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YY/T 1780-2021: (Medical personal protection system)
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YY/T 1780-2021
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Basic data | Standard ID | YY/T 1780-2021 (YY/T1780-2021) | | Description (Translated English) | (Medical personal protection system) | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C48 | | Word Count Estimation | 16,110 | | Issuing agency(ies) | State Drug Administration | YY/T 1780-2021: (Medical personal protection system)---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
(Medical personal protection system)
ICS 11.140
C48
People's Republic of China Pharmaceutical Industry Standard
Medical Personal Protection System
Published on 2021-09-06
2023-09-01 Implementation
Released by the State Drug Administration
foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that some content of this document may be patented. Publication of this document
Institutions do not assume responsibility for identifying these patents.
This standard is proposed by the State Drug Administration.
This standard is under the jurisdiction of Beijing Medical Device Inspection Institute.
This standard was drafted by. Beijing Medical Device Inspection Institute, Beijing Zhongke Shengkang Technology Co., Ltd., Beijing Medical Device Technology Review
center.
The main drafters of this standard. Yue Weihua, Jiang Leyang, Liu Simin, Ma Li, Zhao Dan, Zhang Yaping, Liang Zhenshi, Meng Zhiping, Chen Ran, Wang Chen, Li Jian,
Hu Guangyong.
Medical Personal Protection System
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 article
pieces. 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. Electromagnetic Compatibility Requirements and Tests
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
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 clothingprotectiveclothing
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.
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