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YY/T 1499-2016 English PDF (YYT1499-2016)

YY/T 1499-2016 English PDF (YYT1499-2016)

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

This Standard stipulates the classification and relevant identification requirements for liquid barrier performance of protective apparel intended for use in health care facilities. This Standard is applicable to protective apparel identified with liquid barrier performance or liquid microorganism barrier performance. This Standard is inapplicable to other protective equipment used by medical personnel, such as: (1) protective equipment (for example, radiation protective apparel) that is not identified or not used for liquid or microbial barriers; (2) utensils or equipment for handling hazardous chemicals, chemotherapy drugs or hazardous wastes.
YY/T 1499-2016
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE REPUBLIC OF CHINA
ICS 11.120
C 48
Liquid Barrier Performance and Classification of
Protective Apparel Intended for Use in Health Care
Facilities
ISSUED ON: JULY 29, 2016
IMPLEMENTED ON: JUNE 1, 2017
Issued by: China Food and Drug Administration
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Normative References ... 4
3 Terms and Definitions ... 5
4 Requirements ... 5
5 Test Methods ... 9
Appendix A (informative) An Example of Classification of Barrier Properties of Protective Apparel ... 12
Appendix B (informative) An Example of Sampling Scheme ... 14
Bibliography ... 16
Liquid Barrier Performance and Classification of
Protective Apparel Intended for Use in Health Care
Facilities
1 Scope
This Standard stipulates the classification and relevant identification requirements for liquid barrier performance of protective apparel intended for use in health care facilities. This Standard is applicable to protective apparel identified with liquid barrier performance or liquid microorganism barrier performance.
This Standard is inapplicable to other protective equipment used by medical personnel, such as: (1) protective equipment (for example, radiation protective apparel) that is not identified or not used for liquid or microbial barriers; (2) utensils or equipment for handling hazardous chemicals, chemotherapy drugs or hazardous wastes.
This Standard is inapplicable to medical protective apparel that prevents penetration by solid particles or solid microorganisms.
This Standard does not include guidelines for medical institutions to properly handle or dispose reusable medical protective apparel.
2 Normative References
The following documents are indispensable to the application of this document. In terms of references with a specified date, only versions with a specified date are applicable to this document. In terms of references without a specified date, the latest version (including all the modifications) is applicable to this document. GB/T 4744-2013 Textiles - Testing and Evaluation for Water Resistance - Hydrostatic Pressure Method
YY/T 0689-2008 Clothing for Protection against Contact with Blood and Body Fluids - Determination of Resistance of Protective Clothing Materials to Penetration by Blood- borne Pathogens - Test Method Using Phi-X174 Bacteriophage
ISO 18695-2007 Textiles - Determination of Resistance to Water Penetration - Impact Penetration Test
The manufacturer shall provide the end user with technical information and / or training, so as to explain the barrier performance classification system and its significance. In accordance with product?€?s barrier performance level and the degree of possible contact between medical personnel and blood, body fluids or other potentially infectious materials in the corresponding environment of use, the end user shall be responsible for selecting appropriate products.
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 Test Methods
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 Appendix B
(informative)
An Example of Sampling Scheme
The sensitivity of any product inspection system is related to its quality control scheme and statistical sampling scheme, which is applicable to the product. Sampling scheme shall consider the risks of both the producer and the user. AQL and ??? are defined as the producer?€?s risk in the operating characteristic curve. This point is considered as ?€?the producer?€?s risk?€?, because under the circumstance where the overall non- conforming rate is less than or equal to AQL, it satisfies the producer?€?s expectation of high probability acceptance. (1-???) is the probability of the sample being accepted when the overall non-conforming rate has AQL; ??? represents the probability of the sample being rejected. On the other hand, RQL and ??? determine the rate of non-conforming products accepted with a small probability in the sampling scheme. This point is considered as ?€?the user?€?s risk?€?, because under the circumstance where the overall non- conforming rate is larger than or equal to RQL, it satisfies the user?€?s expectation of high probability rejection. (1-???) is the probability of the sample being rejected when the overall non-conforming rate has RQL.
Operating characteristic curve (OC) is often used to reflect sampling system?€?s capability in determination. This curve represents the change in the overall probability of acceptance as the lot?€?s non-conforming level changes. A high-quality level has a high acceptance probability. As the quality of the sample deteriorates, the acceptance probability will decrease.
In attribute sampling, these curves are usually calculated through the mode of binominal distribution. Figure B.1 is the operating characteristic curve of a sampling scheme (n = 32, Ac = 3). This curve provides a guarantee of the range of possible non- conforming levels.

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