A few days ago, there was a heated debate over whether to adopt Chinese standards, American standards or European standards. Let's elaborate on the national standard of protective clothing in China.
At present, there is no national standard for non-medical protective clothing in China, and the corresponding standard of medical protective clothing is the national standard of the people's Republic of China GB 19082-2009 "technical requirements for medical disposable protective clothing", the standard not only specifies the appearance of protective clothing, but also strictly regulates the liquid barrier function, filtration performance, microbial index, ethylene oxide residue, wearing performance and comfort performance of protective clothing.
Barrier level | Risk of liquid leakage | Reference operation | performance requirement |
AAMI Level 1 | Very little liquid splashing or less pressure on the patient | Ophthalmology, simple otolaryngology surgery | Must pass through the spray impact penetration test, the amount of water seepage<4.5g |
AAMI Level 2 | More fluid ejection and pressure | The simple orthopedic surgery includes tourniquet operation, tonsillectomy and appendectomy | 1. It must pass the spray impact penetration test<1g 2. Hydrostatic pressure test, hydrostatic pressure > 500px.h2o |
AAMI Level 3 | More fluid splashing, more pressure | Mastectomy, arthroscopy, partial general surgery | 1. It must pass the spray impact penetration test<1g 2. Hydrostatic pressure test, hydrostatic pressure > 1250px.h2o |
AAMI Level 4 | High level of protective operation sheet and high protective operating clothes are required | Major thoracic and abdominal surgery, orthopedic surgery without tourniquet, implantation, cardiac surgery, caesarean section | Surgical clothing and shop orders: in addition to the level 3 test requirements, they must pass the Haemophilus virus penetration test |
In the indicators, the liquid barrier function and filtration performance are directly related to the protective effect, which can achieve the purpose of protection by blocking the transmission of virus. The weaving of medical protective clothing is very tight and the pores are very small, which can play an effective protective effect. The classification standard of protective clothing in China is the pharmaceutical industry standard of the people's Republic of China YY / T 1499-2016 "liquid barrier performance and classification of medical protective clothing", which divides the medical protective clothing into four grades. The higher the level, the better the protective performance. In addition, whether the medical protective clothing is up to the standard needs to be inspected by the testing agency.
However, novel coronavirus infection prevention and control system is being issued to the local authorities in January 29th.
Notice on issues related to the production and use of clothing. "Notice" proposed that when the medical protective clothing is insufficient, can use the emergency medical material protective clothing. The emergency medical material protective clothing should conform to the EN14126 standard of the European medical protective clothing (including the liquid barrier level of more than 2), and obtain the EU CE certification, or liquid tight protective clothing (type3, comply with the EN14605 standard), spray tight protective clothing (type4, comply with EN14605 standard), and prevent solid particulate matter protective clothing (type5, meet the ISO13982-1&2 standard). The protective clothing for emergency medical materials is only used for isolation of observation ward (room) and isolation ward (room), and cannot be used for isolation of intensive care unit (ICU) and other places with strict microbial index control. All localities should organize health departments to guide hospitals, disease control units and other units to standardize and rationally use protective clothing for emergency medical materials.