WS/T 602-2018 in English
VALIDSafety management for high frequency surgical unit
- Issued on:2018-08-17
- Implemented on:2019-08-01
- File Format:PDF
- Delivery:Via email within 1~3 business days
$359.00
本标准规定了医疗机构配置使用的高频电刀在临床使用前及使用期间安全管理要求、安全技术要求和安全检测周期。
本标准适用于医疗机构临床使用的高频电刀的安全管理。
Introduction
Analysis of the core content of the standard
Management structure requirements
The standard clearly requires the establishment of a three-level management system: decision-making level (head of medical institution), execution level (medical business/medical device management department), and operation level (using department). Special emphasis is placed on the need for medical device management departments to be equipped with professional medical engineering and technical personnel, who are responsible for formulating the following key documents:
- Safety operating specifications (including 6 types of electrical parameter testing standards)
- Annual testing plan (cycle ≤ 12 months)
- Emergency plan (including electromagnetic interference disposal process)
Key technical indicators
| Test items | CF type equipment requirements | BF type equipment requirements | Test methods |
|---|---|---|---|
| Protective earth impedance | ≤0.1Ω (fixed) | ≤0.2Ω (mobile) | Figure 1 Oscilloscope method |
| High-frequency leakage current | ≤150mA (unipolar/neutral) | Figure 6-9 Shunt measurement | |
| Output power error | ≤±20% rated value | Figure 10-11 Load method | |
Special application scenario management
When a high-frequency electrosurgical unit is used in patients with implantable cardiac devices, the standard requires:
- Preoperative assessment of electromagnetic interference risk (refer to Chapter 36 of GB 9706.4)
- Bipolar mode priority principle (leakage current reduced by 90%)
- Intraoperative backup defibrillator
Implementation Key Points
Test Process Optimization
It is recommended to adopt a three-stage test method:
| 1. Pre-inspection stage | Appearance inspection (5.1.1) + Accessory integrity (5.3.3.1a) |
| 2. Basic testing | Grounding impedance (5.4.1) + Leakage current (5.4.2-5) |
| 3. Performance verification | High-frequency leakage current (5.4.6) + Power calibration (5.4.7) |
Document management specifications
Key records that must be kept:
- Appendix B: Original test data (stored for 5 years after the equipment is scrapped)
- Operator training files (including electromagnetic compatibility knowledge assessment)
- Adverse event report (serious events must be reported within 48 hours)
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