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YY 0322-2018: High frequency electrocautery therapy equipment
Status: Obsolete YY 0322: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY 0322-2018 | English | 239 |
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3 days [Need to translate]
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High frequency electrocautery therapy equipment
| Obsolete |
YY 0322-2018
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| 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
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| 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
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| 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 0322-2018
Basic data | Standard ID | YY 0322-2018 (YY0322-2018) | | Description (Translated English) | High frequency electrocautery therapy equipment | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C42 | | Classification of International Standard | 11.040.60 | | Word Count Estimation | 6,612 | | Date of Issue | 2018-09-28 | | Date of Implementation | 2020-04-01 | | Older Standard (superseded by this standard) | YY 0322-2009 | | Quoted Standard | GB 9706.1-2007; GB 9706.4-2009; GB 9706.15-2008; GB/T 14710-2009; GB/T 16886.1-2011; YY 0505-2012; YY 1057 | | Regulation (derived from) | State Drug Administration Announcement No. 72 of 2018 | | Issuing agency(ies) | State Drug Administration | | Summary | This standard specifies the terms and definitions, composition, requirements, and test methods of the high frequency electrocautery therapeutic apparatus. This standard applies to the high frequency electrocautery treatment instrument defined in 3.1 (hereinafter referred to as the therapeutic device). | YY 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.
High frequency electrocautery therapy equipment
ICS 11.040.60
C42
People's Republic of China Pharmaceutical Industry Standard
Replace YY 0322-2009
High frequency electrocautery therapeutic apparatus
Published on.2018-09-28
2020-04-01 implementation
State Drug Administration issued
Foreword
This standard was 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, except for editorial modifications
The changes are as follows.
--- Revised the definition of high frequency electrocautery therapy device (see 3.1, 3.1 of.2009 edition);
--- Modified the output power requirements (see 5.2,.2009 version 4.2.2);
---Modified the requirements of 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);
--- Removed the definition of load impedance and output (3.2, 3.3 of.2009 edition);
--- Removed the requirements of the output controller (2009 version 4.2.5).
Please note that some of the contents of this document may involve patents. The issuing organization of this document is not responsible for identifying these patents.
This standard was proposed by the State Drug Administration.
This standard is under the jurisdiction of the National Medical Electrical Equipment Standardization Technical Committee Physical Therapy Equipment Subcommittee (SAC/TC10/SC4).
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 versions of this standard were released as follows.
---YY 0322-2000, YY 0322-2009.
High frequency electrocautery therapeutic apparatus
1 Scope
This standard specifies the terms and definitions, composition, requirements, and test methods of the high frequency electrocautery therapeutic apparatus.
This standard applies to the high frequency electrocautery treatment instrument defined in 3.1 (hereinafter referred to as the therapeutic device).
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article.
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
GB 9706.1-2007 Medical electrical equipment - Part 1. General requirements for safety (IEC 60601-1.1988, IDT)
GB 9706.4-2009 Medical electrical equipment - Part 2-2. Particular requirements for safety of high-frequency surgical equipment (IEC 60601-2-2.
2006, IDT)
GB 9706.15-2008 Medical electrical equipment - Part 1-1. Safety common requirements Parallel standard. Safety of medical electrical systems
Seeking (IEC 60601-1-1.2000, IDT)
GB/T 14710-2009 Environmental requirements and test methods for medical appliances
GB/T 16886.1-2011 Biological evaluation of medical devices - Part 1. Evaluation and testing in the process of risk management
(ISO 10993-1.2009, IDT)
YY 0505-2012 Medical electrical equipment - Part 1-2. Safety common requirements Parallel standard. Electromagnetic compatibility requirements and testing
(IEC 60601-1-2.2004, IDT)
YY 1057 medical foot switch general technical conditions
3 Terms and definitions
The following terms and definitions as defined in GB 9706.1-2007 and GB 9706.4-2009 apply to this document.
3.1
Unipolar HF surgical equipment with a rated output power not exceeding 50 W and intended without neutral electrodes.
4 composition
The high frequency electrocautery treatment device is usually composed of a host computer, a surgical accessory, a foot switch, and the like.
5 requirements
5.1 Working frequency
The operating frequency error should not exceed ±10% of the nominal value.
5.2 rated output power
The rated output of the therapy device should not exceed 50W and the error should not exceed ±20% of the nominal value.
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