YY/T 1446-2016 in English
VALIDMedical endoscopes—Endotherapy device—Palmate retractor
- Issued on:2016-01-26
- Implemented on:2017-01-01
- File Format:PDF
- Delivery:Via email within 1~3 business days
$175.00
本标准规定了掌式器械的范围、术语和定义、要求、试验方法。
本标准适用于内窥镜手术所使用的掌式器械。
Introduction
Standard Overview and Technical Background
YY/T 1446-2016 is my country's first dedicated industry standard for endoscopic palm-type instruments, which was issued by the State Food and Drug Administration in 2016. This standard fills the gap in the standardization of endoscopic auxiliary instruments and is mainly applicable to three-finger and five-finger palm-type traction instruments used in minimally invasive surgeries such as gastrointestinal surgery and thoracic surgery.
Analysis of core terminology definitions
| Terminology | Definition points | Clinical significance |
|---|---|---|
| Palm-type instruments | Hard instruments consisting of a handle, a rod, a joint and fingers, used to lift/pull apart tissues | Determines the basic structural design and functional realization of the instrument |
| Maximum width of the insertion part | The maximum external width of the instrument when it enters the human body or the endoscopic channel | Affects the passability of the instrument and the size of the trauma |
| Maximum expansion angle of the head | The maximum angle when the fingers are fully expanded | Determine the scope of tissue exposure and surgical field of view |
Detailed explanation of key technical requirements
4.1 Material safety requirements
The standard proposes three levels of control over materials: chemical composition clarity (brand/code must be indicated), biocompatibility verification (according to GB/T 16886.1), and extractable matter control (heavy metals ≤5μg/mL, pH difference ≤2.0). Special requirements include:
- Coated instruments must provide proof of coating durability
- Martensitic/austenitic stainless steel must pass boiling water corrosion test (YY/T 0149)
4.4 Performance indicators
Typical case: In a joint locking test of a certain brand of five-finger instrument, when a lifting force of 10N is applied, the rod deflection should be ≤10mm (see Figure 2 standard diagram). Clinically, this indicator directly affects surgical stability.
| Performance parameters | Standard requirements | Test methods |
|---|---|---|
| Unfolding uniformity | Angle difference between adjacent fingers ≤5° | Universal measuring tool measurement |
| Adjusting ring torque | ≤manufacturer specified limit | Torque tester |
| Rotation performance | No shake (if applicable) | Actual operation observation |
Key points for standard implementation
Special tips for detection
1. Dimensional verification: Working length deviation needs to be combined with the manufacturer's diagram to locate the measurement point
2. Sterilization verification: After repeated sterilization for 20 times, all performance requirements of 4.4 must still be met
3. Biological evaluation: Materials with a history of clinical application can be exempted from some tests
Manufacturer compliance recommendations
- The instructions must include a description of the compatibility of the instrument and the endoscope
- A schematic diagram of the head in the expanded state (including dimension markings) must be provided
- Non-disposable products must clearly define the limits of disinfection and sterilization parameters
Comparison of technological evolution and standards
Compared with the old version of the guidance document, the main progress of YY/T 1446-2016 is:
• Quantitative indicators: New measurable parameters such as expansion angle uniformity and lifting force deformation
• Safety upgrade: Clarify ethylene oxide residue (≤10μg/g) and dissolution control
• Clinical adaptation: Requires explanation of the matching relationship between the device and the specific endoscope
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