Some standard content:
GB15979—2002
The full text of this standard is mandatory.
Since the release of GB15979—1995 "Hygiene Standard for Disposable Hygiene Products" in 1996, it has made the production enterprises clear about the hygiene requirements and goals, and the management departments have also had a basis for supervision and monitoring, which has played a positive role in promoting the healthy development of the industry and improving the hygiene level. At the same time, with the development of product types and materials, there are some areas in this standard that need to be improved. Therefore, it is proposed to revise this standard. This standard replaces GB15979—1995 from the date of implementation. Appendices A to G of this standard are the appendices of the standard. This standard was proposed by the Ministry of Health of the People's Republic of China. The responsible drafting unit of this standard is: Shanghai Center for Disease Control and Prevention; participating drafting units: Procter & Gamble (China) Co., Ltd., Johnson & Johnson (China) Co., Ltd.
The main drafters of this standard are: Shen Wei, Lu Min, Yang Hongping, Zhou Mi, Pan Xihe, and Liu Yujing. 654
1 Scope
National Standard of the People's Republic of China
Hygienic standard for disposable sanitary products
Hygienic standard for disposable sanitary productsGB 15979—2002
Replaces GB15979--1995
This standard specifies the hygienic standards for products and production environment of disposable sanitary products, the standards for biological monitoring and evaluation of disinfection effects and the corresponding inspection methods, as well as the hygienic requirements for the production, disinfection, storage and transportation of raw materials and products and the requirements for product labeling. In this standard, disposable sanitary products refer to: This standard is applicable to domestic departments, units or individuals engaged in the production and sale of disposable sanitary products, and also to departments, units or individuals that distribute imported disposable sanitary products. 2 Referenced standards
The provisions contained in the following standards constitute the provisions of this standard through reference in this standard. When this standard is published, the versions shown are valid. All standards are subject to revision, and parties using this standard should explore the possibility of using the latest versions of the following standards. GB15981--1995 Evaluation methods and standards for disinfection and sterilization effects 3 Definitions
This standard adopts the following definitions.
Disposable sanitary products
Various daily necessities that are discarded after one use, come into direct or indirect contact with the human body, and are used to achieve human physiological hygiene or health care (antibacterial or antibacterial) and can be solid or liquid. For example, disposable gloves or finger cots (excluding medical gloves or finger cots), paper towels, wet wipes, sanitary wet wipes, phone films, hats, masks, underwear, women's menstrual hygiene products (including sanitary pads), diapers and other excrement hygiene products (excluding toilet paper such as wrinkled toilet paper), condoms, etc. are collectively referred to as "hygiene products" in this standard.
4 Product hygiene indicators
4.1 The appearance must be neat and tidy, in accordance with the inherent characteristics of the sanitary products, and must not have abnormal odors and foreign matter. 4.2 It must not cause adverse irritation and allergic reactions to the skin and mucous membranes and other harmful effects. 4.3 The products must meet the microbiological indicators in Table 1. Table 1
Microbiological indicators
Product types
Gloves or finger cots, paper towels, wet wipes, diapers, underwear, phone masks
Initial contamination bacteria!
Total bacterial colony count
cfu/g or cfu/mL
Approved by the General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China on March 5, 2002 Coliform group
Not detectable
Pathogenic pyogenic bacteria 2
Not detectable
Fungal colony count Total number
cfu/g or cfu/ml
Implementation on September 1, 2002
Product type
Antibacterial (or bacteriostatic) liquid products
Sanitary wet markets
Ordinary grade
Disinfection grade
Women's menstrual hygiene products
Ordinary grade
Disinfection grade
Diapers and other excrement hygiene products
Ordinary grade
Disinfection grade
Condoms
GB 15979-2002
Table 1 (end)
Initial contamination bacteria!
≤10000
≤10000
Total bacterial colony count
efu/g or cfu/ml
Microbiological indicators
Escherichia coli
Shall not be detected
Shall not be detected
Shall not be detected
Shall not be detected
Shall not be detected
Shall not be detected
Shall not be detected
Shall not be detected||t t||Not detectable
Pathogenic pyogenic bacteria 2
Not detectable
Not detectable
Not detectable
Not detectable
Not detectable
Not detectable
Not detectable
Not detectable
1) If the initial contaminating bacteria exceed the values in the table, the killing index should be increased accordingly to reach the bacterial and fungal limits specified in this standard. 2) Pathogenic pyogenic bacteria refer to Pseudomonas aeruginosa, Staphylococcus aureus and hemolytic Streptococcus. Total fungal colony count
efu/g or cfu/mL
Not detectable
Not detectable
Not detectable
≤100
Not detectable
Not detectable
4.4 In addition to meeting the microbiological standards in Table 1, the sanitary wipes must have a killing rate of ≥90% against Escherichia coli and Staphylococcus aureus. If the effect on fungi needs to be indicated, the killing rate against Candida albicans must also be ≥90%. The bactericidal effect must be maintained at room temperature for at least 1 year.
4.5 In addition to meeting the microbiological standards for similar products of the same level in Table 1, the antibacterial (or antibacterial) products must have an antibacterial rate of ≥50% (dissolution) or 26% (non-dissolution) against Escherichia coli and Staphylococcus aureus. If the effect on fungi needs to be indicated, the antibacterial rate of Candida albicans must also be ≥50% (dissolution) or 26% (non-dissolution). The antibacterial effect must be maintained for at least 1 year at room temperature. 4.6 When any sanitary product disinfected with ethylene oxide leaves the factory, the ethylene oxide residue must be ≤250μg/g. 5 Production Environmental Hygiene Indicators
5.1 The total number of bacterial colonies in the air of the assembly and packaging workshop should be ≤2500cfu/m. 5.2 The total number of bacterial colonies on the surface of the workbench should be ≤20cfu/cm. 5.3 The total number of bacterial colonies on the surface of the workers' hands should be ≤300cfu/hand, and no pathogenic bacteria should be detected. 6 Biological monitoring and evaluation of disinfection effect
6.1 Ethylene oxide disinfection: the killing index for Bacillus subtilis var. niger spores (ATCC9372) should be ≥10°. 6.2 Ionizing radiation disinfection: the killing index for Bacillus brevis spores E6d (ATCC27142) should be ≥103. 6.3 Pressure steam disinfection: the killing index for Bacillus stearothermophilus spores (ATCC7953) should be ≥10°. 7 Test methods
7.1 Product test methods
7.1.1 Product appearance: visual inspection, shall comply with the provisions of 3.1 of this standard. 7.1.2 Product toxicology test methods: see Appendix A. 7.1.3 Product microbial detection methods: see Appendix B. 7.1.4 Product bactericidal performance, antibacterial performance and stability test methods: see Appendix C. 7.1.5 Product ethylene oxide residue test methods: see Appendix D. 7.2 Production environment sampling and testing methods: see Appendix E. 656
GB15979—2002
7.3 Disinfection effect biological monitoring evaluation method: see Appendix F. 8 Raw material hygiene requirements
8.1 Raw materials should be non-toxic, harmless and non-polluting. Raw material packaging should be clean and clearly marked with the name of the contents, production unit, production date or production batch number; raw materials that affect the sanitary quality should not be exposed; raw materials with special requirements should be marked with storage conditions and shelf life. 8.2 There should be corresponding inspection reports or certification materials for raw materials that affect the sanitary quality of the product, and microbial monitoring and corresponding measures should be carried out when necessary.
8.3 It is prohibited to use discarded sanitary products as raw materials or semi-finished products. 9 Production environment and process hygiene requirements
9.1 The environment around the production area should be clean and free of garbage and pests such as mosquitoes and flies. 9.2 The production area should have enough space to meet production needs, and the layout must meet the production process requirements, with reasonable separation, personnel and material diversion, and no reverse and crossover in the product process. There should be anti-pollution measures and strict operating procedures for raw materials entering and finished products leaving to reduce microbial contamination in the production environment. 9.3. Effective dust-proof, insect-proof and rodent-proof facilities should be configured in the production area. The floor, wall and work surface should be flat, smooth, dust-free, easy to remove dust and clean and disinfect. There should be sufficient lighting and air disinfection or purification measures to ensure that the production environment meets the requirements of Chapter 5 of this standard. 9.4. Necessary production and quality inspection equipment should be configured, and complete production and quality inspection records should be kept to ensure the hygienic quality of the products. 9.5. If flammable or explosive items are used or harmful substances are produced during the production process, corresponding safety protection measures must be in place to comply with relevant national standards or regulations.
9.6. Raw materials and finished products should be stacked separately. Raw materials and finished products to be inspected, qualified and unqualified should be strictly stacked separately and clearly marked. The warehouse should be dry, clean and ventilated, with insect-proof and rodent-proof facilities and warehouse pads to meet product storage conditions. 9.7 When entering the production area, you must change into work clothes and work shoes, wear a work hat, and those who directly contact the naked products must wear masks, wash and disinfect their hands or wear gloves; there should be a dressing room, wash basin, disinfection pool and buffer zone in front of the production area. 9.8 People engaged in the production of sanitary products should maintain personal hygiene, not keep their nails, not wear jewelry when working, and long hair should be rolled up in the work hat. Patients with dysentery, typhoid, viral hepatitis, active pulmonary tuberculosis, condyloma acuminatum, gonorrhea and suppurative or exudative skin diseases or pathogen carriers shall not participate in production activities that directly contact the products. 9.9 People engaged in the production of sanitary products should undergo health examinations and health knowledge (including production hygiene, personal hygiene, relevant standards and specifications) training before taking up their posts and regularly (once a year), and only qualified persons can take up their posts. 10 Requirements for the disinfection process
10.1 The final disinfection of disinfection-grade products must use effective disinfection methods such as ethylene oxide, ionizing radiation or pressure steam. The disinfection equipment used must meet the relevant health standards.
10.2 According to the product hygiene standards, initial contamination bacteria and disinfection effect biological monitoring and evaluation standards, formulate disinfection procedures, technical parameters, and work systems, and strictly follow the established disinfection process after verification. The disinfection process should be re-verified and determined after changes in the disinfection procedures, technical parameters, or raw materials or production processes that affect the disinfection effect. 10.3 Each disinfection process must be monitored with corresponding process (physical) and chemical indicators, and monitored with corresponding biological indicators every month. Only when the process monitoring, chemical monitoring, and biological monitoring meet the specified requirements can the disinfected items leave the factory. 10.4 After the product is disinfected, the appearance and performance should not be significantly different from those before the disinfection. 11 Packaging, transportation, and purchase and storage requirements
11.1 The units or individuals that carry out the transportation or storage of sanitary products should strictly transport or store them in accordance with the transportation and storage requirements provided by the manufacturer.
11.2 Packaging materials that are in direct contact with the product must be non-toxic, harmless and clean. All packaging materials of the product must have sufficient sealing and firmness to ensure that the product is not contaminated under normal transportation and storage conditions. 657
12 Product labeling requirements
GB 159792002
12.1 Product labeling shall comply with the provisions of the "Product Quality Law of the People's Republic of China" and indicate the implemented health standard number, production date and shelf life (validity period) or production batch number and limited use date on the product packaging. 12.2 Disinfection-grade products shall also indicate the words "disinfection grade" and the disinfection date and validity period or disinfection batch number and limited use date on the sales packaging, and the words "disinfection grade" and the disinfection unit and address, disinfection method, disinfection date and validity period or disinfection batch number and limited use date on the transport packaging.
A1 Toxicology test indicators for various products
GB 15979—2002
Appendix A
(Appendix to the standard)
Product toxicology test methods
When changes in raw materials, production processes, etc. may affect product toxicity, a valid (government-certified third party) finished product toxicology test report should be provided according to Table A1 for different product types. Table A1
Product type
Gloves or finger cots, underwear
Antibacterial (or antibacterial) liquid products
Wet wipes, sanitary wet wipes
Women's menstrual hygiene products
Diapers and other excrement hygiene products
Condoms
Skin irritation test
Vaginal mucosa irritation test
Select according to use 1)
Select according to use 1
1) Products used for vaginal mucosa must undergo vaginal mucosa irritation test, but no skin irritation test is required. A2 Test method
Skin allergy test
Select according to materials
The skin irritation test, vaginal mucosa irritation test and skin allergy test methods shall be carried out in accordance with the corresponding test methods in the "Toxicology Experimental Technology of Disinfectants" in the "Experimental Technical Specifications" (3rd edition) of the Ministry of Health's "Disinfection Technical Specifications" (1999), Part I "Experimental Technical Specifications". The sample preparation method for solid products shall be carried out in accordance with A3. Notes
1 The blank control used in the skin irritation test should be: physiological saline and patch paper. 2 In skin allergy, the doses used in sensitization treatment and provocation treatment should be consistent. A3 Sample preparation
A3.1 For skin irritation test and skin allergy test, cut a patch-sized product in a cross-section. For dry products, such as diapers and women's menstrual hygiene products, moisten them with physiological saline and apply them to the skin, and then cover them with patch paper. For wet products, such as wet wipes, you can cut a suitable area as required, apply them directly to the skin, and then cover them with patch paper.
A3.2 Vaginal mucosal irritation test
A3.2.1 For dry products (such as women's menstrual hygiene products), cut a sufficient amount of the product in a cross-section, add sterile physiological saline at a ratio of 1g/10mL, seal it in an extraction container, stir it, and place it at 37°C ± 1°C for 24h. Cool it to room temperature, stir it, and precipitate the sample solution for inspection. A3.2.2 For wet products (such as sanitary wipes), on the day of the vaginal mucosal irritation test, squeeze out the additive in the wipes as a sample. A4 Judgment criteria
The corresponding part of "Final Judgment of Toxicological Test Results" in the Ministry of Health's "Technical Specifications for Disinfection" (third edition, first volume, "Technical Specifications for Experiments" (1999) shall be used as the test result judgment principle. B1 Product collection and sample processing
GB15979--2002
Appendix B
(Appendix to the standard)
Product microbiological detection method
At least 12 samples shall be selected from = transport packages of the same batch number. For the smallest sales package sample, 1/4 of the sample is used for testing, 1/4 of the sample is used for retention, and the other 1/2 of the sample (which can be sealed on site) is used for re-testing when necessary. The smallest sales package for sampling should not be broken and must not be opened before testing. Use a sterile method to open at least 3 packages for testing under Class 100 purification conditions, take samples from each package, and accurately weigh 10g ± 1g of sample. Cut it into pieces and add it to 200ml of sterile saline solution, mix it thoroughly, and get a saline sample solution. For liquid products, use the original solution directly as the sample solution.
If it is When the test sample contains a large amount of absorbent resin material and it is not possible to suck out enough sample liquid, the amount of diluent can be increased by 50mL each time until enough sample liquid can be sucked out for testing. Adjust the dilution accordingly when calculating the total bacterial colony count and the total fungal colony count. B2 Detection method of total bacterial colony count and initial contamination bacteria This method is suitable for the detection of initial contamination bacteria and total bacterial colony count of products (hereinafter collectively referred to as total bacterial colony count). B2.1 Operation steps
After the above-mentioned physiological saline sample solution has settled naturally, take the supernatant for colony count. Inoculate 5 blood cells in total, each Add 1ml of sample solution to each plate, then pour 15-20ml of melted nutrient agar medium cooled to about 45°C into each plate and mix well. After the agar solidifies, turn the plate over and incubate at 35°C ± 2°C for 48 hours, then count the number of colonies on the plate. B2.2 Result report
Plates with flake-like colonies should not be used; count the colonies on the plates that meet the requirements and calculate the results according to formula (B1): X, = A ×
Total number of bacterial colonies. cfu/g or cfu/mL; where: X.
A5 Total number of bacterial colonies on nutrient agar plates; K--dilution.
When the number of colonies is less than 100, report it as the actual number. When it is greater than 100, use two significant figures. If the total number of colonies in the sample exceeds the provisions of this standard, re-test and report the results according to B2.3. B2.3 Re-test method
...(B1 )
Retest the retained re-test samples twice according to the previous method. If the average value of the two results reaches the provisions of this standard, the sample is considered qualified; if any of the average values of the results exceeds the provisions of this standard, the sample is considered unqualified. B3 Coliform group detection method
B3.1 Operation steps
Take 5ml of sampling solution.Inoculate 50mL lactose bile salt fermentation tube, incubate at 35℃±2℃ for 24h. If no acid or gas is produced, report as coliform group negative. If acid and gas are produced, streak and inoculate eosin methylene blue agar plate, incubate at 35℃±2℃ for 18~24h, and observe the colony morphology on the plate. Typical coliform colonies are black purple or red purple, round, with neat edges, smooth and moist surface, often with metallic luster, and some are purple black with no or slight metallic luster, or pink with darker center. Take 1~2 suspected colonies for Gram staining microscopy, inoculate lactose fermentation tube at the same time, incubate at 35℃±2℃ for 24h, and observe the gas production.
B3.2 Result report
GB 15979—2002
If the lactose fermentation tube produces acid and gas, the lactose fermentation tube produces acid and gas, there are typical coliform colonies on the eosin-methylene blue plate, and the Gram stain is negative without bacillus, it can be reported that the sample detected Escherichia coli. B4 Pseudomonas aeruginosa detection method
B4.1 Operation steps
Take 5ml of the sample solution, add it to 50ml SCDIP culture medium, mix it thoroughly, and culture it at 35℃±2℃ for 18~24h. If Pseudomonas aeruginosa grows, a thin bacterial film will appear on the surface of the culture medium, and the culture medium is often yellow-green or blue-green. Pick the culture from the thin bacterial film of the culture medium, streak it on the hexadecane blue methyl ammonium bromide agar plate, and culture it at 35℃±2℃ for 18~24h to observe the characteristics of the colonies. Pseudomonas aeruginosa grows well on this culture medium, with flat colonies and irregular edges. The culture medium around the colonies is slightly pink, and other bacteria do not grow. Take a smear of the suspected colony for Gram staining. If the microscopic examination shows that it is Gram-negative bacteria, the following tests should be performed: Oxidase test: Take a small piece of clean white filter paper and place it in a sterilized plate. Use a sterile glass rod to pick up the suspected colony and smear it on the filter paper. Then add a drop of newly prepared 1% dimethyl paraphenylenediamine test solution on it. If pink or purple appears within 30 seconds, it is positive for the oxidase test. If it does not change color, it is negative.
Pyocyanin test: Take 2 to 3 suspected colonies and inoculate them on the slant of the culture medium for pyocyanin determination, culture at 35C2℃ for 24 hours, add 3 to 5 mL of chloroform, shake it thoroughly to dissolve the pyocyanin that may exist in the culture, and when the chloroform turns blue, use a pipette to transfer it to another test tube and add 1 ml of 1 mol/L hydrochloric acid. After shaking, let it stand for a while. If pink or purple appears on the upper layer, it is positive, indicating the presence of pyocyanin.
Nitrate reduction gas production test: Pick the pure culture of the colony to be tested and inoculate it in nitrate aged water culture medium, and incubate it at 35°C ± 2°C for 24 hours. If there is gas in the small inverted tube of the culture medium, it is positive. Gelatin liquefaction test: Take the pure culture of the suspected colony, puncture and inoculate it in the gelatin culture medium, and incubate it at 35°C ± 2°C for 24 hours. Take it out and place it at 4-10°C. If it is still liquid, it is positive, and if it is solidified, it is negative. 42 (Growth test: Take the suspected culture, inoculate it on a common agar slant medium, and culture it at 42C for 24 to 48 hours. If Pseudomonas aeruginosa grows, it is positive.
B4.2 Result report
After the sample is isolated and cultured by bacteria enrichment, it is confirmed to be a Gram-negative bacillus. If the oxidase and Pseudomonas aeruginosa tests are both positive, it can be reported that Pseudomonas aeruginosa is detected in the sample. If the pyocyanin test is negative, but the liquefied gelatin, nitrate reduction gas production and 42C growth test are all positive When the test sample is positive, Pseudomonas aeruginosa can still be reported. B5 Staphylococcus aureus detection method
B5.1 Operation steps
Take 5ml of the sample solution, add it to 50ml of SCDLP culture medium, mix it thoroughly, and incubate it at 35℃±2℃ for 24h. Take 1~2 inoculation loops from the above-mentioned enrichment solution, streak it on the blood agar medium, and incubate it at 35℃±2℃ for 24~～48h. On the blood agar plate! The colonies of this bacteria are golden yellow, large and protruding, round, and not Transparent, smooth surface, surrounded by hemolysis zone. Pick typical colonies, smear for Gram staining microscopy, Staphylococcus aureus is a Gram-positive coccus, arranged in grape shape, without spores and capsules. If the microscopic examination meets the above conditions, the following tests should be carried out: Mannitol fermentation test: Take the above colonies and inoculate mannitol culture solution, place at 35°C ± 2°C for 24 hours, and those that ferment mannitol to produce acid are positive.
Plasma coagulase test: Slide method: Take a clean and dry slide, add a drop of physiological saline to the end, Add a drop of rabbit plasma to the other end, pick up the colonies and mix them with saline and plasma respectively. If lumps or granular clots appear in the plasma within 5 minutes, and the saline drop is still uniformly turbid and without coagulation, it is positive. If both do not coagulate, it is negative. If both the saline drop and the plasma drop show coagulation, perform the test tube coagulase test; Test tube method: draw 0.5mL of 1:4 fresh plasma, put it in a sterile small test tube, and add an equal amount of 0.5mL of 24h broth culture of the bacteria to be tested. Mix well, 661
GB 15979--2002
Put it in a 35C±2℃ incubator or water bath, observe it every half an hour, and it is positive if clots appear within 24 hours. At the same time, add 0.5mL of broth culture of known plasma coagulase-positive and -negative strains ml. as positive and negative controls. B5.2 Result report
If there are suspicious colonies growing on the agar plate, which are Gram-positive Staphylococci under microscopic examination, and can ferment mannitol to produce acid, and the plasma coagulase test is positive, it can be reported that the sample has detected Staphylococcus aureus. B6 Hemolytic Streptococcus Detection Method
B6.1 Operation steps
Take 5ml of the sample solution. Add to 50ml of glucose broth and culture at 35℃±2C for 24h. Inoculate the culture on the blood agar plate, and culture at 35℃±2C for 24h to observe the characteristics of the colonies. Hemolytic Streptococci are grayish white, translucent or opaque, with needle-like protrusions, smooth surface, neat edges, and colorless transparent hemolysis circles around them on the blood agar plate. Pick typical colonies for smear Gram staining and microscopic examination. They should be Gram-positive and cocci arranged in chains. If the microscopic examination meets the above conditions, the following tests should be performed:
Streptokinase test: Absorb 0.2mL of potassium oxalate plasma (mix 0.01g potassium oxalate with 5mL of free plasma, centrifuge and precipitate, absorb the supernatant), add 0.8ml of sterile saline, mix well, then add 0.5ml of 24h broth culture of the bacteria to be tested and 0.25ml of 0.25% calcium chloride. Mix well, put in a 35℃±2C water bath, observe once for 2min (generally it can coagulate within 10min), continue to observe and record the melting time after the plasma coagulates. If it does not dissolve within 2h, continue to place it for 24h for observation. If the clot is completely dissolved, it is positive, and if it still does not dissolve after 24h, it is negative. Bacitracin sensitivity test: Apply the test bacteria solution on the blood plate, use sterile tweezers to take a piece of paper containing 0.04 units of bacitracin and place it on the surface of the plate, and use a known positive strain as a control, and place it at 35℃±2℃ for 18~24h. The one with an inhibition zone is positive. B6.2 Result reportWww.bzxZ.net
Microscopic examination of Gram-positive chain-arranged cocci, hemolysis circles appear on the blood plate, and streptokinase and bacitracin tests are positive, and it can be reported that the sample tested has detected hemolytic streptococci.
B7 Fungal colony count detection method
B7.1 Operation steps
After the above-mentioned physiological saline sample solution is naturally settled, take the supernatant for fungal count. Inoculate 5 plates in total, add 1mL of sample solution to each plate, then pour 15-25mL of melted Sabouraud agar medium cooled to about 45℃ into each plate and mix well. After the agar solidifies, turn the plates over and place them at 25℃±2℃ for 7 days. Observe on days 3, 5, and 7, and count the number of colonies on the plates. If the colonies are found to spread, the previous colony count shall prevail.
B7.2 Result report
Plates with flake-like growth of colonies should not be used; count the colonies on the plates that meet the requirements, and calculate the results according to formula (B2): Xz=B×
Where: X2-total number of fungal colonies, cfu/g or cfu/mL; B—total number of fungal colonies on 5 Sabouraud agar plates; K dilution
When the number of colonies is within 100, report it according to the actual number, and use two significant figures when it is greater than 100. If the total colony count of the sample exceeds the requirements of this standard, retest and report the results according to B7.3. B7.3 Retest method
Retest the retained retest sample twice according to the previous method. If both results meet the requirements of this standard, the sample is deemed qualified; if any one of the results exceeds the requirements of this standard, the sample is deemed unqualified. 662
B8 Qualitative detection method for fungi
B8.1 Operation steps
GB 15979—2002
Take 5 ml of the sample solution and add it to 50 mL of Sabouraud culture medium. Incubate at 25°C ± 2°C for 7 days and observe daily for fungal growth. B8.2 Result report
If the culture tube is turbid, it should be transferred to Sabouraud agar medium. If fungal growth is confirmed, the sample can be reported as having detected fungi. Appendix C
(Standard Appendix)
Product bactericidal performance, antibacterial performance and stability test methods C1 Sample collection
In order to make the sample representative, at least 20 minimum sales packaging samples should be randomly selected from three transport packages of the same batch number, of which 5 samples should be retained, 5 samples should be tested for antibacterial or bactericidal performance, and 10 samples should be tested for stability. C2 Test bacteria and bacterial solution preparation
C2.1 Test bacteria
C2.1.1 Bacteria: Staphylococcus aureus (ATCC6538), Escherichia coli (8099 or ATCC25922). C2.1.2 Yeast: Candida albicans (ATCC10231). Preparation of bacterial solution: Take fresh culture (18-24h) of the nutrient agar medium slant of the 3rd to 14th generations of the strain, wash the bacterial lawn with 5mL 0.03mol/L phosphate buffer (hereinafter referred to as PBS), make the bacterial suspension uniform, and then dilute it with the above PBS to the required concentration. C3 Bactericidal performance test method
The sampling site of this test is determined according to the instructions of the manufacturer of the tested product. C3.1 Neutralizer identification test
The following neutralizer identification test must be passed for the bactericidal performance test. C3.1.1 Test grouping
1) Infected sample + 5mL PBS.
2) Infected sample + 5mL neutralizer.
3) Infected counter photo + 5mL neutralizer.
4) Sample + 5ml. Neutralizer + Infected counter photo. 5) Infected counter photo + 5mL PBS.
6) PBS from the same batch.
7) Neutralizer from the same batch.
8) Culture medium from the same batch.
C3.1.2 Evaluation regulations
1) Group 1 has no test bacteria, or only a few test bacteria colonies grow. 2) Group 2 has more test colonies than Group 1, but less than Groups 3, 4, and 5, and meets the requirements. 3) Groups 3, 4, and 5 have similar amounts of test bacteria growing, and the error rate of colony counts between groups should not exceed 15%.
4) Groups 6 to 8 have no sterile growth.
5) Qualified evaluation is obtained after 3 consecutive tests. 663
C3.2 Bactericidal test
C3.2.1 Operation steps
GB 15979—2002
Wash the 24h slant culture of the test bacteria with PBS to prepare a bacterial suspension (the required concentration is: drop 100μI. on the control sample, and the number of recovered bacteria is 1×104～9×10*cfu/piece). Take 4 pieces of the test piece (2.0cmX3.0cm) and the control piece (same material and size as the test piece, but does not contain antibacterial material and has been sterilized), divide them into 4 groups and place them in 4 sterilized plates. Take the above bacterial suspension, drop 100uI. on each sample and control sample, spread evenly, start timing, act for 2, 5, 10, 20min, use sterile tweezers to put the sample into the test tube containing 5mlL of the corresponding neutralizer, mix thoroughly, make appropriate dilutions, then take 2-3 dilutions, take 0.5mL respectively, put them on two flat plates, pour 15ml. of nutrient agar medium (bacteria) or Sabouraud agar medium (yeast) cooled to 40-45℃, turn the plate to make it fully uniform, turn the plate over after the agar solidifies, and culture at 35℃±2℃ for 48h (bacteria) or 72h (yeast), and count the live bacterial colonies. Repeat the test 3 times, and calculate the sterilization rate according to formula (C1): X3 = (A - B)/AX 100%
Where. X sterilization rate,%.
A-average colony count of control sample;
B-average colony count of test sample.
C3.2.2 Evaluation criteria
Sterilization rate ≥ 90%, the product has sterilization effect. C4 Dissolution antibacterial (inhibitory) product antibacterial performance test method C4.1 Operation steps
Wash the 24-hour slant culture of the test bacteria with PBS to prepare a bacterial suspension (the required concentration is: drop 100μI. on the control sample or in 5ml sample solution, and the number of recovered bacteria is 1×104～9×10*cfu/piece or mL). Take 4 pieces (placed in sterilization plane III) or 4 tubes of the test piece (2.0cm×3.0cm) or sample solution (5mL) and the control piece or sample solution (same material and size as the test piece, but does not contain antibacterial material and has been sterilized). Take the above bacterial suspension, drop 100μL on or into each sample piece or sample solution and control sample piece or sample solution, and evenly spread/mix. Start timing, and act for 2, 5, 10, and 20 minutes. Use sterile tweezers to put the sample piece or sample solution (0.5mL) into a test tube containing 5mL PBS, mix thoroughly, and make appropriate dilutions. Then take 2~3 dilutions, take 0.5mL respectively, put them on two flat plates, and pour 15mL of nutrient agar medium (bacteria) or Sabouraud agar medium (yeast) cooled to 40~45℃, rotate the plate to make it fully uniform, turn the plate over after the agar solidifies, and culture at 35℃±2℃ for 48h (bacteria) or 72h (yeast) to count the live colonies. The test was repeated 3 times, and the antibacterial rate was calculated according to formula (C2): X, = (A - B)/AX 100%
Wherein: X--inhibition rate, %;
A. Average colony count of control sample;
B-average colony count of test sample.
C4.2 Evaluation criteria
If the antibacterial rate is ≥50%~90%, the product has antibacterial effect; if the antibacterial rate is ≥90%, the product has strong antibacterial effect. C5 Test method for antibacterial performance of non-dissolving antibacterial (inhibitory) products C5.1 Operation steps
Weigh 0.75g of the test piece (cut into 1.0cm×1.0cm size) and pack it in aliquots. ·( C2
Put 0.75g of the heavy sample into a 250ml conical flask, add 70mL PBS and 5mL bacterial suspension respectively, so that the concentration of the bacterial suspension in PBS is 1×101～9×10cfu/mL.664
GB 15979—2002
Fix the conical flask on an oscillating shaker and shake at 300r/min for 1h. Take 0.5mL of the shaken sample solution, or the sample solution appropriately diluted with PBS, inoculate the sample solution with the agar pouring method, and count the colonies. At the same time, set up a control sample group and a group without sample. The control sample of the control sample group is the same size as the sample but does not contain antibacterial ingredients. The other operating procedures are the same as those of the sample group. In the group without sample, take 5ml of bacterial suspension and 70mL of PBS respectively, add them to a 250mL conical flask, mix them, and take 0.5ml of the mixture of bacterial suspension and PBS at 0 time and after shaking for 1h, and then count the colonies.
The test was repeated 3 times, and the antibacterial rate was calculated according to formula (C3): Xs = (A - B)/AX 100%
Where: X,---inhibition rate,%;
A·Average colony count of the test sample before oscillation; B——Average colony count of the test sample after oscillation. C5.2 Evaluation criteria
·(C3)
The colony count of the group without sample is between 1×104 and 9×10*cfu/mL, and the difference in the average colony count before and after sample oscillation is within 10%, the test is valid; the inhibition rate of the test sample group is higher than that of the control sample group If the difference in rate is >26%, the product has antibacterial effect. C6 Stability Test Method
C6.1 Test Conditions
C6.1.1 Natural Sample Retention: Place the original packaged sample at room temperature for at least 1 year, and perform antibacterial or bactericidal performance test every six months. C6.1.2 Accelerated Test: Place the original packaged sample in a 5457℃ constant temperature box for 14 days or a 37~～40℃ constant temperature box for 3 months, maintain a relative humidity of 75%, and perform antibacterial or bactericidal performance test. C6.2 Evaluation criteria
After natural sample retention, the sterilization rate or bacteriostasis rate of the product reaches the standard value specified in Appendix C3 or Appendix C4, Appendix C5, and the sterilization or bacteriostasis time of the product at room temperature is the natural sample retention time. After 54'C accelerated test, the sterilization rate or bacteriostasis rate of the product reaches the standard value specified in Appendix C3 or Appendix C4, Appendix C5, and the sterilization or bacteriostasis of the product is maintained for at least one year at room temperature. After 37C accelerated test, the sterilization rate or bacteriostasis rate of the product reaches the standard value specified in Appendix C3 or Appendix C4, Appendix C5, and the sterilization or bacteriostasis of the product is maintained for at least two years at room temperature. Appendix D
(Standard Appendix)
Test method for ethylene oxide residue in products
D1 Test purpose
Determine the time for the product to be put into use after disinfection. When new products or raw materials or changes in disinfection processes may affect the physical and chemical properties of the product, they should be tested. D2 Sample collection
After ethylene oxide disinfection, immediately randomly select a certain amount of small package samples from three large packages of the same disinfection batch number. The sampling volume should at least meet the required number of measurements (retain a certain amount for re-testing when necessary). The residual amount should be measured 24 hours after ethylene oxide disinfection and every few days thereafter until the residual amount drops below the standard value specified in 4.6 of this standard.
Tip: This standard content only shows part of the intercepted content of the complete standard. If you need the complete standard, please go to the top to download the complete standard document for free.