11.040.55;35.240.80 标准查询与下载
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This International Standard addresses technical aspects of the medical diagnostic MR-SYSTEM and the MR-EQUIPMENT therein related to the safety of PATIENTS examined with this system, the safety of the MR-WORKER involved with its operation and the safety of the MR-WORKER involved with the development, manufacturing, installation, and servicing of the MR-SYSTEM.
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 + COR1:2012 + A1:2013 + A2:2015 + COR2:2016); German version EN 6060
- ICS
- 11.040.55;35.240.80
- CCS
- C43
- 发布
- 2017-11-01
- 实施
- 2017-11-01
Health informatics - Personal health device communication - Part 10441: Device specialization - Cardiovascular fitness and activity monitor (ISO/IEEE 11073-10441:2015); English version EN ISO 11073-10441:2017
- ICS
- 11.040.55;35.240.80
- CCS
- C07
- 发布
- 2017-05
- 实施
Health informatics - Personal health device communication - Part 00103: Overview (ISO/IEEE 11073-00103:2015); English version EN ISO 11073-00103:2017
- ICS
- 11.040.55;35.240.80
- CCS
- C07
- 发布
- 2017-05
- 实施
Health informatics - Personal health device communication - Part 10441: Device specialization - Cardiovascular fitness and activity monitor
- ICS
- 11.040.55;35.240.80
- CCS
- L70
- 发布
- 2017-02
- 实施
Health informatics - Personal health device communication - Part 00103: Overview
- ICS
- 11.040.55;35.240.80
- CCS
- L70
- 发布
- 2017-02
- 实施
Health informatics - Personal health device communication - Part 10425: Device specialization - Continuous glucose monitor (CGM)
- ICS
- 11.040.55;35.240.80
- CCS
- L70
- 发布
- 2016-06
- 实施
Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis; Amendment 2
- ICS
- 11.040.55;35.240.80
- CCS
- C39
- 发布
- 2015-06
- 实施
- 2015-06-23
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;35.240.80
- CCS
- C39
- 发布
- 2015-06
- 实施
Health informatics - Point-of-care medical device communication - Part 10102: Nomenclature - Annotated ECG (ISO/IEEE 11073-10102:2014); English version EN ISO 11073-10102:2014
- ICS
- 11.040.55;35.240.80
- CCS
- C07
- 发布
- 2014-06
- 实施
Health informatics - Point-of-care medical device communication - Part 10102: Nomenclature - Annotated ECG
- ICS
- 11.040.55;35.240.80
- CCS
- C07
- 发布
- 2014-03
- 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;35.240.80
- CCS
- C39
- 发布
- 2013-04
- 实施
- 2013-04-25
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MR EQUIPMENT and MR SYSTEMS, hereafter referred to also as ME EQUIPMENT.This standard does not cover the application of MR EQUIPMENT beyond the INTENDED USE.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.
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;35.240.80
- CCS
- C43
- 发布
- 2013-04
- 实施
Health informatics - Personal health device communication - Part 10420: Device specialization - Body composition analyzer (ISO 11073-10420:2012); English version EN ISO 11073-10420:2012
- ICS
- 11.040.55;35.240.80
- CCS
- C07
- 发布
- 2013-03
- 实施
Health informatics - Personal health device communication - Part 10421: Device specialization - Peak expiratory flow monitor (peak flow) (ISO 11073-10421:2012); English version EN ISO 11073-10421:2012
- ICS
- 11.040.55;35.240.80
- CCS
- C07
- 发布
- 2013-03
- 实施
Within the context of the ISO/IEEE 11073 family of standards for device communication, ISO/IEEE 11073-10420:2012 establishes a normative definition of the communication between personal body composition analyzing devices and managers (e.g. cell phones, pe
Health informatics - Personal health device communication - Part 10420: Device specialization - Body composition analyzer
- ICS
- 11.040.55;35.240.80
- CCS
- 发布
- 2013-02-15
- 实施
- 2013-02-15
Within the context of the ISO/IEEE 11073 family of standards for device communication, a normative definition of communication is established in ISO/IEEE 11073-10421:2012 between personal telehealth peak expiratory flow monitor devices and compute engines
Health informatics - Personal health device communication - Part 10421: Device specialization - Peak expiratory flow monitor (peak flow)
- ICS
- 11.040.55;35.240.80
- CCS
- 发布
- 2013-01-14
- 实施
- 2013-01-14
Health informatics - Personal health device communication - Part 10420: device specialization - Body composition analyzer
- ICS
- 11.040.55;35.240.80
- CCS
- C07
- 发布
- 2013-01-05
- 实施
- 2013-01-05
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;35.240.80
- CCS
- C42
- 发布
- 2013
- 实施
- 2015-01-01
Replacement: This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MR EQUIPMENT and MR SYSTEMS@ hereafter referred to also as ME EQUIPMENT. This standard does not cover the application of MR EQUIPMENT beyond the INTENDED USE. 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. The standard does not formulate ESSENTIAL PERFORMANCE requirements related to INTERVENTIONAL MR EXAMINATIONS.
Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis; Corrigendum 1
- ICS
- 11.040.55;35.240.80
- CCS
- C39
- 发布
- 2012-03
- 实施
- 2012-04-29
Magnetic resonance equipment for medical imaging - Part 2: Classification criteria for pulse sequences (IEC 62464-2:2010); German version EN 62464-2:2011
- ICS
- 11.040.55;35.240.80
- CCS
- C43
- 发布
- 2011-10
- 实施
