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YY/T 0322-2018: High frequency electrocautery therapy equipment
Status: Valid YY/T 0322: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 0322-2018 | English | 159 |
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3 days [Need to translate]
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High frequency electrocautery therapy equipment
| Valid |
YY/T 0322-2018
|
| YY/T 0322-2018 | English | 159 |
Add to Cart
|
3 days [Need to translate]
|
High frequency electrocautery therapy equipment
| Valid |
YY/T 0322-2018
|
| YY 0322-2009 | English | 319 |
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|
3 days [Need to translate]
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High frequency fulguration therapy equipment
| Obsolete |
YY 0322-2009
|
| YY 0322-2000 | English | 759 |
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5 days [Need to translate]
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High frequency electrocautery therapy equipment
| Obsolete |
YY 0322-2000
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PDF similar to YY/T 0322-2018
Standard similar to YY/T 0322-2018 YY 0778 YY 0950 YY 0903 YY/T 0323 YY/T 0324 Basic data | Standard ID | YY/T 0322-2018 (YY/T0322-2018) | | Description (Translated English) | High frequency electrocautery therapy equipment | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C42 | | Classification of International Standard | 11.040.60 | | Word Count Estimation | 7,771 | | Date of Issue | 2018-09-28 | | Date of Implementation | 2020-04-01 | | Issuing agency(ies) | State Drug Administration | | Summary | This standard specifies the terms and definitions, components, requirements, and test methods of high-frequency electrocautery therapeutic apparatus. This standard applies to the high-frequency electrocautery therapeutic apparatus (hereinafter referred to as therapeutic apparatus) defined in 3.1. | YY/T 0322-2018: High frequency electrocautery therapy equipment---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 0322-2018
Replace YY 0322-2009
High frequency electrocautery therapy device
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:2018-09-28
2020-04-01 Implementation
Released by the State Drug Administration
foreword
This standard is drafted in accordance with the rules given in GB/T 1:1-2009:
This standard replaces YY 0322-2009 "High Frequency Electrocautery Therapy Apparatus": Compared with YY 0322-2009, the main technical
The changes are as follows:
--- Modified the definition of high-frequency electrocautery therapeutic apparatus (see 3:1, 3:1 of the:2009 edition);
--- Modified the requirements for output power (see 5:2, 4:2:2 of the:2009 edition);
--- Modified the requirements for the output indicating device (see 5:4, 4:2:4 of the:2009 edition);
--- Increased standby noise, random file requirements (see 5:5, 5:8);
--- Modified the requirements for electromagnetic compatibility (see 5:11, 4:4 of the:2009 edition);
--- Deleted the definition of load impedance and output (3:2, 3:3 of the:2009 edition);
--- Deleted the output controller requirements (4:2:5 of the:2009 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: Tianjin Medical Device Quality Supervision and Inspection Center:
The main drafters of this standard: Liu Bo, Li Yanan, Qi Lijing, Han Mo, Ji Caiyan, Wu Gang:
The previous editions of this standard are as follows:
---YY 0322-2000, YY 0322-2009:
YY 0322-2018
High frequency electrocautery therapy device
1 Scope
This standard specifies the terms and definitions, components, requirements, and test methods of high-frequency electrocautery therapeutic apparatus:
This standard applies to the high-frequency electrocautery therapeutic apparatus (hereinafter referred to as therapeutic apparatus) defined in 3:1:
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 9706:1-2007 Medical Electrical Equipment Part 1: General Safety Requirements (IEC 60601-1:1988, IDT)
GB 9706:4-2009 Medical Electrical Equipment Part 2-2: Special Requirements for Safety of High Frequency Surgical Equipment (IEC 60601-2-2:
2006, IDT)
GB 9706:15-2008 Medical Electrical Equipment Part 1-1: General Safety Requirements Collateral Standard: Safety Requirements for Medical Electrical Systems
Seek (IEC 60601-1-1:2000, IDT)
GB/T 14710-2009 Environmental requirements and test methods for medical electrical appliances
GB/T 16886:1-2011 Biological evaluation of medical devices Part 1: Evaluation and testing in the risk management process
(ISO 10993-1:2009, IDT)
YY 0505-2012 Medical Electrical Equipment Part 1-2: General Safety Requirements Collateral Standard: Electromagnetic Compatibility Requirements and Tests
(IEC 60601-1-2:2004, IDT)
YY 1057 General Technical Specifications for Medical Foot Switches
3 Terms and Definitions
The following terms and definitions defined in GB 9706:1-2007 and GB 9706:4-2009 apply to this document:
3:1
Monopolar high-frequency surgical equipment with a rated output power not exceeding 50W and intended for use without a neutral electrode:
4 components
The high-frequency electrocautery treatment instrument is usually composed of a host, surgical accessories, foot switches, etc:
5 requirements
5:1 Operating frequency
The operating frequency error should not exceed ±10% of the nominal value:
5:2 Rated output power
The rated output power of the therapeutic device should not exceed 50W, and the error should not exceed ±20% of the nominal value:
YY 0322-2018
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