11.040.55 诊断设备 标准查询与下载
共找到 858 条与 诊断设备 相关的标准，共 58 页
Medical electrical equipment - Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment
- ICS
- 11.040.55
- CCS
- C39
- 发布
- 2011-05
- 实施
Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated type non-invasive sphygmomanometers (IEC 80601-2-30:2009 + Cor. :2010); German version EN 80601-2-30:2010
- ICS
- 11.040.55
- CCS
- C38
- 发布
- 2011-05
- 实施
- 2011-05-01
IEC 62359:2010 is applicable to medical diagnostic ultrasound fields. It establishes: - parameters related to thermal and non-thermal exposure 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; - methods for the determination of an exposure parameter appropriate to certain non-thermal effects. This second edition cancels and replaces the first edition, published in 2005. It constitutes a technical revision. Major changes with respect to the previous edition include the following: - The methods of deter
Ultrasonics - Field characterization - Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields
- ICS
- 11.040.55
- CCS
- 发布
- 2011-04-14
- 实施
- 2011-04-14
IEC 62464-2:2010 specifies the description of pulse sequences of magnetic resonance imaging. The classification in this standard is suitable for: - tender texts; - image annotation; - protocol definition; - technical publications. IEC 62464-2:2010 does not apply to magnetic resonance spectroscopy. The classification does not focus on image contrast (T1, T2, proton density), as this is defined by pulse sequence parameters (e.g. repetition time, echo time) and is not a property of the pulse sequence alone. The pulse sequence classification does not specify the k-space acquisition scheme, reconstruction algorithm or post-processing.
Magnetic resonance equipment for medical imaging - Part 2: Classification criteria for pulse sequences
- ICS
- 11.040.55
- CCS
- 发布
- 2011-04-08
- 实施
- 2011-04-08
IEC 60601-2-33:2010 establishes particular basic safety and essential performance requirements for magnetic resonance equipment to provide protection for the patient and the magnetic resonance worker. This third edition cancels and replaces the second edition published in 2002, its Amendment 1 (2005) and Amendment 2 (2007) and constitutes a technical revision. This third edition of IEC 60601-2-33 is based on the second amendment to Edition 2. It has also been adapted to the third edition of IEC 60601-1 (2005), with technical modifications being introduced where appropriate.
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
- 发布
- 2011-04-01
- 实施
- 2011-04-01
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of PULSE OXIMETEREQUIPMENT intended for use on humans, hereafter referred to as ME EQUIPMENT.This includes any part necessaryfor NORMAL USE, including the PULSE OXIMETER MONITOR, PULSE OXIMETER PROBE, and PROBE CABLE EXTENDER.
Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
- ICS
- 11.040.55
- CCS
- 发布
- 2011-04-01
- 实施
Medical electrical equipment — Part 2-71: Particular requirements for the basic safety and essential performance of functional near-infrared spectroscopy (functional NIRS) equipment
- ICS
- 11.040.55
- CCS
- 发布
- 2011-04
- 实施
This International Standard specifies the description of PULSE SEQUENCES of MAGNETIC RESONANCE imaging. NOTE The classification in this standard is suitable for: – tender texts; – image annotation; – protocol definition; – technical publications. This International Standard does not apply to MAGNETIC RESONANCE spectroscopy. The classification does not focus on image contrast (T1, T2, proton density), as this is defined by PULSE SEQUENCE parameters (e.g. repetition time, echo time) and is not a property of the PULSE SEQUENCE alone. The PULSE SEQUENCE classification does not specify the K-SPACE acquisition scheme, reconstruction algorithm or post-processing.
Magnetic resonance equipment for medical imaging. Classification criteria for pulse sequences
- ICS
- 11.040.55
- CCS
- C43
- 发布
- 2011-03-31
- 实施
- 2011-03-31
Ultrasonics. Field characterization. Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields
- ICS
- 11.040.55
- CCS
- C41
- 发布
- 2011-03-31
- 实施
- 2011-03-31
Medical electrical equipment -- Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis (IEC 60601-2-33:2010)
- ICS
- 11.040.55
- CCS
- 发布
- 2011-02-15
- 实施
- 2011-02-15
Medical electrical equipment -- Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis (IEC 60601-2-33:2010)
- ICS
- 11.040.55
- CCS
- 发布
- 2011-02-15
- 实施
- 2011-02-15
IEC 60601-2-33:2010 establishes particular basic safety and essential performance requirements for magnetic resonance equipment to provide protection for the patient and the magnetic resonance worker. This third edition cancels and replaces the second edition published in 2002, its Amendment 1 (2005) and Amendment 2 (2007) and constitutes a technical revision. This third edition of IEC 60601-2-33 is based on the second amendment to Edition 2. It has also been adapted to the third edition of IEC 60601-1 (2005), with technical modifications being introduced where appropriate.
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
- 发布
- 2011-02-11
- 实施
- 2011-02-11
Replacement: This particular standard applies to BASIC SAFETY and ESSENTIAL PERFORMANCE requirements of MULTIFUNCTION PATIENT MONITORING EQUIPMENT as defined in 201.3.63@ hereafter referred to as ME EQUIPMENT. This particular standard applies to ME EQUIPMENT used in a hospital environment as well as when used outside the hospital environment@ such as in ambulances and air transport. ME EQUIPMENT intended for use under extreme or uncontrolled environmental conditions outside the hospital environment@ such as in ambulances and air transport@ shall comply with this particular standard. Additional standards may apply to ME EQUIPMENT for those environments of use. The scope of this standard is restricted to ME EQUIPMENT intended for connection to a single PATIENT that has either two or more APPLIED PARTS or MULTIPLE FUNCTIONS on an APPLIED PART. This standard does not specify requirements for individual monitoring functions such as ECG@ invasive pressure and pulse oximetry. The particular standards related to these physiological parameters specify requirements from the perspective of stand-alone ME EQUIPMENT. This particular standard addresses the differences related to MULTIFUNCTION PATIENT MONITORING EQUIPMENT@ since such equipment has a broader INTENDED USE than this stand-alone ME EQUIPMENT.
Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment
- ICS
- 11.040.55
- CCS
- C39
- 发布
- 2011-02
- 实施
- 2011-03-04
Replacement: This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of TRANSCUTANEOUS PARTIAL PRESSURE MONITORING EQUIPMENT as defined in 201.3.63 and hereinafter referred to as ME EQUIPMENT@ whether this ME EQUIPMENT is stand alone or part of a system. This standard applies to transcutaneous monitors used with adults@ children and neonates@ and it includes the use of these devices in foetal monitoring during birth. This standard does not apply to haemoglobin saturation oximeters or to devices applied to surfaces of the body other than the skin (for example conjunctiva@ mucosa). If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only@ or to ME SYSTEMS only@ the title and content of that clause or subclause will say so. If that is not the case@ the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS@ as relevant. HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of the general standard. NOTE See also 4.2 of the General Standard.
Medical electrical equipment - Part 2-23: Particular requirements for the basic safety and essential performance of transcutaneous partial pressure monitoring equipment
- ICS
- 11.040.55
- CCS
- C39
- 发布
- 2011-02
- 实施
- 2011-03-04
IEC 80601-2-30:2009 applies to the basic safety and essential performance of automated sphygmomanometers, which by means of an inflatable cuff are used for intermittent indirect measurement of the blood pressure without arterial puncture. It covers electrically-powered intermittent, indirect measurement of the blood pressure without arterial puncture, me equipment with automatic methods for estimating blood pressure, including blood pressure monitors for the home healthcare environment. This first edition of IEC 80601-2-30 cancels and replaces the second edition of IEC 60601-2-30, published in 1999. This edition constitutes a major technical revision as wel
Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
- ICS
- 11.040.55
- CCS
- 发布
- 2011-01-28
- 实施
- 2011-01-28
Medical electrical equipment. Particular requirements for basic safety and essential performance of pulse oximeters
- ICS
- 11.040.55
- CCS
- 发布
- 2011
- 实施
- 2013-01-01
Medical equipment. General requirements for methods of determination of mechanical and thermal fields safe indices for medical ultrasonic diagnostic equipment
- ICS
- 11.040.55
- CCS
- 发布
- 2011
- 实施
- 2012-09-01
1.1 This guide establishes essential and recommended elements in the procedures for the conduct of a psychophysiological detection of deception (PDD) examination. 1.1.1 Other unique PDD applications are addressed separately.
Standard Guide for PDD Examination Standards of Practice
- ICS
- 11.040.55
- CCS
- A92
- 发布
- 2011
- 实施
1.1 This guide establishes essential and recommended elements in the procedures for the conduct of a psychophysiological detection of deception (PDD) examination. 1.1.1 Other unique PDD applications are addressed separately. 1.2 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
Standard Guide for PDD Examination Standards of Practice
- ICS
- 11.040.55
- CCS
- C37
- 发布
- 2011
- 实施
本标准规定了连续测量的电子体温计的性能要求。 本标准适用于由电力驱动的设备，无论是用网电源还是内部电源供电。 此设备能够装备附加的指示装置、打印装置和其他辅助装置。这些附件的要求不在本标准适用范围内。 预期用于测量皮肤温度的温度计不在本标准适用范围内。 本标准并不打算排除基于其他测量原理的设备的适用性，这些设备在连续测量人体温度时能获得等同的性能。 注:设备可能包含一些适用于EN 12470的不同部分（见附录A)的功能。在这种情况下，制造商有责任指明哪些 功能分别适用于EN 12470的哪些部分。例如：具有最大温度记忆装置和可替换温度探头的电子体温计。
Clinical thermometers.Performance of electrical thermometers for continuous measurement
- ICS
- 11.040.55
- CCS
- C39
- 发布
- 2010-12-27
- 实施
- 2012-06-01
