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YY/T 1410-2016: Balance evaluation and exercise systems
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| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 1410-2016 | English | 159 |
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Balance evaluation and exercise systems
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YY/T 1410-2016
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Basic data | Standard ID | YY/T 1410-2016 (YY/T1410-2016) | | Description (Translated English) | Balance evaluation and exercise systems | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C42 | | Classification of International Standard | 11.040.60 | | Word Count Estimation | 8,893 | | Date of Issue | 2016-03-23 | | Date of Implementation | 2017-01-01 | | Regulation (derived from) | Notice of the General Administration of Food and Drug Administration (No. 74 of 2016) | | Issuing agency(ies) | State Food and Drug Administration | YY/T 1410-2016: Balance evaluation and exercise systems---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Balance evaluation and exercise systems
ICS 11.040.60
C42
People's Republic of China Pharmaceutical Industry Standard
Balance test training system
2016-03-23 release
2017-01-01 Implementation
State Food and Drug Administration issued
Directory
Preface III
1 Scope 1
2 normative reference document 1
3 Terms and definitions 1
Category 1
5 composition 2
6 requirements 2
7 Test method 4
Foreword
This standard is 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. The issuer of this document does not assume responsibility for the identification of these patents.
This standard is proposed by the State Food and Drug Administration.
This standard by the National Medical Electrical Apparatus Standardization Technical Committee of Physiotherapy Equipment Subcommittee (SAC/TC10/SC4) centralized.
The drafting unit. the State Food and Drug Administration Tianjin Medical Device Quality Supervision and Inspection Center, Changzhou City, Qian Jing rehabilitation equipment
Limited company.
The main drafters of this standard. Sun Huili, Yuan Xiaobing, Ji Caiyan, Fang Jun, Duan Qiaofeng, Fan Jincheng.
Balance test training system
1 Scope
This standard specifies the terms and definitions, classification, composition, requirements and test methods of the balance test training system.
This standard applies to the balanced test training system (hereinafter referred to as "balancing system") specified in 3.1. The balancing system is expected to be used for disease or
Injury - induced rehabilitation of patients with balanced dysfunction under condition of medical care.
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 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 Biological evaluation of medical devices - Part 1. Evaluation and testing in risk management (GB/T 16886.1-
2011, ISO 10993-1..2009, 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
GB 9706.1-2007 and the following terms and definitions apply to this document.
3.1
Balance test training system balanceevaluation
The use of the patient's center of gravity track measurement and evaluation results, to guide the image so that the patient consciously control the focus to achieve balanced function training
Purpose of medical rehabilitation equipment.
3.2
Support bench (chairs) supportingplatforms (chairs)
A support device for mounting the load plate.
3.3
Force plate
Placed on a support (chair), in contact with the patient and used to collect the pressure signal.
4 classification
Balanced system in accordance with the training can be divided into standing, sitting.
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