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GB 27955-2020: Hygienic requirements for low-temperature hydrogen peroxide gas plasma sterilizer
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 steril...