Medical casters are vital components in hospital beds, medical carts, stretchers, and diagnostic equipment. To ensure safety, hygiene, and performance, different regions enforce different technical standards. In this article, we compare the most widely recognized international standards for medical casters and highlight what global buyers should pay attention to.
1. ISO 22882:2004 – International Standard
This is the main ISO standard for castors and wheels used in institutional and hospital applications. It defines requirements such as:
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Load capacity
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Rolling resistance
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Swivel performance
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Durability tests (e.g., rolling over thresholds)
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Corrosion resistance (salt spray test)
Key Point:
If your hospital equipment is exported globally, meeting ISO 22882 ensures compatibility and safety across many markets.
2. EN 12531 – European Union
The EN 12531 standard is part of the European EN series and covers:
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Static and dynamic load testing
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Brake locking performance
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Resistance to cleaning agents and disinfectants
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Safety and dimensional requirements
Key Point:
For medical equipment manufacturers exporting to Europe, EN 12531 compliance is highly recommended or even mandatory under EU Medical Device Regulation (MDR).
3. ANSI/BIFMA Standards – United States
Although not specifically for casters, BIFMA X5.1 and ANSI standards are often referenced for institutional and furniture casters in the U.S.
Differences to Note:
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Focus more on office/institutional use than hospital hygiene
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Less emphasis on chemical resistance and sterilization
Key Point:
For U.S. market applications like hospital administration carts or office-medical furniture, BIFMA-style caster tests may be sufficient.
4. China YY/T Standards – Domestic Chinese Medical Standards
For domestic Chinese markets and some Southeast Asian countries, YY/T 0148 and related standards apply. These emphasize:
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Product labeling
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Hygiene and sterilization performance
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Compatibility with Chinese hospital regulations
Key Point:
While not internationally recognized, YY/T compliance may help with price-sensitive emerging markets or local government tenders.
5. Testing & Certifications You Should Look For
When sourcing medical casters internationally, ensure suppliers can provide:
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ISO 9001 or ISO 13485 quality system certification
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CE Declaration of Conformity
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Test reports from third-party labs (e.g., TÜV, SGS)
Conclusion
Choosing the right medical caster standard depends on your target market, regulatory environment, and product application.
For global exports, prioritize ISO 22882 and EN 12531. For specialized markets, verify local standards or certification requirements with your distributor.
Need support choosing the right casters for your market?
Contact our team at daniel@dyutrade.com – we’re happy to help with testing, documentation, and custom solutions.
