BSENIS080601-2-85:2021 BSl Standards Publication Medical electrical equipment Part 2-85: Particular requirements for the basic safety and essentia performance of cerebral tissue oximeter equipment bsi. BS EN IS0 80601-2-85:2021 BRITISH STANDARD National foreword This British Standard is the UK implementation of EN IS0 80601-2-85:2021. It is identical to IS0 80601-2-85:2021. The UK participation in its preparation was entrusted to Technical Committee CH/121/9, Lung Ventilators & Related Equipment. A list of organizations represented on this committee can be obtained on request to its committee manager. Contractual and legal considerations This publication has been prepared in good faith, however no representation, warranty, assurance or undertaking (express or implied) is or will be made, and no responsibility or liability is or will be accepted by BsI in relation to the adequacy, accuracy, completeness or 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 respect to its use of this publication. This publication is not intended to constitute a contract. Users are responsible for its correct application. @ The British Standards Institution 2021 Published by BSI Standards Limited 2021 ISBN978 0539026436 ICS 11.040.10 Compliance with a British Standard cannot confer immunity from legal obligations. This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 April 2021. Amendments/corrigenda issued since publication Date Textaffected BSENIS080601-2-85:2021 EN IS0 80601-2-85 EUROPEAN STANDARD NORME EUROPEENNE EUROPAISCHE NORM April 2021 ICS 11.040.10 English Version Medical electrical equipment - Part 2-85: Particular requirements for the basic safety and essential performance of cerebral tissue oximeter equipment (IsO 80601-2-85:2021) Appareils électromédicaux - Partie 2-85: Exigences Medizinische elektrische Gerate - Teil 2-85: Besondere particulieres pour la securite de base et les Anforderungen fur die Sicherheit einschlielich der performances essentielles des oxymetres pour tissu wesentlichen Leistungsmerkmale von Geraten fur die nicht-invasive zerebrale 0xymetrie (IS0 80601-2- cérébral (IS080601-2-85:2021) 85:2021) This European Standard was approved by CEN on 21 January 2021. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status ofa national standard without any alteration.Up-to-date lists and bibliographical references member. This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centrehas the same statusas the officialversions. 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 EUROPEANCOMMITTEEFOR STANDARDIZATION COMITE EUROPEEN DE NORMALISATION EUROPAISCHES KOMITEE FUR NORMUNG CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels @2021 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN IS0 80601-2-85:2021 E worldwide for CEN national Members.