BS EN 60601-1-9:2008+A2:2020

This standard BS EN 60601-1-9:2008+A2:2020 Medical electrical equipment is classified in these ICS categories:

• 13.020.01 Environment and environmental protection in general
• 13.020.99 Other standards related to environmental protection
• 11.040.01 Medical equipment in general

1.1 * Scope

This International Standard applies to the reduction of adverse environmental impacts of medical electrical equipment, hereafter referred to as me equipment.

Medical electrical systems are excluded from the scope of this collateral standard.

1.2 Object

The object of this collateral standard is to specify general requirements, in addition to those of the general standard, for the reduction of the adverse environmental impact of me equipment, 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 60601‑1‑9 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.

1.3.3 Environmental standards

This standard takes into account the ISO 14000 series of environmental standards with particular emphasis on ISO 14062 [8]¹⁾.