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YY/T 0997-2015: Elbow, knee joints passive motion equipment
Status: Valid
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 0997-2015 | English | 149 |
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Elbow, knee joints passive motion equipment
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YY/T 0997-2015
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Basic data | Standard ID | YY/T 0997-2015 (YY/T0997-2015) | | Description (Translated English) | Elbow, knee joints passive motion equipment | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C42 | | Classification of International Standard | 11.040.60 | | Word Count Estimation | 7,731 | | Date of Issue | 2015-03-02 | | Date of Implementation | 2016-01-01 | | Quoted Standard | GB 9706.1-2007; GB/T 14710-2009; GB/T 16886.1-2011 | | Regulation (derived from) | The State Food and Drug Administration Announcement 2015 No. 8 | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This Standard specifies the elbow, knee joint passive motion equipment terminology and definitions, requirements, test methods. 3.1 This Standard applies to equipment regulations. | YY/T 0997-2015: Elbow, knee joints passive motion equipment---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.
Elbow, knee joints passive motion equipment
ICS 11.040.60
C42
People's Republic of China pharmaceutical industry standards
Elbow, knee joint passive motion device
Issued on. 2015-03-02
2016-01-01 implementation
China Food and Drug Administration released
Foreword
This standard was drafted in accordance with GB/T 1.1-2009 given rules.
The standard safety requirements for full implementation of the GB 9706.1-2007 "Medical Electrical Equipment Part 1. General requirements for safety," the
content.
Please note that some of the content of this document may involve patents. Release mechanism of the present document does not assume responsibility for the identification of these patents.
This standard was proposed by the China Food and Drug Administration.
This standard by the National Technical Committee of Standardization for medical electrical physical therapy equipment at the Technical Committee (SAC/TC10/SC4) centralized.
This standard was drafted. Tianjin, the State Food and Drug Administration Medical Device Quality Supervision and Inspection Center.
The main drafters of this standard. Wang Ying, PROCEEDINGS, Li Yanan, Yuan Xiaobing.
Elbow, knee joint passive motion device
1 Scope
This standard specifies the elbow, knee joint passive motion device (hereinafter referred to as the device) terms and definitions, requirements, test methods.
3.1 This standard applies to equipment regulations.
2 Normative references
The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein
Member. For undated references, the latest edition (including any amendments) applies to this document.
GB 9706.1-2007 Medical electrical equipment - Part 1. General requirements for safety
GB/T 14710-2009 medical electrical environmental requirements and test methods
GB/T 16886.1-2011 Biological evaluation of medical devices - Part 1. Evaluation of the risk management process and Test
3 Terms and Definitions
GB 9706.1-2007 defined and the following terms and definitions apply to this document.
3.1
One kind of drive the elbow, knee joint flexion and extension in the direction of motion of the joint co-treatment or rehabilitation of electrical equipment.
4 Requirements
4.1 Working conditions
Unless the manufacturer otherwise specified, shall meet the requirements of GB 9706.1-2007 in Chapter 10.
4.2 Performance Requirements
4.2.1 angle range and tolerance
4.2.1.1 Equipment shall be adjustable angle range, angular range should not exceed the values specified in Table 1.
4.2.1.2 When within an adjustable angular range, the angle is not greater than 50 °, Tolerance. ± 5 °; the angle is greater than 50 °, tolerance. ± 10%.
4.2.2 angular velocity
The angular velocity of the equipment shall be adjusted, the maximum angular velocity shall not exceed the values specified in Table 1, tolerance. ± 20%.
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