GB 27949-2020General requirements of disinfectant of medical instruments (English PDF)

5.5.2 Requirements for simulated field test

5.5.2.1 Sterilizer At the minimum action concentration specified in the instruction manual and the dose of 50% of the shortest action time, if there is no growth of viable bacteria [Bacillus subtilis black variant (ATCC9372) spores] on the simulated medical item to be tested, it shall determine that the simulated field sterilization test of the medical item is qualified.

5.5.2.2 High-level disinfectant At the minimum action concentration specified in the instruction manual and the dose of the shortest action time, if the killing or logarithmic value of the spores of Bacillus subtilis black variant (ATCC9372) on the simulated medical item to be tested is not less than 3.00, it shall determine that the simulated field sterilization test of the medical item is qualified.

5.5.2.3 Intermediate-level disinfectant At the minimum action concentration specified in the instruction manual and the dose of the shortest action time, if the killing or logarithmic value of the Mycobacterium (ATCC19977) on the simulated medical item to be tested is not less than 3.00, it shall determine that the simulated field sterilization test of the medical item is qualified.

5.5.2.4 Low-level disinfectant Among the Staphylococcus aureus (ATCC6538), Pseudomonas aeruginosa (ATCC15422), Candida albicans (ATCC10231), select the microorganism with the strongest resistance to the tested disinfectant as the experimental microorganism. At the minimum action concentration specified in the instruction manual and the dose of the shortest action time, if the killing or extinction log- value of the microorganisms tested on the simulated medical item shall not be less than 3.00, it shall determine that the simulated field sterilization test of the medical item is qualified.

5.6 Requirements for disinfectants used in conjunction with disinfection instruments The special purpose disinfectants used in conjunction with the relevant disinfection and sterilization devices, such as disinfectants for endoscopes, disinfectants for dialysis machine's pipelines, etc., shall meet the requirements of corresponding disinfection and sterilization devices such as WS507,

GB 30689 as well as relevant national standards. It shall verify the simulated disinfection and sterilization effects used in conjunction with related equipment. It is determined according to the relevant test methods in the "Technical specifications for disinfection" (2002 edition).

7.1 General

7.1.1 Medical items are preferred to be handled by thermal disinfection and sterilization.

7.1.2 The method of use shall comply with the standards and specifications of various types of disinfectants.

7.1.3 Before disinfecting or sterilizing the newly launched medical items, it shall first remove the oil stains and protective films; then use detergent to wash it to remove the grease; dry it.

7.1.4 Before disinfection or sterilization of contaminated medical items after use, they shall be fully cleaned and dried; the shaft joint shall be opened during treatment to fully expose it to disinfectant.

7.1.5 The sterilant which needs to be diluted before use as well as the high and intermediate level disinfectant shall be diluted by purified water, to avoid the influence of calcium, magnesium and other impurities on the disinfection effect.

7.2 Soak disinfection

7.2.1 Immerse the medical item to be treated in the disinfectant to make it completely submerged; then cover the disinfection container to let it action for the specified time.

7.2.2 For high-critical and intermediate-critical medical items, after the completion of disinfection and sterilization and before use, it shall use sterile water to rinse it clean or use other methods to remove residual disinfectant.

7.2.3 After immersed sterilization, the medical item shall avoid secondary contamination during the process of washing, transferring, storing. Among them, high-critical medical items shall be stored aseptically after sterilization; intermediate-critical medical items shall be clean-stored after sterilization or high-level disinfection; low-critical medical items shall be clean-stored after low and intermediate-level disinfection.