YY/T 0952-2022 English PDF

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YY/T 0952-2022: Clinical thermoregulatory equipment
Status: Valid

YY/T 0952: Historical versions

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 0952-2022	219	Add to Cart	3 days	Clinical thermoregulatory equipment	Valid
YY 0952-2015	439	Add to Cart	3 days	Temperature control blanket for medical use	Obsolete
YY/T 0952-2015	439	Add to Cart	3 days	Temperature control blanket for medical use	Obsolete

Similar standards

YY/T 1095   YY 0950   YY 0900   YY/T 0951   

Basic data

Standard ID: YY/T 0952-2022 (YY/T0952-2022)
Description (Translated English): Clinical thermoregulatory equipment
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C42
Word Count Estimation: 10,179
Date of Issue: 2022-10-17
Date of Implementation: 2023-10-01
Older Standard (superseded by this standard): YY/T 0952-2015
Issuing agency(ies): State Drug Administration
Summary: This standard specifies the composition and requirements of medical temperature controllers, and specifies the corresponding test methods. This standard is applicable to the equipment used in the clinical environment of medical institutions, through heat exchange between blankets, pads and other components and the human body, to physically heat up and/or cool down the human body outside the body, to achieve the purpose of assisting in regulating body temperature.

YY 0952-2015: Temperature control blanket for medical use

---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.
Temperature control blanket for medical use ICS 11.040.60 C42 People's Republic of China pharmaceutical industry standards Medical temperature control blanket Issued on. 2015-03-02 2017-01-01 implementation China Food and Drug Administration released

Foreword

The standard safety requirements for full implementation of the GB 9706.1-2007 "Medical Electrical Equipment Part 1. General requirements for safety," the Provisions. Electromagnetic compatibility requirements of this standard fully implement the YY 0505 "Medical electrical equipment - Part 1-2. General requirements for safety tie Standard. EMC requirements and test ". This standard was drafted in accordance with GB/T 1.1-2009 given rules. Please note that some of the content of this document may involve patents. Release mechanism of the present document does not assume responsibility for the identification of these patents. This standard was proposed by the China Food and Drug Administration. This standard by the National Technical Committee of Standardization for medical electrical physical therapy equipment at the Technical Committee (SAC/TC10/SC4) centralized. This standard was drafted. Tianjin, the State Food and Drug Administration Medical Device Quality Supervision and Inspection Center, the Beijing Municipal Drug Administration Bureau of Medical Devices Evaluation Center. The main drafters of this standard. Qili Jing, Chen Ran, Zhang Yun, Shuying Xia, Duan Chuan Ying, Wu Nan, Zhang Haiming, Sun is close. Medical temperature control blanket

1 Scope

This standard specifies the terms and definitions of medical temperature control blanket, classification and composition requirements, test methods, marking, labeling, manual, package Loading, transport and storage. This standard applies to medical temperature control blanket 3.1 Definitions (hereinafter referred to as "temperature control blanket"). This standard does not apply to the following devices. --- Hot splint therapy instrument; --- Only for the limbs and forehead cold/hot equipment.

2 Normative references

The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein Member. For undated references, the latest edition (including any amendments) applies to this document. GB/T 191-2008 Packaging - Pictorial signs GB 9706.1-2007 Medical electrical equipment - Part 1. General requirements for safety GB/T 14710-2009 medical electrical environmental requirements and test methods GB/T 16886.1-2011 Biological evaluation of medical devices - Part 1. Evaluation of the risk management process and Test YY 0505-2012 Medical electrical equipment - Part 1-2. General requirements for safety Collateral standard. Electromagnetic compatibility requirements and tests YY 0834-2011 Medical electrical equipment - Part 2. Medical electric blankets, heating pads and electric mattress safety requirements for

3 Terms and Definitions

The following terms and definitions apply to this document. 3.1 In clinical medical use of the environment, by controlling the temperature of the circulating liquid inside the device, with the human body in vitro physical warming and / Or cooling function, to regulate body temperature secondary purpose of the device. 3.2 The average load rate averageno-loadrate Under no-load conditions, the average liter of liquid circulating/cooling rate. 3.3 The maximum average load rate maximumaverageloadrate Under the specified load conditions, temperature control blanket may make analog load reaches maximum average L/cooling rate.

4 Classification and composition

4.1 Classification Single cold type, single-heat, hot and cold. ......

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