IEC 60601-1-1 Medical electrical equipment-Part 1-1: General requirements for safety- Collateral standard: Safetyrequirements for medical electrical systems

This standard applies to the safety of MEDICAL ELECTRICAL SYSTEMS, as defined in 2.201. It describes the safety requirements necessary to provide protection for the PATIENT, the OPERATOR and surroundings.

Terminology and definitions

In this Collateral Standard, terms printed in small capitals are used in accordance with their definitions in IEC 60601-1.

Where the terms “voltage” and “current” are used, they mean the r.m.s. values of an alternating, direct or composite voltage or current.
For the purpose of this standard the following additional definitions apply:

MEDICAL ELECTRICAL SYSTEM (hereinafter referred to as SYSTEM) combination of items of equipment, at least one of which must be MEDICAL ELECTRICAL EQUIPMENT and inter-connected by FUNCTIONAL CONNECTION or use of a MULTIPLE PORTABLE SOCKET-OUTLET NOTE Equipment, when mentioned in connection with a SYSTEM, should be taken to include EQUIPMENT. (See also examples given in annexes BBB and FFF.)

PATIENT ENVIRONMENT

any volume in which intentional or unintentional contact can occur between PATIENT and parts of the SYSTEM or between PATIENT and other persons touching parts of the SYSTEM (see figure 201)

SEPARATION DEVICE

a component or arrangement of components with input parts and output parts that, for safety reasons, prevent a transfer of unwanted voltage or current between parts of a SYSTEM

MULTIPLE PORTABLE SOCKET-OUTLET

a combination of two or more socket-outlets intended to be connected to, or integral with, flexible cables or cords, and which can easily be moved from one place to another while connected to the supply

NOTE A MULTIPLE PORTABLE SOCKET-OUTLET may be a separate item or an integral part of medical or non-medical equipment

FUNCTIONAL CONNECTION

connection, electrical or otherwise, including those intended to transfer signals and/or power and/or substances

LISUN following instruments fully meet IEC 60601-1-1 Medical electrical equipment-Part 1-1: General requirements for safety- Collateral standard: Safetyrequirements for medical electrical systems

LS9955 Automatic Safety Test System