Registration certificate for Medical Equipment of P.R.C.

Registration certificate No.: JXZZ 20152570708

Registrant name: Beijing Baixiang New Technology Co., Ltd.

Registrant address: Room 7, No. 9, Area M2-5, Beijing Xinggu Economic Development zone,
Pinggu District, Beijing

Production address Room 7, No. 9, Area M2-5, Beijing Xinggu Economic Development zone,
Pinggu District, Beijing

Agent name N/A

Agent address N/A

Product name Hydrogen peroxide low-temperature plasma sterilizer

Specification and type PS-60T, PS-60, PS-90, PS-120, PS-150, PS-200, PS-350

Structure and constitution The product is composed of sterilizer body and sterilizer basket.

Range of application The product is suitable for sterilizing of endoscope medical equipment, non-
heat-resistant medical equipment, metal medical instrument, glass medical
instrument, ceramic medical instrument, medical electronic instrument and
guidewires, and medical glassware.

Attachment Product technical requirements

Other contents

Remarks

Examination and approval department: Beijing Food and Drug Administration

Approval date: Aug. 4, 2015
Date of expiry: Aug. 3, 2020

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 Technical requirements of medical equipment
No. of technical requirements of medical equipment JXZZ 20152570708
Product name: Hydrogen peroxide low-temperature plasma sterilizer
1. Product type/specification and division instructions:
1. Product type and division instructions
1.1 Product type
Product types registered and declared this time include PS-60T, PS-60, PS-90, PS-120, PS-150, PS-200 and PS-
350.
1.2 Division instructions
Placing method: table
Volume: sterilizer volume value (L) is English abbreviation of
“plasma and sterilization”.

1.3 Structure and composition

The product is mainly composed of sterilizer body and sterilizer
basket.
1.4 Type difference: Refer to the content of Table 1

External Maximu
Volum Method to open the Weigh
Type dimension m input Power
e door t (Kg)
(W×H×L) power
PS-
650×750×900 60L Single-door 80 2.62kVA AC220V,50Hz
60T
Single-door/double-
PS-60 750×1720×900 60L 120 2.62kVA
door
Single-door/double-
PS-90 820×1720×900 90L 200 3.85kVA
door AC380V, 3N (3 phase,
Single-door/double- 50Hz)
PS-120 820×1720×900 120L 220 3.00kVA
door
835×1750×108 Single-door/double-
PS-150 120L 220 4.00kVA
0 door

2. Performance index:
2. Performance index
2.1 Normal working conditions
a) Working voltage:AC220V±22V, 50Hz±1Hz;
AC380V±38V, 50Hz±1Hz;
b) Environment temperature: 5℃-40℃;
c) Relative humidity: <80%
d) Atmospheric pressure: 86kPa-106kPa
2.2 Appearance
2.2.1 The sterilizer appearance should be smooth and clean, and free of apparent scratch, abrasion and dinting.
2.2.2 Appearance of electroplated part for the sterilizer should be smooth, and free of peeling, bottom exposure
and scratch.
2.2.3 Logo text of the sterilizer should be clear and correct, and all control keys should be flexible and reliable.
2.3 Sterilization procedures

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2.3.1 The sterilizer should be equipped with three automatic sterilization procedures: quick sterilization, standard
sterilization and enhanced sterilization.
2.3.2 Every procedure operation of the sterilizer includes the following steps.
2.3.2.1 Quick sterilization
a) Pre-vacuum phase: Vacuuming - foreign object detection – vacuuming - plasma state – inflating –pressure
maintaining;
b) Sterilization once: Vacuuming - H2O2 taking liquid – preparation for handling – H2O2 handling – preparation
for injection– H2O2 injection – diffusion –inflating – pressure maintaining;
c) Sterilization twice: Vacuuming - H2O2 taking liquid – preparation for handling – H2O2 handling – preparation
for injection– H2O2 injection – diffusion –inflating – pressure maintaining– vacuuming- plasma state;
d) Ventilation:
e) End.
2.3.2.2 Standard sterilization
a) Pre-vacuum phase: Vacuuming - foreign object detection – vacuuming - plasma state – inflating –pressure
maintaining;
b) Sterilization once: Vacuuming - H2O2 taking liquid – preparation for handling – H2O2 handling – preparation
for injection– H2O2 injection – diffusion –inflating – pressure maintaining;
c) Sterilization twice: Vacuuming - H2O2 taking liquid – preparation for handling – H2O2 handling – preparation
for injection– H2O2 injection – diffusion –inflating – pressure maintaining– vacuuming- plasma state;
d) Ventilation:
e) End.
2.3.2.3 Enhanced sterilization
a) Pre-vacuum phase: Vacuuming - foreign object detection – vacuuming - plasma state – inflating –pressure
maintaining;
b) Sterilization once: Vacuuming - H2O2 taking liquid – preparation for handling – H2O2 handling – preparation
for injection– H2O2 injection – diffusion –inflating – pressure maintaining;
c) Sterilization twice: Vacuuming - H2O2 taking liquid – preparation for handling – H2O2 handling – preparation
for injection– H2O2 injection – diffusion –inflating – pressure maintaining– vacuuming- plasma state;
d) Ventilation;
e) End.
2.3.3 Parameters during operation of sterilization procedures
2.3.3.1 Parameters during operation of quick sterilization
a) Vacuum degree of sterilizer chamber
Vacuum processing stage, vacuum degree≤200Pa;
Plasma state stage, vacuum degree≤200Pa;
b) Diffusion time 180s, ±ls.
2.3.3.2 Parameters during operation of standard sterilization
a) Vacuum degree of sterilizer chamber
Vacuum processing stage, vacuum degree ≤l50Pa;
Plasma stage, vacuum degree≤150Pa;
b) Diffusion time 220s,±1s.
2.3.3.3 Parameters during operation of enhanced sterilization
a) Vacuum degree of sterilizer chamber

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Vacuum processing stage, vacuum degree ≤l00Pa;
Plasma stage, vacuum degree ≤l00Pa;
b) Diffusion time 240s,±1s
2.4 Requirements of technical parameter index of the sterilizer
2.4.1 Maximum temperature of sterilizer chamber is less than 60℃: , fluctuation range ±5℃.
2.4.2 Hydrogen peroxide concentration
Hydrogen peroxide concentration ≥ 58%.
2.4.3 Plasma generator frequency
The plasma generator frequency should be 40KHz±10%.
2.4.4 Amount of single-cycle sterilization for hydrogen peroxide should meet requirements of Table 2.
Table 2 Amount of single-cycle sterilization for hydrogen peroxide

Type Amount of single-cycle Type Amount of single-cycle

PS-60T 2ml±10% PS-150 4ml±10%

PS-60 2ml±10% PS-200 4ml±10%
PS-90 2ml±10%
PS-350 5.5ml±10%
PS-120 2ml±10%

2.4.5 Ventilation time

After equipment sterilization, ventilation time is greater than 20s.
2.4.6 Parameter range during sterilization period should meet requirements of Table 3.
Table 3 Parameter range during sterilization period

Sterilization Default Number of

Sterilization cycle Name Unit Setting range
procedures parameters stages
Vacuum
Vacuuming 200 Pa 200-300 2
degree
Plasma state Time 60 S 60-120 2
Quick
Pressure
sterilization Time 60 S 60-180 3
maintaining
Diffusion Time 180 S 180-480 2
Ventilation Time 20 S 20-60 1
Vacuum
Vacuuming 150 Pa 150-300 2
degree
Plasma state Time 60 S 60-120 2
Standard
Pressure
sterilization Time 120 S 60-180 3
maintaining
Diffusion Time 220 S 220-480 2
Ventilation Time 20 S 20-60 1
Enhanced Vacuum
Vacuuming 100 Pa 100-300 2
sterilization degree
Plasma state Time 60 S 60-120 2
Pressure
Time 120 S 60-180 3
maintaining
Diffusion Time 240 S 240-480 2

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 Ventilation Time 20 S 20-60 1

2.5 Sterilization effect

The sterilizer is used to sterilize the stainless-steel tube with inner diameter of 1mm and length of 500mm for
sterilization, and conduct operation in accordance with methods of Appendix B. After quick sterilization of the
equipment, the equipment should be sterile.
The sterilizer is used to sterilize the PTFE tube with inner diameter of 1mm and length of 2000mm for
sterilization, and conduct operation in accordance with methods of Appendix B. After quick sterilization of the
equipment, the equipment should be sterile.
2.6 Plasma efficiency
Make use of quick sterilization, standard sterilization and enhanced sterilization for operation. After sterilization,
conduct operation in line with Appendix C. In the sterilizer chamber, there should be no hydrogen peroxide
residue.
2.7 Hydrogen peroxide residue in the air
During sterilizer work process, check hydrogen peroxide residue in the sterilizer work process. Amount of residue
should meet requirements of GBZ2.1-2007 Chemical Hazards of Occupational Exposure Limit for Hazardous
Agents in the Workplace, i.e. 8h Time-weighted allowable (TWA) of less than or equal to l.5mg/m3.
2.9 Compatibility of hydrogen peroxide for materials and equipment
It is necessary to sterilize metal materials and equipment by hydrogen peroxide during sterilization process,
conduct inspection in line with Appendix D, and ensure that there is no corrosion for the sterilizer and there is no
effect for expected clinical service life.
2.10 Failure prompt functions:
2.10.1 Vacuum alarm
Within set time (5min-l0min), the pressure fails to set vacuum pressure value, and the system sends automatic
alarm.
2.10.2 Foreign object alarm
When there is any leakage in the sterilizer chamber, pressure rise is over set pressure, and system will send alarm.
2.10.3 Door fault
During rising, if there is any foreign object, stop rising and restore to fully open position.
2.10.4 Alarm of door and window of liquid injection fail to close
After the equipment is started, door and window of liquid injection are not closed, and the system automatically
sends alarm.
2.10.5 Alarm of cartridge holder information mismatch
After new cartridge holder is loaded into the injection device, the equipment should conduct detection match of
hydrogen peroxide cartridge holder information. When the cartridge holder is not suitable for the equipment, the
system sends an alarm.
2.10.6 Alarm of overdue cartridge holder
After new cartridge holder is loaded into the injection device, the equipment should conduct detection match of
hydrogen peroxide cartridge holder information. When the cartridge holder is detected to expire, the system sends
an alarm.
2.11 Noise
When the sterilizer is operating under sterilization state, A weighted sound power level noise should not be greater
than 75dB.
2.12 Requirements of sterilization chamber door and interlocking device
2.12.1 Do not open the sterilization chamber door during sterilization cycle.

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2.12.2 After the sterilization chamber door is closed, re-open the door without sterilization period.
2.12.3 It is necessary to replace sealing elements of sterilization chamber door, and check and clean sealing
elements, surface contacting with the door without removal of door structure.
2.12.4 The sterilization chamber door should be installed with safety interlock, and conform to following
regulations:
a) Under normal working conditions, when the door is not locked, the sterilizer cannot start sterilization
procedures;
b) After injecting hydrogen peroxide, if sterilization cycle is ended by manual method or other methods, it is
necessary to effectively eliminate hydrogen peroxide; otherwise, the door cannot be opened;
c) There should be alarm functions synchronized with a) and b) movements.
2.12.5 Double-door sterilizer door should conform to following regulations.
a) Except for maintenance demands, two doors cannot be opened at the same time;
b) Before end of sterilization cycle is not shown, you cannot open the unloading gate;
c) After test cycle is ended, you cannot open the unloading gate;
d) The device used to control start of sterilization cycle should be installed on the load side of the sterilizer.
2.13 Environment test
2.13.1 PS-60T, PS-60, PS-90, PS-120, PS-150, PS-200 and PS-350 should be operated in line with GB/T14710-
2009 Environmental requirement and test methods for medical electrical equipment and Appendix A.
3.14 Safety and performance requirements
The electric safety should meet requirements of GB4793.1.
3. Inspection methods:
3. Inspection methods
3.1 Test equipment and condition
31.1 Test instrument
a) Thermometer with accuracy of ±0.5℃.
b) Vacuum gauge with accuracy of ±10%.
c) Timer with accuracy of 0.5%.
3.1.2 Environmental conditions
The reference test condition should conform to regulations in Table and Table 5 of GB/T14710-2009, and
environment test conditions should conform to requirements of 3.1.2.
3.2 Inspection of appearance
Results of visual inspection and operation inspection should conform to requirements of 2.2.
3.3 Inspection of sterilization procedures
3.3.1 Operation results of the equipment should meet requirements of 2.3.1 and 2.3.2.
3.3.2 Parameters inspection during sterilization
a) Place the vacuum gauge in the connecting pipe tee joint, and observe pressure change. Reading of the
vacuum gauge should meet requirements of 2.3.3.
b) Separately execute quick procedure, standard procedure and enhanced procedure for the equipment. During
diffusion, reading of the timer should meet requirements of 2.3.3.
3.4 sterilizer technical parameters inspection
3.4.1 In the sterilizer chamber, set three stationary point thermometers at front, middle and back positions. When
the device completes pre-heating, take out stationary point thermometer, and its actual measured value should
meet requirements of 2.4.1.

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3.4.2 Inspect documents offered by the manufacturers, and inspect results should meet requirements of 2.4.2.
3.4.3 Connect the power measurement system with output end of the plasma generator. Connect positives (+) and
connect negatives (-). Frequency on the power measurement system should meet requirements of 2.4.3.
3.4.4 Actual measured results should meet requirements of 2.4.4.
3.4.5 Make use of the timer to detect ventilation time, and its results should meet requirements of 2.4.5.
3.4.6 Start power switch to enter parameter query interface for operation, and the results should meet requirements
of 2.4.6.
3.5 Sterilization effect inspection
Check equipment and conditions in 4.5 in line with methods in the Appendix B, and the detection results should
meet requirements of 2.5.
3.6 Inspection of plasma effect
Make use of quick sterilization, standard sterilization and enhanced sterilization procedures to operate the
equipment, and conduct detection by methods in Appendix C. If bacteria culture were positive, it is approved that
there is no hydrogen peroxide residue in the self-contained biological indicator after sterilization, and results
should meet requirements of 2.6.
3.7 Inspection of Hydrogen peroxide residue in the air
According to methods of Appendix A in GBZ2.1-2007, measure hydrogen peroxide residue amount in the ambient
air, and its results should meet requirements of 2.7.
3.8 Biocompatibility inspection of materials to be sterilized
According to methods in Appendix C of GB27955-2011, conduct detection. After low temperature plasma
sterilization, test the metal instrument within 4h. After testing cytotoxicity in line with GB/T16886.5-2003, its
result is negative. If the cytotoxicity is positive, conduct subcutaneous injection reaction test by stimulus and
delayed-type super sensitive test in the GB/T16886.10, and conduct subcutaneous intravenous injection reaction
test by toxicity test method in GB/T16886.11-2011. If the result is negative, it is approved that the human is
compatible with organism, and the result meets requirements of 2.8.
3.9 Inspection of compatibility of hydrogen peroxide for materials and equipment
Inspection regulated metal materials by the method in Appendix D. For samples, evaluate metal surface
corrosivity in line with regulations of Technical Standard for Disinfection (Version 2002) 2.2.4. The result should
meet requirements of 2.9.
3.10 Tests of fault prompt function
3.10.1 Vacuum alarm: The pipeline will leak during vacuuming stage, and the results should meet requirements of
2.10.1.
3.10.2 Foreign object alarm: Place the fabric packing material in the sterilizer chamber. During detection of
foreign object, equipment operation results should meet requirements of 2.10.2.
3.10.3 Alarm of door fault: During door rising, if there is any foreign object, the door will stop rising. The result
should meet requirements of 2.10.3.
3.10.4 Alarm of door and window of liquid injection fail to close: Open the door of the injection window to start
the equipment. The result should meet requirements of 2.10.4.
3.10.5 Alarm of cartridge holder information mismatch: Load the mismatch cartridge holder into the liquid
injection device. The result should meet requirements of 2.10.5.
3.10.6 Alarm of overdue cartridge holder: Load the overdue cartridge holder into the liquid injection device. The
result should meet requirements of 2.10.6.
3.11 Noise test
Use A weighted sound pressure level meter to measure all sides at each 1m from the sterilizer. The result should
meet requirements of 2.11.
3.12 Inspection of sterilization chamber door and interlocking device
Conduct operation in accordance with instructions. The result should meet requirements of 2.12.

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3.13 Environment test
Conduct inspection in accordance with requirements of 2.13.
3.14 Safety test
Conduct inspection in accordance with requirements of 2.14.
4. Term:
4. Term:
None

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Appendix A
Climatic Environment Test Group II and Mechanical Environment Test Group II
Test requirements Detection items
Supply
voltage V
Mediu Rate
Test items Restorati Test Rate
Durati Power- m Final d
on time conditio Initial detection d
on h up state detecti detection valu
h ns valu
on e
e-
+10
10%
%
Rated Overall
Power-
working performance except
up 342
low ≥1 - 5℃ for - 2.11.5 -
during V
temperatur 2.5.2/2.6/2.7/2.8/2.9
test
e /2.10
Low
Power-
temperatur
4 4 up after -40℃ 2.11.5 2.11.5 2.11.5 380V
e storage
test
test
Rated
Power-
working
up 480
high ≥1 - 40℃ 2.11.5 - - -
during V
temperatur
test
e test
Power-
Operation up 480
≥4 - 40℃ - - 2.11.5 -
test during V
test
High
Power-
temperatur
4 1 up after 55℃ 2.11.5 - 2.11.5 380V
e storage
test
test
Rated
Power-
working
up
humidity ≥4 - 40℃ 2.11.5 - 2.11.5 380V
during
and heat
test
test
40℃
Humidity Power- relative
and heat 48 1 up after humidit 2.11.5 - 2.11.5 380V
storage test test y
93±3%
Referen
Power-
Vibration ce test
- up after 2.11.5 - 2.11.5 380V
test conditio
test
n
Referen
Power-
ce test
Crash test - up after 2.11.5 - 2.11.5
conditio
test
n
Transportat - Power- Referen 2.11.5 - Whole 380V
ion test up after ce test performa

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 conditio
test nce
n

Appendix B (informative annex) sterilization effect

1. Principle
In the experiment, common rigid-mirror stainless-steel tubes and soft-mirror polytetrafluoroethylene tubes are
simulated tubes, which are used to test sterilization effect of microorganism. In the experiment, seamless test tubes
with at both opening ends are used. If there is any joint, ensure gas tightness. In the center of the tube, protect
from infection of carrier of bacterial spore. By half-cycle sterilization, the sterilization effect shall be 10 -
6
CFU/carrier sterilization level. Bacillus stearothermophilus spores and spores of bacillus subtilis var niger are
index bacteria, which are used to evaluate sterilization effect of microorganisms. If all tests are negative culture
results, results are qualified. According to the test methods, conduct test of microorganism sterilization effects for
tube limit.
2. Biological indicator
Bacillus stearothermophilus spores (ATCC7953), and spores of bacillus subtilis var niger (ATCC9372) Bacteria
parameter should meet requirements of GB 18281.1.
3. Test device
Carrier: Evenly apply spore suspension on the stain-stainless detection material with diameter of 0.4mm and
length of 20mm~30mm, to prevent contamination bacteria from blocking the tube. Recovered positive bacteria
amount of bacillus stearothermophilus spores should be 1×10 6CFU/carrier ~ 5×l06CFU/ carrier. Recovered
positive bacteria amount of bacillus subtilis var niger should be 1×10 6CFU/carrier ~ 5×l06CFU/ carrier. Under
condition of 56°C, dry bacillus stearothermophilus spores for 72h; Under condition of 37℃, dry spores of bacillus
subtilis var niger for 72h and make into contamination bacteria carrier used for test.
Detection tube: In the experiment, seamless test tubes with at both opening ends are used. If there is any joint,
ensure gas tightness.
Stainless steel seamless tube: 10 pieces.
Polytetrafluoroethylene seamless tube: 10 pieces.
TSB culture medium of bacillus stearothermophilus spores
Dry powder tryptone of 17.0g, phytone of 3.0 g, sodium chloride of 5.0g, dipotassium phosphate of 2.5g, glucose
of 2.5g, are dissolved in distilled water of 1L to make into Trypticase Soy Broth (TSB) culture medium.
Make into Trypticase Soy Broth (TSB) culture medium.
For culture medium of spores of bacillus subtilis var niger, refer to Technical standard for disinfection.
Positive control: Crush the glass tube containing nutrient solution in the biological indicator without sterilization
for culturing.
Negative control: Crush nutrient solution glass tube not containing indicator carrier, and put into the incubator for
culturing.
4. Operation steps
**************** Make 10 test samples in the center of lumen. Put the 10 test samples in instrument box
uniformly and in parallel. If there is only one compartment in sterilizer chamber, put the 10 test samples in
mechanical box uniformly, parallel, place them in the upper and lower layers of shelves, in the center of the
sterilizer chamber. Then, put the 10 samples in two instrument boxes uniformly, and place them in the upper and
down*** in the sterilizer chamber respectively.

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 10 根不锈钢管 10 stainless steel tubes
5 根不锈钢管 5 stainless steel tubes
5 根不锈钢管 5 stainless steel tubes
上层 Upper layer

Carry out half cycle sterilization in accordance with the sterilization operation procedure in Technical Standard for
Disinfection. Bacterial spore carriers shall be taken out with sterile operation after sterilization, and be put in TSB
culture medium, and be cultured 48h under appropriate temperature condition (56℃ for fatty liver bacillus spores,
37℃ for spores of bacillus subtilis var niger). Observe the result of the cultivation, and continue to culture it for
7days if bacterial growth occurs. If there is still no growth of bacterium in the culture result, then judge the result
as negative.
4.2 Deliver bacterial carrier to the middle of the polytetrafluoroethylene (PTFE) lumen with thin filament, and
make 10 pieces of test samples. 10 test samples shall be put in the instrument box uniformly, wrapped with a
double-layer non-woven cloth, and placed inside the sterilizer chamber. If there is only one layer of compartment
in the sterilization chamber, 10 samples shall be placed parallel in the instrument box, and placed in the center of
the sterilizer chamber (see Figure B.3); If upper and down layers of compartment can be placed inside the
sterilizer chamber, 10 samples shall be put in the two instrument box uniformly, and place in the center of the
upper and down compartments of the sterilizer chamber (see Figure B.5).

10 根聚四氟乙烯管 10 pieces of polytetrafluoroethylene tubes

5 根聚四氟乙烯管 5 pieces of polytetrafluoroethylene tubes
5 根聚四氟乙烯管 5 pieces of polytetrafluoroethylene tubes

B. 3
Carry out half cycle sterilization in accordance with the sterilization operation procedure in Technical Standard for
Disinfection. Bacterial spore carriers shall be taken out after sterilization, and be put in TSB culture medium, and
be cultured 48h under appropriate temperature condition (56℃ for fatty liver bacillus spores, 37℃ for spores of
bacillus subtilis var niger). Observe the result of the cultivation, and continue to culture it for 7days if bacterial

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growth occurs. If there is still no growth of bacterium in the culture result, then judge the result as negative.
5. The result of calculation
Repeat the microbial test of the above two materials 5 times respectively with bacillus stearothermophilus spores
and the spores of bacillus subtilis var niger.
6. Result judgment
If there is no the growth of bacterium in the test at all, negative. It should be judged that no bacteria is up to
standard.
Appendix C (reference appendix) - indirect plasma detection method
1 Principle
After the completion of sterilization, ionized hydrogen peroxide plasma will combine into water and oxygen, and
there is no hydrogen peroxide residue on the surface of sterilization matters. Therefore, after sterilization effect
meets the requirement of Technical Standard for Disinfection, it can be judged that hydrogen peroxide plasma has
been generated, and dissociated fully, through the detection the hydrogen peroxide residue in self-contained
biological indicator of food preparation.
2 Inspection of equipment
For the self-contained clinical biological indicator matched with the equipment, the slide glass is sterile;
Biological indicator spores: Bacillus stearothermophilus spores (ATCC7953)
Spores of bacillus subtilis var niger (ATCC9372)
Negative control: Put the nutrient solution glass tube not containing indicator carrier into the incubator for
culturing.
Positive control: After crushing the c containing the culture liquid in the sterile biological indicator, the carrier
film which has not been sterilized, add the suspension liquid containing no more than 10CFU bacteria spores and
put it into an incubator of appropriate temperature for cultivation.
***************Four bacteria-free self-contained biological indicator slide glass were placed on the front and
rear, left and right of the hydrogen peroxide injector.
***************Biological indicator, crushing the glass tube containing the culture solution.
***************A suspension liquid containing no more than 10 CFU of indicator spores was added to the self-
contained biological indicator within 5 hours.
***************The holes on both sides of the indicator bottle caps. After culturing four self-contained
biological indicators containing 10 CFU of indicator spores and positive control in the incubator at the
temperature (hypophilic fatty liver spores at 56 ° C, Bacillus subtilis licheniformis spores at 37 ° C), of **** for
48 hours, if there is no bacterial growth, continue to culture it until 7 days, and if the culture results are still no
bacterial growth, it is judged as negative.
***************There are three operation steps.
As a result, there was indicator bacteria growth. If it was positive, there was no residual hydrogen peroxide on the
slide glass of the self-contained biological indicator matched with the device, and the hydrogen peroxide was
completely ** dissociated.
Appendix D (Informative Appendix) material compatibility detection
***************
After hydrogen peroxide gas ionic body is sterilized by low temperature, there is no corrosion on the surface of
the device. The compatibility of the material of the device after sterilization can be determined, and the
compatibility of the hydrogen peroxide with the device during the sterilization process can be judged.
2. Sample preparation and operation steps
2.1 The raw materials for the manufacturing device are inspection materials, and each material is made into three
samples of 60 cm2 (100 mm x 60 mm). Rinse each sample with a neutral instrument washing liquid and rinse
thoroughly with distilled water to remove surface contaminants and residual detergent. Dry each material with a
non-woven cotton cloth. Dry with clean filtered air (or equivalent) to remove all residual fibers from the sample.
Weigh the sample, and each sample is weighed 3 times after the balance is returned to zero, accurate to 0.1 mg,

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and the average value is taken as the weight before the experiment (when weighing, clean gloves should be worn,
and the sample should not be directly touched by hand). Each inspection specimen of each material is wrapped in
a single layer of Tyvek packaging to prevent bacteria from entering and to ensure the infiltration of hydrogen
peroxide.
2.2 Place the inspection sample in the sterilized equipment instrument box flatly, and place the instrument box in
the center of the upper layer of the sterilizer chamber without the instrument cover. Set the sterilizer chamber
temperature to the minimum allowable limit according to the manufacturer's instructions and inject the maximum
dose of hydrogen peroxide sterilant for full cycle sterilization.
2.3 Repeat the above steps in accordance with the number of times the corrosion-free sterilization to the device
indicated in the technical data of the device.
3. Detection
After the sterilization is completed, the loaded sample is taken out and the metal corrosion evaluation is performed
in accordance with the "Technical Standard for Disinfection".
4. Results determine
The metal surface has a corrosion rate of R < 0.01 and is substantially non-corrosive. The corrosion results of non-
metallic surfaces are judged according to the standards of the device manufacturer.

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