Disposable medical /Medical surgical /Medical protective /Protective /FFP face mask, Medical infrared thermometer

Disposable medical /Medical surgical /Medical protective /Protective /FFP face mask, Medical infrared thermometer

The core of the non-woven mask is the three-layer non-woven fabric:

1) Out layer (SBPP Spunbond Polypropylene) 20gsm
2) Filter layer (MBPP Meltbond Polypropylene MBPP) 25gsm, general good household melt-blown cloth can achieve BEF> 95%
3) Inner layer (SBPP Spunbond Polypropylene) 20gsm

Referred to as SMS 3ply non-woven disposal mask meets the corresponding test requirements

       

China medical surgical mask standard YY0469-2011 test items and requirements


1. Appearance

The appearance of the mask should be neat and in good shape, and there should be no damage or stains on the surface.

2. Structure and size

After wearing the mask, it should be able to cover the wearer's nose and mouth to the forehead. Should meet the design size and tolerance of the mark

3. Nose clip

The mask should be equipped with nose clips, which are made of plastic materials. (It does not have to be a metal nose bridge, plastic can also be used)

Nose clip length should not be less than 8.0 cm

4. Mouth and nose band

The breaking strength at the connection point between each mask band and the mask body should not be less than 10 N

5. Synthetic blood penetration

After 2 mL of synthetic blood is sprayed at 16. 0 kPa (120 mmHg—diastolic pressure of the heart) toward the outer side of the mask, the inner side of the mask should not be penetrated.

6. Bacterial filtration efficiency (BEF> 95% super useful mainly depends on physical electrostatic adsorption) The bacterial filtration efficiency of the mask should not be less than 95%.

7. Particle filtration efficiency (PEF> 30% is useful)

The filtering efficiency of the mask for non-oily particles should not be less than 30%.

8. Pressure difference (ΔP <49Pa)

The pressure difference p for gas exchange between the two sides of the mask should not be greater than 49 Pa.

9. Flame retardant performance-The mask material should be made of non- flammable materials, and the mask should not burn for more than 5 s after leaving the flame.

10. Microbial content

Non-sterile masks Microbial content: <100cfu / g

Sterile masks should be sterile.

11. Residual amount of ethylene oxide-For masks sterilized by ethylene oxide, the residual amount of ethylene oxide should not exceed 10 μg / g.

12. Biocompatibility

Cytotoxicity-The cytotoxicity of the mask should not be greater than level 2.

Skin irritation-The primary irritation score of the mask should not be greater than 0.40

Delayed-type hypersensitivity-without sensitizing materials, the delayed-type hypersensitivity of masks should not be greater than level 1

Mask technical standards and sales, Technical standards for reference:

Ordinary mask: GB / T 32610-2016
Disposable medical masks: medical standard YY / T 0969-2013 or enterprise standard (non-mandatory standard)
Medical surgical mask: YY / T 0469-2011
Particulate protective mask: GB2626-2019 (LA certification for special labor protection products safety mark certification)
Medical protective mask: GB19083-2010
Protective mask: plus P100 filter cotton

EU Masks are divided into two types of personal protective masks PPE and medical masks

1. Personal protective masks PPE: According to the PPE Regulation (EU) 2016/425 regulations EN149: 2001 A1: 2001 is a mandatory standard, all PPE protective masks exported to the EU must obtain CE certification under this regulation.

Divided into three levels according to the filtering effect
FFP1:> 80% (salt particles Nacl, oil particles: DOP such as paraffin oil)
FFP2:> 94%
FFP3:> 99%

2. Medical mask: BSEN14683-2019 standard is divided into three levels. Low standard Type, Type, TypeR

Sales of medical masks

1. China sales--Manufacturers need to have three certificates:
enterprise business license
second-class medical device production license
second-class medical device registration certificate

2. Exporting to the EU with a CE certificate :
PPE for civil masks is CE according to EN149: 2001, A2009
Medical masks MDR do CE according to EN14683-2019 or CE 93/42 / EEC Directive to do MDD CE or find European registration to file for CE self-conformity declaration

3.  it is not recommended to use disposable civilian masks as general products exports to the United States

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