SN/T 5473.1-2022 in English
VALIDTechnical requirements for the inspection of export medical devices - Part 1: Breathing machine
- Issued on:2022-03-14
- Implemented on:2022-10-01
- File Format:PDF
- Delivery:Via email within 1~3 business days
$243.00
Introduction
Interpretation of the core content of the standard
This standard was officially implemented on October 1, 2022. It was formulated by the General Administration of Customs and is applicable to the export inspection of various types of ventilators, including 7 major categories of products such as therapeutic ventilators and home respiratory support equipment.
Key technical requirements
| Items | Inspection requirements | Reference standards |
|---|---|---|
| Electrical safety | Leakage current ≤10μA, grounding resistance ≤0.1Ω | GB 9706.1-2020 |
| Mechanical safety | Protection of moving parts, sharp edge treatment | ISO 10651 series |
| Electromagnetic compatibility | Radiated disturbance ≤30dBμV/m | IEC 60601-1-2 |
Requirements for special types of ventilators
Case: Home respiratory support equipment must additionally meet the requirements of ISO 10651-6 on continuous oxygen supply stability and should maintain basic ventilation function for at least 30 minutes in the event of a power outage.
Comparison with international standards
Compared with the US ASTM standard, this standard is more stringent in terms of IP protection level (required ≥IP22) and alarm system response time (≤15 seconds).
Implementation suggestions
- Establish a supplier audit system for key components
- Add an EMC pre-test link
- Improve risk management documentation (including FMEA analysis)
Technology evolution analysis
The 2022 version of the standard adds special requirements for high-frequency ventilators (ISO 80601-2-87) and respiratory gas monitors (ISO 80601-2-55), reflecting the standardization trend of critical care equipment after the epidemic.
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