YY/T 0486-2024 in English
VALIDRequirements for marking and accompanying information on endotracheal tubes for laser surgery
- Issued on:2024-02-07
- Implemented on:2025-03-01
- File Format:PDF
- Delivery:Via email within 1~3 business days
$232.00
| Standard No: | YY/T 0486-2024 |
| Document status: | VALID |
| Title in English: | Requirements for marking and accompanying information on endotracheal tubes for laser surgery |
| Title in Chinese: | 激光手术专用气管导管 标记和随附信息的要求 |
| Language: | English |
| File Format: | Electronic (PDF) |
| Delivery: | Via email within 1~3 business days |
| Issued on: | 2024-02-07 |
| Implemented on: | 2025-03-01 |
| ICS Classification: | 11.040.10-Anaesthetic, respiratory and reanimation equipment |
| Chinese Classification: | C46-Surgery devices |
| Professional Classification: | YY-Pharmaceutics |
| Related Keywords: | laser surgery
laser resistance test requirements laser-resistant endotracheal tubes endotracheal tubes laser surgery introduction background |
Introduction
Background of Standard Revision and Technological Evolution
As the core standard in the field of endotracheal tubes for laser surgery in my country, YY/T 0486-2024 replaces the 2016 version and achieves three major technological breakthroughs:
| Comparison Dimensions | 2016 Version | 2024 Version |
|---|---|---|
| Reference Standards | ISO 11990-1/2 | Uniformly adopt ISO 11990 |
| Symbol Specifications | Undefined | Added ISO 7000 Symbol Selection Requirements |
| Test diagram | Basic requirements | Refine the power/time curve specifications |
Analysis of core technical requirements
4.2 Marking specifications
The new standard requires that laser-resistant endotracheal tubes must be permanently marked with:
- Manufacturer information and product model
- Nominal inner diameter (in millimeters)
- Instructions on fire prevention measures for the cuff (such as pre-filled with saline)
- Clear identification of laser-resistant areas
Typical case: A certain brand of catheter did not have the boundary of the laser-resistant area marked, which caused the non-protected area to melt during laser surgery, resulting in a medical accident.
5.4 Laser resistance test requirements
The test report must include:
- Power range: 0-100W (expandable)
- Duration: 1-10 seconds
- Spot diameter: 0.5mm standard value
- Laser type must be marked (CO₂/Nd:YAG, etc.)
Enterprise implementation suggestions
Label system upgrade
It is recommended to use dual language labels (Chinese and English), including:
| Elements | Packaging label | Shelf packaging label |
|---|---|---|
| Sterilization status | Required | Required |
| Laser type | Recommended | Mandatory |
| Cuff diameter | Mandatory | Optional |
Risk Control Points
Special attention should be paid to:
- Marking materials should pass the anesthetic corrosion test
- Sterilization compatibility verification for reusable catheters
- Clinical warning statements should include a reminder of the impact of body fluids
Loading PDF document...
Error loading PDF. Please make sure the file is valid and try again.
We also recommend
-
YY/T 0339-2024 in English
Airway suction catheter
2024-09-29 -
YY/T 0338-2023 in English
Tracheostomy Tubes and Adapters
2023-06-20 -
YY/T 0636.1-2021 in English
Medical suction equipment-Part 1:Electrically powered suction equipment
2021-03-09
