AAMI TIR21387-2023 Sterilization of health care products—Guidance on the requirements for the validation and routine processing of ethylene oxide sterilization processes using parametric release 医疗保健产品的灭菌ーー使用参数释放法的环氧乙烷灭菌过程的验证和常规处理的要求指南.pdf

A Technica l Report prepared by AAMI and registered w ith ANSI AAMl/ISO TIR21387:2023 Sterilization of health care products-Guidance 。n the requirements for the validation and routine processing of ethylene 。xide sterilization ~rocesses using parametric release Appr。ved 30 June 2023 by AAM I Registered 2 7 Aug ust 2023 by Ame rican Nati。nal Standards Institute, Inc. Abstract: Providesguidance on the requirements of ISO 111 35 that apply when parametric release is used to release the product after exp。sure t。 the sterilization process. Pn。vides a path fo r transiti 。n 。f existing cycles, as well as a path tor the devel。pment and impl emen坦lion of a pa rametric release specifi cati。nf。r a new cycle .Highlights the imp。时ance and i nterrela植。nshipof。ther process factors’ ，怠。 l。ad config urati 。n and equipment performan悍， whi ch influence reproducibility of an ethyle陪 oxide (EO) sterilization process. Keywords: ethylene oxide , steri lizatio n , pa rametric release, va lidation Published by AAM I 901 N. Glebe R。ad, Sui te 300 Arlingl。n, VA22203 旦旦旦.ll皿L且!9. © 2023 by the Ass。ciation for the Advancement of Medical Instrumentation All Rights Reserved Th is publication is subj ect to copyright claims of ISO and AAMI. No part of th is publication may be reproduced or d istributed in any form, including an electronic retrieval system , wi th。ut the prior written permi ssi。n of AAMI. All requests pe同ainingto th is documentshould be submitted to AAM l. It is illegal underfederal law (17 U.S.C. § 101 , et seq .) to make copies 。f all 。r any part of this document (whether internally or externally) with。ut the p rior written perm ission of the Assoc iation for the Advancement of Medical lnstrum自1tation. Vi