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eLibrary > BS EN 60601-2-66:2015 - TC Tracked Changes. Medical electrical equipment - Particular requirements for the basic safety and essential performance of hearing instruments and hearing instrument systems >

BS EN 60601-2-66:2015 - TC Tracked Changes. Medical electrical equipment - Particular requirements for the basic safety and essential performance of hearing instruments and hearing instrument systems, 2020

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BS EN 60601-2-66:2015 - TC Tracked Changes. Medical electrical equipment - Particular requirements for the basic safety and essential performance of hearing instruments and hearing instrument systems, 2020

30315341_new.pdf [Go to Page]
EN60601-2-66{2015}e.pdf [Go to Page]
European foreword
Endorsement notice
Annex ZA (normative) Normative references to international publications with their corresponding European publications
Annex ZZ (informative) Coverage of Essential Requirements of EU Directives
30315343-VOR.pdf [Go to Page]
English [Go to Page]
CONTENTS
FOREWORD
INTRODUCTION
201.1 Scope, object and related standards
201.2 Normative references
201.3 Terms and definitions
201.4 General requirements
201.5 General requirements for testing me equipment
201.6 Classification of me equipment and me systems
201.7 Me equipment identification, marking and documents
201.8 *Protection against electrical hazards from me equipment
201.9 *Protection against mechanical hazards of me equipment and me systems
201.10 Protection against unwanted and excessive radiation hazards
201.11 *Protection against excessive temperatures and other hazards
201.12 *Accuracy of controls and instruments and protection against hazardous outputs
201.13 *Hazardous situations and fault conditions for me equipment
201.14 *Programmable electrical medical systems (pems)
201.15 *Construction of me equipment
201.16 *Me systems
201.17 *Electromagnetic compatibility of me equipment and me systems
Annexes
Annex E (informative) Examples of the connection of the measuring device (MD) for measurement of the patient leakage current and patient auxiliary current
Annex G (normative) Protection against hazards of ignition of flammable anaesthetic mixtures
Annex H (informative) Pems structure, pems development life-cycle and documentation
Annex I (informative) Me systems aspects
Annex J (informative) Survey of insulation paths
Annex K (informative) Simplified patient leakage current diagrams
Annex L (normative) Insulated winding wires for use without interleaved insulation
Annex AA (informative) Particular guidance and rationale
Annex BB (informative) Abbreviations
Bibliography
Index of defined terms used in this particular standard
Figure 201.101 – Measuring circuit for leakage current
Table 201.102 – Mechanical hazards to be considered
Table AA.101 – Summary of the approach of this standard
Français [Go to Page]
SOMMAIRE
AVANT-PROPOS
201.1 Domaine d’application, objet et normes connexes
201.2 Références normatives
201.3 Terminologie et définitions
201.4 Exigences générales
201.5 Exigences générales relatives aux essais des appareils em
201.6 Classification des appareils em et des systèmes em
201.7 Identification, marquage et documentation des appareils em
201.8 *Protection contre les dangers d’origine électrique provenant des appareils em
201.9 *Protection contre les dangers mécaniques des appareils em et systèmes em
201.10 Protection contre les dangers dus aux rayonnements involontaires ou excessifs
201.11 *Protection contre les températures excessives et les autres dangers
201.12 *Précision des commandes, des instruments et protection contre les caractéristiques de sortie présentant des risques
201.13 *Situations dangereuses et conditions de défaut des appareils em
201.14 *Systèmes électromédicaux programmables (semp)
201.15 *Construction de l'appareil em
201.16 *Systèmes em
201.17 * Compatibilité électromagnétique des appareils em et des systèmes em
Annexes
Annexe E (informative) Exemples de connexion du dispositif de mesure (DM) pour le mesurage du courant de fuite patient et du courant auxiliaire patient
Annexe G (normative) Protection contre les dangers d'inflammation des mélanges anesthésiques inflammables
Annexe H (informative) Structure de semp, cycle de développement semp et documentation
Annexe I (informative) Aspects des systèmes em
Annexe J (informative) Étude des chemins d'isolation
Annexe K (informative) Schémas simplifiés de courant de fuite patient
Annexe L (normative) Fils de bobinage isolés pour utilisation sans isolation intercalée
Annexe AA (informative) Lignes directrices particulières et justifications
Annexe BB (informative) Abréviations
Bibliographie
Index des termes définis utilisés dans la présente Norme particulière
Figure 201.101 – Circuit de mesure pour COURANT DE FUITE (voir 201.8.7.4.7)
Tableau 201.102 – DANGERS MECANIQUES à considérer
Tableau AA.101 – Résumé de l’approche de la présente Norme [Go to Page]

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BS EN 60601-2-66:2015 - TC Tracked Changes. Medical electrical equipment - Particular requirements for the basic safety and essential performance of hearing instruments and hearing instrument systems, 2020

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