11.040.50 射线照相设备 标准查询与下载
共找到 1767 条与 射线照相设备 相关的标准，共 118 页
Medical electrical equipment — Part 2-8: Particular requirements for the basic safety and essential performance of therapeutic X-ray equipment operating in the range 10 kV to 1 MV
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- 11.040.50
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- 2017-12-29
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Medical electrical equipment－Dosimeters with ionization chambers as used in radiotherapy
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- 11.040.50
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- 2017-12-29
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Evaluation and routine testing in medical imaging departments — Part 2-6: Constancy tests — Imaging performance of computed tomography X-ray equipment
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- 11.040.50
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- 2017-12-29
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Electrical and loading characteristics of X-ray tube assemblies for medical diagnosis
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- 11.040.50
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- 2017-12-29
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Medical electrical equipment－Dosimeters with ionization chambers as used in radiotherapy
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- 11.040.50
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- 2017-12-29
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Medical electrical equipment — Part 2-8: Particular requirements for the basic safety and essential performance of therapeutic X-ray equipment operating in the range 10 kV to 1 MV
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- 11.040.50
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- 2017-12-29
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Nuclear medicine instrumentation ─ Routine tests ─ Part 4: Radionuclide calibrators
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- 11.040.50
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- 2017-12-29
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Evaluation and routine testing in medical imaging departments — Part 2-6: Constancy tests — Imaging performance of computed tomography X-ray equipment
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- 11.040.50
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- 2017-12-29
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Evaluation and routine testing in medical imaging departments — Part 2-6: Constancy tests — Imaging performance of computed tomography X-ray equipment
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- 11.040.50
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- 2017-12-29
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Standard Guide for Digital Detector Array Radiography
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- 11.040.50
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- 2017-12-01
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Medical electrical equipment -- Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
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- 11.040.50
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- C43
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- 2017-11-01
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Medical electrical equipment -- Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices
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- 11.040.50
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- C43
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- 2017-11-01
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本标准规定了电子阴道镜的基本性能、电气安全、电磁兼容性要求及试验方法。 本标准适用于电子阴道镜(以下简称“仪器”)。该仪器适用于对妇科阴道进行检查和观察，其不接触人体。
Electronic colposcopy technical requirements
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- 11.040.50
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- C40
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- 2017-10-25
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- 2018-01-25
1.1 This international standard applies to the practice of marking of items that might be used in the magnetic resonance (MR) environment. 1.2 The purpose of this practice is to mark items that might be brought into the MR environment and to recommend information that should be included in the marking. 1.3 The standard specifies the permanent marking of items, which are used in an MR environment, by means of terms and icons. 1.4 MR image artifacts are not considered to be a performance issue and so are not addressed in this international standard practice (see X1.5). 1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of his standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
Standard practice for marking medical devices and other items for safety in the magnetic resonance environment
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- 11.040.50
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- 2017-10-03
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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 – Particular requirements for the safety of high-voltage generators of diagnostic X-ray generators and of IEC 60601-2-32, Medical electrical equipment – 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.
Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment
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- 11.040.50
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- 2017-10-03
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This Technical Specification defines terms and specifies methods for quantifying the imaging performance of real-time, ultrasound B-mode scanners. The types of transducers used (see sections 7.6 and 10.7 of [1]) with these scanners include a) phased array, b) linear arrays, c) convex arrays, d) mechanical sector scanners, e) 3-D probes operating in 2-D imaging mode (see Annex K), f) 3-D probes operating in 3-D imaging mode for a limited number of sets of reconstructed 2-D images (see Annex K). The test methodology is applicable for transducers operating in the 2 MHz to 15 MHz frequency range.
Ultrasonics - Pulse-echo scanners - Low-echo sphere phantoms and method for performance testing of gray-scale medical ultrasound scanners applicable to a broad range of transducer types
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- 11.040.50
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- 2017-10-03
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Replacement: This International Standard applies to BASIC SAFETY and ESSENTIAL PERFORMANCE of equipment incorporating one or more sources of OPTICAL RADIATION in the wavelength range 200 nm to 3 000 nm, with the exception of laser radiation, and intended to create non-visual photobiological effects in humans or animals for therapeutic, diagnostic, monitoring, cosmetic/aesthetic or veterinary applications; hereafter referred to as light source equipment (LS EQUIPMENT). This particular standard does not apply to equipment for sun tanning, for ophthalmic instruments or for infant phototherapy. NOTE Safety requirements in this particular standard are intended to address only HAZARDS to the eye and skin; hazards to internal tissues are not included in its scope. LS EQUIPMENT may consist of a single or multiple sources of OPTICAL RADIATION, with or without power supply, or may be incorporated into a complex system that includes optical, electrical or mechanical systems or sources of other radiation. NOTE Annexes AA to EE have been included for purposes of general guidance and to illustrate many typical cases. However, the annexes should not be regarded as definitive or exhaustive.
Medical electrical equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use
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- 2017-10-03
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This technical report provides background information for users of IEC 62359 to understand the relative merits of several of the potential replacements for the thermal index (TI) as described in IEC 60601-2-37 and IEC 62359. The report discusses: – parameters related to thermal aspects of diagnostic ultrasonic fields; – methods for the determination of an exposure parameter relating to temperature rise in theoretical tissue-equivalent models, resulting from absorption of ultrasound. The report is intended to be used by: – those involved in the development and maintenance of IEC 62359; – manufacturers of medical electrical equipment for risk assessment; – health care regulatory authorities, test houses and other organizations responsible for implementing standards for medical electrical equipment.
Models for evaluation of thermal hazard in medical diagnostic ultrasonic fields
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- 2017-10-03
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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 – Particular requirements for the safety of high-voltage generators of diagnostic X-ray generators and of IEC 60601-2-32, Medical electrical equipment – 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
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- 11.040.50
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- 发布
- 2017-10-03
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Medical electrical equipment－Part 2-44：Particular requirements for the basic safety and essential performance of x-ray equipment for computed tomography
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- 11.040.50
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- 发布
- 2017-09-29
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