GB 27955-2020 (GB27955-2020) & related versions
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Hygienic requirements for low-temperature hydrogen peroxide gas plasma sterilizer
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General requirements for low-temperature hydrogen peroxide gas plasma sterilizer
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GB 27955-2020: PDF in English
GB 27955-2020
GB
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 11.080
C 50
Replacing GB 27955-2011
Hygienic Requirements for Low-Temperature
Hydrogen Peroxide Gas Plasma Sterilizer
ISSUED ON: APRIL 09, 2020
IMPLEMENTED ON: NOVEMBER 01, 2020
Issued by: State Administration for Market Regulation;
Standardization Administration of PRC.
Table of Contents
Foreword ... 3
1 Scope ... 5
2 Normative References ... 5
3 Terms and Definitions ... 6
4 Technical Requirements ... 6
5 Application Range ... 9
6 Precautions for Use ... 10
7 Inspection Rules ... 10
8 Inspection Method ... 10
9 Marking and Packaging ... 13
10 Transportation and Storage ... 13
Appendix A (Normative) Test Methods of Sterilization Effect ... 14
Appendix B (Normative) Biological Monitoring Method for Low-Temperature
Hydrogen Peroxide Gas Plasma Sterilization ... 18
Appendix C (Normative) Preparation Method of Test Sample ... 20
Appendix D (Normative) Material Compatibility Test ... 21
Hygienic Requirements for Low-Temperature
Hydrogen Peroxide Gas Plasma Sterilizer
1 Scope
This Standard specifies the technical requirements, application range, precautions for
use, inspection rules, inspection methods, marking and packaging, transportation and
storage for the low-temperature hydrogen peroxide gas plasma sterilizer.
This Standard is applicable to low-temperature hydrogen peroxide gas plasma
sterilizers for sterilizing medical devices, appliances and articles that are not resistant
to humidity and high temperature.
2 Normative References
The following documents are essential to the application of this document. For the
dated documents, only the versions with the dates indicated are applicable to this
document; for the undated documents, only the latest version (including all the
amendments) are applicable to this document.
GB/T 191 Packaging – Pictorial Marking for Handling of Goods
GB/T 1616 Hydrogen Peroxide for Industrial Use
GB/T 16886.5 Biological Evaluation of Medical Devices - Part 5: Tests for In Vitro
Cytotoxicity
GB/T 16886.10 Biological Evaluation of Medical Devices - Part 10: Tests for
Irritation and Skin Sensitization
GB/T 16886.11 Biological Evaluation of Medical Devices - Part 11: Tests for
Systemic Toxicity
GB 19192-2003 Hygienic Requirement for Contact Lens Care Solution
GBZ 159 Specifications of Air Sampling for Hazardous Substances Monitoring in
the Workplace
GBZ/T 300.48 Determination of Toxic Substances in Workplace Air - Part 48:
Ozone and Hydrogen Peroxide
4.1.1.2 The sterilization program includes three stages: conditioning stage, sterilization
stage and ventilation stage, which can be repeated and crossed.
4.1.2 Conditioning stage
4.1.2.1 The lower limit of the pressure of the sterilization chamber shall be no higher
than the pressure specified by the manufacturer, and shall be no higher than 80Pa.
4.1.2.2 The temperature of the inner wall of the sterilization chamber shall be no less
than 45°C at the end of the conditioning stage.
4.1.2.3 If plasma occurs, the maintenance time and input power shall comply with the
manufacturer's provisions; the measured value of the maintenance time shall be no
less than the minimum value specified by the manufacturer; and the measured error
of the input power shall be within ±10%.
4.1.2.4 If there is purification, the concentration and dosage of hydrogen peroxide after
purification shall comply with the manufacturer's provisions, and the error shall be
within ±5%.
4.1.2.5 An alarm shall be issued when the sterilized items are too wet.
4.1.3 Sterilization stage
4.1.3.1 The temperature of the inner wall of the sterilization chamber shall be no
greater than 60°C; the sterilization effect of the minimum temperature of the equipment
shall be verified.
4.1.3.2 The maintenance time of the sterilization stage shall comply with the
manufacturer's provisions; and the measured value of the maintenance time shall be
no less than the minimum value specified by the manufacturer.
4.1.3.3 The sterilization pressure range should comply with the manufacturer's
provisions.
4.1.3.4 The hydrogen peroxide concentration range during the sterilization stage shall
comply with the manufacturer's provisions.
4.1.3.5 The concentration of hydrogen peroxide in the sterilization chamber should be
monitored in real time.
4.1.4 Ventilation stage
4.1.4.1 The lower limit of the pressure of the sterilization chamber shall be no higher
than the pressure specified by the manufacturer, and shall be no greater than 80Pa.
4.1.4.2 When plasma occurs, the maintenance time and input power shall comply with
the manufacturer's provisions. The measured value of the maintenance time shall be
4.5 Evaluation and monitoring of sterilization effect
Half cycle full load operation, aseptic growth.
4.6 Safety
4.6.1 Environmental exposure
4.6.1.1 The sterilizer shall be equipped with a hydrogen peroxide decomposition (filter)
device and an alarm to prompt replacement function. The manufacturer shall specify
its replacement cycle in the instruction manual.
4.6.1.2 In the workplace that meets the ambient ventilation conditions specified in the
sterilizer instruction manual, the residual amount of hydrogen peroxide shall meet the
8h time-weighted allowable concentration (TWA) ≤ 1.5mg/m3.
4.6.2 Biocompatibility
The items after sterilization shall be biocompatible with the human body.
4.6.3 Material compatibility
Compatibility evaluation is carried out after sterilization of metal and non-metal material
instruments. The result shall be basically no corrosion; and the evaluation result is
limited to tested materials. The appearance of the sterilized material shall not have
obvious changes, such as color, shape, and cracks, etc.
5 Application Range
5.1 The low-temperature hydrogen peroxide gas plasma sterilizer is suitable for
medical equipment, appliances and articles that are not resistant to humidity or high
temperature.
5.2 The sterilizer shall not be used to sterilize the following objects:
a) Items that are not completely dry;
b) Articles or materials that absorb liquids;
c) Items made of cellulose-containing materials or any other items containing wood
pulp;
d) One-end occluded cavity;
e) Liquid or powder;
f) Single-use items;
Run the sterilizer in accordance with the instruction manual provided by the
manufacturer to determine whether it satisfies 4.1.1.1 and 4.1.1.2.
8.1.2 Inspection in conditioning stage
8.1.2.1 Connect the pressure measuring device to the pressure test port of the
sterilization chamber; run the sterilization cycle to determine whether it satisfies 4.1.2.1.
8.1.2.2 Use the temperature sensor to measure the inner wall of the sterilization
chamber; and run the sterilization cycle to determine whether it satisfies 4.1.2.2.
8.1.2.3 Use a stopwatch to measure the time of plasma in generation stage; a
dedicated power meter to measure the operating power of the plasma generator; run
the sterilization cycle to determine whether it satisfies 4.1.2.3.
8.1.2.4 Run the sterilization cycle. After the purification stage is over, stop the operation
of the device; disassemble the purification device; extract the hydrogen peroxide
solution; measure the concentration according to the method specified in Technical
Standard for Disinfection (2002 Edition), and determine whether it satisfies 4.1.2.4.
8.1.3 Inspection in sterilization stage
8.1.3.1 Use the temperature sensor to measure the inner wall of the sterilization
chamber; run the sterilization cycle to determine whether it satisfies 4.1.3.1.
8.1.3.2 Run the sterilization cycle; use a stopwatch to measure the time in sterilization
stage; and determine whether it satisfies 4.1.3.2.
8.1.3.3 Connect the pressure measuring device to the pressure test port of the
sterilization chamber; run the sterilization cycle to determine whether it satisfies 4.1.3.3.
8.1.3.4 The hydrogen peroxide concentration sensor should be checked regularly to
determine whether it meets 4.1.3.4.
8.1.4 Inspection in ventilation stage
8.1.4.1 Connect the pressure measuring device to the pressure test port of the
sterilization chamber; run the sterilization cycle to determine whether it satisfies 4.1.4.1.
8.1.4.2 Run the sterilization cycle; use a stopwatch to measure the time of plasma in
generation stage; use a dedicated power meter to measure the operating power of the
plasma generator; and determine whether it satisfies 4.1.4.2.
8.1.4.3 Run the sterilization cycle. After the sterilization cycle is over, take the test
equipment that has been processed by one sterilization cycle (the lumen of PTFE with
an inner diameter of 1mm is 2m, and the lumen of stainless-steel tube with an inner
diameter of 1mm is 500mm). Soak in 100mL of purified water for 1min; prepare
Appendix A
(Normative)
Test Methods of Sterilization Effect
A.1 Method principle
This experiment uses the common hard mirror stainless steel lumen and soft mirror
PTFE lumen as the simulated lumen to verify the sterilization effect of microorganisms.
This test should use a seamless test lumen with openings on two ends, if there are
seams, air tightness shall be ensured. A carrier stained with bacterial spores is placed
in the center of the lumen, and grows aseptically through a half-period sterilization
cycle. Using bacillus stearothermophilus spores as the index bacteria, the microbial
sterilization effect was evaluated at the same time. All the tests were negative culture
results, then the results were judged to be qualified.
A.2 Biological indicator
Bacillus stearothermophilus spores (ATCC7953).
A.3 Verification equipment
A.3.1 Carrier: Coat the spore suspension evenly on a stainless-steel test material with
a diameter of 0.4mm and a length of 20mm~30mm; as long as it does not block the
lumen after infection. The amounts of bacteria recovered from the positive spores of
bacillus stearothermophilus shall be 1×106 CFU/carrier~5×106 CFU/carrier; use it after
natural drying at room temperature.
A.3.2 Test lumen: A seamless test lumen with openings on two ends shall be used in
this test. If there are seams, air tightness shall be ensured.
A.3.3 Stainless steel material lumens without seam: 10 pieces.
A.3.4 Teflon seamless lumens: 10 pieces.
A.3.5 TSB culture medium of bacillus stearothermophilus spores: 17.0g of dry powder
tryptone, 3.0g of vegetable peptone, 5.0g of sodium chloride, 2.5g of dipotassium
hydrogen phosphate, 2.5g of glucose, a total of 30g dissolved in 1L of distilled water;
then prepare Tryptone Soy Broth (TSB) medium.
A.4 Operation procedures
A.4.1 The infected carrier is delivered to the center of the stainless-steel lumen; and
10 test samples are prepared. Place 10 test samples evenly in parallel in the
instrument box; wrap them with double non-woven fabrics; and place them in the
Appendix B
(Normative)
Biological Monitoring Method for Low-Temperature Hydrogen
Peroxide Gas Plasma Sterilization
B.1 Biological indicator of bacillus stearothermophilus spores
The carrier shall have no adsorption effect on hydrogen peroxide; and the amounts of
bacteria on each carrier shall reach 1×106 CFU. The resistance of the used spores to
hydrogen peroxide gas shall be stable and qualified; and the used products shall
satisfy the relevant national management required biological monitoring of luminal or
non-luminal organisms monitoring package on the sterilization quality of the sterilizer.
B.2 Monitoring method of lumen biological monitoring package
When sterilizing luminal instruments, use a luminal biological PCD or a verification
device equivalent to a luminal biological PCD for monitoring. The device shall be
proven to be a sterilization challenge device that has the same or even stronger
resistance than the luminal PCD. The lumen biological monitoring package shall be
placed in the most difficult part to sterilize in the sterilizer (according to the suggestion
from the manufacturer's instruction manual, away from the hydrogen peroxide injection
port, such as the back of the lower instrument shelf in the sterilization chamber) for full-
load sterilization. After the sterilization cycle is completed, immediately take out the
luminal biological PCD from the sterilizer; and incubate at 56°C±2°C for 7 days (or
follow the product instructions); and observe the culture results.
B.3 Monitoring method of non-luminal biological monitoring package
When sterilizing non-luminal instruments, use the non-luminal biological monitoring
packages to monitor; Self-contained biological indicators shall be placed in Tyvek
packaging bags. After sealed packaging, it is placed in the most difficult part to sterilize
in the sterilizer (according to the suggestion from the manufacturer's instruction manual,
away from the hydrogen peroxide injection port, such as the back of the lower
instrument shelf in the sterilization chamber). Immediately after the sterilization cycle
is completed, take out non-luminal biological monitoring package from the sterilizer;
and incubate according to the self-contained biological indicator instructions; and
observe the culture results.
B.4 Judgment of results
If the positive control group is culture-positive, the negative control group is culture-
negative, and the experimental group is culture-negative, and it shall be judged as
qualified for sterilization. If the positive control group is cultured-positive, the negative
Appendix D
(Normative)
Material Compatibility Test
D.1 Principle of the method
After the instruments are sterilized at low temperature by hydrogen peroxide gas
plasma for many times, the surface of the instruments is not corroded. Measure the
compatibility of the equipment materials after sterilization; and then determine the
compatibility of hydrogen peroxide to the equipment during the sterilization process.
D.2 Sample preparation and operation procedures
D.2.1 Prepare samples with reference to 3.4.2 in Technical Standard for Disinfection
(2002 Edition).
Metal sheet sample: round, diameter of 24.00mm, thickness of 1.00mm, passing
through a small hole with a diameter of 2.00mm, the total surface area of about
9.80cm2 (including the upper, lower, peripheral surface and the side of the small hole).
The finish is 6. The raw materials are as follows:
Carbon steel (see GB/T 700 for specifications)
Copper (see GB/T 2059 for specifications)
Aluminum (see GB/T 1173 for specifications)
Stainless steel (see GB/T 1220 for specifications)
Rinse each sample with a neutral instrument washing solution; and then rinse
thoroughly with distilled water to remove surface contaminants and residual cleaning
agents. Dry each material with a non-woven cotton cloth. Blow dry with clean filtered
air (or equivalent) to remove residual fibers on the sample. The samples are weighed,
and each sample is weighed 3 times after the balance returns to zero, accurate to
0.1mg; and take the average value as the pre-test weight (when weighing, clean gloves
shall be worn and the samples shall not be directly touched with hands). Wrap the test
samples of each material in a single-layer Tyvek packaging bag to prevent bacteria
from entering, and at the same time to ensure the infiltration of hydrogen peroxide.
D.2.2 Place the test sample flat in the sterilization instrument box, without covering the
instrument box lid; and place the instrument box at the center of the upper layer of the
sterilization chamber. Set the sterilization chamber temperature to the lowest allowable
limit according to the manufacturer's operating instructions, and inject the maximum
dose of hydrogen peroxide sterilant for full cycle sterilization.
......
| Standard ID | GB 27955-2020 (GB27955-2020) | | Description (Translated English) | Hygienic requirements for low-temperature hydrogen peroxide gas plasma sterilizer | | Sector / Industry | National Standard | | Classification of Chinese Standard | C50 | | Classification of International Standard | 11.080 | | Word Count Estimation | 14,194 | | Date of Issue | 2020-04-09 | | Date of Implementation | 2020-11-01 | | Drafting Organization | Environmental and Health-related Product Safety Institute of Chinese Center for Disease Control and Prevention, Peking Union Medical College Hospital, Peking University Stomatological Hospital, Hebei Provincial Health Commission Comprehensive Supervision and Law Enforcement Service Center, Shandong Provincial Health and Health Commission Law Enforcement Supervision Bureau, Hubei Provincial People's Hospital, Qingdao University Affiliated Hospital, Shandong Provincial Hospital, Jiangxi Provincial Health Supervision Institute, Zhejiang Provincial Center for Disease Control and Prevention, Shaw Hospital Affiliated to Zhejiang University School of Medicine | | Administrative Organization | National Health Commission of the People's Republic of China | | Proposing organization | National Health Commission of the People's Republic of China | | Issuing agency(ies) | State Administration for Market Regulation, National Standardization Administration |
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