AS IEC 60601.1.6:2017 pdf free

AS IEC 60601.1.6:2017 pdf free.Medical electrical equipment
The first edition of this collateral standard was published in 2004, and introduced a USABILITY ENGINEERING PROCESS tailored to ME EQUIPMENT. The second edition was published in 2006 and was intended to align the collateral standard with the third edition of IEC 60601-1一principally the inclusion in IEC 60601-1:2005 of the requirement to conduct a RISK MANAGEMENT PROCESS following ISO 14971. The USABILITY ENGINEERING PROCESS described in the second edition of IEC 60601-1-6 was little altered from that in the first edition.
Shortly after the publication of the 2004 edition of IEC 60601-1-6， IEC Subcommittee 62A formed a joint project with ISO Technical Committee 210 to develop a general USABILITY ENGINEERING PROCESS standard applicable to all MEDICAL DEVICES as defined in the ISO quality system standard, ISO 13485:2003. This project was similar in scope to the effort that took the RISK MANAGEMENT PROCESS described in IEC 60601-1-4 and generalized it to produce ISO 14971. The result of the joint IEC/SC 62A- ISO/TC 210 USABILITY standard project was IEC 62366:2007.
The scope of IEC 60601-1 and of this collateral standard is confined to performing a TYPE TEST of ME EQUIPMENT; it does not extend to life-cycle monitoring. For this reason, the monitoring of production and post-production information and the planning  hereof, as required by the ISO 14971 framework, is excluded from the USABILITY ENGINEERING PROCESS described in this standard. The requirement in IEC 62366 for periodic maintenance of the USABILITY ENGINEERING PROCESS is also excluded.
As with the RISK MANAGEMENT PROCESS before it, the existence of a generalized standard for USABILITY ENGINEERING eliminates the need for much, but not all, of the content in the second edition of IEC 60601-1-6. For example, IEC 62366 defines the USER as the “person using, i.e.operating or handling, the MEDICAL DEVICE”. This definition includes those who clean, maintain or install the MEDICAL DEVICE. In IEC 60601-1:2005+A1:2012，persons performing those functions are described as SERVICE PERSONNEL. This subclause bridges between the general PROCESS requirement in IEC 62366 and the specific application to ME EQUIPMENT.AS IEC 60601.1.6 pdf free download.