YY/T 1780-2021Medical personal protective equipment (English PDF)
医用个人防护系统
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
September 6, 2021
Implementation date
September 1, 2023
Scope
YY/T 1780-2021 is the English-translated version of 医用个人防护系统.
YY/T 1780-2021 is the Chinese pharmaceutical industry standard for the medical personal protective system worn in the operating room, the ensemble that shields the body, head and face of the staff from splashes of potentially infectious body fluid, from micro-organisms and from particles during invasive procedures.
It sets the composition and structure of the system, the requirements and the test methods, and the marks, instructions for use, packaging, transport and storage, covering the barrier performance of the materials and of the seams, the field of vision and the anti-fogging of the visor, the ventilation and the comfort of the wearer, and the way the system is put on and taken off. Issued on 6 September 2021, it has applied since 1 September 2023.
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Document preview — YY/T 1780-2021
National Standard of the People's Republic of China
- Classification
- C 48
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword
- 1 Scope
- 2 Normative references
- 3 Terms and Definitions
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
1 Scope
This standard specifies the composition and structure, requirements, test methods, signs and use of medical personal protective systems (hereinafter referred to as protective systems). Instructions, packaging, transportation, storage.
This standard is applicable to the operating room, in the invasive operating environment, in order to prevent potentially infectious body fluids, microorganisms and particulate matter from affecting the A medical personal protective system that provides isolation and protection from splashes on the body, head and face of medical staff in the operating room.
This standard does not apply to positive or negative pressure tight medical personal protective systems.
2 Normative references
The following documents are essential for the application of this document. For dated references, only the dated version applies to this document. For undated references, the latest edition (including all amendments) applies to this document.
GB/T 191-2008 Graphical signs of packaging, storage and transportation
GB/T 2410-2008 Determination of transmittance and haze of transparent plastics
GB 4793.1 Safety Requirements for Electrical Equipment for Measurement, Control and Laboratory Use Part 1: General Requirements
GB 4943.1 Information Technology Equipment Safety Part 1: General Requirements
GB 9706.1 Medical Electrical Equipment Part 1: General Requirements for Basic Safety and Essential Performance
GB/T 14710-2009 Environmental requirements and test methods for medical electrical appliances
GB/T 16886.1 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing in Risk Management Process
GB/T 18268.1 Electromagnetic Compatibility Requirements for Electrical Equipment for Measurement, Control and Laboratory Use Part 1: General Requirements
GB 19082-2009 Technical requirements for medical disposable protective clothing
GB/T 23315-2009 Velcro
YY 0505 Medical Electrical Equipment Part 1-2.Parallel Standard for General Requirements for Safety
YY/T 0506.2-2016 Surgical drapes, gowns and clean suits for patients, medical staff and instruments - Part 2: Performance requirements and experiment method
YY/T 1499-2016 Liquid barrier properties and classification of medical protective clothing Pharmacopoeia of the People's Republic of China (four volumes of the 2020 edition)
3 Terms and Definitions
The following terms and definitions apply to this document.
3.1 Medical personal protective system
It consists of a helmet, a helmet air supply system, a disposable hood, a disposable protective clothing, etc. It is worn by the operating room personnel to prevent blood loss.
Isolation protection system used in combination for the splashing and combined use of liquid, body fluids, powders and other pollutants on the body, head and face of the operating room personnel.
3.2 Protective clothing
As the body protection component of the medical personal protection system, it is used for medical personnel to contact potentially infectious patient body fluids, microbes during work.
......
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
- GB/T 191-2008Graphical symbols marking for handling and storage of packages
- GB/T 2410-2008Determination of the Luminous Transmittance and Haze of Transparent Plastics
- GB 4793.1Safety requirements for electrical equipment for measurement,control,andlaboratory use-Part 1:General requirements
- GB 4943.1Audio/video,information and communication technology equipment—Part 1: Safety requirements
- GB 9706.1Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- GB/T 14710-2009The environmental requirement and test methods for medical electrical equipment
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Related Standards
GB 4793.1-2007 — Safety requirements for electrical equipment for measurement,control,andlaboratory use-Part 1:General requirements
GB 4943.1-2022 — Audio/video,information and communication technology equipment—Part 1: Safety requirements
GB 9706.1-2020 — Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
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YY/T 1780-2021
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