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

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

YY/T 1904 covers medical protective goggles and face shields, the eye and face protection worn against splashes of blood and body fluids and against airborne droplets. It specifies the requirements such protectors have to meet, the test methods that verify them, and the marking, packaging, transport and storage rules that accompany them. The properties at stake are the ones that decide whether the protection actually works in use: the field of vision, the optical quality of the lens, the resistance to liquid penetration and the fit against the face. Written into a Chinese standard after the demand surge of the pandemic years, it is the document a hospital tender or an export contract refers to, and the text a manufacturer certifies against when registering medical eye protection in China.

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

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]