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Delivery: <= 4 days. True-PDF full-copy in English will be manually translated and delivered via email.
YY/T 0299-2022: (Medical Ultrasound Couplant)
Status: Valid YY/T 0299: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 0299-2022 | English | 349 |
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4 days [Need to translate]
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(Medical Ultrasound Couplant)
| Valid |
YY/T 0299-2022
|
| YY 0299-2016 | English | 599 |
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3 days [Need to translate]
|
Medical ultrasonic couplants
| Obsolete |
YY 0299-2016
|
| YY 0299-2008 | English | 519 |
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3 days [Need to translate]
|
Medical ultrasonic couplant
| Obsolete |
YY 0299-2008
|
| YY 0299-1998 | English | 359 |
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3 days [Need to translate]
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Medical ultrasonic couplants
| Obsolete |
YY 0299-1998
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Standard similar to YY/T 0299-2022
Basic data | Standard ID | YY/T 0299-2022 (YY/T0299-2022) | | Description (Translated English) | (Medical Ultrasound Couplant) | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C19 | | Word Count Estimation | 18,172 | | Issuing agency(ies) | State Drug Administration | YY 0299-2016: Medical ultrasonic couplants---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.
Medical ultrasonic couplants
ICS 11.040.50
C41
People's Republic of China Pharmaceutical Industry Standard
Replacing YY 0299-2008
Medical ultrasonic coupling agent
2016-01-26 release
2018-01-01 implementation
State Food and Drug Administration issued
Directory
Preface I
1 Scope 1
2 normative reference document 1
3 Terms and definitions 1
4 Product Category 2
5 component limit 2
Technical requirements 2
7 Test methods 3
8 Inspection rules 4
9 Packaging, marking, transportation, storage 5
Appendix A (normative appendix) Method for measuring the density of medical ultrasonic coupling agents 6
Appendix B (normative) Effects of sound attenuation in water on attenuation coefficient measurements and correction methods 8
Appendix C (informative) The relationship between the acoustic attenuation of distilled water and the temperature
Appendix D (informative) The relationship between the density of distilled water and the temperature
Appendix E (informative) The relationship between the velocity of sound and the temperature of distilled water
Foreword
The technical content of this standard is mandatory.
This standard is drafted in accordance with the rules given in GB/T 1.1-2009.
The main changes compared to YY 0299-2008 are.
- Increased microbial requirements (6.1) and their test methods (7.1);
- modified biocompatibility requirements (see 6.2,.2008 5.1) and its test methods (see 7.2,.2008 6.1);
--- Change the slope of the acoustic attenuation coefficient to ≤0.1 dB/(cm · MHz) (Table 1 of.2008).
Please note that some of the contents of this text may be related to patents. The issuer of this text does not assume responsibility for the identification of these patents.
This standard is proposed by the State Food and Drug Administration.
This standard by the National Medical Electrical Standardization Technical Committee of medical ultrasound equipment standardization sub-technical committee (SAC/TC10/SC2)
Go back.
The drafting of this standard. Institute of Acoustics, Chinese Academy of Sciences, the State Food and Drug Administration Hubei medical equipment quality supervision and inspection
Heart and China Shipbuilding Heavy Industry Group 715 Institute.
The main drafters of this standard. Niu Fengqi, Xia Yiwu, Zhu Chenggang, Cheng Yang, Chen Yi.
This standard replaced the previous version of the standard release.
--- YY 0299-1998;
--- YY 0299-2008.
Medical ultrasonic coupling agent
1 Scope
This standard specifies the definition, classification, requirements, test methods, inspection rules and packaging, marking, transport and maintenance of medical ultrasonic coupling agents.
Storage.
This standard applies to medical ultrasonic coupling agent products (hereinafter referred to as products), including the enterprise as a commodity manufacturing, sales, including medical
Institutions for personal use. The product is used as a penetrating medium between the probe and the human body in the diagnosis and treatment of ultrasound.
2 normative reference documents
The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this article
Pieces. For undated references, the latest edition (including all modifications) applies to this document.
GB/T 191 packaging and storage icon
GB/T 14233.2-2005 Methods of test for medical infusion, transfusion, and injectable utensils - Part 2. Biological test methods
GB/T 15261 Method for measuring the acoustical properties of ultrasonographic materials
GB/T 16886.10-2005 Biological evaluation of medical devices - Part 10. Stimulation and delayed type hypersensitivity test
GB/T 27949 Hygienic requirements for disinfectants in medical devices
GB/T 27951 Skin disinfectant hygiene requirements
Cosmetics hygiene standards.2007 edition of the Ministry of Health
Disinfection technical specifications.2002 edition of the Ministry of Health
Pharmacopoeia of the People's Republic of China (2).2010 edition
3 terms and definitions
The following terms and definitions apply to this document.
3.1
Medical ultrasonic therapy agent medicalultrasoniccouplant; medicalultrasoundcouplingagent
In ultrasound diagnosis and treatment operations, filled or coated in the ultrasonic probe, between the treatment head and human tissue, for transmission of ultrasound
Medium.
3.2
Sterile Medical Ultrasound Coupling Agent medicalultrasoundsterilecouplingagent
Meet the sterile requirements of medical ultrasonic coupling agent.
3.3
Non - sterile medical ultrasonic coupling agent medicalultrasound non - sterilecouplingagent
The total number of bacteria and specific bacterial species and the number of colonies limit the medical ultrasonic coupling agent.
3.4
Disinfection type medical ultrasonic coupling agent medicalultrasounddisinfectingcouplingagent
On the probe, the treatment of the head and the use of both parts of the human body with a disinfectant medical ultrasonic coupling agent.
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