Electrical potential therapy equipment
1 Scope
This standard specifies the terms and definitions, requirements, test methods, inspection rules, marking, labeling and instructions for use, and packaging, transportation and storage of electrical potential therapy equipment.
This standard is applicable to the electrical potential therapy equipment specified in 3.1 (hereinafter referred to as the equipment). It is also applicable to combined equipment with potential therapy function.
This standard is not applicable to the following equipment:
——static sticker;
——wearable equipment.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
GB/T 191-2008 Packaging - Pictorial marking for handling of goods (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: General requirements for safety - 1. Collateral standard: Safety requirements for medical electrical systems (IEC 60601-1-1:2000, IDT)
GB/T 14710-2009 Environmental requirement and test methods for medical electrical equipment
GB/T 16886.1-2011 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009, IDT)
YY/T 0466.1-2009 Medical devices- Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2007, IDT)
YY 0505-2012 Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standards: Electromagnetic compatibility - Requirements and tests (IEC 60601-1-2:2004, IDT)
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
electrical potential therapy equipment
equipment for therapy by electric field generated by voltage with r.m.s value of not more than 30kV and frequency of not more than 100kHz, including equipment that use AC and DC electric fields
3.2
applied part
component that comes into contact or may come into contact with the patient during therapy, including local probe, pad, blanket for systemic therapy, mattress, chair, pedal, etc., and output cables that may come into contact with patients near the aforementioned parts
3.3
pad
flexible applied component which i
Foreword I
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
5 Test methods
6 Inspection rules
7 Marking, labeling and instructions for use
8 Packaging, transportation and storage
Annex A (Informative) General guidance
Annex B (Normative) Durability test devices
