ANSI TIR17665-3-2014 Sterilization of health care products - Moist Heat - Guidance on the designation of a medical product to a product family and processing category for steam ste.pdf

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1、ANSI/AAMI/ ISO TIR17665-3: 2014/(R)2016Technical Information ReportSterilization of health care productsMoist heat Guidance on the designation of a medical product to a product family and processing category for steam sterilizationAn ANSI Technical Report prepared by AAMI ANSI/AAMI/ISO TIR17665-3:20

2、14/(R)2016 Sterilization of health care productsMoist heat Guidance on the designation of a medical product to a product family and processing category for steam sterilization Approved 31 December 2012 by AAMIRegistered 18 May 2014 and reaffirmed 11 November 2016 by American National Standards Insti

3、tute Abstract: This Technical Specification provides guidance about the attributes of a medical device to be considered by the user when assigning a medical device to a product family for the purpose of identifying and aligning it to a processing category for a specific moist heat sterilization proc

4、ess.Published by AAMI 4301 N. Fairfax Drive, Suite 301 Arlington, VA 22203-1633 www.aami.org HU UH 2014 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

5、 or distributed in any form, including an electronic 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 (whet

6、her internally or externally) without the prior written 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

7、document, complete the reprint request form at www.aami.org or contact AAMI at 4301 N. Fairfax Drive, Suite HU UH301, Arlington, VA 22203-1633. Phone: +1-703-525-4890; Fax: +1-703-525-1067. Printed in the United States of America ISBN 978-1-57020-571-2AAMI Technical Information Report A technical in

8、formation report (TIR) is a publication of the Association for 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 val

9、uable because the industry and the professions have an immediate 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 approv

10、al, public review, and resolution of all comments. This process 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

11、 is approved for distribution by a technical committee and the 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 le

12、ast every 10 years. For a TIR, AAMI consults with a technical 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 u

13、seful, the TIR is removed from circulation. A TIR may be developed 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 di

14、ffering viewpoints on technical issues. CAUTION NOTICE: This 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 stand

15、ards, 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 are adopted by

16、government regulatory agencies or procurement authorities, in 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

17、, Arlington, VA 22203-1633. ANSI Technical Report This AAMI 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 Tec

18、hnical Report series of publications according to the Procedures 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

19、: Standards Department, 4301 N. Fairfax Drive, Suite 301, Arlington, VA 22203-1633. Contents PageGlossary of equivalent standards vi Committee representation vii Background of AAMI adoption of ISO TS 13004:2013 . x Foreword . xi Introduction xii 1 Scope. 1 2 Normative references. 1 3 Terms and defin

20、itions. 1 4 Classification 2 4.1 General attributes 2 4.2 Detailed attributes 2 4.2.1 Design 3 4.2.2 Material 3 4.2.3 Weight 4 4.2.4 Sterile barrier system and/or packaging system 5 5 Product family (pf) 5 5.1 Example 1 pf 1 6 5.2 Example 2 pf 24 6 5.3 Example 3 pf 27 7 6 Processing category 9 7 Ste

21、rilization process parameters 9 8 Additional considerations . 9 8.1 Services . 9 8.2 Process selection . 9 Annex A (informative) Process parameters 11 Annex B (informative) Characterization of a procedure set Examples . 13 B.1 Assessment/extraction set (oral) 13 B.1.1 General 13 B.1.2 Product family

22、 15 B.2 Cystoscope, bridge and tap set . 15 B.2.1 General 15 B.2.2 Product family 17 B.3 Cataract ophthalmic No. 6 set 17 B.3.1 General 17 B.3.2 Product family 19 B.4 General orthopedic set . 19 B.4.1 General 19 B.4.2 Product family 21 B.5 General laparoscopy set 22 B.5.1 General 22 B.5.2 Product fa

23、mily 24 B.6 LCS knee set (1 of 6) . 25 B.6.1 General 25 B.6.2 Product family 27 B.7 Femur repair and nail extraction set 27 B.7.1 General 27 B.7.2 Product family 29 Annex C (informative) Designating a processing category . 31 Annex D (informative) Processing categories Examples . 33 General instrume

24、nts. 33 D.1.1 Assessment of family member 1 33 D.1.2 Product family 34 D.1.3 Assessment of family member 2 35 D.1.4 Product family 36 D.1.5 Assessment of family member 3 36 D.1.6 Product family 37 D.1.7 Assessment of family member 4 38 D.1.8 Product family 39 D.1.9 Assessment of family member 5 39 D

25、.1.10 Product family 40 D.1.11 Master product . 41 D.1.12 Product family 42 D.2 Implant sets and complex orthopedic sets . 42 Bibliography . 49 D.1Glossary of equivalent standards International Standards adopted in the United States may include normative references to other International Standards.

26、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/glossary.pdf vi

27、 2014 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO TIR17665-3:2014 Committee representation Association for the Advancement of Medical Instrumentation Radiation Sterilization Working Group The adoption of ISO Technical Specification (TS) 17665-3, as an AAMI Technical Info

28、rmation Report was initiated by the AAMI Radiation Sterilization Working Group, which also functions as the U.S. Technical Advisory Group to the relevant work in the International Organization for Standardization (ISO). U.S. representatives from the AAMI Industrial Moist Heat Sterilization Working G

29、roup (U.S. Sub-TAG for ISO/TC 198/WG 3, Industrial Moist Heat Sterilization) played an active role in developing the ISO Technical Specification. At the time this document was published, the AAMI Sterilization Standards Committee had the following members: Chairs: Victoria M. Hitchins, PhD, FDA/CDRH

30、 Michael H. Scholla, PhD, Dupont Protection Technologies Members: Christopher Anderson, Boston Scientific Corporation Trabue D. Bryans, BryKor LLC Nancy Chobin, RN CSPDM, St Barnabas Healthcare System Charles Cogdill, Covidien Ramona Conner, RN MSN CNOR, Association of Perioperative Registered Nurse

31、s Jacqueline Daley, Sinai Hospital of Baltimore Kimbrell Darnell, CR Bard Lisa Foster, Medpoint LLC Joel R. Gorski, PhD, NAMSA Joyce M. Hansen, Johnson however, there may be a need to develop customized sterilization processes to sterilize medical devices or combinations of medical devices that pose

32、 a particular challenge to the pre-set sterilization processes. The designs and nature of materials used to construct medical devices are increasing in complexity. Materials used in the manufacture of sterile barrier systems and/or packaging systems and the combinations of different medical devices

33、in procedure sets can adversely affect conductivity, air removal and moist heat penetration, causing a failure to obtain the required sterility assurance level. The classification of a medical device into a product family can assist with the development of moist heat sterilization process conditions

34、 for this medical device. Assigning a medical device to a particular product family is the first stage of performance qualification at the point of use as specified in ISO 17665-1 and ISO/TS 17665-2. The efficacy of sterilization for a medical device using the sterilization process for that product

35、family should be assessed and documented together with any pre-treatments, such as cleaning, disinfection to reduce bioburden followed by lubrication and humidification of some materials e.g. those containing cellulose. In this part of ISO 17665 the attributes which relate to efficient sterilization

36、 and which are used to identify a product family have been selected from operational experience, engineering considerations and experimental data relating to the efficacy of the different types of moist heat sterilizers and their sterilization processes, and the types and design of differing medical

37、 devices and sterile barrier systems and/or packaging systems. Medical devices that are labelled by the manufacturer as being capable of being sterilized via moist heat may be categorized into product families by a user. However, not all medical devices will fit into one of the product families desc

38、ribed in this part of ISO 17665. In these cases, new product families will need to be identified based on the consideration of the products attributes and require additional performance qualification. Medical devices that have been classified into different product families are often processed in th

39、e same sterilization load when assembled into a randomly selected load configuration. This approach is common and acceptable in health care facilities where it is generally not feasible to qualify each sterilization load, provided that the sterilization process and sterilizer have been shown to be c

40、apable of sterilizing the range of product families constituting the sterilization load. Care should be taken to ensure that the combination of product families does not create a greater sterilization challenge than that set by the individual product families. In addition, consideration should be gi

41、ven to possible adverse interactions between medical devices such as the contamination of instruments with textile fibres. The examples shown in Annex B and D are illustrations of how the coding system is intended to be used in developing a sterilizer load. This part of ISO 17665 should be read in c

42、onjunction with ISO 17665-1 and ISO/TS 17665-2. xii 2014 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO TIR17665-3:2014 AAMI Technical Information Report ANSI/AAMI/ISO TIR17665-3:2014/(R)2016 Sterilization of health care productsMoist heat Guidance on the designation of a m

43、edical product to a product family and processing category for steam sterilization 1 Scope This part of ISO 17665 provides guidance about the attributes of a medical device to be considered by the user when assigning a medical device to a product family for the purpose of identifying and aligning it

44、 to a processing category for a specific moist heat sterilization process. NOTE While this part of ISO 17665 is applicable to health care facilities, it may be used by a manufacturer of a sterile medical device and/or whenever information on reprocessing is required (see ISO 17664). 2 Normative refe

45、rences 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.

46、ISO 17665-1:2006, Sterilization of health care products Moist heat Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 17665-1 and the

47、 following apply. 3.1 master product medical device or procedure set used to represent the most difficult to sterilize item in a product family or processing category 3.2 processing category collection of different products or product families that can be sterilized together 3.3 steam penetration re

48、sistance challenge to a sterilization process from a medical device, including any sterile barrier/packaging system that may delay attainment of the process parameters for moist heat sterilization on all parts of the medical device 3.4 user responsible body, which can be an individual or group, acco

49、untable for ensuring products are sterilized and suitable for intended use 2014 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO TIR17665-3:2014 1 4 Classification Each medical device, whether new or modified, should be classified using the general attributes listed in Table 1. Specific characteristics of a medical device should, as applicable, be identified from the subclauses detailed in 4.2. NOTE 1 Requirements for information to be provided by the manufacturer for the reprocessing of resterilizable medical devices are given in I