PD CEN IS0/TS 16775:2021 BSl Standards Publication Packaging for terminally sterilized medical devices Guidance on the application of IS0 11607-1 and IS0 11607-2 bsi. PDCENIS0/TS16775:2021 PUBLISHEDDOCUMENT National foreword This Published Documentis the UK implementation of CEN ISQ/TS 16775:2021. It is identical to ISQ/TS 16775:2021. It supersedes PD CENISO/TS 16775:2014, which is withdrawn. TheUK participation inits preparationwas entrusted to Technical Committee CH/198,Sterilization andAssociated Equipment and Processes. A list of organizations represented on this committee can be obtained on requestto its committee manager. Contractual and legalconsiderations This publication has been prepared in good faith, however no representation, warranty,assurance or undertaking (express or implied) is or will bemade,and no responsibility or liability is or will be reasonableness of this publication. All and any such responsibility and liability is expressly disclaimed to the full extent permitted by the law. This publication is provided as is, and is to be used at the recipient's own risk. The recipient is advised to consider seeking professional guidance with respecttoitsuseofthispublication. This publication is not intended to constitute a contract. Users are responsiblefor its correct application. @TheBritishStandardsInstitution2021 PublishedbyBSIStandards Limited2021 ISBN9780539141924 ICS11.080.30 Compliance with a British Standard cannot confer immunity from legal obligations. This Published Document waspublished underthe authority ofthe StandardsPolicyandStrategyCommitteeon30November2021. Amendments/corrigenda issued sincepublication Date Text affected CEN IS0/TS 16775 TECHNICALSPECIFICATION SPECIFICATION TECHNIQUE TECHNISCHE SPEZIFIKATION November 2021 ICS11.080.30 Supersedes CENIS0/TS16775:2014 English Version Packaging for terminally sterilized medical devices - Guidance on the application of Is0 11607-1 and Is0 11607-2 (IS0/TS 16775:2021) Emballages des dispositifsmedicaux sterilisés Verpackungen fur in der Endverpackung zu au stade terminal -Lignes directrices sterilisierende Medizinprodukte- Leitfaden relatives a I'application de I'IS0 11607-1 fur die Anwendung von IS011607-1und et IIS0 11607-2 (IS0/TS16775:2021) ISO 11607-2 (IS0/TS 16775:2021) This Technical Specification (CEN/TS) was approved by CEN on 22 August 2021 for provisional application The period of validity of this CEN/TS is limited initially to three years. After two years the members of CEN will be requestedto submit their comments,particularly on the question whether the CEN/TS can be convertedintoa European Standard. CEN/TS available promptlyat national level in an appropriate form.It is permissible to keep conflicting national standards in force (in parallel to the CEN/TS) until the final decision about the possible conversion of the CEN/TS into an EN is reached. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece,Hungary,Iceland, Ireland, Italy,Latvia, Lithuania, Luxembourg, Malta Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. cen EUROPEAN COMMITTEE FOR STANDARDIZATION COMITE EUROPEEN DE NORMALISATION EUROPAISCHES KOMITEEFURNORMUNG CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels 2021CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN IS0/TS 16775:2021: E worldwide for CEN national Members