YY/T 0752-2016 in English
VALIDElectrical surgical equipment for osseous tissue
- Issued on:2016-01-26
- Implemented on:2017-01-01
- File Format:PDF
- Delivery:Via email within 1~3 business days
$127.00
| Standard No: | YY/T 0752-2016 |
| Document status: | VALID |
| Title in English: | Electrical surgical equipment for osseous tissue |
| Title in Chinese: | 电动骨组织手术设备 |
| Language: | English |
| File Format: | Electronic (PDF) |
| Delivery: | Via email within 1~3 business days |
| Issued on: | 2016-01-26 |
| Implemented on: | 2017-01-01 |
| Superseding: |
YY/T 0752-2009 Electric surgical equipment for osseous tissue
|
| ICS Classification: | 11.040.30-Surgical instruments and materials |
| Chinese Classification: | C35-Orthopedic devices |
| Professional Classification: | YY-Pharmaceutics |
| Related Keywords: | electrical surgical equipment
orthopedic surgical equipment dental equipment medical electrical equipment yy 0505-2012 electromagnetic compatibility requirements gb/t internal power supply equipment |
| Related Topics: | bone
Operation yy/t 0752-2016 yy/t+0752-2016 yy+t+0752-2016 surgical equipment surgical equipment surgical equipment mobile device tissue monitoring equipment bone tissue animal tissue block animal tissue block bone tissue tissue engineered bone |
本标准规定了电动骨组织手术设备的术语和定义、产品分类、技术要求、试验方法。
本标准适用于网电源供电的电动骨组织手术设备。
本标准不适用于内部电源供电的骨组织手术设备，不适用于牙科的同类设备。
本标准代替YY/T 0752-2009电动骨组织手术设备。
Introduction
Standard Revision Background and Technological Evolution
YY/T 0752-2016, as a new standard replacing the 2009 version, reflects the technological progress and changes in clinical needs in the field of orthopedic surgical equipment. This revision mainly focuses on the standardization of the definitions of host and handset, adds clear definitions of working speed and workload, and optimizes multiple performance indicator requirements.
Analysis of core terminology definitions
| Terms | 2009 version definitions | 2016 version revision points |
|---|---|---|
| Host | Described only as a control device | Clearly required to have mechanical kinetic energy/electrical energy supply and real-time monitoring functions |
| Mobile phone | Simple functional description | Detailed split structure requirements, including power handle, handpiece and other components |
| New terms | None | Added quantitative definitions of working speed (3.7) and workload (3.8) |
Comparison of key technical requirements
Changes in speed accuracy requirements
The new standard classifies and refines the speed error requirements:
- Error ±15% when ≤3000r/min
- Error ±10% when 3000-30000r/min
- Error ±8% when ≥30000r/min
Specially added the error control requirement for working load point speed, and deleted the special provisions for saw products in the original standard.
Product classification and performance requirements
For the first time, the standard clearly divides the connection method into three categories:
- Flexible shaft type: must meet the minimum bending radius ≤120mm
- Cable type: Connector tension requirement ≥20N
- Hybrid type: has both characteristics
Key performance indicators of mobile phones:
- Radial runout: maximum requirement ≤0.08mm (≥30000r/min)
- Axial runout: ≤0.5mm
- Surface temperature rise: ≤20℃
Safety and environmental test requirements
The equipment must also meet the following requirements:
| Standard number | Applicable projects |
|---|---|
| GB 9706.1-2007 | General safety requirements for medical electrical equipment |
| YY 0505-2012 | Electromagnetic compatibility requirements |
| GB/T 14710-2009 | Environmental test requirements (Recommended Group II) |
Implementation suggestions and precautions
Key points for corporate compliance
- The speed stability of the mobile phone under the newly added workload needs to be re-verified
- Noise testing needs to distinguish between rotating (≤75dB) and non-rotating (≤90dB)
- After deleting the original Appendix A, the technical requirements for cutting tools need to be established by the company itself
Special note: The standard clearly does not apply to dental equipment and internal power supply equipment. Relevant companies need to distinguish the scope of application of their products.
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