Mindray PM-9000, Руководство по эксплуатации

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Safety
1-8
1.3 CE Marking
The patient monitor bears CE mark indicating its conformity with the provision of
Council Directive 93/42/EEC concerning medical devices, and fulfills the essential
requirement of Annex I of this directive.
The patient monitor is in radio-interference protection class A in accordance with
EN55011.
The product complies with the requirement of standard EN60601-1-2
“Electromagnetic Compatibility – Medical Electrical Equipment”.
1.4 Reference Literature
1. Medical Device Directive 93/42/EEC
2. EN60601-1+A1+A2 or IEC60601-1+A1+A2, Medical Electrical Equipment,
Part 1: General Requirements for Safety
3. EN60601-1-1 or IEC60601-1-1, Medical Electrical Equipment- Part 1-1:
General Requirements for Safety - Collateral Standard: Safety Requirements
for Medical Electrical Systems
4. IEC60601-1-4, Medical Electrical Equipment- Part 1-4: General Requirements
for Safety - Collateral Standard: Programmable Electrical Medical Systems
5. IEC60601-2-49 Medical Electrical Equipment-Part 2-49: Particular
Requirements for the Safety of Multifunction Patient Monitoring Equipment