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Position: Chinese Standard in English/YY 0310-2005
YY 0310-2005   General specifications for X-ray equipment for computed tomography (English Version)
Standard No.: YY 0310-2005 Status:superseded remind me the status change

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Language:English File Format:PDF
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Standard No.: YY 0310-2005
English Name: General specifications for X-ray equipment for computed tomography
Chinese Name: X射线计算机体层摄影设备通用技术条件
Chinese Classification: C43    Medical radiographic equipment
Professional Classification: YY    Professional Standard - Pharmaceutics
ICS Classification: 11.040.50 11.040.50    Radiographic equipment 11.040.50
Issued by: China Food and Drug Administration
Issued on: 2005-12-7
Implemented on: 2006-12-1
Status: superseded
Superseded by:YY/T 0310-2015 General specifications for X-ray equipment for computed tomography
Superseded on:2016-1-1
Superseding:YY 0310-1998 General specifications of X-ray equipment for computed tomography
Language: English
File Format: PDF
Word Count: 3000 words
Price(USD): 304.0
Delivery: via email in 1 business day
1 Scope This standard specifies the classification, naming and basic components, requirements as well as test methods of X-ray equipment for computed tomography (hereinafter referred to as CT scanning device). This standard is applicable to X-ray equipment for computed tomography. 2 Normative References The following standards contain provisions which, through reference in this text, constitute provisions of this national standard. For dated references, subsequent amendments (excluding contents of corrigenda) to, or revisions of, any of these publications do not apply. However, parties to agreements based on this standard are encouraged to investigate the possibility of applying the most recent editions of the standards. For any undated references, the latest edition of the normative document is applicable to this standard. GB 5579 "High-voltage Cable Plug and Socket Connections for Medical X-Ray Equipment" GB 9706.1 "Medical Electrical Equipment-Part 1: General Requirements for Safety" (GB 9706.1-1995, idt IEC 60601-1: 1988) GB 9706.11 "Medical Electrical Equipment-Part 2: Particular Requirements for the Safety of X-ray Source Assemblies and X-ray Tube Assemblies for Medical Diagnosis" (GB 9706.11-1997, idt IEC 601-2-28: 1993) GB 9706.12 "Medical Electrical Equipment-Part 1: General Requirements for Safety 3.Collateral Standard: General Requirements for Radiation Protection in Diagnostic X-ray Equipment" (GB 9706.12-1997, idt IEC 60601-13: 1994) GB 9706.14 "Medical Electrical Equipment-Part 2: Particular Requirements for the Safety of Associated Equipment of X-ray Equipment" (GB 9706.14-1997, idt IEC 60601-2-32: 1994) GB 9706.15 "Medical Electrical Equipment-Part 1: General Requirements for Safety 1.Collateral Standard: Safety Requirements for Medical Electrical Systems" (GB 9706.15-1999, idt IEC 60601-1-1: 1995) GB 9706.18 "Medical Electrical Equipment-Part 2: Particular Requirements for the Safety of X-ray Equipment for Computed Tomography" (GB 9706.18-2006, IEC 60601-2-44: 2002, IDT) GB 10151 "Medical X-ray Equipment - Specifications for High Voltage Cable Plug and Socket" GB/T 19042.5 "Evaluation and routine testing in medical imaging departments - Part 3-5: Acceptance tests-Imaging performances of computed tomography X-ray equipment" (GB/T 19042.5-2006, IEC 61223-3-5: 2004, IDT) YY/T 0291 "Environmental Requirements and Test Methods for Medical X-ray Equipment" 3 Terms and Definitions For the purposes of this standard, the terms and definitions established in GB 9706.18 and GB/T 19042.5 as well as the following one apply. 3.1 Artifact The false image appearing in CT image, which is not an actual object. 4 Classification, Naming and Basic Components 4.1 The CT scanning device is subject to Type B equipment in Category I according to the protection type and protective degree against electric shock. 4.2 The naming rule is specified according to product standard. 4.3 Basic components; the CT scanning device is mainly composed of the following components: a) Scanning frame; b) X-ray generator; c) Patient bracket; d) Control console; e) Computer image processing system. If necessary, the available selective accessories shall be designated.
Foreword I 1 Scope 2 Normative References 3 Terms and Definitions 4 Classification, Naming and Basic Components 5 Requirements 6 Test Methods
Referred in YY 0310-2005:
*GB 5579-1985 High-voltage cable plug and socket connections for medical X-ray equipment
*GB 9706.1-2020 Medical electrical equipment—Part 1: General requirements for basic safety and essential performance
*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 9706.15-2008 Medical electrical equipment - Part 1: General requirements for safety - 1. Collateral standard: Safety requirements for medical electrical systems
*GB 9706.18-2006 Medical electrical equipment - Part 2: Particular requirements for the safety of X-ray equipment for computed tomography
*GB 10151-1988 Medical X-ray equipment--Specification for high voltage cable plug and socket connections
*GB/T 19042.5-2006 Evaluation and routine testing in medical imaging departments - Part 3-5: Acceptance tests-Imaging performances of computed tomography X-ray equipment
*YY/T 0291-2016 Environmental requirements and test methods for medical X-ray equipment
Code of China
Standard
YY 0310-2005  General specifications for X-ray equipment for computed tomography (English Version)
Standard No.YY 0310-2005
Statussuperseded
LanguageEnglish
File FormatPDF
Word Count3000 words
Price(USD)304.0
Implemented on2006-12-1
Deliveryvia email in 1 business day
Detail of YY 0310-2005
Standard No.
YY 0310-2005
English Name
General specifications for X-ray equipment for computed tomography
Chinese Name
X射线计算机体层摄影设备通用技术条件
Chinese Classification
C43
Professional Classification
YY
ICS Classification
Issued by
China Food and Drug Administration
Issued on
2005-12-7
Implemented on
2006-12-1
Status
superseded
Superseded by
YY/T 0310-2015 General specifications for X-ray equipment for computed tomography
Superseded on
2016-1-1
Abolished on
Superseding
YY 0310-1998 General specifications of X-ray equipment for computed tomography
Language
English
File Format
PDF
Word Count
3000 words
Price(USD)
304.0
Keywords
YY 0310-2005, YY/T 0310-2005, YYT 0310-2005, YY0310-2005, YY 0310, YY0310, YY/T0310-2005, YY/T 0310, YY/T0310, YYT0310-2005, YYT 0310, YYT0310
Introduction of YY 0310-2005
1 Scope This standard specifies the classification, naming and basic components, requirements as well as test methods of X-ray equipment for computed tomography (hereinafter referred to as CT scanning device). This standard is applicable to X-ray equipment for computed tomography. 2 Normative References The following standards contain provisions which, through reference in this text, constitute provisions of this national standard. For dated references, subsequent amendments (excluding contents of corrigenda) to, or revisions of, any of these publications do not apply. However, parties to agreements based on this standard are encouraged to investigate the possibility of applying the most recent editions of the standards. For any undated references, the latest edition of the normative document is applicable to this standard. GB 5579 "High-voltage Cable Plug and Socket Connections for Medical X-Ray Equipment" GB 9706.1 "Medical Electrical Equipment-Part 1: General Requirements for Safety" (GB 9706.1-1995, idt IEC 60601-1: 1988) GB 9706.11 "Medical Electrical Equipment-Part 2: Particular Requirements for the Safety of X-ray Source Assemblies and X-ray Tube Assemblies for Medical Diagnosis" (GB 9706.11-1997, idt IEC 601-2-28: 1993) GB 9706.12 "Medical Electrical Equipment-Part 1: General Requirements for Safety 3.Collateral Standard: General Requirements for Radiation Protection in Diagnostic X-ray Equipment" (GB 9706.12-1997, idt IEC 60601-13: 1994) GB 9706.14 "Medical Electrical Equipment-Part 2: Particular Requirements for the Safety of Associated Equipment of X-ray Equipment" (GB 9706.14-1997, idt IEC 60601-2-32: 1994) GB 9706.15 "Medical Electrical Equipment-Part 1: General Requirements for Safety 1.Collateral Standard: Safety Requirements for Medical Electrical Systems" (GB 9706.15-1999, idt IEC 60601-1-1: 1995) GB 9706.18 "Medical Electrical Equipment-Part 2: Particular Requirements for the Safety of X-ray Equipment for Computed Tomography" (GB 9706.18-2006, IEC 60601-2-44: 2002, IDT) GB 10151 "Medical X-ray Equipment - Specifications for High Voltage Cable Plug and Socket" GB/T 19042.5 "Evaluation and routine testing in medical imaging departments - Part 3-5: Acceptance tests-Imaging performances of computed tomography X-ray equipment" (GB/T 19042.5-2006, IEC 61223-3-5: 2004, IDT) YY/T 0291 "Environmental Requirements and Test Methods for Medical X-ray Equipment" 3 Terms and Definitions For the purposes of this standard, the terms and definitions established in GB 9706.18 and GB/T 19042.5 as well as the following one apply. 3.1 Artifact The false image appearing in CT image, which is not an actual object. 4 Classification, Naming and Basic Components 4.1 The CT scanning device is subject to Type B equipment in Category I according to the protection type and protective degree against electric shock. 4.2 The naming rule is specified according to product standard. 4.3 Basic components; the CT scanning device is mainly composed of the following components: a) Scanning frame; b) X-ray generator; c) Patient bracket; d) Control console; e) Computer image processing system. If necessary, the available selective accessories shall be designated.
Contents of YY 0310-2005
Foreword I 1 Scope 2 Normative References 3 Terms and Definitions 4 Classification, Naming and Basic Components 5 Requirements 6 Test Methods
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