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YY/T 1623-2018: Test method of effectiveness of sterilization process for reusable medical devices
YY/T 1623-2018
Test method of effectiveness of sterilization processes for reusable medical devices
ICS 11.080.01
C47
People's Republic of China Pharmaceutical Industry Standard
Reusable medical device sterilization process effectiveness
experiment method
Published on.2018-09-21
2019-09-26 implementation
State Drug Administration issued
Content
Foreword III
Introduction IV
1 range 1
2 Normative references 1
3 Terms and Definitions 1
4 Overview 2
5 test equipment 2
6 reagent 2
7 Step 3
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that some of the contents of this document may involve patents. The issuing organization of this document is not responsible for identifying these patents.
This standard was proposed by the State Drug Administration.
This standard is under the jurisdiction of the National Disinfection Technology and Equipment Standardization Technical Committee (SAC/TC200).
This standard was drafted. Guangdong Medical Device Quality Supervision and Inspection Institute, Hangzhou Deno Technology Co., Ltd., Weihai Weigao Haisheng Medical Design
Preparation Co., Ltd.
The main drafters of this standard. Huang Hongxin, Lin Manting, Zhou Zhilong, Jiang Wei, Liang Zexin.
introduction
This standard describes the test method for determining the effectiveness of the reusable medical device sterilization process, which is a practical test.
Test method. This standard applies to reusable medical devices that are cleaned and sterilized according to the manufacturer's instructions.
This standard sets the reusable medical device to have no visible dirt after cleaning, but there may still be some residual bioburden. be usable
The bacterial suspension simulates the most difficult to sterilize bioburden. Commercially available bacterial suspensions can be used to sterilize instruments.
Compared to natural bacteria on reusable medical devices, bacterial spores are more resistant to test sterilants, so they are tested
Examine microorganisms. It should be determined that the bacterial spores used meet the specific sterilization process to be evaluated and the corresponding resistance (D value) requirements for the sterilant.
Direct connection based on the complexity, size and compatibility of the device (for long-term culture) or long-term immersion
This method is not feasible for sterility testing. Therefore, techniques such as elution, rinsing, and swabbing should be used to recover the test microscopy of the infected device.
biological.
The bacterial spore infection technique in this test method is only one possible method in the sterility test method of the device. Bacterial spore
The object indicator is a traditional tool used for sterilization process monitoring and is also suitable for sterilization evaluation of medical devices.
The meaning of this standard is to demonstrate that all of the accessible surfaces and interiors of a reusable medical device that has been cleaned after a specific sterilization process
The lumen can reach a sterile level.
Reusable medical device sterilization process effectiveness
experiment method
1 Scope
This standard specifies test methods for determining the effectiveness of a reusable medical device sterilization process. This standard applies to established
The test for the effectiveness of the sterilization process does not apply to the validation of the sterilization process.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only the dated version applies to this article.
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
GB/T 6682 Analytical laboratory water specifications and test methods
GB 18281.2 Sterilization of biological indicators for health care products - Part 2. Biological indicators for s.
GB 18281.3 Sterilization of biological indicators for health care products - Part 3. Biological indicators for damp heat sterilization
GB 18281.4 Sterilization of biological indicators for health care products - Part 4. Biological indicators for dry heat sterilization
The Pharmacopoeia of the People's Republic of China (2015 Edition)
3 Terms and definitions
The following terms and definitions apply to this document.
3.1
Bioburden
The total number of microorganisms on or in a product and/or package.
3.2
Colony forming unit colonyforming unit; CFU
The macroscopic colonies formed by the growth and reproduction of microorganisms on solid medium.
3.3
Bacterial suspension inoculum
A number of viable microorganisms (typically expressed in CFU) and types (genes and populations) used to stain test samples or devices.
3.4
Sterilizer sterilant
A formulation that kills all microorganisms, including bacterial bacterial spores, to the point of sterilization.
3.5
Sterile sterile
No viable microorganisms.
3.6
Recovery of bacteria amount compared to recoverycontrol
A colony forming unit (CFU) obtained by recovering bacteria and dried unsterilized instruments from the inside or the surface of each piece.
3.7
Process test cycle processtestcycle
Use a complete sterilization cycle of sterilization parameters within the manufacturer's specified range.
3.8
Reusable medical device reusablemedicaldevices
The manufacturer declares that the medical device can be reused after processing.
4 Overview
4.1 This standard determines the effectiveness of the sterilization process by analyzing the recovery of bacterial counts and the results of the process test cycle. The amount of recovered bacteria should be compared
Greater than or equal to 106 CFU/piece.
4.2 Residual bacterial spores are recovered by flushing, wiping or rinsing with eluents. Can be mechanically oscillated, sonicated and eluent
Repeat washing and other methods to increase the recovery rate.
4.3 After the sample has been processed through a complete sterilization process, all residual bacterial spores on the device should be recovered using a specific elution technique.
4.4 Perform a process test cycle with a minimum of 5 instruments, or a minimum of 5 consecutive process test cycles for a single device.
This proves that the sterilization process is effective.
4.5 The person conducting the test shall have an educational background in microbiology or related professional knowledge.
4.6 The sterility inspection and microbial limit inspection shall comply with the corresponding requirements of the four parts of the Pharmacopoeia of the People's Republic of China (2015 Edition).
5 test equipment
Should include at least the following equipment.
a) sterile cotton swabs;
b) pressure steam sterilizer;
c) (48 ± 2) ° C constant temperature water bath;
d) (35 ± 2) ° C and (55 ± 2) ° C bacteria incubator;
e) a disposable or reusable sterile membrane filter with a 0.45 μm pore size;
f) Other devices or equipment specified by the manufacturer of the sterilizing agent, medical device or sterilizer.
6 reagents
6.1 Purity of reagents
Chemically pure reagents should be used for all tests. Unless otherwise stated, all reagents in the test shall be guaranteed to comply with the relevant current national standards.
Provisions. If other purity reagents are used, the reagents should be determined to have a higher purity and ensure that the required accuracy is not reduced.
6.2 Water purity
Unless otherwise stated, the test water should meet the third grade water specified in GB/T 6682.
6.3 medium
6.3.1 For the preparation of the medium and eluent, the water of the third grade or higher specified in GB/T 6682 should be used.
6.3.2 Sterile eluent. See the preparation method of the rinsing liquid in the four parts of the Pharmacopoeia of the People's Republic of China (2015 edition).
6.3.3 Pancreatic soy meal liquid medium. According to each test, select the common concentration or double concentration, add neutralizer sterilization (if needed)
To) and choose the right volume. See the preparation method of liquid medium in the four parts of the Pharmacopoeia of the People's Republic of China (2015 edition).
6.3.4 Pancreatic soy meal agar medium. According to each test, select the common concentration or double concentration, add neutralizer to sterilize; at (48±
2) Use at a temperature of °C. See the preparation method of the four agar medium in the Pharmacopoeia of the People's Republic of China (2015 edition).
6.4 Test microorganism/bacterial suspension
6.4.1 Standard suspension for damp heat sterilization. Bacillus licheniformis containing 108 CFU/mL, steamed to GB 18281.3
Steam sterilization resistance standard.
6.4.2 The standard bacterial suspension for ethylene oxide or dry heat sterilization is. Bacillus subtilis containing 108 CFU/mL, reaching GB 18281.2
Ethylene oxide resistance standard or GB 18281.4 dry heat sterilization resistance standard.
6.4.3 If the above microorganisms are not suitable for sterilizing agents, or the above sterilization methods are not applicable, other microorganisms shall be used, and evidence and number of experiments shall be provided.
The applicability of the microorganism has been proven.
6.4.4 The source, production, storage and shelf life of bacterial spore strains should be confirmed in accordance with relevant national regulations.
6.5 Neutralizer
If using a neutralizing agent, see the Pharmacopoeia of the People's Republic of China (2015 Edition) Four 1105 Non-sterile Products Microbiological Limit Check. Microorganisms
Description of the neutralizer in the counting method.
7 steps
7.1 Select the required evaluation device.
7.2 Read the cleaning instructions for each required evaluation device to ensure that all required accessories are complete and available. According to the manufacturer's instructions for the device
Wash and dry.
7.3 Infect the device, the infected part should include the most difficult part of the device. The number of infected parts should be based on the complexity of the device.
set. The rationale for identifying and proving the most difficult parts of the device should be documented.
7.4 Procedures for staining, elution, control, neutralization, growth promotion (sensitivity check) and process test cycles, the laboratory should
Verification and standard operating practices.
7.5 Determination of the amount of recovered bacteria
7.5.1 Surface parts
7.5.1.1 Micropipette method
The suspension containing 107 CFU or more containing the suspension was directly stained to the surface by a micropipette. If the manufacturer specifies that the device is
Drying the bacterial solution is required for drying before the aseptic process. Soak the instrument in the eluent or rinse immediately or wipe the infected area with a cotton swab
Transfer to a sterile test tube or other sterile container. Shake it to mix thoroughly. Dilute the gradient and pipette 1 mL of the appropriate gradient
To the culture dish, cool to a molten agar medium not exceeding 45 ° C, and pour into the plate of the sampled solution, 15 mL ~ 20 mL per plate.
After the agar is solidified, it is cultured at a suitable temperature. Colony counts were performed after 48 hours of culture, and the counts were repeated every day until 7 days. By choosing the right one
The dishes are counted, the average number of microorganisms at each dilution level is determined, and then the dilution factor is used to calculate the microbes on the dyeing device.
The total number of objects. The average of all replicated data is obtained.
7.5.1.2 Cotton swab method
Wet a sterile cotton swab containing a suspension of 107 CFU or more of the bacterial suspension and wipe the selected area. If the manufacturer has specified
Dry the dyed liquid when the equipment is required to dry before the aseptic process. Microbial counts should be performed by immediately eluting and wiping the surface of the infected device.
Gradient dilutions and plate down were performed as described in 7.5.1.1 for microbial counting. The average of all replicated data is obtained.
7.5.2 Internal parts infected with bacteria
Properly connect the cleaning or rinsing accessories recommended by the medical device manufacturer, which will contain more than or equal to 107 CFU of bacterial suspension suspension.
Wash the inner cavity or the concave wall. If the manufacturer specifies the drying requirements of the device prior to the aseptic process, the bacterial solution is dried. Use one without
Bacterial irrigation equipment (such as syringes, pumps, etc.), using aseptic technique, lavage the lumen or concave wall with a certain amount of eluent
Bacterial suspension. All eluates were collected, thoroughly mixed, and subjected to gradient dilution and inverted plate as described in 7.5.1.1 for microbial counting. Draw
There is an average of repeated test data.
Note. Small lumens may be difficult to dry when dry.
7.6 Growth promotion (sensitivity check) and neutralization control
It should be demonstrated by experiment that any neutralizing agent can stop the antibacterial action of the sterilizing agent and does not inhibit the germination or growth of the test bacterial spores. See "Chinese
Test Method for Neutralizers in the Pharmacopoeia of the People's Republic of China (2015 Edition).
7.7 Determination of the results of the process test cycle
7.7.1 Repeat the procedure described in 7.5.1.1, 7.5.1.2 or 7.5.2 to perform a complete sterilization process on the instrument in addition to the elution step. root
Place the infected device in the sterilization chamber and its process, according to the manufacturer of the sterilizer or sterilizer.
7.7.2 After the sterilization process, the instrument requires a process test cycle, and the following three methods can be used for the sterility test. Simultaneous positive control and
For negative control trials, see the Pharmacopoeia of the People's Republic of China (2015 edition) for the positive and negative controls of the four 1100 bioassays.
Description.
7.7.2.1 The bacterial device is directly immersed in the medium. These instruments are directly transferred to the medium by aseptic technique, cultured and
The growth of microorganisms was observed daily for 7 days.
7.7.2.2 Aft...