YY/T 1626-2019Electrical upper/lower limbs round exercise therapy equipment (English PDF)

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009.

1 Scope

This standard specifies the terms and definitions, classification, requirements and test methods for electric upper and lower limb circular motion training equipment.

This standard is applicable to the use of medical monitoring. The end of the limb of the patient makes a circular motion along the fixed axis, driving the unilateral or bilateral upper limbs and/or lower Comprehensive exercise training for the entire limb of the limb to enhance the joint mobility and muscle strength of the motorized upper and lower extremity circular motion training Equipment (hereinafter referred to as "device"). This standard does not apply to.

--- Single joint exercise training equipment, including finger, wrist, elbow, shoulder, hip, knee, ankle joint exercise training equipment, and a variety of single joint transport Combined equipment for dynamic training functions;

--- Pushing, pulling, lifting, squatting, stepping and other non-circular motion training equipment, even if there are rotating parts in the moving parts of the equipment;

--- Only provide active training equipment, including active training equipment that provides feedback information such as sound and images;

--- Equipment that is not expected to be used in medical rehabilitation environments and people with movement disorders, such as fitness equipment.

2 Normative references

The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this document. For undated references, the latest edition (including all amendments) applies to this document.

GB 9706.1 Medical electrical equipment - Part 1. General requirements for safety (GB 9706.1-2007, IEC 60601-1:1988 A1.

1991 A2..1995, IDT)

GB/T 14710 Medical electrical requirements and test methods

GB 24436-2009 Rehabilitation training equipment safety general requirements

YY 0505 Medical electrical equipment - Part 1-2. Safety general requirements. Parallel standard. Electromagnetic compatibility requirements and testing (YY 0505-2012, IEC 60601-1-2:2004, IDT)

YY 0607 Medical electrical equipment - Part 2. Particular requirements for safety of nerve and muscle stimulators (YY 0607-2007,

IEC 60601-2-10:1987, IDT)

YY 0868 Electrode and muscle stimulator electrode

3 Terms and definitions

The following terms and definitions apply to this document.