Norma Técnica
Código
IEC 62353 Ed. 1.0 b  
Código Secundário : K
Data de Publicação : 15/05/2007
Título : Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment
Título Idioma Sec. : Appareils électromédicaux - Essai récurrent et essai après réparation d'un appareil électromédical
Comitê : 62A Common aspects of electrical equipment used in medical practice
Páginas : 103
Status : Em Vigor  
Idioma : Inglês
Organismo : IEC - International Electrotechnical Commission
Preço (R$) : 1620,00
Objetivo : Applies to testing of medical electrical equipment and medical electrical systems, hereafter referred to as me equipment and me systems, or parts of such equipment or systems, which comply with IEC 60601-1, before putting into service, during maintenance, inspection, servicing and after repair or on occasion of recurrent tests to assess the safety of such me equipment or me systems or parts thereof. For equipment not built to IEC 60601-1 these requirements may be used taking into account the safety standards for the design and information in the instructions for use of that equipment. This standard contains tables with allowable values relating to different editions of IEC 60601-1. For the purpose of this standard, the application of measuring methods is independent of the edition according to which the me equipment or me system is designed. This standard contains: - "general requirements", which contain clauses of general concern, and - "particular requirements", further clauses handling special types of me equipment or me systems and applying in connection with the "General requirements". This standard is also applicable to tests after repair. The testing shall be defined according to the extent of work performed and applicable guidance from the manufacturer.
Normas Necessárias para a aplicação da IEC 62353 Ed. 1.0 b
ICS/CIN
11.040 - Equipamento médico
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