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108
MAN 01/EN/03 CRONO PAR 50 06/13
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 electromedical systems.
IEC EN 60601-1-2/A1:2006-10. Medical electrical equipment, Part 1: general
requirements for basic safety and essential performance – collateral standard:
Electromagnetic 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:
Electromagnetic 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 stan-
dard: Programmable electromedical 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 electromedical 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 electromedical systems.
IEC EN 60601-1-11:2011-07. Medical electrical equipment, Part 1: General
requirements for basic safety and essential performance - Collateral Standard:
Requirements for medical electrical equipment and medical electrical systems
used in the home healthcare environment.
APPENDIX 8
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