YY/T 1499-2016Liquid barrier performance and classification of protective apparel intended for use in health care facilities (English PDF)

4.2 Performance Requirements

4.2.1 Barrier properties

4.2.1.1 General rules

In accordance with 5.2.1, determine the barrier performance level of the protective zone and non-protective zone of protective apparel.

In accordance with the barrier properties of the critical zone, protective apparel shall be classified and identified. The liquid barrier performance of all the critical zone components, including seams and attachment points of accessories, shall be determined. In the form of numbers, the minimum barrier performance level of the critical zone components of the product shall be indicated. It is unnecessary to determine the liquid barrier performance level (see 4.2.3) of the seam between the critical zone and other protective zones and the seam between the critical zone and non-protective zone. In accordance with the performance of the product at the end of the indicated service life (for example, post-treatment performance in accordance with the mode and the times of treatment recommended by the manufacturer), determine the liquid barrier performance level of reusable medical protective apparel.

4.2.1.2 Level of barrier performance

In accordance with the stipulations in 5.2.1, conduct sampling and tests of the critical zone of protective apparel; classify protective apparel in accordance with the following stipulations and Table 1.

Level-1: under the conditions specified in 5.2.1, use the method specified in ISO 18695-2007, conduct liquid barrier performance test. The absorption capacity of all the critical zone components shall be not more than 4.5 g; AQL is 4% / RQL is 20%. In accordance with the stipulations in 4.1.3, the test result shall be reported in the manufacturer's product technical information.

Level-2: under the conditions specified in 5.2.1, use the method specified in ISO 18695-2007 and GB/T 4744-2013, conduct liquid barrier performance test. The absorption capacity of all the critical zone components shall be not more than 1.0 g; hydrostatic pressure shall be not less than 2 kPa 20 cm H2O; AQL is 4% / RQL is 20%.

In accordance with the stipulations in 4.1.3, the test result shall be reported in the manufacturer's product technical information.

The critical zone of protective apparel (excluding isolation apparel) shall at least include the area from the chest to the knee, and the area of sleeve from the cuff to the elbow. The manufacturer shall specify the exact size of the critical zone, and in accordance with the stipulations in 4.1.3 a), provide information of barrier performance of each critical zone component. The manufacturer shall also, in accordance with the stipulations in 4.1.3 b), provide detailed information of barrier performance of the non-critical zone.

Please refer to Appendix A for an example of the above-mentioned stipulations.

5.1 Identification

Conduct visual inspection. The result shall comply with the stipulations in 4.1.

5.2 Performance

5.2.1 Barrier properties

5.2.1.1 Sampling

Before conducting the liquid barrier performance test, conduct sampling in accordance with the following principles:

a) Sample size: when the manufacturer is determining whether the barrier performance level of critical zone components or other zones complies with the requirements in 4.1 and 4.2.1, an acceptable statistical design and analytical method shall be adopted to select a sample size that can ensure that AQL is not more than 4% / RQL is not more than 20%.

b) Sample: if the product uses different materials in different parts, then, each part shall respectively be sampled, whether it is inside or outside the critical zone.

Samples shall be taken from different products of the same lot. If multiple tests must be carried out (for example, when the critical zone is composed of more than one component, such as: the connection points of materials, seams and accessories), then, each component may be sampled from the same sample.

Each tested material and component shall comply with the requirements for final product in design and structure. In all the barrier performance tests, the outermost surface of the sample shall be used as the test layer. If the test area is a reinforced layer or constituted of multiple layers of materials, then, they shall be stacked in a correct order and tested together. When materials or components are tested in accordance with ISO 18695-2007 and GB/T 4744-2013, samples shall be placed in the same mode in each test. When the test