GB 27955-2020Hygienic requirements for low-temperature hydrogen peroxide gas plasma sterilizer (English PDF)

1 Scope

GB 27955-2020 is the Chinese national standard on hygienic requirements for low-temperature hydrogen peroxide gas plasma sterilizer, in the field of health care technology. It carries no /T suffix, which in the Chinese system means compliance is mandatory: a product or a practice within its scope has to meet it to be lawfully made, sold or carried out in China. It was issued on 9 April 2020 by the State Administration for Market Regulation; Standardization Administration of China, and has been in force since 1 November 2020. Classification: ICS 11.080, CCS C50. This page is published from the official record of the standard held by the Chinese standards administration: the identification, the dates, the classification and the issuing body are taken from there. The clause text, the tables and the numeric limits are in the document itself, which is delivered complete in English translation.

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 Technical Requirements...

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 Inspection Method...

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