GB 9706.5-1992
Replaced
YY/T 1904-2023
Active
Industry standards-Medicine
YY/T 1904-2023 Eye and face protectors for medical use
YY/T 1904-2023 Eye and face protectors for medical use
Basic Information
Standard Code:
YY/T 1904-2023
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical hygiene products
ICS Name:
Hospital equipment
Publish Date:
2023-11-22
Implement Date:
2025-12-01
Publisher:
国家药品监督管理局
Technical Committee:
全国医用防护器械标准化工作组(SAC/SWG 30)
Pages:
24 pages
Scope
本文件规定了医用防护眼罩和医用防护面罩的要求、试验方法、标志、包装、运输和贮存。
本文件适用于在医疗工作环境下佩戴,防止患者血液、体液、分泌物等直接溅入眼、面部引起感染的一次性使用的医用防护眼罩、医用隔离眼罩(以下简称眼罩)和医用防护面罩、医用隔离面罩(以下简称面罩)。
本文件不适用于非医用及其他医疗用途的眼罩和面罩。
Development Information
Drafting Units:
湖南省药品检验检测研究院、北京市医疗器械检验研究院(北京市医用生物防护装备检验研究中心)、上海市安全生产科学研究所、四川省药品检验研究院(四川省医疗器械检测中心)、可孚医疗科技股份有限公司、广州邦士度眼镜有限公司、长沙悦翼医疗科技有限公司、河南驼人贝斯特医疗器械有限公司、威海威高医用材料有限公司
Drafting Persons:
颜敏、刘磅、商景林、刘克洋、刘思敏、魏志刚、杨婧、伍亮、刘晓雪、胡志红、张菁、邢玉珊、黄海萍、曾思思、刘园园、张亚萍、赵丹、冉棋、李梦玉、胡广勇
Referenced Standards
GB/T 14233.1-2022 Test methods for infusion,transfusion,injection equipments for medical use—Part 1:Chemical analysis methods
GB/T 30042-2013 Personal protective equipment—Eye and face protection—Vocabulary
GB/T 32166.2-2015 Personal protective equipment—Eye and face protection—Occupational eye and face protectors—Part 2:Test methods
YY 0469-2023 Surgical mask
YY/T 0691-2008 Clothing for protection against infectious agents—Medical face masks—Test method for resistance against penetration by synthetic blood(fixed volume,horizontally projected)
中华人民共和国药典 2020年版 四部
GB/T 2410-1980 Transparent plastics—Transmissivity and haze test
GB/T 2410-2008 Determination of the luminous transmittance and haze of transparent plastics
GB/T 14866-1993 Universal technical requirements for eye and face protectors
GB 14866-2006 The specifications for personal eye-protectors
GB 14866-2023 General technical specification for eye and face protector
GB/T 16886.1-2001 Biological evaluation of medical devices—Part 1:Evaluation and testing
GB/T 16886.1-2011 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process
GB/T 16886.1-2022 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process
YY/T 0466.1-2009 Medical devices—Symbols to be used with medical device labels, labelling and information to be supplied—Part 1:General requirements
YY/T 0466.1-2016 Medical devices—Symbols to be used with medical device labels,labelling and information to be supplied—Part 1:General requirements
YY/T 0466.1-2023 Medical devices—Symbols to be used with information to be supplied by the manufacturer—Part 1:General requirements
Related Standards
GB 9706.6-1992
Replaced
GB 9706.6-1992 Particular requirements for the safety of microwave therapy equipment
GB/T 14710-1993
Replaced
GB/T 14710-1993 The environmental requirements and test methods for medical electrical equipment
GB 9706.7-1994
Replaced
GB 9706.7-1994 Medical electrical equipment—Particular requirements for the safety of ultrasonic therapy equipment
GB 12130-1995
Replaced
GB 12130-1995 Medical hyperbaric oxygen chamber
GB 9706.1-1995
Replaced