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YY/T 0324: Historical versions
| Std ID | Version | USD | Buy | Deliver [PDF] in | Title (Description) |
| YY/T 0324-2019 | English | 199 |
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3 days [Need to translate]
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Infrared screening equipment for mammary gland
|
| YY 0324-2008 | English | 279 |
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3 days [Need to translate]
|
Infrared examining equipment for mammary gland
|
| YY 0324-2000 | English | 759 |
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5 days [Need to translate]
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Infrared inspect equipment for mammaryg land
|
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Basic data
| Standard ID | YY/T 0324-2019 (YY/T0324-2019) |
| Description (Translated English) | Infrared screening equipment for mammary gland |
| Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) |
| Classification of Chinese Standard | C42 |
| Classification of International Standard | 11.040.60 |
| Word Count Estimation | 10,153 |
| Date of Issue | 2019 |
| Date of Implementation | 2020-06-01 |
| Issuing agency(ies) | State Drug Administration |
| Summary | This standard specifies the terms and definitions, composition and classification, requirements and test methods of infrared breast examination instruments. This standard is applicable to the instrument that irradiates the breast tissue through infrared light probe, and displays the captured image on the screen through the camera system to check breast diseases. |
YY/T 0324-2019: Infrared screening equipment for mammary gland
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Infrared screening equipment for mammary gland
ICS 11.040.60
C42
People's Republic of China Pharmaceutical Industry Standard
Replacing YY 0324-2008
Infrared breast tester
Published on.2019-05-31
2020-06-01 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 0324-2008 "Infrared Breast Inspector", compared with YY 0324-2008, except for editorial modifications
The changes are as follows.
--- Added the definition of infrared breast tester (see 3.1);
--- Increased composition (see 4.1);
--- Modified the classification (see Chapter 4.2 of the.2008 edition);
--- Modified the effective spectral wavelength range of the probe (see 5.2.2, 4.2.1 of the.2008 edition);
--- Increased UV radiation (see 5.2.3);
--- Increased probe surface temperature (see 5.2.4);
--- Increased protection of the eyes (see 5.2.5);
--- Increased the infrared response capability of the camera (see 5.3.2);
--- Increased material requirements (see 5.5);
--- Increased cleaning and disinfection requirements (see 5.6);
--- Increased electromagnetic compatibility requirements (see 5.9);
--- Increased the spectral weighting function for evaluating UV hazards (see Appendix A).
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, Beijing Medical Device Technology Evaluation Center.
The main drafters of this standard. Chen Cheng, Wang Ying, Yang Jiangang.
The previous versions of this standard were released as follows.
---YY 0324-2000, YY 0324-2008.
Infrared breast tester
1 Scope
This standard specifies the terms and definitions, composition and classification, requirements and test methods of infrared breast testers.
This standard is applicable to the illumination of the breast tissue through the infrared light probe, and the captured image is displayed on the screen through the camera system.
An instrument for examining breast diseases (hereinafter referred to as an inspection instrument).
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 7247.1-2012 Safety of laser products - Part 1. Equipment classification, requirements
GB 9706.1-2007 Medical electrical equipment - Part 1. General requirements for safety (IEC 60601-1.1988, 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)
GB/T.20145-2006 Photobiosafety of lamps and lamp systems
YY 0505-2012 Medical Electrical Equipment - Part 1-2. Safety General Requirements Parallel Standard. Electromagnetic Compatibility Requirements and Test
(IEC 60601-1-2.2004, IDT)
3 Terms and definitions
The following terms and definitions apply to this document.
3.1
The breast tissue is illuminated by an infrared light probe, and the captured image is displayed on the screen through the camera system, and the breast disease is advanced.
An instrument for screening.
4 Composition and classification
4.1 Composition
The infrared breast tester is generally composed of an infrared probe, a host, and a camera.
4.2 Classification
Infrared probes are generally classified into halogen light sources, LED light sources, and laser light sources.
YY/T 0324-2019
Infrared screening equipment for mammary gland
ICS 11.040.60
C42
People's Republic of China Pharmaceutical Industry Standard
Replacing YY 0324-2008
Infrared breast tester
Published on.2019-05-31
2020-06-01 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 0324-2008 "Infrared Breast Inspector", compared with YY 0324-2008, except for editorial modifications
The changes are as follows.
--- Added the definition of infrared breast tester (see 3.1);
--- Increased composition (see 4.1);
--- Modified the classification (see Chapter 4.2 of the.2008 edition);
--- Modified the effective spectral wavelength range of the probe (see 5.2.2, 4.2.1 of the.2008 edition);
--- Increased UV radiation (see 5.2.3);
--- Increased probe surface temperature (see 5.2.4);
--- Increased protection of the eyes (see 5.2.5);
--- Increased the infrared response capability of the camera (see 5.3.2);
--- Increased material requirements (see 5.5);
--- Increased cleaning and disinfection requirements (see 5.6);
--- Increased electromagnetic compatibility requirements (see 5.9);
--- Increased the spectral weighting function for evaluating UV hazards (see Appendix A).
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, Beijing Medical Device Technology Evaluation Center.
The main drafters of this standard. Chen Cheng, Wang Ying, Yang Jiangang.
The previous versions of this standard were released as follows.
---YY 0324-2000, YY 0324-2008.
Infrared breast tester
1 Scope
This standard specifies the terms and definitions, composition and classification, requirements and test methods of infrared breast testers.
This standard is applicable to the illumination of the breast tissue through the infrared light probe, and the captured image is displayed on the screen through the camera system.
An instrument for examining breast diseases (hereinafter referred to as an inspection instrument).
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 7247.1-2012 Safety of laser products - Part 1. Equipment classification, requirements
GB 9706.1-2007 Medical electrical equipment - Part 1. General requirements for safety (IEC 60601-1.1988, 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)
GB/T.20145-2006 Photobiosafety of lamps and lamp systems
YY 0505-2012 Medical Electrical Equipment - Part 1-2. Safety General Requirements Parallel Standard. Electromagnetic Compatibility Requirements and Test
(IEC 60601-1-2.2004, IDT)
3 Terms and definitions
The following terms and definitions apply to this document.
3.1
The breast tissue is illuminated by an infrared light probe, and the captured image is displayed on the screen through the camera system, and the breast disease is advanced.
An instrument for screening.
4 Composition and classification
4.1 Composition
The infrared breast tester is generally composed of an infrared probe, a host, and a camera.
4.2 Classification
Infrared probes are generally classified into halogen light sources, LED light sources, and laser light sources.
...
