Philips iE33 - Safety Requirements

4535 611 98931 iE33 Service Manual Page 40
CSIP Level 1 General Information: Safety Requirements
Safety
Requirements
• Electromechanical safety standards met:
- C22.2 No. 601.1, Canadian Standards Association, Standard for Medical Electrical Equip-
ment
- JIS T 0601-1, Japanese Standard for Medical Electrical Equipment
- EN 60601-1, European Norm, Safety of Medical Electrical Equipment
- EN 60601-1-2, European Norm, Collateral Standard, Electromagnetic Compatibility
- EN 60601-2-37, European Norm, Particular Requirements for the Safety of the Ultra-
sonic Medical Diagnostic and Monitoring Equipment
- UL60601-1, Underwriters Laboratories Standard for Medical Electrical Equipment
• Agency approvals:
- Canadian Standards Association (CSA)
- CE Mark in accordance with the European Community Medical Device Directive issued
by British Standards Institute (BSI)
- Japanese Ministry of Health, Labor, and Welfare