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WS/T 651-2019 English PDF

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WS/T 651-2019: Evaluation requirement of indicators for medical purpose-low temperature steam and formaldehyde sterilization processes
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Basic data

Standard ID: WS/T 651-2019 (WS/T651-2019)
Description (Translated English): Evaluation requirement of indicators for medical purpose-low temperature steam and formaldehyde sterilization processes
Sector / Industry: Health Industry Standard (Recommended)
Classification of Chinese Standard: C59
Classification of International Standard: 11.080
Word Count Estimation: 13,134
Date of Issue: 2019
Date of Implementation: 2019-07-01
Issuing agency(ies): National Health Commission

WS/T 651-2019: Evaluation requirement of indicators for medical purpose-low temperature steam and formaldehyde sterilization processes

---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Evaluation requirement of indicators for medical purpose-low temperature steam and formaldehyde convention processes ICS 11.080 C 59 WS People's Republic of China Health Industry Standard Medical low temperature steam formaldehyde sterilization indicator evaluation requirements Evaluation requirement of indicators for medical purpose-low temperature steam and Mold purge processes Published on.2019 - 01 - 30 2019 - 07 - 01 implementation National Health and Wellness Committee of the People's Republic of China

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009. This standard was drafted. Shandong Provincial Center for Disease Control and Prevention, China Center for Disease Control and Prevention, environmental and health related product safety Institute, Jiangsu Provincial Center for Disease Control and Prevention, Shandong Mental Health Center, Guangdong Inspection and Quarantine Technology Center, Linyi County Safety Production Supervision Bureau of Management, Weifang Medical College. The main drafters of this standard. Cui Shuyu, Yang Bin, Zhang Liubo, Li Zikai, Liu Lei, Su Guanmin, Sun Wenkui, Zhang Jian, Shen Yi, Sun Hui Hui, Chen Wei, Dong Fei, Meng Wei, Zhao Keyi, Wen Xianqin, Xu Yan, Sun Qihua, Liao Ruyan, Tian Zhongmei, Liu Xiaokang, Zhou Jianfang, Zou Hua Hua, Yang Jing, Xie Caro, Wang Xiaoyun. Medical low temperature steam formaldehyde sterilization indicator evaluation requirements

1 Scope

This standard specifies the classification, general requirements, chemical indicator requirements and biological indicator requirements for medical low temperature steam formaldehyde sterilization indicators. This standard is applicable to indicators that reflect the sterilization process of medical low temperature steam formaldehyde through changes in chemical and biological indicators.

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 18281.1 Sterilization biological indicators for health care products - Part 1. General Management Specification for Labeling Instructions for Disinfecting Products (2005) Ministry of Health (Wei Jian Fa [2005] No. 426)

3 Terms and definitions

The following terms and definitions apply to this document. 3.1 Low temperature steam and formaldehyde sterilization When the temperature is lower than 85 ° C, after forced air is discharged, steam formaldehyde is injected under negative pressure, and the articles to be sterilized are exposed to steam formaldehyde. Maintain a certain period of time in a stable state to meet sterilization requirements. 3.2 Chemical indicator The indicator and its carrier are combined in a predetermined form and exposed to one or more predetermined process variables in a low temperature steam formaldehyde sterilization procedure. Biochemical or physical changes. 3.3 Biological indicator A bacterial carrier having a determined resistance to the low temperature steam formaldehyde sterilization process under the set conditions. 3.4 D value D value The time required to kill 90% of the total number of specific microorganisms under set exposure conditions. 3.5 Survival time survial time; ST The maximum time that a particular microorganism tested survived under set exposure conditions. 3.6 Killing time; killing time; KT The minimum time required to kill a particular microorganism tested during exposure conditions.

4 indicator classification

4.1 Chemical indicators 4.1.1 Sterilization process indicator Indicates whether the sterilized items of each individual unit have undergone a sterilization procedure, including cards, tapes, labels, and the like. 4.1.2 Sterilization effect indicator It is used to prove whether the individual unit items have reached the set value of the selected parameter after the entire sterilization process. 4.2 Biological indicators 4.2.1 According to the structure, it can be divided into flaky biological indicators and self-contained biological indicators. The flaky biological indicators need to use positive control and negative. Control, while self-contained biological indicators only require a positive control. 4.2.2 According to the culture time, it can be divided into conventional biological indicators and rapid biological indicators.

5 General requirements for indicators

5.1 Medical low temperature steam formaldehyde sterilization process evaluation parameters should include the action time, temperature, formaldehyde concentration. 5.2 The packaging label and instructions shall comply with the requirements of the “Management Specifications for Labeling Instructions for Disinfecting Products”. 5.3 The indicator shall indicate its purpose. 5.4 Indicators should be combined with different process challenge devices to simulate the most difficult parts of the sterilization factor. 5.5 Indicators should indicate storage conditions and expiration dates. 5.6 After the sterilization cycle that meets the preset parameters, the indicator changes should be consistent with the manufacturer's specified qualification requirements; If the limit parameter does not meet or the preset parameters are unreasonable, the indicator change shall be inconsistent with the manufacturer's specified qualification requirements. 5.7 Biological indicators used for routine monitoring should be used in conjunction with chemical indicators. Both are qualified to achieve sterilization. 5.8 The indicator packaging material and carrier should avoid the selection of materials that adsorb formaldehyde, and should not affect the use of the indicator to ensure its harmless. 5.9 Take the packaged indicator and place it under the storage conditions of the production mark, store it to the specified validity period, take it out and evaluate it again. The display shall meet the technical requirements specified in this standard.

6 Chemical indicator requirements

6.1 Sterilization process chemical indicators The chemical indicator of the sterilization process shall be tested and meet the requirements as specified in Table 1. See Appendix A for the determination method. Table 1 Test and performance requirements for sterilization process indicators Test number Test Conditions Performance requirements Test time test temperature formaldehyde concentration A1 90 min±1 min 80°C±2°C 0 mol/L No change or change from manufacturer's specifications A2 20 s ± 5 s 60 ° C ± 0.5 ° C 1.0 mol/L ± 0.01 mol/L No change or different from the manufacturer's specified changes A3 15 min ± 15 s 70 ° C ± 2 ° C 1.0 mol/L ± 0.01 mol/L should be the same as the manufacturer's changes Note 1. If the process chemical indicator is only indicated for use in a sterilization cycle at temperatures below 55 ° C or above 65 ° C, the test in Table 1 shall be as specified by the manufacturer. The highest temperature and formaldehyde concentration are carried out. Note 2. In order to prove the applicability to special processes, the manufacturer's specified low temperature steam formaldehyde sterilization procedure should be added for additional functional testing. 6.2 Sterilization effect chemical indicator Sterilization effect chemical indicators shall be tested and meet the requirements in accordance with the conditions set forth in Table 2. See Appendix A for the determination method. Table 2 Test conditions and performance requirements for sterilization effect indicators Test number Test Conditions Performance requirement test time (min) test temperature (°C) Formaldehyde concentration (mol/L) B1 t T 0 No change or change from manufacturer's specifications B2 75% t T-3 80% C No change or change from manufacturer's specifications B3 t TC should be the same as the manufacturer's specified change Note. t is the test time specified by the manufacturer; T is the test temperature specified by the manufacturer; C is the formaldehyde concentration specified by the manufacturer.

7 Biological indicator requirements

7.1 indicator bacteria 7.1.1 The indicated strain should be Bacillus stearothermophilus or other strains of comparable performance. Recommended thermophilic Bacillus licheniformis NCIB 8224, DSM 6790, ATCC 7953, ATCC 10149, and ATCC 12980 were used for testing to prepare spores. If used For other strains, the resistance should be determined first. 7.1.2 The final product supplied by the manufacturer shall be free of bacteria. 7.2 indicator number and resistance 7.2.1 The manufacturer shall indicate the number and resistance characteristics of the indicator bacteria. 7.2.2 The number of indicator bacteria should be ≥1.0×105 CFU/carrier. For the indicator of the finished product, the amount of bacteria recovered by the carrier and the amount of bacteria in the instructions The error is between –50% and +300%. See Appendix B for the determination method. 7.2.3 At 60 ° C, the value of D in time (min) indicates the resistance of the indicator, accurate to one decimal place. Per batch The biological indicator or the carrier of the secondary/lot number should be marked with the corresponding D value. 7.2.4 The biological indicator indicates that the D value of the microorganism should be ≥ 6.0 min; other indicated microorganisms should have a D value that meets the conditions of use. See Appendix C for the determination method. 7.2.5 Verification of the D value, according to the measurement method of Appendix C. The ST value verifies the D value, and the sample should have all the bacteria growth; the KT value verifies the D value, and the sample It should have been grown aseptically. The ST value and the KT value are calculated according to the equations (1) and (2), respectively.   Value D×2lgST ON  ...(1)   Value D×4lgKT ON  ...(2) In the formula. ST--survival time in minutes (min); KT--kill time in minutes (min); N0--the average number of recovered bacteria per batch of biological indicators, in CFU/carrier. 7.3 Carrier and inner packaging 7.3.1 The test shall meet the following conditions. a) Exposure temperature. the maximum exposure temperature specified by the manufacturer for the carrier and inner packaging; if not specified by the manufacturer, the exposure temperature At least 100 ° C. b) Exposure time. at least 160 min. 7.3.2 Any material of the biological indicator system shall not remain or release any inhibitory test bacteria growth during and after sterilization. Substance. The measurement method was carried out in accordance with GB 18281.1. 7.3.3 The carrier and inner packaging shall not be damaged during the sterilization process. AA

Appendix A

(normative appendix) Chemical indicator detection method A.1 detector detection method A.1.1 The detector should be able to set, monitor and confirm parameters such as temperature, time and formaldehyde concentration. A.1.2 Sterilization process The chemical indicator is placed in the detector and tested according to the test conditions required by Table 1. The sterilization effect is placed on the chemical indicator. In the tester, test according to the test conditions required in Table 2. A.1.3 The same batch of chemical indicators shall be tested for not less than 10 in each test, and the test shall be not less than 3 times. A.2 Formaldehyde solution test (only applicable to the detection of chemical indicators prepared from materials without water absorption) A.2.1 Sterilization process indicator The formaldehyde solution is prepared according to the requirements of 6.1. The sterilization effect indicator is formulated according to the requirements of 6.2. liquid. A.2.2 Preheat the formaldehyde solution to the test temperature specified in 6.1 or 6.2. A.2.3 Place the chemical indicator on a fixed sample holder that does not affect the performance of the chemical indicator. A.2.4 Place the sample holder in a preheated formaldehyde solution, and ensure that the chemical indicator is immersed in the formaldehyde solution and measured according to the time specified in 6.1 or 6.2. test. A.2.5 Remove the sample holder from the formaldehyde solution to remove excess formaldehyde. The color of the indicator is maintained at a certain level within 1.5 minutes. Change again, detect the performance of the indicator, and record the results. A.2.6 The same batch of chemical indicators shall be tested for not less than 10 in each test, and the test shall be not less than 3 times. BB

Appendix B

(normative appendix) Biological indicator B.1 At least 4 bacterial carriers are tested for each batch of biological indicators. B.2 Take a sterile test tube containing 10 mL of TPS (0.1% tryptone in physiological saline solution), add appropriate amount of sterile glass beads, and give biological indications. The carrier of the infected bacteria is put into a test tube and thoroughly mixed with an electric mixer to prepare a bacterial suspension. B.3 Select the appropriate dilution of the bacterial suspension, and draw 1.0 mL of the well-mixed suspension into the sterile plate. Inoculate 2 for each dilution a plate. Generally, two to three dilutions are required. B.4 Pour the thermophilic bacillus spore recovery medium or the corresponding medium melted at 40 ° C to 45 ° C into the bacterial suspension In the dish, 15 mL to 20 mL per plate. B.5 After the agar is solidified, turn the plate upside down and place it in a constant temperature incubator at 56 °C ± 2 °C. B.6 Incubate to 72h and count the number of colonies. It is generally observed with the naked eye and, if necessary, with a magnifying glass. The number of reported colonies is between 15 CFU and 300 CF. The result of the dilution of U. B.7 Calculate the average number of colonies per bacterial carrier or each biological indicator based on dilution factor and inoculum size. CC

Appendix C

(normative appendix) Microbial resistance test method C.1 Vaccination carrier exposure conditions C.1.1 The concentration of formaldehyde in the aqueous solution is 1 mol/L ± 0.01 mol/L. C.1.2 Exposure temperature 60 °C ± 0.5 °C. C.1.3 The exposure time can be maintained from 1 min to 150 min with an accuracy of ±10 s. C.2 method C.2.1 Take 10 mL of formaldehyde solution in a test tube, preheat to the exposure temperature, and completely immerse the biological indicator carrier therein. C.2.2 Ensure that the carrier is completely immersed in the formaldehyde solution and minimize tube vibration. C.2.3 Strictly perform aseptic procedures. C.2.4 After the end of the exposure time, remove the carrier from the formaldehyde solution. C.2.5 After removing excess liquid from the surface of the carrier, place it in a 2% sodium sulfite solution neutralizer for at least 10 minutes to neutralize the residue. Leave the formaldehyde solution. Seal the tube and minimize vibration to prevent the test organisms on the carrier from falling out. Note. 2% sodium sulfite solution can be treated by filtration sterilization. Other neutralizing agents that are validated can also be used. C.2.6 Select the appropriate medium to resuscitate the test microorganism. Soy casein digestion medium is recommended. C.2.7 Transfer the carrier to a test tube containing 10 mL of medium and seal the tube. C.2.8 Place the tube at 90 ° C for 60 min. C.2.9 For the determination of the viable count, see Appendix B. C.3 Determination of D values by microbial survival curve method C.3.1 The sample is exposed to the exposure conditions specified in C.1. C.3.2 At least 5 exposures, including a) The sample is immersed in the formaldehyde solution in 1 exposure; b) having 1 exposure to reduce the total number of viable bacteria to at least 0.01% of the initial inoculum, and the amount of viable bacteria is greater than 50 CFU; c) At least 3 exposures during the two exposure intervals a) and b). C.3.3 The interval between each 2 adjacent exposures shall be equal. C.3.4 No less than 4 bacterial carriers should be used for each exposure in each measurement. The same number of identical samples must be used for each exposure. C.3.5 After each exposure, treat the sample according to C.2.4~C.2.9. C.3.6 Using the commonly used logarithm of the total number of surviving bacteria obtained, plot the time (min), and perform regression analysis by least squares method to determine The best linear curve. Regression analysis should not include surviving data points within the range of 0.51 og of the original inoculated bacteria. Calculated straight line slope The negative reciprocal value is equal to the D value expressed in minutes. See Table C.1 for examples of data. C.3.6.1 The slope of the best linear curve is calculated according to formula (C.1). )()( )()( 2AnC ABnG  ...(C.1) In the formula. m -- the slope of the best linear curve; n -- the sum of the data points; G -- the sum of the logarithm of the number of viable cells and the time between exposures; A -- the sum of exposure intervals; B -- the sum of the logarithm of the number of viable bacteria; C -- the sum of squared exposure intervals. Table C.1 Examples of D value data using microbial survival curve method Number of viable cells a Exposure interval (min) =t Log10y t t(log10y) (log10y) Y1 t1=0.0 log10y1 (t1 )=0 t1(log10y1)=0 (log10y1) Y2 t2 log10y2 (t2 ) t2(log10y2) (log10y2) Y3 t3 log10y3 (t3 ) t3(log10y3) (log10y3) Y4 t4 log10y4 (t4 ) t4(log10y4) (log10y4) Y5 t5 log10y5 (t5 ) t5(log10y5) (log10y5) itA  10log iyB  itC   10) (log Ii ytG  10) (log iyE Define variable ABCGE Note. Regression analysis should not include surviving data points in the range of 0.5 log10y1 C.3.6.2 D value is calculated according to formula (C.2). 1-value...(C.2) C.3.7 The linear correlation coefficient of the obtained viable strain curve should be not less than 0.8. The linear correlation coefficient is calculated according to formula (C.3).                nBEnAC nBAG //   ...(C.3) In the formula. E -- the sum of the squares of the logarithm of the number of viable cells. C.4 Calculate the D value by partial negative analysis C.4.1 The sample is exposed to the exposure conditions specified in C.1. C.4.2 There are at least 5 types of exposure, including. a) all test samples are grown under one exposure condition; b) part of the test sample is grown under two exposure conditions; c) All test samples did not grow after successive exposures under 2 exposure conditions. C.4.3 The interval between each 2 adjacent exposures shall be equal. C.4.4 No less than 20 bacterial carriers should be used for each exposure in each measurement. The same number of identical samples should be used for each exposure. C.4.5 After each exposure, the sample is inoculated with the enrichment solution containing the neutralizing agent, and the results are observed after the culture is carried out according to the temperature and time specified by the manufacturer. An example of the data is given in Table C.2. C.4.6 Calculation of D value C.4.6.1 Limited Holcomb-Spearman-Karber method (LHSKP), the average time of sterilization is calculated according to formula (C.4).  iKHSK r Dd UU ... (C.4) In the formula. ......

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