60601 1 4
Norme NF EN 60601-1-4
NF EN 60601-1-4, octobre 1999, Norme Annulée, Appareils électromédicaux – Partie 1 : règles générales de sécurité – 4 – Norme collatérale : systèmes électromédicaux programmables, Cette norme traite de la sécurité des appareils électromédicaux et dessystèmes électromédicaux comprenant des sous-systèmes électroniques programmables, Voir plus , Visualiser l’extrait
ISO
IEC TR 60601-4-1:2017E is intended to help a manufacturer through the key decisions and steps to be taken to perform a detailed risk management and usability engineering processes for medical electrical equipment or a medical electrical system, hereafter referred to as MEE or MES, employing a degree of autonomy DOA, This document provides a definition of DOA of MEE or MES and a medical
ISO
IEC TR 60601-4-1:2017E is intended to help a manufacturer through the key decisions and steps to be taken to perform a detailed risk management and usability engineering processes for medical electrical equipment or a medical electrical system, hereafter referred to as MEE or MES, employing a degree of autonomy DOA,
IEC 60601-4-1:2017en, Medical electrical equipment
IEC 60601-4-1:2017en в, IEC 60601-4-1:2017en Medical electrical equipment ? Part 4–1: Guidance and interpretation ? Medical electrical equipment and medical electrical systems employing a degree of autonomy, Buy, Follow, Table of contents, CONTENTS, FOREWORD, INTRODUCTION, 1 Scope, 2 Normative references , 3 Terms and definitions, 4 Degree of autonomy doa 4,1 Introduction to …
EVS-EN 60601-1-4:2000
IEC 60601-1-4:1996; EN 60601-1-4:1996 ICS Groups, 11,040,01 Medical equipment in general 35,240,80 IT applications in health care technology Directives or regulations, 93/42/EEC Medical devices MDD Although the standard’s status is withdrawn, it still has
Edition 4,0 2014-02 INTERNATIONAL STANDARD NORME
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IEC 60601–1-2 Edition 4,0 2014-02 INTERNATIONAL STANDARD NORME INTERNATIONALE Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests Appareils électromédicaux – Partie 1-2: Exigences générales pour la sécurité de base et les performances essentielles
What You Need to Know: IEC 60601-1-2 4th Edition
Who does IEC 60601–1-2 apply to? Why do medical device manufacturers need to pay attention? Lorenzo Cividino: In general, this standard applies to medical devices sold and/or used in many nations throughout the world, Equipment manufacturers are required to comply with this standard in order to be approved to sell the equipment as a medical device, The IEC60601-1-2 is a collateral …
IEC 60601-1-11:2010fr, Appareils électromédicaux
1,3,1 cei 60601–1 Pour les appareils em et les systèmes em, la présente norme collatérale complète la CEI 60601–1, Lorsqu?il est fait référence à la CEI 60601–1 ou à la présente norme collatérale, soit individuellement soit en combinaison, les conventions suivantes sont utilisées:
IEC 60601-1 for Medical Electrical Equipment
IEC 60601–1 Edition 3,2 will probably become a widely accepted standard in the U,S,, Canada, the EU, Japan, Brazil, Russia and Australia, Some major import countries and regions e,g, EU and Australia for such equipment are required to take into account the state-of-the-art SOTA requirements why newer IEC/ISO standards cannot be ignored after their typically given transition period of 3-4
MEDICAL ELECTRICAL EQUIPMENT — PART 1: GENERAL
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EN 60601–1:2006 – 4 – Annex ZA normative Normative references to international publications with their corresponding European publications The following referenced documents are indispensable for the application of this document, For dated references, only the edition cited applies, For undated references, the latest edition of the referenced document including any amendments applies, NOTE
Official Journal L 90I/2020
EN 60601-1-4:1996/A1:1999 IEC 60601-1-4:1996/A1:1999 Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC, 201, EN 60601–1-6:2010, Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability IEC 60601–1-6:2010 Notice: This European standard …
EUR-Lex
EN 60601-1-4:1996/A1:1999 IEC 60601-1-4:1996/A1:1999 Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC, 201, EN 60601–1-6:2010, Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability IEC 60601–1-6:2010 Notice: This European standard …
INTERNATIONAL IEC STANDARD CEI NORME 60601-1-9 …
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60601–1-9 First edition Première édition 2007-07 Medical electrical equipment – Part 1-9: General requirements for basic safety and essential performance – Collateral Standard: Requirements for environmentally conscious design Appareils électromédicaux – Partie 1-9: Exigences générales pour la sécurité de base et les performances essentielles – Norme collatérale: Exigences
IEC 60601-2-52:2009en, Medical electrical equipment
e,g, 201,1 in this standard addresses the content of Clause 1 of the general standard or applicable collateral standard with the prefix ?20x? where x is the final digits of the collateral standard document number e,g, 202,4 in this particular standard addresses the content of Clause 4 of the IEC 60601–1-2 collateral standard, 203,4 in this
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