GB 9706.5-1992
Replaced
YY 1881-2023
Active
Industry standards-Medicine
YY 1881-2023 Powered air-purifying respirator(PAPR) used in healthcare settings
YY 1881-2023 Powered air-purifying respirator(PAPR) used in healthcare settings
Basic Information
Standard Code:
YY 1881-2023
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Public medical equipment
ICS Name:
Hospital equipment
Publish Date:
2023-06-20
Implement Date:
2025-07-01
Publisher:
国家药品监督管理局
Technical Committee:
医用生物防护产品标准化技术归口单位
Pages:
48 pages
Scope
本文件规定了医用正压送风式呼吸器的分类和标记、要求、检测方法、标志和使用说明、包装和储存。本文件适用于医疗工作环境或其他经评估存在病原微生物气溶胶暴露风险的环境下,用于过滤空气中的微生物颗粒,阻隔飞沫、血液等污染物的正压送风式呼吸防护装置。本文件不适用于有毒有害气体防护的动力送风式呼吸器,也不适用于工业粉尘、燃烧、爆炸、缺氧环境及逃生用呼吸器。
Development Information
Referenced Standards
GB/T 2410-2008 Determination of the luminous transmittance and haze of transparent plastics
GB 2626-2019 Respiratory protection—Non-powered air-purifying particle respirator
GB/T 3785.1-2010 Electroacoustics—Sound level meters—Part 1:Specifications
GB/T 12903-2008 Personal protective equipment terminology
GB/T 14710-2009 Environmental requirement and test methods for medical electrical equipment
GB/T 15508-1995 Acoustics—Speech articulation testing method
GB/T 21294-2014 Testing methods of physical and chemical performance of garments
GB 30864-2014 Respiratory protection—Powered air-purifying respirator
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)
ISO 16900-5:2016
ISO 16900-5:2016/Amd 1:2018
中华人民共和国药典 四部
GB 9706.1-1995 Medical electrical equipment—Part 1:General requirements for safety
GB 9706.1-2007 Medical electrical equipment—Part 1:General requirements for safety
GB 9706.1-2020 Medical electrical equipment—Part 1:General requirements for basic safety and essential performance
GB/T 14233.1-1998 Infusion,transfusion,injection equipment for medical use—Part 1:Chemical analysis methods
GB/T 14233.1-2008 Test methods for infusion,transfusion,injection equipments for medical use—Part 1:Chemical analysis methods
GB/T 14233.1-2022 Test methods for infusion,transfusion,injection equipments for medical use—Part 1:Chemical analysis methods
GB/T 16886.10-2000 Biological evaluation of medical devices—Part 10:Tests for irritation and sensitization
GB/T 16886.10-2005 Biological evaluation of medical devices—Part 10:Tests for irritation and delayed-type hypersensitivity
GB/T 16886.10-2017 Biological evaluation of medical devices—Part 10:Tests for irritation and skin sensitization
GB/T 16886.10-2024 Biological evaluation of medical devices—Part 10:Tests for skin sensitization
GB/T 24218.3-2010 Textiles—Test methods for nonwovens—Part 3:Determination of tensile strength and elongation(strip method)
YY 0469-2004 Technical requirements for surgical mask
YY 0469-2011 Surgical mask
YY 0469-2023 Surgical mask
YY/T 0866-2011 Total inward leakage determination method of protective face mask for medical use
YY 9706.102-2021 Medical electrical equipment—Part 1-2:General requirements for basic safety and essential performance—Collateral standard:Electromagnetic compatibility—Requirements and tests
YY/T 0866-2024 Total inward leakage(TIL) determination method of protective face mask for medical use
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