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YY/T 0706-2008   Particular specifications for mammographic X-ray equipment (English Version)
Standard No.: YY/T 0706-2008 Status:superseded remind me the status change

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Language:English File Format:PDF
Word Count: 3500 words Price(USD):284.0 remind me the price change

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Implemented on:2010-1-1 Delivery: via email in 1 business day
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Standard No.: YY/T 0706-2008
English Name: Particular specifications for mammographic X-ray equipment
Chinese Name: 乳腺X射线机专用技术条件
Chinese Classification: C43    Medical radiographic equipment
Professional Classification: YY    Professional Standard - Pharmaceutics
Issued by: China Food and Drug Administration
Issued on: 2008-10-17
Implemented on: 2010-1-1
Status: superseded
Superseded by:YY/T 0706-2017 Particular specifications for mammographic X-ray equipment
Superseded on:2018-4-1
Abolished on:2018-04-01
Language: English
File Format: PDF
Word Count: 3500 words
Price(USD): 284.0
Delivery: via email in 1 business day
1 Scope This standard specifies terms, classification, requirements and test methods for mammographic x-ray equipment (hereinafter referred to as mammographic equipment). This standard is applicable to mammographic x-ray equipment equipped with x-ray film intensifying screen and operated in contact and amplify way, which is special for medical units for mammographic X-ray photography. This standard is not applicable to special accessories such as digital imaging devices, biopsy plates and stereotaxic devices. 2 Normative References The following standards contain provisions which, through reference in this text, constitute provisions of this standard. For dated reference, subsequent amendments to (excluding correction to), or revisions of, any of these publications do not apply. However, the parties to agreements based on this standard are encouraged to investigate the possibility of applying the most recent editions of the standards. For undated references, the latest edition of the normative document referred to applies. GB 5579-1985 High-voltage Cable Plug and Socket Connections for Medical X-ray Equipment GB 9706.1-1995 Medical Electrical Equipment - Part 1: General Requirements for Safety (IEC 60601-1: 1988, IDT) GB 9706.11-1997 Medical Electrical Equipment - Part 2: Particular Requirements for the Safety of X-ray Source Assemblies and X-ray Tube Assemblies for Medical Diagnosis (idt IEC 60601-2-28: 1993) GB 9706.12-1997 Medical Electrical Equipment - Part 1: General Requirements for Safety 3 - Collateral Standard: General Requirements for Radiation Protection in Diagnostic X-ray equipment (idt IEC 60601-1-3: 1994) GB 9706.14-1997 Medical Electrical Equipment - Part 2: Particular Requirements for the Safety of Associated Equipment of X-ray Equipment (idt IEC 60601-2-32: 1994) GB 9706.24-2005 Medical Electrical Equipment - Part 2-45: Particular Requirements for the Safety of Mammographic X-ray Equipment and Mammographic Stereotactic Devices (IEC 60601-2-45: 2001, TDT) GB/T 10149-1988 Terminology and Symbol for Medical X-ray Equipment GB/T 17006.9-2003 Evaluation and Routine Testing in Medical Imaging Departments - Part 2-10: Constancy Tests - X-ray Equipment for Mammography (IEC 61223-2-10: 1999, IDT) GB/T 19042.2-2005 Evaluation and Routine Testing in Medical Imaging Departments - Part 3-2: Acceptance Tests - Imaging Performance of Mammographic X-ray Equipment (IEC 61223-3-2: 1996, IDT) YY 0076-1992 Coating Classifications for Metal Product - Technical Conditions YY/T 0106-2008 General Specifications for Medical Diagnostic X-ray Equipment YY/T 0291-2007 Environmental Requirements and Test Methods for Medical X-ray Equipment YY 0505-2005 Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standards: Electromagnetic Compatibility Requirements and Tests (IEC 60601-1-2: 2001, IDT) 3 Terms and Definitions For the purpose of this standard, the terms and definitions established in GB/T 10149-1988 and the following ones apply. 3.1 Gantry for radiography It refers the equipment used for supporting components such as the head of X-ray tube. 3.2 Compression device It refers to the special devices used for compressing mamma on the mammographic equipment, including compression plates, supports for patients and devices for controlling the compression movement etc. 3.3 Compression plates It refers to transparent plates used for compressing mammas of patients on the mammographic equipment. 4 Classification and Composition 4.1 Classification Mammographic equipment may be divided into fixed type and movable type according to product structure. 4.2 Composition Mammographic equipment at least shall be equipped with the following main components: a) X ray generator system; b) Gantry for radiography.
1 Scope 2 Normative References 3 Terms and Definitions 4 Classification and Composition 5 Requirements 6 Test Methods
Referred in YY/T 0706-2008:
*GB 5579-1985 High-voltage cable plug and socket connections for medical X-ray equipment
*GB 9706.1-1995 Medical electrical equipment--Part 1:General requirements for safety
*GB 9706.11-1997 Medical electrical equipment-Part 2: Particular requirements for the safety of X-ray source assemblies and X-ray tube assemblies for medical diagnosis
*GB 9706.12-1997 Medical electrical equipment-Part 1: General requirements for safety 3.collateral STANDARD: General requirements for radiation protection in diagnostic X-ray equipment
*GB 9706.14-1997 Medical electrical equipment - Part 2: Particular requirements for the safety of associated equipment of X-ray equipment
*GB 9706.24-2005 Medical electrical equipment - Part 2-45: Particular requirements for the safety of mammographic X-ray equipment and mammographic sterotactic devices
*GB/T 10149-1988 Terminology and symbol for medical X-ray equipment
*GB/T 17006.9-2003 Evaluation and routine testing in medical imaging departments—Part 2-10:Constancy tests—X-ray equipment for mammography
*GB/T 19042.2-2005 Evaluation and routine testing in medical imaging departments-Part 3-2:Acceptance tests-Imaging performance of mammographic X-ray equipment
*YY 0076-1992 Coating classifications for metal product - Technical conditions
*YY/T 0106-2008 General specifications for medical diagnostic X-ray equipment
*YY/T 0291-2007 Environmental requirements and test methods for medical x-ray equipment
*YY 0505-2005 Medical electrical equipment?Part 1-2: General requirements for safety?Collateral stanards: Electromagnetic compatibility?Requirements and tests
Code of China
Standard
YY/T 0706-2008  Particular specifications for mammographic X-ray equipment (English Version)
Standard No.YY/T 0706-2008
Statussuperseded
LanguageEnglish
File FormatPDF
Word Count3500 words
Price(USD)284.0
Implemented on2010-1-1
Deliveryvia email in 1 business day
Detail of YY/T 0706-2008
Standard No.
YY/T 0706-2008
English Name
Particular specifications for mammographic X-ray equipment
Chinese Name
乳腺X射线机专用技术条件
Chinese Classification
C43
Professional Classification
YY
ICS Classification
Issued by
China Food and Drug Administration
Issued on
2008-10-17
Implemented on
2010-1-1
Status
superseded
Superseded by
YY/T 0706-2017 Particular specifications for mammographic X-ray equipment
Superseded on
2018-4-1
Abolished on
2018-04-01
Superseding
Language
English
File Format
PDF
Word Count
3500 words
Price(USD)
284.0
Keywords
YY/T 0706-2008, YY 0706-2008, YYT 0706-2008, YY/T0706-2008, YY/T 0706, YY/T0706, YY0706-2008, YY 0706, YY0706, YYT0706-2008, YYT 0706, YYT0706
Introduction of YY/T 0706-2008
1 Scope This standard specifies terms, classification, requirements and test methods for mammographic x-ray equipment (hereinafter referred to as mammographic equipment). This standard is applicable to mammographic x-ray equipment equipped with x-ray film intensifying screen and operated in contact and amplify way, which is special for medical units for mammographic X-ray photography. This standard is not applicable to special accessories such as digital imaging devices, biopsy plates and stereotaxic devices. 2 Normative References The following standards contain provisions which, through reference in this text, constitute provisions of this standard. For dated reference, subsequent amendments to (excluding correction to), or revisions of, any of these publications do not apply. However, the parties to agreements based on this standard are encouraged to investigate the possibility of applying the most recent editions of the standards. For undated references, the latest edition of the normative document referred to applies. GB 5579-1985 High-voltage Cable Plug and Socket Connections for Medical X-ray Equipment GB 9706.1-1995 Medical Electrical Equipment - Part 1: General Requirements for Safety (IEC 60601-1: 1988, IDT) GB 9706.11-1997 Medical Electrical Equipment - Part 2: Particular Requirements for the Safety of X-ray Source Assemblies and X-ray Tube Assemblies for Medical Diagnosis (idt IEC 60601-2-28: 1993) GB 9706.12-1997 Medical Electrical Equipment - Part 1: General Requirements for Safety 3 - Collateral Standard: General Requirements for Radiation Protection in Diagnostic X-ray equipment (idt IEC 60601-1-3: 1994) GB 9706.14-1997 Medical Electrical Equipment - Part 2: Particular Requirements for the Safety of Associated Equipment of X-ray Equipment (idt IEC 60601-2-32: 1994) GB 9706.24-2005 Medical Electrical Equipment - Part 2-45: Particular Requirements for the Safety of Mammographic X-ray Equipment and Mammographic Stereotactic Devices (IEC 60601-2-45: 2001, TDT) GB/T 10149-1988 Terminology and Symbol for Medical X-ray Equipment GB/T 17006.9-2003 Evaluation and Routine Testing in Medical Imaging Departments - Part 2-10: Constancy Tests - X-ray Equipment for Mammography (IEC 61223-2-10: 1999, IDT) GB/T 19042.2-2005 Evaluation and Routine Testing in Medical Imaging Departments - Part 3-2: Acceptance Tests - Imaging Performance of Mammographic X-ray Equipment (IEC 61223-3-2: 1996, IDT) YY 0076-1992 Coating Classifications for Metal Product - Technical Conditions YY/T 0106-2008 General Specifications for Medical Diagnostic X-ray Equipment YY/T 0291-2007 Environmental Requirements and Test Methods for Medical X-ray Equipment YY 0505-2005 Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standards: Electromagnetic Compatibility Requirements and Tests (IEC 60601-1-2: 2001, IDT) 3 Terms and Definitions For the purpose of this standard, the terms and definitions established in GB/T 10149-1988 and the following ones apply. 3.1 Gantry for radiography It refers the equipment used for supporting components such as the head of X-ray tube. 3.2 Compression device It refers to the special devices used for compressing mamma on the mammographic equipment, including compression plates, supports for patients and devices for controlling the compression movement etc. 3.3 Compression plates It refers to transparent plates used for compressing mammas of patients on the mammographic equipment. 4 Classification and Composition 4.1 Classification Mammographic equipment may be divided into fixed type and movable type according to product structure. 4.2 Composition Mammographic equipment at least shall be equipped with the following main components: a) X ray generator system; b) Gantry for radiography.
Contents of YY/T 0706-2008
1 Scope 2 Normative References 3 Terms and Definitions 4 Classification and Composition 5 Requirements 6 Test Methods
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