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YY/T 1904-2023Eye and face protectors for medical use (English PDF)

医用防护眼（面）罩

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

November 22, 2023

Implementation date

December 1, 2025

Scope

YY/T 1904-2023 is the English-translated version of 医用防护眼（面）罩.

YY/T 1904-2023 is the Chinese standard "Eye and face protectors for medical use". Its scope clause reads: 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. Its clauses include terms and definitions.

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Document preview — YY/T 1904-2023

National Standard of the People's Republic of China

ICS: 11.140
Classification: C48

Issued by: National Medical Products Administration

Preface
1 Scope
2 Normative references
3 Terms and Definitions
4 Requirement
4.1 Eye mask
4.1.1 Appearance
4.1.2 Structural design
4.1.3 Connection firmness
4.1.4 Optical performance
4.1.5 Impact resistance
4.1.6 Anti-fog performance
4.1.7 Resistance to synthetic blood splatter (if applicable)
4.1.8 Protection performance
4.1.9 Microbiological indicators
4.1.10 Ethylene oxide residue
4.1.11 Biological evaluation
4.2 Mask
4.2.1 Appearance
4.2.2 Structural design
4.2.3 Connection firmness
4.2.4 Optical performance
4.2.5 Impact resistance
4.2.6 Anti-fog performance
4.2.7 Microbiological indicators
4.2.8 Ethylene oxide residue
4.2.9 Biological evaluation
5 Test methods
5.1 General Principles
5.2 Eye mask
5.2.1 Appearance
5.2.2 Structural design
5.2.3 Connection firmness
5.2.4 Optical performance
5.2.5 Impact resistance
5.2.6 Anti-fog performance
5.2.7 Resistance to synthetic blood splatter
5.2.8 Protection performance
5.2.9 Microbiological indicators
5.2.10 Ethylene oxide residue
5.2.11 Biological evaluation
5.3 Mask
5.3.1 Appearance
5.3.2 Structural design
5.3.3 Connection firmness
5.3.4 Optical performance
5.3.5 Impact resistance
5.3.6 Anti-fog performance
5.3.7 Microbiological indicators
5.3.8 Ethylene oxide residue
5.3.9 Biological evaluation
6 Sign
7 Packaging, transportation and storage
7.1 Packaging
7.2 Transportation
7.3 Storage
Appendix A (Normative) Anti-fog performance test
Appendix B (Normative) Droplet protection performance test
Appendix C (Normative) Gas and fine dust protection performance test

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] […]

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 21 pages — is available in the English PDF.

Referenced standards

Normative references

Similar standards

YY/T 1633|YY/T 1642|YY/T 1632|YY/T 1293.3|YY/T 1947

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