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YY/T 1642-2019 English PDF (YYT1642-2019)

YY/T 1642-2019 English PDF (YYT1642-2019)

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YY/T 1642-2019: Single-use medical protective hood

This Standard specifies the technical requirements, test methods, marking and instructions for use, packaging and storage of single-use medical protective hood. This Standard applies to the single-use medical protective hood worn by medical personnel, disease control and epidemic prevention workers when exposed to potentially infectious pollutants. Limited-use medical protective hood may refer to this Standard.
YY/T 1642-2019
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE REPUBLIC OF CHINA
ICS 11.120
C 48
Single-use medical protective hood
ISSUED ON: JULY 24, 2019
IMPLEMENTED ON: FEBRUARY 01, 2021
Issued by: National Medical Products Administration
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Normative references ... 4
3 Terms and definitions ... 5
4 Technical requirements ... 5
5 Test methods ... 9
6 Marking and instructions for use ... 12
7 Packaging and storage ... 13
Single-use medical protective hood
1 Scope
This Standard specifies the technical requirements, test methods, marking and instructions for use, packaging and storage of single-use medical protective hood.
This Standard applies to the single-use medical protective hood (hereinafter referred to as protective hood) worn by medical personnel, disease control and epidemic prevention workers when exposed to potentially infectious pollutants. Limited-use medical protective hood may refer to this Standard.
This Standard does not apply to medical radiation protection hood, single-use medical hood, and single-use surgical hood.
2 Normative references
The following documents are indispensable for the application of this document. For the dated references, only the editions with the dates indicated are applicable to this document. For the undated references, the latest edition (including all the amendments) are applicable to this document.
GB/T 2410-2008 Determination of the luminous transmittance and haze of
transparent plastics
GB/T 3923.1-2013 Textiles - Tensile properties of fabrics - Part 1:
Determination of maximum force and elongation at maximum force using the strip method
GB/T 4744 Textiles - Testing and evaluation for water resistance - Hydrostatic pressure method
GB/T 4745 Textiles - Testing and evaluation for water resistance - Spray test method
GB/T 5455-2014 Textiles - Burning behaviour - Determination of damaged
length, afterglow time and afterflame time of vertically oriented specimens GB/T 12704.1-2009 Textiles - Test method for water-vapour transmission of fabrics - Part 1: Desiccant method
GB/T 14233.1-2008 Test methods for infusion, transfusion, injection
4.3.6??Antistatic property
The carried charge of the protective hood shall not be greater than 0.6 ??C/piece. 4.3.7 Electrostatic attenuation property
The electrostatic attenuation time of the main material of the protective hood shall not exceed 0.5 s.
4.3.8 Breaking strength
The breaking strength of the main material of the protective hood shall not be less than 40 N.
4.3.9 Elongation at break
The elongation at break of the main material of the protective hood shall not be less than 15%.
4.4 Luminous transmittance and haze
4.4.1 Luminous transmittance
The eye-protection lens's luminous transmittance to visible light shall not be less than 90%.
4.4.2 Haze
The haze of the eye-protection lens shall be ???4%.
4.5 Flame retardant property
The flame retardant property of the protective hood material shall meet the following requirements:
a) Damaged length is not more than 200 mm;
b) Afterflame time does not exceed 15 s;
c) Afterglow time does not exceed 10 s.
4.6 Microbiological index
4.6.1 The microbiological index of non-sterile protective hood shall meet the requirements of Table 2.
TAKE 3 samples and inspect them visually. The results shall meet the
requirements of 4.2.3.
5.3 Properties
5.3.1 Impermeability to water
Carry out the test according to the method of GB/T 4744. The results shall meet the requirements of 4.3.1.
5.3.2 Amount of water-vapour transmission
The material of the protective hood is tested in accordance with the method A desiccant method specified in GB/T 12704.1-2009. The results shall meet the requirements of 4.3.2.
5.3.3 Surface moisture resistance
The outer side of the protective hood material is tested in accordance with the spray test specified in GB/T 4745. The results shall meet the requirements of 4.3.3.
5.3.4 Resistance to synthetic blood penetration
Carry out the test according to GB 19082-2009 Appendix A. The results shall meet the requirements of 4.3.4.
5.3.5 Filter efficiency
TEST a minimum of 3 protective hood samples. According to the method of 5.7 in GB 19082-2009, determine the filter efficiency of the protective hood body and the joints respectively. The results shall meet the requirements of 4.3.5. 5.3.6 Antistatic property
Carry out the test according to the method specified in 5.9 of GB 19082-2009. The results shall meet the requirements of 4.3.6.
5.3.7 Electrostatic attenuation property
5.3.7.1 Test environment
Before testing the samples, place them in an environment with relative humidity of 50%??3% and temperature of 23 ??C??1 ??C for 24 h. The test is also performed under this condition.
5.3.7.2 Sampling
5.7 Ethylene oxide residue
Carry out the test according to the gas chromatography specified in Clause 9 of GB/T 14233.1-2008. The results shall meet the requirements of 4.7.
6 Marking and instructions for use
6.1 Marking
6.1.1 Marking of single package of protective hood
The single package of protective hood shall have at least the following information:
a) Product name and model;
b) Design specifications and tolerances;
c) Name of the manufacturing enterprise or supplier;
d) Executive standard number or product technical requirements number;
e) Product registration number;
f) It shall be marked with the words ?€?Please refer to the instructions before use?€? or relevant safety warning information;
g) Storage conditions and expiry date;
h) Production date or lot number;
i) For sterilized products, there shall be a corresponding sterilization mark. It shall indicate the sterilization method and the sterilization validity period; j) It shall mark "single-use" or related symbols.
6.1.2 Marking of packing case
The packing case of protective hood shall have at least the following information: a) Product name and model;
b) Name and address of the manufacturing enterprise or supplier;
c) Executive standard number or product technical requirements number;
d) Product registration number;

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