C43 医用射线设备 标准查询与下载



共找到 1065 条与 医用射线设备 相关的标准,共 71

Medical electrical equipment -- Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography

ICS
11.040.50
CCS
C43
发布
2012-09-01
实施

Medical electrical equipment -- Part 1-3: General requirements for basic safety and essential performance -- Collateral Standard: Radiation protection in diagnostic X-ray equipment

ICS
11.040.50;13.280
CCS
C43
发布
2012-09-01
实施

Evaluation and routine testing in medical imaging departments -- Part 2-6: Constancy tests -- Imaging performance of computed tomography X-ray equipment

ICS
11.040.50;37.040.99
CCS
C43
发布
2012-09-01
实施

Medical electrical equipment - Dosimeters with ionization chambers as used in radiotherapy

ICS
17.240
CCS
C43
发布
2012-09-01
实施
2012-09-22

Replacement: This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of DENTAL EXTRA-ORAL X-RAY EQUIPMENT@ hereafter also called ME EQUIPMENT. The scope includes ME SYSTEMS containing such ME EQUIPMENT. NOTE 1 This includes PANORAMIC equipment@ CEPHALOMETRIC equipment@ and equipment for dental volumetric reconstruction (hereafter DVR) as defined in 201.3.203 below. NOTE 2 DVR includes dental CBCT (cone beam computed tomography)@ which is also known with other names in certain parts of the world@ e.g. DVT (digital volumetric tomography); DVR also includes tomosynthesis. NOTE 3 This may include the imaging of other anatomical parts (e.g. the hand) as long as required for dental treatment (e.g. orthodontic treatment). NOTE 4 This may include anatomical objects of interest to the ENT (ear@ nose@ and throat) specialist. The scope of this standard is restricted to X-RAY EQUIPMENT where: ? the X-RAY TUBE ASSEMBLY contains the HIGH-VOLTAGE TRANSFORMER ASSEMBLY and ? the geometrical relations between the X-RAY SOURCE@ the anatomical object being imaged in the PATIENT@ and the X-RAY IMAGE RECEPTOR@ are preset in the design and cannot be arbitrarily altered by the OPERATOR during INTENDED USE. NOTE 5 DENTAL INTRA-ORAL X-RAY EQUIPMENT is excluded from the scope of this standard. NOTE 6 FOCAL SPOT TO IMAGE RECEPTOR DISTANCE and FOCAL SPOT to object distance are preset in the design of DENTAL EXTRA-ORAL X-RAY EQUIPMENT. NOTE 7 For DENTAL X-RAY EQUIPMENT not in the scope of this document because of the restriction above@ applicable clauses of IEC 60601-2-54 may be used with this document. ME EQUIPMENT and ME SYSTEMS in the scope of IEC 60601-2-44@ IEC 60601-2-54@ IEC 60601-2-45@ IEC 60601-2-65 or IEC 60601-2-43 are excluded from the scope of this particular standard. The scope of this International Standard also excludes RADIOTHERAPY SIMULATORS and equipment for bone or tissue absorption densitometry. Excluded from the scope is also ME EQUIPMENT intended to be used for DENTAL RADIOSCOPY. Within its specific scope@ the clauses of this particular standard supersede and replace those of IEC 60601-2-7@ Medical electrical equipment ?C Particular requirements for the safety of high-voltage generators of diagnostic X-ray generators and of IEC 60601-2-32@ Medical electrical equipment ?C Particular requirements for the safety of associated equipment of X-ray equipment. NOTE 8 Requirements for X-RAY GENERATORS and for ASSOCIATED EQUIPMENT@ which were previously specified in IEC 60601-2-7 and IEC 60601-2-32@ have been included in either IEC 60601-1:2005 (Ed3) or this particular standard. Therefore IEC 60601-2-7 and IEC 60601-2-32 are not part of the IEC 60601-1 3rd edition scheme for DENTAL EXTRA-ORAL X-RAY EQUIPMENT. All requirements addressing integrated X-RAY TUBE ASSEMBLIES are covered by this particular standard. Therefore IEC 60601-2-28 does not apply to ME EQUIPMENT in the scope of this International Standard with the exception of X-RAY TUBE ASSEMBLIES that are replaceable in the field. NOTE 9 Requirements particular to DENTAL X-RAY-EQUIPMENT which were included in previous editions of the collateral standard IEC 60601-1-3 or the particular standard IEC 60601-2-28 have been extracted and moved into this particular standard. NOTE 10 For X-RAY EQUIPMENT in the scope of this particular standard X-RAY TUBE ASSEMBLIES are X-RAY MONOBLOCK ASSEMBLIES. 1) The general standard is IEC 60601-1:2005@ Medical electrical equipment ?C Part 1: General requirements for basic safety and essential performance

Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment

ICS
11.040.50;11.060.20
CCS
C43
发布
2012-09
实施
2017-07-11

Replacement: This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of DENTAL INTRA-ORAL X-RAY EQUIPMENT and its main components@ hereafter also called ME EQUIPMENT. The scope of this standard is restricted to X-RAY EQUIPMENT where the X-RAY TUBE ASSEMBLY contains the HIGH-VOLTAGE TRANSFORMER ASSEMBLY. DENTAL EXTRA-ORAL X-RAY EQUIPMENT is excluded from the scope of this standard NOTE 1 The X-RAY GENERATOR in DENTAL INTRA-ORAL X-RAY EQUIPMENT always comprises an X-RAY MONOBLOCK ASSEMBLY. Therefore in this particular standard the concept of X-RAY TUBE ASSEMBLY is replaced by that of X-RAY MONOBLOCK ASSEMBLY. NOTE 2 Main components may be for instance the X-RAY MONOBLOCK ASSEMBLY and an ELECTRONIC X-RAY IMAGE RECEPTOR. NOTE 3 Photostimulated phosphor plates and their readers (hardware and software) are excluded from the scope of this particular standard@ since they have no electrical APPLIED PARTS in the PATIENT ENVIRONMENT@ and are not ME EQUIPMENT. ME EQUIPMENT and ME SYSTEMS in the scope of IEC 60601-2-63@ IEC 60601-2-44@ IEC 60601-2-54@ IEC 60601-2-45 or IEC 60601-2-43 are excluded from the scope of this particular standard. The scope of this International Standard also excludes RADIOTHERAPY SIMULATORS and equipment for bone or tissue absorption densitometry. Excluded from the scope is also ME EQUIPMENT intended to be used for DENTAL RADIOSCOPY. Within its specific scope@ the clauses of this particular standard supersede and replace those of IEC 60601-2-7@ Medical electrical equipment ?C Particular requirements for the safety of high-voltage generators of diagnostic X-ray generators and of IEC 60601-2-32@ Medical electrical equipment ?C Particular requirements for the safety of associated equipment of X-ray equipment. NOTE 4 Requirements for X-RAY GENERATORS and for ASSOCIATED EQUIPMENT@ which were previously specified in IEC 60601-2-7 and IEC 60601-2-32@ have been included in either IEC 60601-1:2005 (Ed3) or in this particular standard. Therefore IEC 60601-2-7 and IEC 60601-2-32 are not part of the IEC 60601-1 3rd edition scheme for DENTAL INTRA-ORAL X-RAY EQUIPMENT. All requirements addressing integrated X-RAY TUBE ASSEMBLIES are covered by this particular standard. Therefore IEC 60601-2-28 does not apply to ME EQUIPMENT in the scope of this International Standard.

Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment

ICS
11.040.50;11.060.20
CCS
C43
发布
2012-09
实施
2017-05-20

Medical electrical equipment - Part 2-44: Particular requirements for basic safety and essential performance of X-ray equipment for computed tomography

ICS
11.040.50;35.240.80
CCS
C43
发布
2012-08
实施
2012-09-01

Radiotherapy equipment. Coordinates, movements and scales

ICS
11.040.50
CCS
C43
发布
2012-07-31
实施
2012-07-31

Medical electrical equipment. Dosimeters with ionization chambers as used in radiotherapy

ICS
17.240
CCS
C43
发布
2012-07-31
实施
2012-07-31

Medical electrical equipment - Part 2-44 : particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography.

ICS
11.040.50;35.240.80
CCS
C43
发布
2012-07-01
实施
2012-07-13

本检定系统表适用于(10~60) kV X射线空气比释动能计量器具的检定。它规定了(10~60) kV X射线空气比释动能国家基准的用途,基准所包括的全套基本计量器具,计量学参数,借助于标准向工作计量器具传递空气比释动能量值的程序,并指明其不确定度和检定方法。

Verification Regulation of Measuring Instruments for Air-Kerma of (10~60) kV X-Ray

ICS
CCS
C43
发布
2012-06-18
实施
2012-12-18

本规程适用于医用计算机X射线摄影系统(Computed Radiography System,简称CR系统)、数字X射线摄影系统(Digital Radiography System,简称DR系统)X射线辐射源的首次检定、后续检定和使用中检查。 本规程不适用于乳腺和牙科用数字化摄影系统X射线辐射源的检定。

Verification Regulation of X-ray Radiation Sources for Medical Computed Radiography System and Digital Radiography System

ICS
CCS
C43
发布
2012-06-18
实施
2012-09-18

Magnetic resonance equipment for medical imaging -- Part 1: Determination of essential image quality parameters

ICS
11.040.50
CCS
C43
发布
2012-06-01
实施

Medical electrical equipment -- Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis

ICS
11.040.55
CCS
C43
发布
2012-06-01
实施

Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device

ICS
11.040.40
CCS
C43
发布
2012-05
实施

Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy (IEC 60601-2-54:2009); German version EN 60601-2-54:2009, Corrigendum to DIN EN 60601-2-54 (

ICS
11.040.50
CCS
C43
发布
2012-04
实施

Recording of the medical application of ionizing radiation - Part 2: Diagnosis and therapy using unsealed radioactive materials

ICS
11.040.50;11.040.55;13.280
CCS
C43
发布
2012-03-01
实施

Medical electrical equipment - Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices (IEC 60601-2-45:2011); German version EN 60601-2-45:2011

ICS
11.040.50
CCS
C43
发布
2012-03
实施
2012-03-01

Image quality assurance in diagnostic X-ray departments - Part 13: RöV constancy test of projection radiography systems with digital image receptors

ICS
11.040.50;37.040.25
CCS
C43
发布
2012-03
实施

이 표준은 촬영 및 투시에 대해 의도한 목적으로 사용되는 의료용 전기기기 및 의료용 전기기

Medical electrical equipment-Parts 2-54:Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy

ICS
11.040.50
CCS
C43
发布
2012-01-02
实施
2012-01-02



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