[Case Study] The Registration of Medical Isolation Mask

Medical isolation masks, as important medical protective materials for epidemic prevention and control, played an important role during the epidemic. According to Chinese medical device regulations, medical isolation masks are managed as the Class I medical device. The CIRS Group has compiled the technical requirements for the filing and recording of medical isolation masks in accordance with relevant laws and standards and requirements.

1.Overview of medical isolation mask products

- Product name: Medical isolation mask

- Product description: It usually consists of protective cover, foam strip and fixing device made of polymer material. Non-sterile, single-use.

- Intended use: It is used in medical institutions for protection during examination and treatment, blocking body fluids, blood splatter or splashes.

- Contraindications: This product is only used as an operator to prevent splashing objects from contamination during medical activities. It is strictly forbidden to use this product to replace closed protective equipment.

2. Classification information

3.Technical requirements

The technical requirements of medical isolation masks include the following:

①Material: It must be made of polymer materials that meet the requirements. (For example: polypropylene (PP) resin conforming to GB / T 12670-2008 or soft polyvinyl chloride plastic for GB 15593-1995 blood transfusion (liquid) devices)

② Size: The basic size should conform to the marking of the outer packaging, and its tolerance range should be ± 10% of each marked value.

③ Appearance: The medical isolation mask should be clean and free of stains and dirt; it should be complete without damage or separation; the lens should be smooth, free of burrs and scratches; the color of the lens should be transparent and the sight should be clearly visible when worn.

④Structure: The medical isolation mask should be able to completely cover the wearer's face. It should be kept upright in the longitudinal direction without sagging, and there should be no creases when it is bent horizontally.

⑤ Elongation rate of rubber band (for rubber band fixing band): The elastic band should be flexible and the elastic band elongation rate should be less than a certain value.

⑥Installation and fixing requirements: The breaking strength at the connection between the fixing device and the mask should not be less than a certain value; the joint of the medical isolation mask should be firm. The horizontal plane is subjected to a certain gravitational pull, and the vertical direction is subjected to a certain gravitational pull, which lasts for 30s, and should not fall off.

4. Applicable technical standards or specifications

5. Clinical trial requirements

As a Class I medical device, medical isolation masks are exempt from clinical trials and only need to provide a clinical evaluation report.

6.Filing/recording duration

The medical isolation mask is Class I medical device, which adopts the filing system. Submits filing information on-site after applying online. After passing the review, a voucher for medical isolation mask will be issued on the spot.

The medical certificate of the medical isolation mask includes two parts: the Class I medical device record voucher and the Class I medical device record information form.

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