My Life My Shop Cor1, Инструкция по эксплуатации

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Risk Management
ISO 14971:2012 Medical devices — Application of risk
management to medical devices.
Labeling
ISO 15223-1:2012 Medical devices. Symbols to be used with
medical device labels, labeling and information to be supplied.
General requirements
User manual
EN 1041: 2008 Medical equipment manufacturers to provide
information
General Requirements
for Safety
IEC 60601-1: 2005+A1:2012 Medical electrical equipment
- Part 1: General requirements for basic safety and essential
performance
Electromagnetic compatibility
IEC 60601-1-2:2007 Medical electrical equipment - Part
1-2: General requirements for basic safety and essential
performance - Collateral standard: Electromagnetic
compatibility - Requirements and tests
Performance and clinical
requirements ANSI/AAMI SP10:2002/A2: 2008 Manual, electronic, or
automated
Software life-cycle processes
IEC 62304:2006+AC: 2008 Medical device software - Software
life cycle processes
Guidance and manufacturer’s declaration - electromagnetic emission
The device is intended for use in the electromagnetic environment specified below. The
customer or the user of the device should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment - guidance
RF Emissions - CISPR 11 Group 1
The device uses RF energy only for its internal function.
Therefore, its RF emissions are very low and are not likely
to cause any interference in nearby electronic equipment.
RF Emissions - CISPR 11 Class B
Harmonic emissions -
IEC 61000-3-2 Not
Applicable
Voltage Fluctuations / Flicker
Emissions IEC 61000-3-3 Not
Applicable