User guide

MAN 01/EN/01 CRONO S-PID 50 02/13

TECHNICAL STANDARDS

• IEC EN 60601-1:2007-05. Medical electrical equipment, Part 1: general

requirements for basic safety and essential performance.

• IECEN60601-1/EC:2010-05. Medical electrical equipment, Part 1: general

requirements for basic safety and essential performance.

• IECEN60601-1-1:2003-06. Medical electrical equipment, Part 1: general

requirements for basic safety and essential performance – collateral standard:

Safety requirements for electro-medical systems.

• IECEN60601-1-2/A1:2006-10. Medical electrical equipment, Part 1: general

requirements for basic safety and essential performance – collateral standard:

Electro-magnetic compatibility – Requirements and tests.

• IECEN60601-1-2:2010-01. Medical electrical equipment, Part 1: general

requirements for basic safety and essential performance - collateral standard:

Electro-magnetic compatibility – Requirements and tests.

•IECEN60601-1-4:1997-08. Medical electrical equipment, Part 1: general

requirements for basic safety and essential performance – 4. Collateral

standard: Programmable medical electrical systems.

• IECEN60601-1-4/A1:2000-06. Medical electrical equipment, Part 1: general

requirements for basic safety and essential performance – collateral standard:

Programmable medical electrical systems.

• IECEN60601-1-8:2009-11. Medical electrical equipment, Part 1: general

requirements for basic safety and essential performance – collateral standard:

Alarm systems - General requirements, tests and guidance for alarm systems

in medical electrical equipment and medical electrical systems.

• IECEN60601-2-24:2012-10. Medical electrical equipment, Part 2: particular

requirements for the safety of infusion pumps and controllers.

• IECEN60529:1997-06. Ingress protection ratings provided by enclosures

(IP Code).

APPENDIX 7