Complied Standards List, Fcc Statement, Emc Guidance - Greater Goods Balance 0605 User Manual

COMPLIED STANDARDS LIST
Risk management: ISO/EN 14971:2012 Medical devices — Application of risk management
to medical devices
Labeling: ISO/EN 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. IEC 60601-1-11
Medical electrical equipment - Part 1-11: 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
Electromagnetic compatibility: IEC/EN 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
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