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YY 0899-2020: General requirements for accessories of microwave equipment in medical practices
Status: Valid YY 0899: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY 0899-2020 | English | 189 |
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3 days [Need to translate]
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General requirements for accessories of microwave equipment in medical practices
| Valid |
YY 0899-2020
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| YY 0899-2013 | English | 479 |
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3 days [Need to translate]
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General requirements for accessories of microwave equipment in medical parctices
| Obsolete |
YY 0899-2013
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PDF similar to YY 0899-2020
Standard similar to YY 0899-2020 YY 0778 YY 0950 YY 0900 YY/T 0323 YY 0897 Basic data | Standard ID | YY 0899-2020 (YY0899-2020) | | Description (Translated English) | General requirements for accessories of microwave equipment in medical practices | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C42 | | Classification of International Standard | 11.040.60 | | Word Count Estimation | 10,155 | | Date of Issue | 2020-06-30 | | Date of Implementation | 2022-06-01 | | Issuing agency(ies) | State Drug Administration | YY 0899-2020: General requirements for accessories of microwave equipment in medical practices---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.
General requirements for accessories of microwave equipmentin medical practices
ICS 11.040.60
C42
People's Republic of China Pharmaceutical Industry Standard
Replacing YY 0899-2013
General requirements for medical microwave equipment accessories
2020-06-30 released
2022-06-01 implementation
Issued by the State Drug Administration
Table of contents
Foreword Ⅰ
1 Scope 1
2 Normative references 1
3 Terms and definitions 1
4 Requirements 2
5 Test method 5
Foreword
All technical content of this standard is mandatory.
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard replaces YY 0899-2013 "General Requirements for Medical Microwave Equipment Accessories", compared with YY 0899-2013, except for editorial
The main changes are as follows.
---Modified the definition of accessories for medical microwave equipment (see 3.2, 3.2 in the.2013 edition);
---Added non-contact physiotherapy applicator, contact physiotherapy applicator, hyperthermia applicator, body tissue thermocoagulator, prostate thermocoagulation component,
Definition of temperature measurement accessories and cooling components (see 3.3~3.9);
---Deleted the definition of thermocoagulator and puncture temperature measuring needle (see 3.3 and 3.4 in the.2013 edition);
---Modified the requirements for external marking (see 4.2, 4.2 of the.2013 edition);
---Added the requirements of the instructions (see 4.3);
---Modified physical performance requirements and test methods (see 4.4, 5.4, 4.3 and 5.3 in the.2013 edition);
---The requirements and test methods of the applicator have been added (see 4.5.2, 5.5.2);
---Deleted the requirements and test methods for the temperature rise of the output cable, the adapter, the standing wave ratio of the radiator, and the heat map of the radiator (see the.2013 edition)
4.4.3~4.4.5, 5.4.3~5.4.5);
---Corrosion resistance requirements and test methods have been revised [see 4.6.1, 5.6.1, 4.5.1, 5.5a) in the.2013 edition];
---Modified the requirements and test methods for ethylene oxide residues (see 4.6.2, 5.6.2, 4.5.2, 5.5.2 of the.2013 edition);
---Modified the requirements of sterility (see 4.8, 4.7 of the.2013 edition);
---The requirements for inspection rules, marking, packaging, transportation and storage have been deleted (see Chapter 6, Chapter 7, Chapter 8 of the.2013 edition);
--- Deleted Appendix A (see Appendix A of the.2013 edition).
Please note that certain contents of this document may involve patents. The issuing agency 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 Appliance Standardization Technical Committee Physical Therapy Equipment Subcommittee (SAC/TC10/SC4).
Drafting organizations of this standard. Tianjin Medical Device Quality Supervision and Inspection Center, Nanjing Kangyou Medical Technology Co., Ltd., Kehui (China) Medical
Medical Equipment Technology Co., Ltd., Tianjin Shunbo Medical Equipment Co., Ltd., Anyang Xiangyu Medical Equipment Co., Ltd.
The main drafters of this standard. Duan Qiaofeng, Ye Mingyang, Liu Hui, Jia Ruoxian, Tang Shujun, Li Minghua, Li Fei.
The previous versions of the standard replaced by this standard are as follows.
---YY 0899-2013.
General requirements for medical microwave equipment accessories
1 Scope
This standard specifies the terms, definitions, requirements, and test methods for medical microwave equipment accessories.
This standard applies to medical microwave equipment accessories used in conjunction with medical microwave equipment in medical practice for the purpose of treatment.
2 Normative references
The following documents are indispensable for the application of this document. For dated reference documents, only the dated version applies to this article
Pieces. For undated references, the latest version (including all amendments) applies to this document.
GB 9706.1 Medical Electrical Equipment Part 1.General Requirements for Safety
GB 9706.6 Medical Electrical Equipment Part 2 Special Requirements for the Safety of Microwave Therapy Equipment
GB/T 14233.1-2008 Medical transfusion, blood transfusion, injection equipment inspection methods Part 1.Chemical analysis methods
GB/T 14233.2 Test methods for medical infusion, blood transfusion, and injection equipment Part 2.Biological test methods
GB/T 16886.1 Biological Evaluation of Medical Devices Part 1.Evaluation and Testing in the Process of Risk Management
GB/T 16886.7-2015 Biological Evaluation of Medical Devices Part 7.Residues of Ethylene Oxide Sterilization
YY/T 0149 Test method for corrosion resistance of stainless steel medical equipment
YY 0838 Microwave thermocoagulation equipment
3 Terms and definitions
The following terms and definitions defined in GB 9706.1, GB 9706.6, and YY 0838 apply to this document.
3.1
Medical microwave equipment
Microwave equipment that treats patients by using electromagnetic waves with a frequency greater than 300MHz but not greater than 30GHz, commonly including micro
Wave physiotherapy equipment, microwave thermocoagulation equipment and microwave hyperthermia equipment.
3.2
Medical microwave equipment accessories
For the purpose of treatment, accessories used in conjunction with medical microwave equipment usually include output cables and connectors, applicators, and temperature measuring accessories.
Parts, cooling components, etc.
3.3
Non-contact physical therapy applicator
Used with microwave physiotherapy equipment, it is a non-contact applicator for physiotherapy.
3.4
Contact physiotherapy app
Used with microwave physiotherapy equipment, it is a contact applicator for physiotherapy of ear canal, vagina, anorectal and other parts.
3.5
Hyperthermia Applicator
With microwave hyperthermia equipment, it is a non-contact applicator for tumor treatment.
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