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YY/T 0506.6-2009 English PDF (YYT0506.6-2009)

YY/T 0506.6-2009 English PDF (YYT0506.6-2009)

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YY/T 0506.6-2009: Surigical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment. Part 6: Test method to determine the resistance to wet bacterial penetration

YY/T 0506.6-2009
Surigical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment. Part 6. Test method to determine the resistance to wet bacterial penetration ICS 11.040
C46
People's Republic of China Pharmaceutical Industry Standard
YY/T 0506-6-2009/ISO 22610..2006
Surgical sheets for patients, medical staff and instruments,
Surgical gowns and clean clothes
Part 6. Test method for penetration of moisture-resistant microorganisms (ISO 22610..2006, IDT)
2009-06-16 released
2010--12-01 implementation
Issued by the State Food and Drug Administration
Foreword
YY/T 0506 "Surgical sheets, surgical gowns and clean clothes for patients, medical staff and instruments" consists of the following parts. --- Part 1. General requirements for manufacturers, treatment plants and products; --- Part 2. Performance requirements and performance levels;
--- Part 3. Test methods;
--- Part 4. Dry flocculation test method;
--- Part 5. Test method for blocking penetration of dry microorganisms; --- Part 6. Test method for penetration of moisture-resistant microorganisms. This part is the sixth part of YY/T 0506.
This part is equivalent to ISO 22610..2006 "Surgical drapes, surgical gowns and clean clothes for patients, medical staff and instruments to block wet bacteria Penetration testing method ".
Appendix A, Appendix B and Appendix C of this part are normative appendices. This part is under the jurisdiction of the Jinan Medical Device Quality Supervision and Inspection Center of the State Food and Drug Administration. This part was drafted by Shandong Medical Device Product Quality Inspection Center. The main drafters of this section. You Shaohua, Wang Wenqing, Hou Li, Wang Xin, Huang Jingchun. YY/T 0506-6-2009/ISO 22610..2006
introduction
There are many examples showing that in the wet state, the liquid can carry bacteria to migrate to and pass through the barrier material. For example, skin flora The wet penetration of the cover material.
The European Medical Device Guidelines clearly state that manufacturers are responsible for preventing device-related infectious diseases. Users recommend products that require coordinated and approved international test methods. The test methods described in this section use microbiological techniques and are therefore expected to be performed only in professional laboratories competent for such work. Note. Due to the complexity of this method, it is not suitable for routine quality control. YY/T 0506-6-2009/ISO 22610..2006
Surgical sheets for patients, medical staff and instruments,
Surgical gowns and clean clothes Part 6.
Test method for penetration of moisture-resistant microorganisms
Warning. The use of this part of YY 0506 may involve hazardous materials, operations and equipment. This section does not cover all of the standard uses safe question. Before using this part, establish the corresponding safety and health operation specifications and determine the adaptability defined by the regulations is the user of this part Responsibility.
1 Scope
This part of YY/T 0506 specifies a test method and related test equipment (see Appendix A), which can be used to determine the material in the The ability to resist the penetration of bacteria in liquids during mechanical friction. 2 Normative references
The clauses in the following documents become the clauses of this part by citing this part of YY/T 0506. For all cited documents with dates, All subsequent amendments (not including errata content) or revisions are not applicable to this section, however, agreement is encouraged based on this section The parties concerned study whether the latest versions of these documents are available. For the cited documents without date, the latest version applies to this section. GB/T 397.2. Tear performance of textile fabrics Part 2. Determination of tear strength of tongue-shaped specimens (GB/T 397.1- 2009, ISO 13937-2..2000, IDT)
GB/T 39233.1 Tensile properties of textile fabrics Part 1. Determination of breaking strength and breaking elongation strip method (GB/T 3923.1-197, neq, ISO 13934-1..1994)
GB 6529 Standard atmosphere for humidity control and testing of textiles (GB/T 6529-2008, ISO 139..2005, MOD) GB/T 8629 Home washing and drying procedures for textile testing (GB/T 8269-2001, eqv ISO 6330..2000) GB 18278 Sterilization confirmation and routine control of medical and health care products require industrial wet heat sterilization (GB 18278-2000, idt (ISO 11134..1994)
GB/T 19633 Packaging for terminally sterilized medical devices (GB/T 1963-2005, ISO 11607..1997, IDT) YY/T 0287 is used in medical device quality management system for regulatory requirements (Y/T 0287-2003, ISO 13485..2003, IDT)
GB/T 20367 Sterilization of medical and health care products Confirmation and routine control requirements of humid heat sterilization in medical and health care institutions (GB/T 20367-2006, ISO 13683..1997, IDT)
ISO 15797 Textiles, Industrial Cleaning and Cleaning Procedures for Textile Workwear Testing 3 Terms and definitions
The following terms and definitions apply to this part of YY/T 0506.
3.1
Petri dish containing sterile nutrient agar medium.
Note. See Appendix B for the composition of the nutrient medium.
3.2
The material used to prepare the fungus slices.
YY/T 0506-6-2009/ISO 22610..2006
3.3
Materials used to cover patients, instruments, or specific surfaces, such as surgical drapes, to prevent fine skin bacteria and/or other non-sterile The bacteria reached the surgical wound.
3.4
Material contaminated with a known number of test bacteria specified strain propagules. 3.5
A part of the instrument for detecting the penetration of wet bacteria, which is used to contact the bacterial plate and the test piece with the surface of the agar culture dish. 3.6
Complete evaluation of each test piece taken from the sample, including five petri dishes to count the bacterial slices directly, the sixth petri dish is used for estimation The number of challenged bacteria remaining on the back of the test piece. 3.7
The test piece (25cm × 25cm) used to measure the penetration material of the moisture-resistant bacteria. 3.8
A standardized material used to assess the accuracy of a laboratory's wet penetration resistance bacteria penetration test. 3.9
Barrier properties to penetrate liquid carrying bacteria when subjected to mechanical friction. 4 Principle
Place the test piece on the agar Petri dish. Put a piece of bacteria with the same specifications (with the bacteria facing down) on the test piece, and then cover it with a thickness of about 10μm The high-density polyethylene (HDPE) film uses two tapered steel rings to clamp the three layers of material together and apply a certain amount of tensile force. A wear test The test finger is placed on the material and is used to apply the prescribed force to the bacterial patch and the test piece to bring the test piece into contact with the agar. The test refers to the rotation The rotating rod acts on the material within 15 min in such a way that it can move across the surface of the culture dish. The tightness of the material assembly depends on the steel ring itself Determine the weight to ensure that only a small area of the test piece is in contact with the agar surface at any one time. After the test has been conducted for 15 min, replace it with a new agar petri dish, and repeat the test with the same bacterial slice and test piece. Perform 5 sets of tests, each time operating 15min. This allows the test to estimate the total penetration time. Finally, the same technique is used to estimate the bacterial contamination on the test piece. To observe bacterial colonies, culture the agar petri dish, and then count the number of colonies. The results can be processed in a cumulative form to characterize the barrier performance of the material and the total time penetration (see Appendix C). 5 Reagents and materials
5.15 Groups of agar petri dishes, each group includes 6 petri dishes with a diameter of 14 cm and infused with nutrient agar (see Chapter B.4 and 7.1). 5.2 5 pieces of bacterial-bearing material, 25cm × 25cm, used to prepare bacterial slices (see 7.2). 5.3 5 pieces of high-density polyethylene (HDPE) film, 25cm × 25cm, thickness about 10μm, used for isolation test finger, HDPE film density should be 950kg/m3 ± 2kg/m3, the mass flow rate (190 ℃, 5kg) is 0.027g/min.
5.4 Staphylococcus aureus ATCC29213.
5.5 Five test samples, 25 cm × 25 cm (see 7.3).
YY/T 0506-6-2009/ISO 22610..2006
5.6 The reference material (used in 10.3) is composed of 135g/m2 microfilament polyester fiber, according to GB/T 8269 or ISO 15797 The washing process was washed three times.
6 Equipment
6.1 A cylinder with a diameter of about 9 cm and a height of 4 cm.
6.2 Equipment, as shown in Appendix A.
The device has an electrically driven, timer-controlled turntable that can hold a 14 cm diameter agar culture dish. End of horizontal rod The part is equipped with a vertical test finger, which can make the test finger reciprocate laterally from the center of the rotating (60r/min) agar culture dish to the periphery. use A counterweight that can be moved along a horizontal rod to adjust the force exerted on the material by the test finger, the rod is turned outward by a rotation of 5.60r/min Guided by the wheel. The test finger is removable and the head is a polished hemisphere with a radius of 11 mm. It should be disinfected between each test. The test means that the force of 3N ± 0.02N applied to the material can be measured with a dynamometer mounted on the rod, or with the day on the turntable Flat measurement. Set with removable weights.
Only one point of the test material is in contact with the agar at any given time. To ensure that the test finger moves across the agar surface, it should be used The method described in Chapter 10 is regularly monitored, and quality records for implementing the method should be retained. 7 Preparation of samples and test pieces
7.1 Agar Petri Dish
Introduce nutrient agar (see Appendix B) into six 14 cm diameter petri dishes to 3 mm ± 0.2 mm from the mouth of the dish. Before the test Prepare agar culture dishes (see 5.1) for 24h ± 4h and store them above the water so that the mass loss of the agar is minimized. Every joan Remove the lid of the lipid culture dish on a clean table and dry it at room temperature for 20 min. There should be no visible liquid (condensed water) on the agar surface. Petri dish height is right It is standardized, so the height of Petri dishes from different suppliers may be different. Therefore, the injection of agar with the correct distance of agar from the mouth of the dish should be determined The mass or volume of fat. When injecting agar into the dish, the method of volume measurement or weight measurement should be used, and the agar should be monitored from the mouth of the culture dish. Distance, you can place a razor blade in the center of the agar surface, and place a steel ruler across the mouth of the petri dish, and then measure with a wire gauge or vernier Measure the distance between the steel ruler and the blade. Each batch of Petri dishes should measure this distance and record it in the test report. 7.2 Bacterial-bearing materials
The bacteria-carrying material (see 5.2) should be a wettable 30-μm thick solvent-cast (solvent-cast) polyurethane film, in the machine direction The elongation rate is 350% ± 50%, and the lateral elongation rate is 400% ± 75%. The film is attached to paper. Cut a few pieces of 25cm × 25cm in size from the bacteria-bearing material, sandwich it between filter paper pieces and put them in a paper sterilization bag. GB/T 20367 uses 121 ° C steam sterilization.
7.3 Specimen
Under sterile conditions, according to GB/T 397.2 or GB/T 392.23.1, randomly select five pieces of 25cm × 25cm from the material to be tested Test piece or 25 cm diameter test piece.
8 steps
8.1 Preparation of bacterial tablets
Staphylococcus aureus ATCC29213 was cultured on pancreatin soybean agar at 36 ℃ ± 1 ℃ for 18h ~ 24h, and 2 ~ 3 colonies were connected In the soy broth (see Chapter B.2) from 3 to 3 mL of pancreatin, culture at 36 ℃ ± 1 ℃ for 18h ~ 24h. Use peptone water (see Chapter B.3) Dilute 1.10 to a concentration of 1 × 104CFU/mL to 4 × 104CFU/mL, and count the final bacterial suspension. Open the sterile bag and take out the polyurethane film still attached to the paper. Put the wettable polyurethane film surface of the bacteria-bearing material sheet (according to the supplier's instructions, such as If the wettable side is the side that is in contact with the attached paper, remove the attached paper from the film) and place it on a clean plate with the face up. For ease of operation, Use double-sided tape to fix the four corners of the bacteria-bearing material to the plate. Use the Petri dish cover as a template to mark a corresponding area on the bacterial membrane Field, apply 1.0 mL of Staphylococcus aureus suspension in this area, and then put the bacterial slices at 56 ° C to dry for about 30 min. During drying Use a sterilized glass applicator to continue coating the bacterial suspension on the bacteria-carrying membrane to make the bacterial solution evenly distributed. YY/T 0506-6-2009/ISO 22610..2006
Use the same day after the preparation.
8.2 Status adjustment
If necessary, adjust the state of the test piece according to GB 6529, or adjust and test the condition under standard normal room temperature conditions. shape The method of state adjustment shall be recorded in the test report.
8.3 Test setting
Adjust the weight on the control lever so that the force applied by the test finger to the agar is 3N ± 0.02N. Place the first agar Petri dish on the turntable.
8.4 Application of materials
Use the following technique. Use a round weight composed of inner and outer rings with a total weight of 800g ± 1g (see Figure A.2 and Figure A.3). Add standard tension. Place the cylinder (6.1) in the center of the inner ring, and then cover the test piece on the cylinder and the inner ring, after removing the attached paper The bacterial patch is placed face-down on the test piece. Finally, cover the polyurethane film with a layer of HDPE film and push down the outer ring to make the three layers of material firm Securely clamped between the two rings.
8.5 Test
Put the above ring assembly gently on the first agar culture dish with the lid removed, and the steel ring can be freely suspended outside the rotating disk. Will try The test finger is placed on the HDPE membrane inside the mouth of the dish so that the test piece can come into contact with the agar surface. The test refers to applying 3N pressure according to the above regulations, so that The instrument runs for 15 minutes.
After 15 minutes, immediately remove the ring kit and set it aside.
Remove the first Petri dish from the rotating disk and put the lid on. Immediately place the second Petri dish and ring kit on the rotating disk. Perform the above steps with the same ring assembly for the following four Petri dishes. After the five petri dishes were tested, the bacterial slices were removed and discarded. The test piece was turned upside down and covered with HDPE membranes. Operate 15min on the sixth petri dish to complete the first parallel test group. The remaining four specimens were also run in the same manner as above for six petri dishes each for 15 min, and each specimen used a freshly prepared bacterial slice. If liquid accumulates on the surface of the agar, place it on a clean bench and dry. Place each agar petri dish under cover and place at 36 ℃ ± 1 ℃ for 48h. Count the number of S. aureus colonies in each petri dish. The number of colonies in the 15 mm radius area in the center of the petri dish is not counted. If there is one or more dishes with a count greater than 750CFU (excluding the colonies in the 15mm radius area of the center of the culture dish mentioned above) Number), the test can be repeated. If the retest still has one or more dishes with a count greater than 750CFU, indicating that the material may not have sufficient Enough barrier characteristics can terminate the test.
Calculate the test results according to Appendix C.
9 Test report
The test report shall include the following.
a) proceed according to this section;
b) Check according to 10.2 and 10.3;
c) Test conditions, namely temperature and humidity;
d) The distance from the surface of the agar to the mouth of the petri dish; e) Identification of covering materials;
f) Description of the five test pieces cut according to 7.3;
g) The material containing bacteria complies with the instructions in 7.2; h) Colony count of 6 test petri dishes in each of 5 test pieces (parallel); i) Count of S. aureus suspension used.
10 Performance monitoring
10.1 General
The following two methods should be used to evaluate laboratory performance. There should be a documented procedure for performance monitoring, and the date of the most recent evaluation should be recorded. YY/T 0506-6-2009/ISO 22610..2006
10.2 Carbon paper
Use the steel ring described in 8.4 to assemble them in the order of a layer of white paper, a layer of carbon paper, and a layer of HDPE film. The diameter of the petri dish is placed on the rotating plate with the bottom face up, and the steel ring assembly is placed on the petri dish as described in 8.4. Start the operation for 15 minutes, remove the white paper, and check whether the test finger leaves a uniform and consistent contact mark on the entire Petri dish surface. 10.3 With reference materials
The control materials specified in 5.6 and the test methods given in this section shall be used to evaluate the accuracy of the laboratory. The frequency of evaluation shall be in accordance with YY/T 0287, so that the laboratory can check the accuracy and operator deviations. Before the inter-laboratory comparison, a In general use, the material cannot infer any information about the test method. The reference material should be packaged in a sterilization bag conforming to GB/T 1963, and sterilized by 121 ° C according to GB 18278. The test results of the reference material should be in the range of 0.70 to 0.96 indicated by RCU5 (see Appendix C). YY/T 0506-6-2009/ISO 22610..2006
Appendix A
(Normative appendix)
Equipment for testing the penetration of moisture-resistant microorganisms 1 --- Counterweight;
2 --- Balance bar with test finger;
3 --- Elastic balance sleeve;
4 --- stainless steel test finger;
5—-eccentric shaft;
6 --- Turntable;
7- Electronic timer;
8 --- spherical bearings.
Figure A. 1 Equipment
YY/T 0506-6-2009/ISO 22610..2006
The unit is mm
Figure A. 2 Inner ring
YY/T 0506-6-2009/ISO 22610..2006
The unit is mm
Figure A. 3 Outer ring
YY/T 0506-6-2009/ISO 22610..2006
Appendix B
(Normative appendix)
Nutrient medium
B. 1 Tryptic soy agar
Tryptone 15g
Soy flour papaya enzyme digest 5g
Sodium chloride 5g
17g agar
Distilled water 1000mL
Put the dry powder into water to heat, stir to dissolve and mix. Sterilize for 15 min at 121 ° C, shake well and mix well. B. 2 Tryptic Soy Broth
Tryptone 17g
Soy flour papaya enzyme digest 3g
Glucose 2.5g
Sodium chloride 5g
Dipotassium hydrogen phosphate 2.5g
Distilled water 1000mL
B. 3 Peptone water
Peptone 10g
Sodium chlo...

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