AAMI TIR 20-2001 环氧乙烷灭菌 参数放行(英文版).pdf

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Technical Information Report

AAMITIR20:2001

Parametricreleaseforethyleneoxidesterilization

Parametricreleasefor ethyleneoxidesterilization

Approved 24 September 2001 byAssociation for the Advancement of Medical Instrumentation

Abstract:

This AAMI technical information report (TIR) provides guidance to augment information andrequirements for parametric release provided in ANSI/AAMI/ISO 11135:1994 Medtica/ devices- Validation and routine control of ethylene oxide (EO) sterilization. This TIR is intended to assistthose individuals using ANSI/AAMI/ISO 11135:1994 in understanding the steps necessary to develop and validate an ethylene oxide sterlization process that meets the standard'sappropriate actions where alternatives are given. The guidance in this TiR is limited to the requirements for parametric release. This TiR also provides guidance for choosing thesections of the standard that specifically address parametric release.

Keywords:

ethylene oxide parametric release sterilization validation

AAMITechnical InformationReport

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valuable because the industry and the professions have an immediate need for it. Although the material presented in a TiR may need further evaluation by experts releasing the information is

between these documents. A TIR differs markedly from a standard or remended practice and readers should understand the differences

Standards and remended practices are subject to a formal process of mittee approval public review andof American National Standards by the American National Standards Institute. resolution of all ments. This process of consensus is supervised by the AAMI Standards Board and in the case

A TIR is not subject to the same formal approval process as a standard. However a TiR is approved for distributionby a technical mittee and the AAMI Standards Board.

on-reaffirmedrevised orwithdrawnand theactionformallyaprovedusuallyeveryyearsbut at least every0 Another difference is that although both standards and TIRs are periodically reviewed a standard must be actedyears.ForaTIRAAMI consults witha technicalmittee about 5years afterthe publication date (and periodically thereaffer for guldance n whether thedocument isstil usefulthat is to check that the information isrelevant orofhistorical value. If the information is not useful the TiR is removed from circulation.

A TIR may be developed because it is more responsive to underlying safety or performance issues than a standardpermits the inclusion of differing viewpoints on technical issues.

CAUTiON NOTICE: This AAMI technical information report may be revised or withdrawn at any time. Because itinformation that may be more recent than this document. addresses a rapidly evolving field or technology readers are cautioned to ensure that they have also considered

All standardsremendedpractices technical informationreportsand other types of technicaldocumentsdeveloped byAAMIarevoluntaryand theirapplicationissolelywithin the discretionand professionaljudgment f the user of the document. Occasionally voluntary technical documents are adopted by govemment regulatoryagencies or procurement authorities in which case the adopting agency is responsible for enforcement of its rules and regulations.

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Published by

Association for the Advancement of Medical InstrumentationArlington VA 22201-4795 1110 N. Glebe Road Suite 220

@ 2002 by the Association for the Advancement of Medical Instrumentation

All Rights Reserved

Publicatin rtintpyingtragerranssinltronicallyrtherefalrnyrtf thdocument without the prior written permission of the Association for the Advancement of Medical Instrumentation isstrictly prohibited by law. It is illegal under federal law (17 U.S.C. 101 et seq.) to make coples of all or any part of Advancement of Medical Instrumentation. Violators risk legal action including civil and criminal penalties anddamages of $100 000 per offense. For permission regarding the use of all or any_part of this document contact

Printed in the United States of America

Contents

Page

Glossary of equivalent standards . VCommittee representation.. vllIntroduction.1 Scope. .12 Cited references. 13 Definitions . 1Equipment requirements. 34.1 4.2 Preconditioning... Steriization chamber. 4 4Process analysis 4.3 Aeration/degassing.. 5 45 5.1 Overview... 55.2 5.3 EO analysis sampling location(s) Frequency of EO analysis. .5 .55.4 EO analysis accuracy- .5Process development... .56.1 6.2 Overview.. Use of biological indicators to develop the sterilization process 5 76.3 Methods of determining lethalit... 6.3.1 Methods overview. 7 76.3.2 6.3.3 Steps required by both methods.. Method A: Survivor curve construction-Enumeration of the Bls. 8 76.3.4 6.3.5 Method B: Fraction negative... Steriization cycle development process troubleshooting .9 86.4 6.5 Performance of Method A or B in a pilot or a production chamber 10 106.5.1 6.5.2 Four ways that Method A or B may be performed. Establishing relationship between pilot chamber and production chamber.. 10 116.6 6.7 Calculation of the sterlization cycle Documentation of the process development . 12 12T Validation . 127.1 7.2 Performance qualification (PQ)-Microbiological. Commissioning (IQ/OQ) . 12 127.3 7.4 Performance qualification-Physical. Load configuration... 13 137.5 Revalidation.. 138 Routine processing - 149 Product release.... .. 149.1 9.2 Electronic records and signatures.. General.. Writen procedures. 14 149.3 14

Annexes

Gas analysis issues BSensor monitoring tables A 15CFactors influencing accuracy and decisions regarding the direct analysis of EO concentration... 20 17

Tables

Site selection of Bl sample. 10B.1 Sterilization. 17B.2 Preconditioning and/or conditioning. 18B.3 Sterilization.. 19Figure

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