BS EN 60601-1-2:2015+A1:2021

This standard BS EN 60601-1-2:2015+A1:2021 Medical electrical equipment is classified in these ICS categories:

• 33.100.10 Emission
• 33.100.20 Immunity
• 11.040.01 Medical equipment in general

This International Standard applies to the basic safety and essential performance of medical electrical equipment and medical electrical systems, hereafter referred to as me equipment and me systems.

This collateral standard applies to the basic safety and essential performance of me equipment and me systems in the presence of electromagnetic disturbances and to electromagnetic disturbances emitted by me equipment and me systems.

Basic safety with regard to electromagnetic disturbances is applicable to all me equipment and me systems.

1.2 Object

The object of this collateral standard is to specify general requirements and tests for basic safety and essential performance with regard to electromagnetic disturbances and for electromagnetic emissions of me equipment and me systems. They are in addition to the requirements of the general standard and serve as the basis for particular standards.

1.3 Related standards

1.3.1 IEC 60601‑1

For me equipment and me systems, 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 60601‑1‑2 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.