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YY/T 0833-2020: General technical requirements for compression physiotherapy equipment for limbs
Status: Valid YY/T 0833: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 0833-2020 | English | 189 |
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General technical requirements for compression physiotherapy equipment for limbs
| Valid |
YY/T 0833-2020
|
| YY/T 0833-2020 | English | 189 |
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3 days [Need to translate]
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General technical requirements for compression physiotherapy equipment for limbs
| Valid |
YY/T 0833-2020
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| YY 0833-2011 | English | 399 |
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Compression physiotherapy equipment for limbs
| Obsolete |
YY 0833-2011
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PDF similar to YY/T 0833-2020
Standard similar to YY/T 0833-2020 YY 0778 YY 0950 YY 0903 YY 0838 YY 0839 Basic data | Standard ID | YY/T 0833-2020 (YY/T0833-2020) | | Description (Translated English) | General technical requirements for compression physiotherapy equipment for limbs | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C42 | | Classification of International Standard | 11.040.60 | | Word Count Estimation | 10,144 | | Date of Issue | 2020-02-21 | | Date of Implementation | 2022-01-01 | | Issuing agency(ies) | State Drug Administration | | Summary | This standard specifies the terms and definitions, classification and composition, requirements, and test methods of limb compression physiotherapy equipment (hereinafter referred to as equipment). This standard applies to electrical equipment that places a pressurized chamber around the limbs, applies positive pressure to the limbs according to a certain treatment procedure, and performs physical therapy on patients through changing air pressure. This standard does not apply to the following equipment: hemostatic equipment; anti-decubitus air cushion; shock wave therapy equipment; cupping device; air bag type external counterpulsation device; ballistic external pressure wave therapy equipment; training equipment for ischemic preconditioning; first aid equipment. | YY/T 0833-2020: General technical requirements for compression physiotherapy equipment for limbs---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.
ICS 11:040:60
C42
Pharmaceutical Industry Standard of the People's Republic of China
YY 0833-2020
Replace YY 0833-2011
General technical requirements for limb compression physiotherapy equipment
equipment for limbs
According to the State Drug Administration medical device industry
Standard Announcement (No: 76 of 2022), this standard is from
From September 7, 2022, it will be converted into a recommended standard, no
Enforce it again:
Released on 2020-02-21 Implemented on 2022-01-01
Released by the State Drug Administration
foreword
All technical contents of this standard are mandatory:
This standard is drafted in accordance with the rules given in GB/T 1:1-2009:
This standard replaces YY 0833-2011 "Extremity Compression Physiotherapy Equipment": Compared with YY 0833-2011, except for editorial modifications, the main
The technical changes are as follows:
--- Increased the definition of treatment pressure, pressure pulse width, output pressure (see Chapter 3);
--- Added requirements for treatment procedures and test methods (see 5:1, 6:1);
--- Modified the requirements and test methods for treatment pressure (see 5:2, 6:2, 5:3, 5:4, 5:5, 6:3, 6:4, 6:5 of the:2011 edition);
--- Modified the requirements and test methods for overvoltage protection (see 5:3, 6:3, 5:6, 6:6 of the:2011 edition);
--- Modified the requirements and test methods of the functional switch (see 5:4, 6:4, 5:8, 6:8 of the:2011 edition);
--- Modified the requirements and test methods for pressure relief measures (see 5:5, 6:5, 5:9, 6:9 of the:2011 edition);
--- Increased the requirements and test methods for fault prompts (see 5:6, 6:6);
--- Modified the requirements and test methods for working noise (see 5:7, 6:7, 5:15, 6:15 of the:2011 edition);
--- Modified the requirements and test methods for appearance and structure (see 5:8:1, 6:8:1, 5:2, 6:2 of the:2011 edition);
---Modified the requirements and test methods for pressure resistance (see 5:8:2, 6:8:2, 5:11, 6:11 of the:2011 edition);
--- Modify the fatigue performance requirements and test methods (see 5:8:3, 6:8:3, 5:12, 6:12 of the:2011 edition);
--- Modify the connection requirements (see 5:9, 5:14 of the:2011 edition);
--- Increased electromagnetic compatibility requirements and test methods (see 5:11, 6:11);
---Deleted the requirements and test methods for timing devices (see 5:7, 6:7 of the:2011 edition);
---Deleted the airtightness requirements and test methods (see 5:10, 6:10 of the:2011 edition):
Please note that some contents of this document may refer to patents: The issuing agency of this document assumes no responsibility for identifying these patents:
This standard was proposed by the State Drug Administration:
This standard is under the jurisdiction of the Physical Therapy Equipment Sub-Technical Committee (SAC/TC10/SC4) of the National Medical Electrical Appliances Standardization Technical Committee:
This standard was drafted by: Tianjin Medical Device Quality Supervision and Inspection Center, Chongqing Medical Device Quality Inspection Center, Sichuan Qianli Beiyi
Kang Medical Technology Co:, Ltd:, Kangdis (Shanghai) Medical Devices Co:, Ltd:
The main drafters of this standard: Gao Shan, Zhang Yun, Liu Bo, Zhou Ping, Jiang Yu, Wang Zhifang, Zhang Wen:
The previous releases of the standards replaced by this standard are as follows:
---YY 0833-2011:
YY 0833-2020
General technical requirements for limb compression physiotherapy equipment
1 Scope
This standard specifies the terms and definitions, classification and composition, requirements and test methods of limb compression physiotherapy equipment (hereinafter referred to as equipment):
This standard is applicable to putting the pressurized cavity around the limbs, applying positive pressure to the limbs according to a certain treatment procedure, and treating the patient with the changed air pressure:
Electrical equipment for physical therapy:
This standard does not apply to the following equipment:
---Hemostasis equipment;
---Anti-decubitus air cushion;
---Shock wave therapy equipment;
--- Cupping device;
--- Air bag type external counterpulsation device;
---Ballistic extracorporeal pressure wave therapy equipment;
--- Training equipment for ischemic preconditioning;
--- First aid equipment:
2 Normative references
The following documents are indispensable for the application of this document: For dated references, only the dated version applies to this document
pieces: For undated references, the latest version (including all amendments) applies to this document:
GB 9706:1 Medical Electrical Equipment Part 1: General Safety Requirements
GB/T 14710 Environmental requirements and test methods for medical electrical appliances
GB/T 16886:1 Biological evaluation of medical devices Part 1: Evaluation and testing
YY 0505 Medical Electrical Equipment Part 1-2: General Safety Requirements Collateral Standard: Electromagnetic Compatibility Requirements and Tests
3 Terms and Definitions
The following terms and definitions defined in GB 9706:1 apply to this document:
3:1
Put the pressurized cavity around the limb, apply positive pressure to the limb according to a certain treatment procedure, and perform physical therapy on the patient through the changing air pressure:
medical electrical equipment:
3:2
therapeutic sequence
It consists of parameters such as pressurization chamber type, pressurization sequence, treatment pressure, pressure holding time, intermittent time (if applicable), total treatment time, etc:
A complete output program that can be run automatically:
3:3
therapeutic pressure
In a specific treatment procedure, the target pressure expected to be delivered to the surface of the limb usually refers to the pressure that can be maintained for more than 1 second in a pressure maintenance phase:
YY 0833-2020
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