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YY/T 1904-2023: Eye and face protectors for medical use
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Eye and face protectors for medical use
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YY/T 1904-2023
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Basic data | Standard ID | YY/T 1904-2023 (YY/T1904-2023) | | Description (Translated English) | Eye and face protectors for medical use | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C48 | | Classification of International Standard | 11.140 | | Word Count Estimation | 22,245 | | Date of Issue | 2023-11-22 | | Date of Implementation | 2025-12-01 | | Issuing agency(ies) | State Drug Administration | | Summary | This standard specifies the requirements, test methods, marking, packaging, transportation and storage of medical protective goggles and medical protective masks. This standard applies to disposable medical protective goggles, medical isolation goggles (hereinafter referred to as goggles) and medical protective masks, medical Isolation mask (hereinafter referred to as mask). This standard does not apply to eye masks and face shields for non-medical and other medical purposes. | YY/T 1904-2023: Eye and face protectors for medical use---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
ICS 11.140
CCSC48
Pharmaceutical Industry Standards of the People's Republic of China
Medical protective eye (face) mask
Released on 2023-11-22
2025-12-01 Implementation
The State Drug Administration issued
Table of Contents
Preface III
1 Scope 1
2 Normative references 1
3 Terms and Definitions 1
4 Requirement 2
4.1 Eye mask 2
4.1.1 Appearance 2
4.1.2 Structural design 3
4.1.3 Connection firmness 3
4.1.4 Optical performance 3
4.1.5 Impact resistance 4
4.1.6 Anti-fog performance 4
4.1.7 Resistance to synthetic blood splatter (if applicable) 4
4.1.8 Protection performance 4
4.1.9 Microbiological indicators 4
4.1.10 Ethylene oxide residue 4
4.1.11 Biological evaluation 4
4.2 Mask 4
4.2.1 Appearance 4
4.2.2 Structural design 5
4.2.3 Connection firmness 5
4.2.4 Optical performance 5
4.2.5 Impact resistance 5
4.2.6 Anti-fog performance 5
4.2.7 Microbiological indicators 5
4.2.8 Ethylene oxide residue 5
4.2.9 Biological evaluation 6
5 Test methods 6
5.1 General Principles 6
5.2 Eye mask 6
5.2.1 Appearance 6
5.2.2 Structural design 6
5.2.3 Connection firmness 6
5.2.4 Optical performance 7
5.2.5 Impact resistance 8
5.2.6 Anti-fog performance 8
5.2.7 Resistance to synthetic blood splatter 8
5.2.8 Protection performance 8
5.2.9 Microbiological indicators 8
5.2.10 Ethylene oxide residue 9
5.2.11 Biological evaluation 9
5.3 Mask 9
5.3.1 Appearance 9
5.3.2 Structural design 9
5.3.3 Connection firmness 9
5.3.4 Optical performance 10
5.3.5 Impact resistance 10
5.3.6 Anti-fog performance 10
5.3.7 Microbiological indicators 11
5.3.8 Ethylene oxide residue 11
5.3.9 Biological evaluation 11
6 Sign 11
7 Packaging, transportation and storage 12
7.1 Packaging 12
7.2 Transportation12
7.3 Storage 12
Appendix A (Normative) Anti-fog performance test 13
Appendix B (Normative) Droplet protection performance test 15
Appendix C (Normative) Gas and fine dust protection performance test 16
Reference 17
Foreword
This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for standardization work Part 1.Structure and drafting rules for standardization documents"
Drafting.
Please note that some of the contents of this document may involve patents. The issuing organization of this document does not assume the responsibility for identifying patents.
This document is proposed by the State Food and Drug Administration.
This document is under the jurisdiction of the National Medical Protective Equipment Standardization Working Group (SAC/SWG30).
This document was drafted by. Hunan Provincial Institute of Drug Inspection and Testing, Beijing Institute of Medical Device Inspection (Beijing Medical Bioprotection
Equipment Inspection Research Center), Shanghai Institute of Work Safety Science, Sichuan Institute of Drug Inspection (Sichuan Medical Device Testing Center),
Kefu Medical Technology Co., Ltd., Guangzhou Bangshidu Eyewear Co., Ltd., Changsha Yueyi Medical Technology Co., Ltd., Henan Tuoren Best
Medical Equipment Co., Ltd., Weihai Weigao Medical Materials Co., Ltd.
The main drafters of this document are. Yan Min, Liu Bang, Shang Jinglin, Liu Keyang, Liu Simin, Wei Zhigang, Yang Jing, Wu Liang, Liu Xiaoxue, Hu Zhihong, Zhang Jing,
Xing Yushan, Huang Haiping, Zeng Sisi, Liu Yuanyuan, Zhang Yaping, Zhao Dan, Ran Qi, Li Mengyu, and Hu Guangyong.
Medical protective eye (face) mask
1 Scope
This document specifies the requirements, test methods, marking, packaging, transportation and storage of medical protective eyewear and medical protective masks.
This document is suitable for wearing in a medical working environment to prevent patients' blood, body fluids, secretions, etc. from splashing directly into the eyes and face and causing infection.
Disposable medical protective eye masks, medical isolation eye masks (hereinafter referred to as eye masks) and medical protective masks, medical isolation masks (hereinafter referred to as
mask).
This document does not apply to eye masks and face masks for non-medical and other medical purposes.
2 Normative references
The contents of the following documents constitute the essential clauses of this document through normative references in this document.
For referenced documents without a date, only the version corresponding to that date applies to this document; for referenced documents without a date, the latest version (including all amendments) applies to
This document.
GB/T 2410 Determination of light transmittance and haze of transparent plastics
GB/T 14233.1-2022 Inspection methods for medical infusion, blood transfusion and injection equipment Part 1.Chemical analysis methods
GB 14866 Technical requirements for personal eye protection
GB/T 16886.1 Biological evaluation of medical devices Part 1.Evaluation and testing in the risk management process
GB/T 30042-2013 Glossary of terms for personal protective equipment - eye and face protection
GB/T 32166.2-2015 Personal protective equipment Eye and face protection Occupational eye and face protection Part 2.Measurement methods
YY/T 0466.1 Medical devices Symbols for labelling, marking and providing information on medical devices Part 1.General requirements
YY 0469-2023 Medical surgical mask
YY/T 0691-2008 Test method for the resistance of medical masks used for protection against infectious pathogens to penetration by synthetic blood (fixed volume, water
Flat jet)
Pharmacopoeia of the People's Republic of China 2020 Edition Volume IV
3 Terms and definitions
The following terms and definitions apply to this document.
3.1
Eye mask goggle
Eye protection that is worn on the face and tightly around the eye sockets.
[Source. GB/T 30042-2013, 5.1.9, modified]
3.2
Face-shield
Protective gear that covers the eyes and all or most of the face and can be mounted directly on the head using a bracket and/or headband.
[Source. GB/T 30042-2013, 5.1.8, modified]
3.3
field of view
The range of visual acuity measured based on the position of the pupil and the lenses in the wearing position when the eye mask is placed on the appropriate head shape.
[Source. GB/T 30042-2013, 5.2.6, modified]
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