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 p...