ISO/TR 21730-2007

保健信息学 无线移动通信和计算技术在卫生保健设备中的使用 医疗设备电磁兼容性（无意电磁干扰的管理）建议

Health informatics. Use of mobile wireless communication and computing technology in healthcare facilities. Recommendations for electromagnetic compatibility (management of unintentional electromagneti...

实施日期：2007-02-15

IEC 60601-2-18-2009

医用电气设备 第2-18部分:内窥镜设备的基本安全和基本性能专用要求

Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment

发布日期：2009-08-12  实施日期：2009-08-12

BS EN ISO 10993-9-2009

医疗器械的生物评定.潜在降解产品鉴定和量化框架

Biologische Beurteilung von Medizinprodukten. Rahmen zur Identifizierung und Quantifizierung von m?glichen Abbauprodukten Biological evaluation of medical devices Part 9:Framework for identification an...

实施日期：2009-06-30

BS EN 61223-3-5-2004

医疗成像部门的评价及常规试验.验收试验.计算机断层摄影X射线设备的成像性能

Bewertung und routinemaessige Pruefung in Abteilungen fuer medizinische Bildgebung. Abnahmepruefungen. Leistungsmerkmale zur Bildgebung von Roentgeneinrichtungen fuer Computertomographie Evaluation and...

实施日期：2004-11-12

GB/T 20013.4-2010

核医学仪器 例行试验 第4部分：放射性核素校准仪

Nuclear medicine instrumentation - Rutine tests - Part4:Radionuclide calibrator

发布日期：2010-09-02  实施日期：2011-02-01

EN ISO 18113-5-2009

In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). Part 5:In vitro diagnostic instruments for self-testing

实施日期：2009-12-01

EN ISO 11137-3-2006

Sterilization of health care products. Radiation. Part 3:Guidance on dosimetric aspects

实施日期：2006-04-01

IEC 60601-2-31-2008

医用电气设备 第2-31部分:带内部能源的体外心脏起搏器的基本安全和基本性能专用要求

Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source

发布日期：2008-03-26  实施日期：2008-03-26

PD 6587-1996

Profiles for medical image interchange

NF C74-320/A11-2012

Medical electrical equipment - Part 2-19 : particular requirements for the basic safety and essential performance of infant incubators.

NF C74-211-1994

Medical electrical equipment. Functional performance characteristics of radiotherapy simulators.

GB 18467-2011

献血者健康检查要求

Whole blood and component donor selection requirements

发布日期：2011-12-30  实施日期：2012-07-01

EN ISO 10079-3-2009

Medical suction equipment. Part 3:Suction equipment powered from a vacuum or pressure source

实施日期：2009-03-01

IEC 60601-2-63-2012

医疗电气设备 第2-63部分:牙科口腔X光设备基本安全和基本性能的特殊要求

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

发布日期：2012-09-19  实施日期：2012-09-19

NF S93-005-2008

Sterile single-use syringes, with or without needle, for insulin.

ISO 8600-7-2012

内窥镜 医用内窥镜及其某些附件 第7部分:防水型医疗内窥镜的基本要求

Endoscopes. Medical endoscopes and endotherapy devices. Part 7:Basic requirements for medical endoscopes of water-resistant type

实施日期：2012-07-06

NF S97-104-2004

Non-invasive sphygmomanometers - Part 4 : test procedures to determine the overall system accuracy of automated non-invasive sphygmomanometers.

NF S95-202-1-2008

Medical vehicles and their equipment - Air ambulances - Part 1 : requirements for medical devices used in air ambulances.

BS EN 60601-1-10-2008

Medizinische elektrische Ger?te. Allgemeine Festlegungen für die Sicherheit einschlie?lich der wesentlichen Leistungsmerkmale. Erg?nzungsnorm. Anforderungen an die Entwicklung von physiologischen geschlossenen Regelkreisen Medical electrical equipment. Part 1-10:General requirements for basic safety and essential performance. Collateral Standard:Requirements for the development of physiologic closed-loop controllers Appareils électromédicaux. Exigences générales pour la sécurit de base et les pe

实施日期：2008-08-29

BS EN 15986-2011

Symbol for use in the labelling of medical devices. Requirements for labelling of medical devices containing phthalates

实施日期：2011-03-31