Medical grade cotton swab machine global medical certification standards and efficient production solutions
Date: 5/22/2025 3:39:00 PM Click: 57
Why must medical cotton swabs comply with international medical standards?
Medical cotton swabs are one of the most basic consumables consumed by medical institutions on a daily basis, and the global market size is expected to reach US$2.78 billion in 2025 (Grand View Research data). Unlike ordinary cotton swabs, true medical-grade products must meet three core requirements:
1. Material safety: cotton heads must use 100% medical absorbent cotton, and rods must pass cytotoxicity tests
2. Production cleanliness: must be produced in a 100,000-level purification workshop, and some products require EO sterilization
3. Physical properties: cotton head shedding rate <0.1%, rod bending strength ≥15N
Comparison of global mainstream certification standards
| Certification system | Scope of application | Scope of application |
| China YY/T 0330 | Class II medical devices | Total bacterial count ≤20CFU/g |
| US FDA 21CFR | Class I medical devices | Pass hemolysis test |
| EU EN ISO 13485 | CE certification | Sterility assurance level SAL≤10^-6 |
Key technological breakthroughs in the production of medical cotton swabs
Our newly developed FBN-01S fully automatic production line solves the three major pain points in the industry:
1. Humidity control: patented drying technology is used to reduce the moisture content of bamboo/wooden sticks to below 0.3%
2. Clean packaging: integrated ISO Class 8 clean packaging unit
3. Intelligent detection: AI visual system removes cotton heads that do not meet the standards in real time
Why do the world's top 10 medical device suppliers choose integrated equipment?
Save 30% of labor costs (traditional production lines require 8 people, now only 2 people)
The success rate of passing FDA/CE certification has increased to 98%
The equipment investment can be recovered in as fast as 6 months (calculated based on a daily output of 500,000 swabs)
