AS IEC 60601.1.6:2017 pdf free download – 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 — principally the inclusion in IEC 60601 -1 :2005 of the requirement to conduct a RISK MANAGEMENT PROCESS following ISO 1 4971 . 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 21 0 to develop a general USABILITY ENGINEERING PROCESS standard applicable to all MEDICAL DEVICES as defined in the ISO quality system standard, ISO 1 3485:2003. 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 1 4971 . The result of the joint IEC/SC 62A – ISO/TC 21 0 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 thereof, as required by the ISO 1 4971 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 :201 2, 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 .
Clause 6 of IEC 62366:2007 specifies the general requirements for the material to be included in the ACCOMPANYING DOCUMENT , if such a document is provided. The ACCOMPANYING DOCUMENT is required to include a summary of the application specification (see 5.1 of IEC 62366). This replacement paragraph clarifies that for ME EQUIPMENT the summary is described in the same terms used in subclause 7.9.2.5 of IEC 60601 -1 :2005+A1 :201 2 to specify the ME EQUIPMENT description. In IEC 60601 -1 , the ACCOMPANYING DOCUMENTS consist of the instructions for use and the technical description. IEC 62366, on the other hand, discusses the ACCOMPANYING DOCUMENT without specifically identifying any sub-parts. IEC 60601 -1 anticipates that the instructions for use and the technical description can be provided as separate physical documents. If they are, then the summary of the application specification is required to appear in both documents.