Due to the standards of different countries, non-woven isolation garments are divided into different grades.
According to the standards of EU countries, isolation gowns need to meet EN13795 standards.
EN 13795 is composed of three standards, mainly the standard of "patients, medical staff and instruments, surgical drapes, surgical gowns and clean clothes".
Judgment is based on EN 13795-1:2019 "Requirements and test methods for surgical gowns and surgical drapes Part 1: Surgical gowns and surgical drapes"
Its compliance requirements need to be inspected and tested in accordance with the corresponding standards for the following parts.
|
Test items |
Judgment basis |
skills requirement |
|
Bursting strength (dry state) fabric |
EN ISO 13938-1:1999 |
≥40kPa |
|
Bursting strength (wet) fabric |
EN ISO 13938-1:1999 |
≥40kPa |
|
Breaking strength (dry state) fabric |
EN 29073-3:1992 |
≥20 N |
|
Breaking strength (wet) fabric |
EN 29073-3:1992 |
≥20 N |
|
Hydrostatic pressure fabric |
EN ISO 811:2018 |
≥20cm H₂O |
|
Cleanliness-microbial fabric |
EN ISO 11737-1:2018 |
≤300 CFU/100c㎡ |
|
Anti-dry microbial fabric |
EN ISO 22612:2005 |
≤300CFU |
|
Anti-humidity microbial fabric |
EN ISO 22610:2006 |
≥2.8 |
|
Dry flocculation fabric |
EN ISO 9073-10:2004 |
≤4.0 |
About Wellmien
Founded in 2006, Wellmien has grown to a company specializing in disposable medical supplies and Personal Protection Equipment (PPE), integrating with design, manufacture and sales capacity. Our sales headquarter is in Suzhou, Jiangsu and manufacturing plants cover a total area of 8,000m2 including 1,500m2 of clean room.
Wellmien provides globally medical care and food processing facilities with products including face masks, gowns, coveralls, aprons, bouffant caps, shoe covers, sleeve covers, under pads, disposable gloves, wound-care products, surgical gowns, first-aid products and surgical packs etc. Our products are best sold to worldwide markets and widely applied to different settings such as hospitals, care centers, wholesalers, government agencies or institutes, food industries and households, etc. With excellent OEM services, our annual sales exceed 20 million USD.
Wellmien is ISO13485 certified and implements a strict Quality Management System (QMS). Our main products are approved by US FDA and EU CE certified. With superior products and services, our company has won the trust and support from new and old customers all over the world. If you have any inquiry, please do not hesitate to contact us!