NF S95-164-2009

Medical supply units.

GB 16360-1996

临床核医学放射卫生防护标准

Radiological protection standard for clinical nuclear medicine

适用范围：本标准规定了临床核医学工作中有关工作人员和工作场所的放射卫生防护要求。本标准适用于临床核医学应用放射性核素和药物进行诊断和治疗(不包括敷贴治疗)的单位和工作人员。

发布日期：1996-05-23  实施日期：1996-12-01

IEC 60601-2-27-2011

医用电气设备 第2-27部分:心电图监护设备安全(包括基本性能)的特殊要求

Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment

适用范围：IEC 60601-2-27:2011 applies to electrocardiographic monitoring equipments used in a hospital environment as well as when used outside the hospital environment, such as in ambulances and air transport. ...

发布日期：2011-03-30  实施日期：2011-03-30

BS EN ISO 11608-4-2007

Pen-Injektoren zur medizinischen Anwendung. Anforderungen an und Prüfverfahren für elektronische und elektromechanische Pen-Injektoren Pen-injectors for medical use. Part 4:Requirements and test methods for electronic and electromechanical pen-injectors Stylos-injecteurs. usage médical. Exigences et méthodes d'essai pour stylos-injecteurs électroniques et électro-mécaniques

实施日期：2007-09-28

ISO 11810-2-2007

激光以及与激光相关的设备 手术单和/或患者保护罩的耐激光性试验方法及分类 第2部分:二级点燃

Lasers and laser-related equipment -- Test method and classification for the laser-resistance of surgical drapes and/or patient-protective covers -- Part 2: Secondary ignition

适用范围：ISO 11810-2:2007 is applicable to disposable and re-usable, as well as woven and non-woven materials used as surgical drapes and/or patient protective covers which claim to be laser-resistant. The purp...

发布日期：2007-05-01  实施日期：2007-05-01

EN ISO 22612-2005

Clothing for protection against infectious agents. Test method for resistance to dry microbial penetration ISO 22612:2005

实施日期：2005-03-01

BS EN 60645-6-2010

Akustik. Audiometer. Ger?te zur Messung von otoakustischen Emissionen Electroacoustics. Audiometric equipment. Part 6:Instruments for the measurement of otoacoustic emissions Electroacoustique. Appareillage audiométrique. Instruments pour la mesure des émissions otoacoustiques

实施日期：2010-02-28

BS EN 1782-1998+A1-2009

Tracheal tubes and connectors

实施日期：1998-08-15

DIN EN 302510-2-2007

Electromagnetic compatibility and Radio spectrum Matters (ERM) - Short Range Devices (SRD) - Radio equipment in the frequency range 30 MHz to 37, 5 MHz for Ultra Low Power Active Medical Membrane Implants and Accessories - Part 2 : Harmonized EN covering essential requirements of article 3.2 of the R&TTE Directive

实施日期：2007-11-01

NF S95-155/A2-2010

Medical gas pipeline systems - Part 1 : pipeline systems for compressed medical gases and vacuum - Amendment 2.

BS EN 60601-2-8-1998

医疗电气设备.安全的特殊要求.10KV至1MV范围内X射线治疗设备的操作规范

Medizinische elektrische Geraete. Besondere Festlegungen fuer die Sicherheit von Therapie-Roentgeneinrichtungen im Betreibsbereich von 10 kV bis 1 MV Medical Electrical Equipment-Part 2:Particular Requ...

适用范围：Addition: This Particular Standard applies to therapeutic X-RAY EQUIPMENT with NOMINAL X-RAY TUBE VOLTAGES in the range 10 kV to 1 MV when connected to alternating SUPPLY MAINS.

实施日期：1998-05-15

ISO 29781-2008

假体和矫形器 当描述下肢截肢或先天性下肢缺失的人身体活动时所包括的因素

Prostheses and orthoses -- Factors to be included when describing physical activity of a person who has had a lower limb amputation(s) or who has a deficiency of a lower limb segment(s) present at birt...

适用范围：ISO 29781:2008 describes the factors to be included when describing the physical activity of a person who has had a lower limb amputation(s) or who has a deficiency of a lower limb segment(s) present a...

发布日期：2008-12-01  实施日期：2008-12-01

IEC 60601-2-36-1997

医用电气设备 第2-36部分:体外引发碎石设备安全专用要求

Medical Electrical Equipment. Part 2:Particular Requirements for the Safety of Equipment for Extracorporeally Induced Lithotripsy Appareils Electromedicaux. Partie 2:Regles Particulieres De Securite De...

适用范围：Addition:This Particular Standard applies to the safety of EQUIPMENT FOR EXTRACORPOREALLY INDUCED LITHOTRIPSY as defined in 2.1.101.The applicability of this Particular Standard is limited to component...

实施日期：1997-03-01

ISO 8362-2-2008

注射容器及附件 第2部分:注射小瓶用瓶塞

Injection containers and accessories -- Part 2: Closures for injection vials

适用范围：ISO 8362-2:2008 specifies the shape, dimensions, material, performance requirements and labelling of closures for injection vials covered by ISO 8362-1 and ISO 8362-4. The dimensional requirements are ...

发布日期：2008-10-01  实施日期：2008-10-01

ANSI/AAMI/ISO 13959-2009

Water for hemodialysis and related therapies [Replaced: AAMI RD62]

实施日期：2009-01-01

IEC 60601-2-22-2007

医用电气设备 第2-22部分:诊断和治疗激光设备安全专用要求

Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment

适用范围：Applies to the safety and essential performance of laser equipment for either surgical, therapeutic, medical diagnostic, cosmetic, or veterinary applications, intended for its use on humans or animals,...

发布日期：2007-05-23  实施日期：2007-05-23

EN 60601-2-49-2001

Medical Electrical Equipment - Part 2-49: Particular Requirements for the Safety of Multifunction Patient Monitoring Equipment IEC 60601-2-49:2001

BS EN 60601-2-33-2002+A2-2008

Medical electrical equipment. Particular requirements for the safety of magnetic resonance equipment for medical diagnosis

实施日期：2002-10-18

BS EN 13348-2008

Kupfer und Kupferlegierungen. Nahtlose Rundrohre aus Kupfer für medizinische Gase oder Vakuum Copper and copper alloys. Seamless,round copper tubes for medical gases or vacuum Cuivre et alliages de cuivre. Tubes ronds sans soudure en cuivre pour gaz médicaux ou le vide

实施日期：2008-10-31

IEC 60601-2-39-2007

医用电气设备 第2-39部分:腹膜透析仪安全专用要求

Medical electrical equipment. Part 2-39:Particular requirements for basic safety and essential performance of peritoneal dialysis equipment Appareils électromédicaux. Partie 2-39:Exigences particulière...

适用范围：This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE ofPERITONEAL DIALYSIS ME EQUIPMENT as defined in 201.3.208, hereafter referred to asPD EQUIPMENT. It applies to PD EQUI...

实施日期：2007-11-01