26、e processing of a medical device that requires cleaning followed by disinfection and/or sterilization to ensure that the device is safe and effective for its intended use. This includes information for processing prior to use or reuse of the medical device. The provisions of this standard are applic
27、able to medical devices that are intended for invasive or other direct or indirect patient contact. Processing instructions are not defined in this standard. Rather, this standard specifies requirements to assist manufacturers of medical devices in providing detailed processing instructions that con
28、sist of the following activities where applicable: a) Pre-treatment at the point of use before processing;b) Preparation before cleaning;c) Cleaning;d) Disinfection;e) Drying;f) Inspection, maintenance and functionality testing;g) Packaging;h) Sterilization;i) Storage;j) Transportation.Keywords: ins
29、tructions, disinfection, validation, storage, transportation 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 pre
30、clude anyone, whether they have approved the standard 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: T
31、his AAMI standard may be revised or withdrawn at any 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 AAM
32、I, or by visiting the AAMI website at HUwww.aami.orgUH. 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
33、 document. Occasionally, voluntary technical documents 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 AAMI 4301 N. Fairfax Drive, Suite 301 Arlington, VA 22203-1633
34、HUwww.aami.orgUH 2017 by the Association for the Advancement of Medical Instrumentation All Rights Reserved This publication is subject to copyright claims of ISO and AAMI. No part of this publication may be reproduced or distributed in any form, including an electronic retrieval system, without the
35、 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 Associat
36、ion 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 HUwww.aami.orgUH or contact AAMI at
37、 4301 N. Fairfax Drive, Suite 301, Arlington, VA 22203-1633. Phone: +1-703-525-4890; Fax: +1-703-276-0793. Printed in the United States of America ISBN 978-1-57020-685-6 Contents Page Glossary of equivalent standards iv Committee representation . v Background of ANSI/AAMI adoption of ISO 17664:2017
38、. viii Foreword ix Introduction x 1 Scope 1 2 Normative references 2 3 Terms and definitions 2 4 Validation of the processes identified in the information provided by the medical device manufacturer . 5 5 Risk analysis 6 6 Information to be provided by the medical device manufacturer 6 7 Presentatio
39、n of the information 12 Annex A (informative) Commonly utilized processing methods 14 Annex B (informative) Example of processing instructions for reusable medical devices . 19 Annex C (informative) Classification of medical devices 21 Annex D (informative) Additional guidance on information to be p
40、rovided by the medical device manufacturer . 24 Bibliography . 25 iv 2017 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 17664:2017 Glossary of equivalent standards International Standards adopted in the United States may include normative references to other International
41、Standards. AAMI 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/glos
42、sary.pdf 2017 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 17664:2017 v Committee representation Association for the Advancement of Medical Instrumentation Instructions for Reusable Device Reprocessing Working Group The adoption of ISO 17664 as an American National Standa
43、rd was initiated by the AAMI Instructions for reusable device reprocessing Working Group (ST/WG 12). AAMI ST/WG 12 functions as a U.S. Technical Advisory Group to the relevant work in the International Organization for Standardization (ISO). U.S. representatives from AAMI ST/WG 12 played a very acti
44、ve part in developing the ISO standard. At the time this document was published, the AAMI Instructions for Reusable Device Reprocessing Working Group had the following members: Cochairs: Members: Ralph Basile Nancy Chobin Ralph Basile, Healthmark Industries Company Inc Garry Bassi, CMC Sterilization
45、 Ltd Greg Baumgardner, Zimmer Inc Dave Billman, Innovative Sterilization Technologies LLC Rachel Brewer, IUVO BioScience Bill Brodbeck, Steris Corporation Renee Camp, IUVO BioScience Nancy Chobin, St Barnabas Healthcare System Linda Condon, Johns Hopkins Hospital Lena Cordie, Qualitas Professional S
46、ervices LLC Jackie Daley Kim Darnell, CR Bard Steven Elliott, NAMSA Gordon Ely, MiMedx Group John Erickson, University of Iowa Hospitals and Clinics Sue Ellen, Erickson Newark Beth Israel Medical Center Brian Fortier, Quality Processing Resource Group LLC Marga Foster, Medline Industries Inc Sarah F
47、riedberg, Stryker Instruments Division Marcia Frieze, Case Medical Inc Elyse Gaudreau, TSO3 Inc Brent Geiger, Cantel Inc Russell Gilbert, Cox Health Systems Zory Glaser, Johns Hopkins University-School of Public Health Nicole Grant, Medtronic Inc Campus Shelley Green, Company for Individuals Doug Ha
48、rbrecht, Sterility Assurance LLC Rachel Hill, Becton Dickinson preparation before cleaning; cleaning; disinfection; drying; inspection and maintenance; packaging; sterilization; storage; and transportation. U.S. participation in ISO/TC 198 is organized through the U.S. Technical Advisory Group to IS
49、O/TC 198, administered by the Association for the Advancement of Medical Instrumentation. Experts from the United States made a considerable contribution to this standard. ANSI/AAMI/ISO 17664 was approved by the American National Standards Institute (ANSI) on 18 August 2017 and supersedes ANSI/AAMI ST81:2004 (R)2016, Sterilization of Medical Devices - Information to be Provided by the Manufacturer for the Processing of Resterilizable Medical Devices. AAMI and ANSI procedures require that standards be reviewed every five years and, if necessary, revised to reflect technological
