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YY/T 1626-2019

Chinese Standard: 'YY/T 1626-2019'
Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusRelated Standard
YY/T 1626-2019English209 Add to Cart Days<=3 Electrical upper/lower limbs round exercise therapy equipment Valid YY/T 1626-2019
YY/T 1626-2019Chinese15 Add to Cart <=1-day [PDF from Chinese Authority, or Standard Committee, or Publishing House]  

   

BASIC DATA
Standard ID YY/T 1626-2019 (YY/T1626-2019)
Description (Translated English) Electrical upper/lower limbs round exercise therapy equipment
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C42
Classification of International Standard 11.040.60
Word Count Estimation 10,122
Date of Issue 2019-05-31
Date of Implementation 2020-06-01
Drafting Organization Tianjin Medical Device Quality Supervision and Inspection Center, Shandong Zepu Medical Technology Co., Ltd., Beijing Medical Device Technology Evaluation Center, Changzhou Qianyu Rehabilitation Co., Ltd., Anyang Xiangyu Medical Equipment Co., Ltd.
Administrative Organization National Medical Electrical Equipment Standardization Technical Committee Physical Therapy Equipment Subcommittee (SAC/TC 10/SC 4)
Proposing organization State Drug Administration
Issuing agency(ies) State Drug Administration

YY/T 1626-2019
Electrical upper/lower limbs round exercise therapy equipment
ICS 11.040.60
C42
People's Republic of China Pharmaceutical Industry Standard
Electric upper and lower limb circular motion training equipment
Published on.2019-05-31
2020-06-01 implementation
State Drug Administration issued
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that some of the contents of this document may involve patents. Publication of this document
The organization does not assume responsibility for identifying these patents.
This standard was proposed by the State Drug Administration.
This standard is under the jurisdiction of the National Medical Electrical Equipment Standardization Technical Committee Physical Therapy Equipment Subcommittee (SAC/TC10/SC4).
This standard was drafted. Tianjin Medical Device Quality Supervision and Inspection Center, Shandong Zepu Medical Technology Co., Ltd., Beijing Medical Device
Machinery Technology Review Center, Changzhou Qianyu Rehabilitation Co., Ltd., Anyang Xiangyu Medical Equipment Co., Ltd.
The main drafters of this standard. Zhang Wei, Qi Lijing, Liu Zhijian, Chen Ran, Ren Zhijun, Fan Jincheng, Xue Hufang, Li Fei, Zong Xixi.
Electric upper and lower limb circular motion training equipment
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 article.
Pieces. 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.
3.1
Used under medical supervision, the patient's limb ends move in a circular motion along the fixed axis, driving the entire limb of the unilateral or bilateral upper and/or lower limbs.
Comprehensive exercise training (including shoulder, elbow, wrist, hip, knee, ankle and related muscle groups) to enhance joint mobility and muscle strength in patients with dyskinesia
Electric exercise training equipment.
3.2
Passive mode passivemode
The training mode of passive movement of patients, the power comes from the equipment.
YY/T 1626-2019
Electrical upper/lower limbs round exercise therapy equipment
ICS 11.040.60
C42
People's Republic of China Pharmaceutical Industry Standard
Electric upper and lower limb circular motion training equipment
Published on.2019-05-31
2020-06-01 implementation
State Drug Administration issued
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that some of the contents of this document may involve patents. Publication of this document
The organization does not assume responsibility for identifying these patents.
This standard was proposed by the State Drug Administration.
This standard is under the jurisdiction of the National Medical Electrical Equipment Standardization Technical Committee Physical Therapy Equipment Subcommittee (SAC/TC10/SC4).
This standard was drafted. Tianjin Medical Device Quality Supervision and Inspection Center, Shandong Zepu Medical Technology Co., Ltd., Beijing Medical Device
Machinery Technology Review Center, Changzhou Qianyu Rehabilitation Co., Ltd., Anyang Xiangyu Medical Equipment Co., Ltd.
The main drafters of this standard. Zhang Wei, Qi Lijing, Liu Zhijian, Chen Ran, Ren Zhijun, Fan Jincheng, Xue Hufang, Li Fei, Zong Xixi.
Electric upper and lower limb circular motion training equipment
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 article.
Pieces. 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.
3.1
Used under medical supervision, the patient's limb ends move in a circular motion along the fixed axis, driving the entire limb of the unilateral or bilateral upper and/or lower limbs.
Comprehensive exercise training (including shoulder, elbow, wrist, hip, knee, ankle and related muscle groups) to enhance joint mobility and muscle strength in patients with dyskinesia
Electric exercise training equipment.
3.2
Passive mode passivemode
The training mode of passive movement of patients, the power comes from the equipment.
Related standard:   YY/T 1624-2019  YY/T 1685-2020
Related PDF sample:   YY/T 1095-2015  YY 0950-2015
   
 
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