YY 0649-2016Electrical potential therapy equipment (English PDF)

1 Scope

This standard specifies the terms and definitions of potential therapy equipment, requirements, test methods, inspection rules and signs, labels, instructions,

Packaging, transportation and storage.

This standard applies to the potential treatment equipment specified in 3.1 (hereinafter referred to as equipment). Combination therapy with potential therapy function, this standard

The same applies.

This standard does not apply to the following equipment.

--- electrostatic paste;

--- wearable equipment.

2 normative reference documents

The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this article

Pieces. For undated references, the latest edition (including all modifications) applies to this document.

GB/T 191-2008 Packaging and storage icon (ISO 780..1997, MOD)

GB 9706.1-2007 Medical electrical equipment - Part 1. General requirements for safety (IEC 60601-1. 1988, IDT)

GB 9706.15-2008 Medical electrical equipment - Part 1-1. General requirements for safety - Side standard. Medical electrical system safety (IEC 60601-1-1..2000, IDT)

Environmental requirements and test methods for medical appliances GB/T 14710-2009

GB/T 16886.1-2011 Biological evaluation of medical devices - Part 1. Evaluation and testing in risk management (ISO 10993-1..2009, IDT)

Medical devices - Symbols for labeling, marking and providing information on medical devices - Part 1. Generic requirements for medical devices YY/T 0466.1-2009 (ISO 15223-1..2007, IDT)

YY 0505-2012 Medical electrical equipment - Part 1-2. General requirements for safety - Parallel standards. Electromagnetic compatibility requirements and tests (IEC 60601-1-2..2004, IDT)

3 terms and definitions

The following terms and definitions apply to this document.