YY/T 0506.6-2009Surgical 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 (English PDF)

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.

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.

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).

5.25 pieces of bacterial-bearing material, 25cm × 25cm, used to prepare bacterial slices (see 7.2).

5.35 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 °C, 5kg) is 0.027g/min.

5.5 Five test samples, 25 cm × 25 cm (see 7.3).

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.

7 Preparation of samples and test pieces

8 Steps

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

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 chloride 5g Polytriol ester 1g Distilled water 1000mL B. 4 Nutritional agar Beef extract 3g Peptone 5g Sodium chloride 8g 17g agar Distilled water 1000mL See Section B for the preparation method. Chapter 1, use within one day after preparing Petri dishes.

YY/T 0506-6-2009/ISO 22610.:2006

Appendix C (Normative appendix)

Calculation of test results C. 1 Calculation of the estimated total number of challenge bacteria The estimated total number of challenge bacteria T is calculated according to formula (C.1).

T = Z + X1 + X2 + X3 + X4 + X5 (C.1) In the formula.

Z --- After the five agar petri dishes were tested, the number of colonies remaining on the test piece was measured on the sixth agar petri dish;

X1, X5 --- the number of colonies on the five petri dishes in a parallel test with the same test piece and the same bacterial slice.

C. 2 Calculation Cumulative penetration rate of No. 1 to No. 5 dishes, RCU1, and RCU5 are calculated according to formula (C.2) to formula (C.6). (C.2) (X1 + X2) (C.3) (X1 + X2 + X3) (C.4) (X1 + X2 + X3 + X4) (C.5) (X1 + X2 + X3 + X4 + X5) (C.6)

C. 3 Calculation of bacterial penetration coefficient The bacterial penetration coefficient CBP is used to describe the relationship between penetration and time. The more previous data in this calculation, the greater the weight, but with the overall challenge The number of bacteria is irrelevant. Method calculation, including the following formula (7) and formula (8). (RCU1 + RCU2 + RCU3 + RCU4)

RCU5 + (C. 7) (4X1 + 3X2 + 2X3 + X4)

(X1 + X2 + X3 + X4 + X5) + (C.8)

From equation (C.8), it can be seen that CBP has nothing to do with the estimated total number of challenged bacteria (this total is obviously lower than the actual value). It also shows that When No. 1 to No. 4 Petri dishes have no penetration, CBP = 12 This has nothing to do with the counting of Petri dish No. 5.

C. 4 Calculation of barrier index Barrier index IB, used to indicate the fraction of challenge microorganisms that did not penetrate the barrier, but does not consider whether the test specimen penetrated early or late penetrate. It has been found that the magnitude of the value of IB gives an acceptable ranking of materials. CBP and RCU5 decrease with increasing barrier performance, while IB It increases with increasing barrier performance.

The IB can also be expressed in a variety of ways, including equations (C.9) and (C.10). From formula (C.9), we know that it is related to CBP and RCU5, namely

YY/T 0506-6-2009/ISO 22610.:2006 It is related to the estimated total number of challenge bacteria.

IB = 6- (CBP × RCU5) + RCUUM5 [] 2 (C.9)

IB = 6-(RCU1 + RCU2 + RCU3 + RCU4 + RCU5) (C.10)

YY/T 0506-6-2009/ISO 22610.:2006 Book YY/T 0506-6-2009/ISO 22610.:2006 references 602. OSI/9002-6. T/Y […]