Medical electrical equipment. Part 1-6: General requirements for basic safety and essential performance. Collateral standard: Usability(IEC 60601-1-6:2010)
This International Standard specifies a PROCESS for a MANUFACTURER to analyse, specify, design, VERIFY and VALIDATE USABILITY, as it relates to BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT, hereafter referred to as ME EQUIPMENT. This USABILITY ENGINEERING PROCESS assesses and mitigates RISKS caused by USABILITY problems associated with CORRECT USE and USE ERRORS, i.e., NORMAL USE. It can be used to identify but does not assess or mitigate RISKS associated with ABNORMAL USE. If the USABILITY ENGINEERING PROCESS detailed in this collateral standard has been complied with and the acceptance criteria documented in the USABILITY VALIDATION plan have been met (see 5.9 of IEC 62366:2007), then the RESIDUAL RISKS, as defined in ISO 14971, associated with USABILITY of ME EQUIPMENT are presumed to be acceptable, unless there is OBJECTIVE EVIDENCE to the contrary (see 4.1.2 of IEC 62366:2007). 1.2 Object The object of this collateral standard is to specify general requirements that are in addition to those of the general standard and to serve as the basis for particular standards. 1.3 Related standards 1.3.1 IEC 60601-1 For ME EQUIPMENT, this collateral standard complements IEC 60601-1. When referring to IEC 60601-1 or to this collateral standard, either individually or in combination, the following conventions are used: • "the general standard" designates IEC 60601-1 alone; • "this collateral standard" designates IEC 60601-1-6 alone; • "this standard" designates the combination of the general standard and this collateral standard. 1.3.2 Particular standards A requirement in a particular standard takes priority over the corresponding requirement in this collateral standard.
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