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YY/T 1633-2019 PDF in English


YY/T 1633-2019 (YY/T1633-2019, YYT 1633-2019, YYT1633-2019)
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YY/T 1633-2019: PDF in English (YYT 1633-2019)

YY/T 1633-2019
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.120
C 48
Single-use medical protective overboot
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 ... 7 
6 Marking and instructions for use ... 9 
7 Packaging and storage ... 10 
Single-use medical protective overboot
1 Scope
This Standard specifies the technical requirements, test methods, marking and
instructions for use, packaging and storage of single-use medical protective
overboot.
This Standard applies to single-use medical protective overboot (hereinafter
referred to as protective overboot) used by medical personnel, disease control
and epidemic prevention workers when exposed to potentially infectious
pollutants such as blood, body fluids, secretions, excreta, vomit indoors.
Limited-use medical protective overboot may refer to this Standard.
This Standard does not apply to non-protective single-use medical overboot.
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 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 14233.1-2008 Test methods for infusion, transfusion, injection
equipment for medical use - Part 1: Chemical analysis methods
GB 15979-2002 Hygienic standard for disposable sanitary products
GB 19082-2009 Technical requirements for single-use protective clothing for
medical use
Pharmacopeia of the People's Republic of China, Volume IV (2015)
3 Terms and definitions
The following terms and definitions apply to this document.
3.1 Single-use medical protective overboot
A type of boot-like protective cover used to protect the feet and legs of medical
personnel, disease control and epidemic prevention workers, and prevent direct
exposure to potentially infectious pollutants.
4 Technical requirements
4.1 Structure and specification
4.1.1 The size design of the protective overboot shall be able to cover the user's
feet and legs. Its size shall conform to the design size of the identification, with
a tolerance of ±10%. A typical structural example of a protective overboot is
shown in Figure 1.
4.1.2 The structure of the protective overboot shall be reasonable and easy to
put on and take off.
4.1.3 The protective overboot shall be designed to have a form of closing, which
may adopt closing modes such as elastic closing, drawstring closing, or
strapping.
4.2 Appearance
4.2.1 The protective overboot shall be free of mildew spots. The surface is not
allowed to have defects such as impurities, adhesion, cracks, and damage.
4.2.2 The connection part of the overboot shall be flat and tight.
5.2.1 TAKE 3 samples and check them visually. The results shall meet the
requirements of 4.2.1.
5.2.2 TAKE 3 samples and check them visually. The results shall meet the
requirements of 4.2.2.
5.3 Properties
5.3.1 Impermeability to water
The protective overboot material is tested in accordance with the method of
GB/T 4744. The results shall meet the requirements of 4.3.1.
5.3.2 Resistance to synthetic blood penetration
The protective overboot material is tested in accordance with the test method
for resistance to synthetic blood penetration specified in Appendix A of GB
19082-2009. The results shall meet the requirements of 4.3.2.
5.3.3 Surface moisture resistance
The protective overboot material is tested in accordance with the method
specified in GB/T 4745. The results shall meet the requirements of 4.3.3.
5.3.4 Breaking strength
The protective overboot material is tested in accordance with the strip method
specified in GB/T 3923.1-2013. If the protective overboot is a plastic material,
the test gauge distance shall be set to 50 mm. The results shall meet the
requirements of 4.3.4.
5.3.5 Elongation at break
The protective overboot material is tested in accordance with the strip method
specified in GB/T 3923.1-2013. If the protective overboot is a plastic material,
the test gauge distance shall be set to 50 mm. The results shall meet the
requirements of 4.3.5.
5.3.6 Filter efficiency
TEST a minimum of 3 protective overboot samples. According to the method
specified in 5.7 of GB 19082-2009, determine the filter efficiency of the
protective overboot sample and the joints of the sample respectively. The
results shall meet the requirements of 4.3.6.
5.4 Microbiological index
The packing case of protective overboot 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 certificate number;
e) Specification and quantity;
f) Storage conditions and expiry date;
g) Production date or lot number.
6.2 Instructions for use
The instructions for use shall be in Chinese at a minimum and give at least the
following information:
a) Uses and restrictions of use;
b) Inspections required before use;
c) Method of use;
d) Storage conditions;
e) Meaning of the symbols, color codes, and/or illustrations used;
f) It shall give possible problems and precautions;
g) Recommendations on the usage time of protective overboot;
h) Executive standard number or product technical requirements number;
i) Product registration number;
j) Disposal method after use.
7 Packaging and storage
7.1 Packaging
7.1.1 The protective overboot shall be packaged to prevent mechanical damage
and contamination before use.
......
 
Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.