You may be both familiar and unfamiliar with surgical gowns, but do you know what performance index requirements a qualified surgical gown should meet, what the evaluation criteria are, and what the differences in requirements are in different countries and regions?
In general, the relevant tests for surgical gowns include three main aspects: performance requirements, biocompatibility testing, and other requirements.
1.Domestic standards
China's standards on surgical gowns are mainly YY/T 0506 "surgical sheets, gowns and clean clothes for patients, medical personnel and instruments" series, containing a total of 8 parts, which are modified and developed with reference to the EU standard EN 13795 series.
2.EU standard
The applicable standard of EU surgical gowns is EN 13795-1:2019 "Requirements and test methods for surgical gowns and surgical sheets Part 1: Surgical gowns and surgical sheets", which specifies the performance indicators of surgical gowns.
3.American standard
The American Society for Testing and Materials released ASTM F2407-2020 "Standard Specification for Surgical Gowns for Medical Facilities" in 2020, which stipulates the mechanical properties, barrier properties, wadding, moisture permeability and abrasion resistance of surgical gowns used in the medical field.
The ISO 10993 series of standards is the international common standard for the biological evaluation of medical devices, and the domestic counterpart is the GB/T 16886 series of standards.