WS 506-2016 in English
VALIDRegulation for disinfection and sterilization technique of dental instruments
- Issued on:2016-12-27
- Implemented on:2017-06-01
- File Format:PDF
- Delivery:Via email within 1~3 business days
$379.00
本标准规定了口腔器械消毒灭菌的管理要求、基本原则、操作流程、灭菌监测、灭菌物品放行和器械储存要求。
本标准适用于各级各类开展口腔疾病预防、诊断、治疗服务的医疗机构。已实现消毒供应中心集中供应的,其口腔器械的处置方法可参照本标准执行。
Introduction
Analysis of the core framework of the standard
| Hazard level | Instrument type | Handling requirements | Shelf life |
|---|---|---|---|
| High risk | Dental handpieces, root canal instruments | Must be sterilized | Exposed sterilization for 4h/packaged for 7-180d |
| Moderate risk | Mouth mirror, probe | Sterilization or high-level disinfection | ≤7 days |
| Low risk | Model tray | Low-medium level disinfection | ≤7 days |
Key technical points
1. Special processing flow for dental handpieces
Dental handpiecesAs Class A cavity-loading instruments, the following must be performed:
- Immediately after treatment, perform internal pipeline flushing for 30 seconds
- Special oiling maintenance (pressure range 200-250kPa)
- Only Class B sterilization cycle processing
- Ultrasonic cleaning is prohibited
2. Key parameters of small sterilizers
| Temperature (℃) | Minimum time (min) | Applicable load |
|---|---|---|
| 121 | 15 | General instruments |
| 134 | 3 | Dental handpiece |
Solutions to implementation difficulties
Handling common clinical problems
Problem 1: Grease residue inside the implant handpiece
Solution: Use a pressure water gun (200-250kPa) with a special cleaning agent to rinse the bearing area
Problem 2: Loss of small instruments such as burs
Solution: Use a special instrument box with a lid and equip it with a magnetic basket during ultrasonic cleaning
Background of standard evolution
This standard introduces the concept of cavity load classification (Class A/B) into the oral field for the first time, targeting complex instruments such as dental handpieces:
- Before 2016: Refer to ordinary medical devices
- 2016 version: Clarify the L/D ratio requirement (1≤L/D≤750)
- Add a new mechanical cleaning temperature limit (≤45℃)
Quality monitoring system
Three-level monitoring mechanism
- Physical monitoring:Print temperature-pressure curve for each cycle
- Chemical monitoring:Place indicator card in each package
- Biological monitoring:Test for Bacillus stearothermophilus at least once a month
Record keeping requirements: ≥3 years

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