YY/T 0506.7-2014Surgical drapes, gowns and clean air suits for patients, clinical staff and equipment - Part 7: Test methods for determination of cleanliness-microbial (English PDF)

Foreword

YY/T 0506 "Surgical drapes, gowns and clean air suits for patients, clinical staff and equipment" consists of the following parts.

- Part 1: General requirements for manufacturers, processors and products;

- Part 2: Performance requirements and performance levels;

- Part 3: Test methods;

- Part 4: Test method for linting in the dry state;

- Part 5: Test method for resistance to dry microbial penetration;

- Part 6: Test method to determine the resistance to wet bacterial penetration;

- Part 7: Test methods for determination of cleanliness-microbial. This Part is Part 7 of YY/T 0506.

This Part is drafted in accordance with the rules given in GB/T1.1-2009.

1 Scope

The method given in this Part of YY/T 0506 is applicable to the evaluation of cleanliness-microbial of surgical drapes, gowns and clean air suits.

2 Normative references

The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.

GB/T 19973.1 Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products

YY/T 0506.1 Surgical drapes, gowns and clean air suits for patients, clinical staff and equipment - Part 1: General requirements for manufacturers, processors and products

3 Terms and definitions

For the purpose of this document, the terms and definitions defined in GB/T 19973.1, YY/T 0506.1, YY/T 0506.2 and YY/T 0506.3 apply.

4 Principle

SET the suitable elution procedure, USE the bag peristalsis method to elute the microbials naturally contaminated on the sample, FILTER the eluent by membrane, CULTURE and COUNT the filter membrane, to obtain the total number of microbials eluted from the sample.

5 Instruments and reagents

5.2 Homogenizer, with sterile homogenate bag.

5.3 Filter device, with sterile filter bowl.

5.4 Sterile microporous membrane, with a nominal pore size of 0.45 µm.

6 Test methods

7 Method description

7.1 Some products may not achieve high recovery rate when eluted using the elution parameters recommended in 6.1.2. If the recovery rate is found to be less than 50 %, adjustments to the elution parameters and/or addition of surfactants may be considered.

7.3 In the routine inspection of a specific product, under the premise that the test method is not changed, the results may be calculated using the obtained correction factor, and it is not necessary to determine the correction factor for each test.

8 Test report

The test report should contain at least the following information. […]