European isolation gown requirements
In Europe, medical isolation gowns are classified as Class I medical devices.
The compliance requirements are different depending on whether the product is in a sterile state when it is delivered.
If the product is non-sterile, its compliance path shall be completed following the path of self-declaration of conformity + registration by the European Authorized Representative; if the product is sterile, it needs to be registered by the European Authorized Representative after the conformity assessment by the EU-recognized notified body.
Isolation gowns can be tested with reference to the requirements of EN13795. At the same time, the cytotoxicity, skin irritation and sensitization requirements in the product biocompatibility requirements shall be considered.
U.S. isolation gown standards
From the perspective of global standards, the U.S. isolation gown standards are regarded to be more comprehensive. The PB70 standard divides medical isolation gowns into 4 levels according to the protection level, as shown in Figure 1:
Figure 1 U.S. isolation gown levels
The FDA’s requirements are very clear. For Level 3 and Level 4 isolation gowns, 510K shall be applied for, and the code is FYC; for Level 1 and Level 2 isolation gowns, 510K can be exempted, and the code is OEA.