BS EN 60601-1-4:1997

Medical electrical equipment - Part 1-4: General requirements for safety - Collateral standard: Programmable electrical medical systems

General requirements for safety and design of programmable electrical medical systems.

This European Standard specifies requirements for the process by which a programmable electrical medical systems (PEMS) is designed. This Standard also serves as the basis for requirements of Particular Standards, including serving as a guide to safety requirements for the purpose of reducing and managing risk. This Collateral Standard is aimed at:

a) certification bodies;

b) manufacturers;

c) writers of Particular Standards.

This standard covers:

d) requirements specification;

e) architecture;

f) detailed design and implementation including software development;

g) modification;

h) verification and validation;

i) marking and accompanying documents.

Aspects not covered by this standard include:

j) hardware manufacturing;

k) software replication;

l) installation and commissioning;

m) operation and maintenance;

n) decommissioning

The concepts of risk management and a development life-cycle that are the basis of this standard can also be of value in the development of medical electrical equipment.

This European Standard’s requirements are in addition to those of BS 5724-1:1989. It includes the following cross references:

IEC 601-1:1988, IEC 601-1-1:1992, IEC 788:1984, ISO 9000-3:1991, ISO 9001:1994.