Disposable Medical Face Mask

Stability Study Report

1 Introduction to product performance:
The Disposable Medical Face Masks are flat pleated type mask, utilizing Tie-On
or Ear Loops way for wearing, and they all have Nose Piece design for fitting the
face mask around the nose.The Disposable Medical Face Masks are sold
non-sterile and are intended to be single use, disposable device.This product is
the inner packing individually wrapped with PE film bag, and some by ethylene
oxide sterilization.Stored in the relative humidity is not more than 80%, no
corrosive gas and well-ventilated room.Valid for three years (36 months).

2 selected batches
The essence of the stability test is the commitment to stability experiment, three
batches for continuous production batch of products.
Stability test of three groups of batch number: 20170306, 20170307, 20170308
3 batches of production information
The Disposable Medical Face Masks consist of face piece, elastic bands and nose
piece. The photofraphy is presented as below for reference .
Raw materials and packaging materials

NO. Parts name Material Specification Material

Polyester 85% Latex-free white round elastic

1 Elastic bands
Spandex 15% string
2
38g/m white SMS non-woven
100%
2 Tie bands fabric with 2cm
Polypropylene (PP)
width
200*95mm, 20g/m2 white
Face masks Inner 100%
3 double spunbond non-woven
layer Polypropylene (PP)
fabric

Face masks outer 100% 175*95mm, 25g/m2 blue

4
layer Polypropylene (PP) double spunbond non-woven
fabric
Face masks middle 100% 175*95mm, 25g/m2
5
layer Polypropylene (PP) melt-blown non-woven fabric
 PP strip with iron or malleable iron or aluminum
6 Nose piece
aluminum inside wire

7 Inner box Cardboard 450g/m2 grey cardboard

600-700g/m2 white or brown

8 Outer box Double corrugated
double corrugated
4 project
According to ISO14683:2017 standard samples for physical properties, chemical
properties, features can be conducted.
5 Inspection conditions
Equipment
Investigation type Inspection conditions Equipment
model
Stability Constant
Temperature 60 ℃±2 ℃
Accelerated test test temperature
Relative humidity of 75%±5%
chamber and humidity
Stability Constant
Test for a long temperature of 25 ℃±2 ℃
test temperature
time Relative humidity of 60%±10%
chamber and humidity
6 Review project
Inspection time (month)
0 3 6 9 12 18 24 36
Review project
Physical
√ √ √ √ √ √ √ √
properties
test Chemical
√ √ √ √ √ √
items properties
Biological
√ √ √ √
properties
7 Results:
7.1 accelerated test
Review project
Inspection
Lot No. Physical Chemical Biological Results
date
properties properties properties
Meet the Meet the Meet the
20170306 （0month） Pass
requirements requirements requirements
 Meet the Meet the Meet the
（14day） Pass
requirements requirements requirements
Meet the Meet the Meet the
（28day） Pass
requirements requirements requirements
Meet the Meet the Meet the
（56day） Pass
requirements requirements requirements
Meet the Meet the Meet the
（108day） Pass
requirements requirements requirements
20170307 Meet the Meet the Meet the
（0month） Pass
requirements requirements requirements
Meet the Meet the Meet the
（14day） Pass
requirements requirements requirements
Meet the Meet the Meet the
（28day） Pass
requirements requirements requirements
Meet the Meet the Meet the
（56day） Pass
requirements requirements requirements
Meet the Meet the Meet the
（108day） Pass
requirements requirements requirements
20170308 Meet the Meet the Meet the
（0month） Pass
requirements requirements requirements
Meet the Meet the Meet the
（14day） Pass
requirements requirements requirements
Meet the Meet the Meet the
（28day） Pass
requirements requirements requirements
Meet the Meet the Meet the
（56day） Pass
requirements requirements requirements
Meet the Meet the Meet the
（108day） Pass
requirements requirements requirements
7.2Test for a long time
Review project
Inspecti Result
Lot No. Physical Chemical Biological
on date s
properties properties properties
Meet the Meet the Meet the
20170306 0month Pass
requirements requirements requirements
 Meet the Meet the Meet the
3 months Pass
requirements requirements requirements
Meet the Meet the Meet the
6 months Pass
requirements requirements requirements
Meet the Meet the Meet the
9months Pass
requirements requirements requirements
Meet the Meet the Meet the
12months Pass
requirements requirements requirements
Meet the Meet the Meet the
18 months Pass
requirements requirements requirements
Meet the Meet the Meet the
24 months Pass
requirements requirements requirements
Meet the Meet the Meet the
36months Pass
requirements requirements requirements
Meet the Meet the Meet the
0month Pass
requirements requirements requirements
Meet the Meet the Meet the
3 months Pass
requirements requirements requirements
Meet the Meet the Meet the
6 months Pass
requirements requirements requirements
Meet the Meet the Meet the
9months Pass
requirements requirements requirements
20170307
Meet the Meet the Meet the
12months Pass
requirements requirements requirements
Meet the Meet the Meet the
18 months Pass
requirements requirements requirements
Meet the Meet the Meet the
24 months Pass
requirements requirements requirements
Meet the Meet the Meet the
36months Pass
requirements requirements requirements
Meet the Meet the Meet the
0month Pass
requirements requirements requirements
20170308
Meet the Meet the Meet the
3 months Pass
requirements requirements requirements
 Meet the Meet the Meet the
6 months Pass
requirements requirements requirements
Meet the Meet the Meet the
9months Pass
requirements requirements requirements
Meet the Meet the Meet the
12months Pass
requirements requirements requirements
Meet the Meet the Meet the
18 months Pass
requirements requirements requirements
Meet the Meet the Meet the
24 months Pass
requirements requirements requirements
Meet the Meet the Meet the
36months Pass
requirements requirements requirements
8 deviation appeared in the process of investigation and handling
Not seen in deviation investigation process.
9 Investigation result analysis
9.1 data data (see three batch of product stability inspection record and accelerated
aging)
9.2 in the study of the stability of the three years, during the investigation period
respectively 0 months, 3 months, 6 months, 9 months, 12 months, 18 months and 24
months and 36 months sampling inspection, inspection of product physical
properties, chemical properties, biological properties all conform to the requirements
of the standard;Accelerated aging test, long-term investigation test compared with
the original test results (0) did not change significantly, very stable, the inspection
period this batch of product quality is stable.
10 stability test conclusion:
My company will be the product is valid for three years.

JiangXi JinSheng Medical Devices Group Co.,Ltd.

March 20, 2020