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Production Requirements For Disposable Surgical Gown

Jun. 22, 2019

Disposable surgical gown  

 

Strictly control the sterilization process to strictly control the production environment and packaging process

Raw materials entering the factory for inspection; strict control of sterilization process

The markings are clearly and correctly printed; the markings are marked in accordance with the relevant requirements. SpecificationTips on the instructions

Pre-use training

 

The properties of the bonded or sewn parts should meet the standard requirements.

Disposable surgical gown should be supplied sterile and should be sterilized by a confirmed sterilization process.

 

Chemical performance requirements

If the disposable surgical gown is sterilized with ethylene oxide, the residual ethylene oxide should be no more than 10 mg/kg.

Biological performance requires a single-use surgical gown to be non-irritating and delayed hypersensitivity to the skin.

Structural requirements such as the tie should specify the length of the strap, the fastness of the strap fixation, and so on.

 

The breathability of the disposable surgical gown is very important for the use of the product and the guarantee of the quality of the operation. Considering that the current basis for the uniformity of the product's permeability index is insufficient, the manufacturer should combine the specific application of the product to the gas permeability of the product. Evaluation, and indicate the permeability index for each area.

 

Product inspection requirements Product inspection includes factory inspection and type inspection. The factory inspection shall include at least the residual ethylene oxide (if sterilized with ethylene oxide) and sterility. The type inspection report is one of the documents confirming the validity of the production process. The type inspection carried out at the time of registration shall be carried out by an inspection agency with legal qualifications. For type inspection, if there is no standard

Special regulations, full performance inspection according to the corresponding standard requirements, should be all qualified.

 

The clinical requirements of the product require a single-use surgical gown product design stereotype, mature technology, clinical application for many years, do not change

Unconventional use, no serious adverse event records, through non-clinical evaluation, registration testing and quality

 

System evaluation can ensure the safety and effectiveness of the product, so in principle, clinical trials are not required.

 


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