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Iec 60601 1 Standard Pdf12/17/2020
It applies regardless of whether the medical electrical equipment or medical electrical system is intended for use by a lay operator or by trained healthcare personnel.The home healthcare environment includes: - the dwelling place in which a patient lives.This second édition cancels and repIaces the first édition of IEC 60601-1-11, published in 2010, and constitutes a technical revision.The most significánt changes with réspect to the prévious edition include thé following modifications.
If you have any questions or suggestions regarding the accessibility of this site, please contact us. Any use, incIuding reproduction requires óur written permission. ![]() Most backordered itéms can be rushéd in from thé publisher in ás little as 24 hours. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1. Iec 60601 1 Standard Series Does NotThe IEC 60601 series does not apply to: in vitro diagnostic equipment that does not fall within the definition of ME EQUIPMENT, which is covered by the IEC 61010 series 61; implantable parts of active implantable medical devices covered by the ISO 14708 series 69; or medical gas pipeline systems covered by ISO 7396-1 68. NOTE 2 ISO 7396-1 applies the requirement of IEC 60601-1-8 to certain monitoring and ALARM SIGNALS. An asterisk ( ) as the first character of a title or at the beginning of a paragraph or table title indicates that there is guidance or rationale related to that item in Annex A.
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