BS EN 60601-1-6:2010+A2:2021

This standard BS EN 60601-1-6:2010+A2:2021 Medical electrical equipment is classified in these ICS categories:

• 11.040.01 Medical equipment in general

1.1 * Scope

This International Standard specifies a process for a manufacturer to analyse, specify, develop and evaluate the 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, then the usability of me equipment as it relates to basic safety and essential performance is presumed to be acceptable, unless there is objective evidence to the contrary.

NOTE Such objective evidence can subsequently originate from post-production surveillance.

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, including any amendments;

• "this collateral standard" designates IEC 60601‑1‑6 alone, including any amendments;

• "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.