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
发布日期:2012-12-01 实施日期:2012-12-01
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for development,validation and routine control of a sterilization process for medical devices first edition [superseded:Iso 11...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
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
Electromechanical elementary relays. Part 1:General requirements Edition 3.0
适用范围:This part of IEC 61810 applies to electromechanical elementary relays (non-specified time allor-nothing relays) for incorporation into equipment. It defines the basic functionalrequirements and safety-...
实施日期:2008-02-01
实施日期:2006-12-01
Schutzkleidung gegen infektioese Agenzien. Pruefverfahren zur Bestaendigkeit gegen mikrobielle Penetration im trockenen Zustand Clothing for protection against infectious agents Test method for resista...
适用范围:This test method provides a means for assessing the resistance to penetration through barrier materials ofbacteria-carrying particles.NOTE Due to its complexity, this EN ISO 22612 cannot be considered ...
实施日期:2005-03-24
Sterilization of health care products -- Radiation -- Part 2: Establishing the sterilization dose
实施日期:2013-06-01
实施日期:2009-03-01
实施日期:2010-02-28
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