YY/T 0506.5-2009Surgical drapes, gowns and clean air suits for patients, clinical staff and equipment - Part 5: Test method for resistance to dry microbial penetration (English PDF)

1 Scope

This part of YY/T 0506 stipulates the test method that is used to evaluate the resistance of permeability to bacterial particles of barrier materials.

2 Normative references

The terms in the following documents become the terms of this part by reference to this part of YY/T 0506. For dated references, all subsequent amendments (not including errata content) or revisions do not apply to this part.

However, parties to agreements that are based on this part are encouraged to study whether the latest versions of these documents can be used. For undated references, the latest edition applies to this part.

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

The terms and definitions of YY/T 0506.1 apply to this part of YY/T 0506.

4 Principle

This test is carried out on test pieces that are respectively fixed on a container.

Among these containers, 5 containers that carry bacillus subtilis talc powder and 1 container that is added with untainted talc powder are used as controls.

Insert a petri dish at the bottom of each container that is close to the bottom of the test piece.

The equipment that supports the container is oscillated by a gas ball oscillator; all the talc powders that penetrate the test piece fall onto the petri dish; take out the petri dish and cultivate. Count the growing bacterial colonies.

5 Test conditions

Adjust the state and test the samples at 20 °C ± 2 °C and the relative humidity of 65% ± 5%.

6 Equipment

7 Procedure

7.2 Put the test pieces into sterilization bags and sterilize according to the method that is given by the manufacturer.

7.4 Use dead plates and fixtures to fix the bottom of the container to the slab reliably.

7.5 Remove the test piece from the bag by aseptic technique and place it on the mouth of each test container.

7.6 Fix the cover on the container by pushing the piston down, so that the test piece is fixed under a controlled degree of relaxation.

7.7 Remove the piston.

7.8 Add 0.5 g + 0.1 g of contaminated talc powder to the test piece through the piston mouth; add the uncontaminated talc powder to the sixth container as a control.

7.9 Use a film to seal the piston mouth.

7.11 Insert uncovered petri dishes through the narrow openings at the bottom of each container.

7.12 Use adhesive tape to close the narrow opening.

7.13 Vibrate for 30 minutes at a vibration frequency of 20 800 times per minute.

7.14 Remove the plastic bag and the adhesive tape.

7.15 Insert the cover of the petri dish through the narrow opening.

7.16 Take out the petri dish and incubate at 35 °C for 24 h.

7.17 Count the formed bacterial colonies. The read of the control dish should be 0. Otherwise, it indicates that there is foreign contamination, and the test should be terminated.

7.10 Cover a small plastic bag to each container

7.3 Place each container in a sterilization bag and sterilize

7.1 Cut 12 200 mm × 200 mm test pieces […]