实施日期：2007-05-31
Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source
适用范围：IEC 60601-2-31:2008 applies to the basic safety and essential performance of external pacemakers powered by an internal electrical power source. The minimum safety requirements specified in this partic...
发布日期：2008-03-26 实施日期：2008-03-26
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing
适用范围：This part of DIN EN ISO 18113 specifies requirements for information supplied by the manufacturer of IVD reagents for self-testing. Furthermore, this part of DIN EN ISO 18113 applies to information sup...
实施日期：2010-05-01
Sterilization of health care products. Ethylene oxide. Part 1:Requirements for development,validation and routine control of a sterilization process for medical devices first edition [superseded:Iso 11...
适用范围：This part of ISO 11135 specifies requirements for the development, validation and routine control of anethylene oxide sterilization process for medical devices.NOTE 1 Although the scope of this part of...
发布日期：2007-04-27 实施日期：2007-05-01
Medical Electrical Equipment—Part 2-33:Particular Requirements for the Safety of Magnetic Reconance Equipment for Medical Diagnosis
发布日期：2008-04-25 实施日期：2009-12-01
Quality control for radiation sterilization of medical and hygienical products
适用范围：本标准规定了医疗卫生用品辖射灭菌和消毒的术语和定义、辐射灭菌和消毒要求、产品辐射处理要求、微生物监测方法和要求、辐射产品的放行要求和辐射后的管理要求。 本标准适用于所有幵展辐射灭菌和消毒的单位。
发布日期：2014-12-22 实施日期：2015-07-01
Chirurgische Implantate. Totale Knieendoprothesen. Bestimmung des Belastungsverhaltens von Tibiaunterlagen zum Kniegelenkersatz Implants for Surgery-Total Knee-Joint Prostheses-Part 1:Determination of ...
适用范围：This part of ISO 14879 specifies a test method for determining the endurance properties, under specified laboratory conditions, of tibial trays used in knee-joint prostheses to support and secure the p...
实施日期：2000-07-15
实施日期：2009-05-01
Schlafapnoe-Atemtherapie. Schlafapnoe-Atemtherapieger?te Sleep apnoea breathing therapy Part 1:Sleep apnoea breathing therapy equipment Thérapie respiratoire de l'apnée du sommeil. ?quipement de thérap...
适用范围：IEC 60601-1:1988, Clause 1 applies, except as follows.Amendment (add at the end of the Subclause 1.1):This part of ISO 17510 specifies requirements for equipment intended for sleep apnoea breathing the...
实施日期：2009-04-30
Standard Specification for Wrought Seamless Nickel-Titanium Shape Memory Alloy Tube for Medical Devices and Surgical Implants
适用范围：<p>1.1 This specification covers the requirements for wrought nickel-titanium shape memory alloy tube, nominally 54.5 % to 57.0 mass/mass (weight) % nickel, in the superelastic condition, used for the ...
实施日期：2007-04-01
Standard specification for virgin poly(L-lactic acid) resin for surgical implants
发布日期：2008-04-25 实施日期：2009-06-01
Aktive implantierbare medizinische Geraete. Allgemeine Festlegungen fuer die Sicherheit,Aufschriften und vom Hersteller zur Verfuegung zu stellende Informationen Active Implantable Medical Devices Part...
适用范围：This Part 1 of EN 45502 specifies requirements that are generally applicable to ACTIVE IMPLANTABLE MEDICAL DEVICES. For particular types of ACTIVE IMPLANTABLE MEDICAL DEVICES, these essential requireme...
实施日期：1998-02-15
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