# Which international safety and quality standards does the MediShield™ fabric comply with?

> Source: https://breathablefilm.com/news/knowledge-center/which-international-safety-and-quality-standards-does-the-medishield-fabric-comply-with/
> Author: kh_sales02
> Published: 2026-05-05
> Updated: 2026-08-28

## Key takeaways

- MediShield™ complies with AAMI Level 4, the highest surgical gown protection level, meeting the most stringent liquid strike-through requirements.
- It passes ASTM F1671, the gold-standard viral barrier test using the Phi-X174 bacteriophage to confirm zero viral transmission under pressure.
- MediShield™ also holds EN 14126 biological barrier certification, giving it the international compliance needed for operating rooms and high-risk infection wards.

## Frequently asked questions

### Which international safety and quality standards does the MediShield fabric comply with?

MediShield complies with AAMI Level 4, the highest surgical gown protection level, certified for critical zones with high fluid exposure and viral penetration risk, and meets the most stringent liquid strike-through requirements. It also passes ASTM F1671, the gold-standard viral barrier test using the Phi-X174 bacteriophage to confirm zero viral transmission under pressure, and holds EN 14126 biological barrier certification, giving it the international compliance needed for operating rooms and high-risk infection wards.

### Why does MediShield™ need to meet AAMI Level 4 specifically, rather than a lower level?

AAMI Level 4 is the highest surgical gown protection classification, reserved for critical zones with high fluid exposure and viral penetration risk, such as operating rooms during procedures with heavy blood or fluid contact. MediShield™ targets this level so it meets the most stringent liquid strike-through requirements for the highest-risk medical environments.
