医疗设备综合 -环标网

已选条件： 医疗设备综合

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标准编号	标准名称	发布部门	发布日期	状态
AS/NZS IEC 60601.2.25:2016	Medical electrical equipment Particular requirements for the basic safety and essential performance of electrocardiographs	Standards ..	2016-06-02	现行
IEC/TR 80001-2-8 Ed. 1.0	Application of risk management for IT-networks incorporating medical devices Part 2-8: Application guidance - Guidance on standards for establishing the security capabilities identified in IEC TR 80001-2-2	Internatio..	2016-05-19	现行
IEC/TR 60601-4-2 Ed. 1.0	Medical electrical equipment Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems	Internatio..	2016-05-13	现行
DIN EN 62366 (2016-05)	Medical Devices - Application Of Usability Engineering To Medical Devices (iec 62366:2007 + A1:2014)	German Ins..	2016-05-01	现行
DIN EN 60601-1-2 (2016-05)	Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements And Tests (iec 60601-1-2:2014)	Verband De..	2016-05-01	现行
IEC 80601-2-35 Ed. 2.1	Medical electrical equipment Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads and mattresses and intended for heating in medical use	Internatio..	2016-04-29	现行
IEC/TR 62366-2 Ed. 1.0	Medical devices Part 2: Guidance on the application of usability engineering to medical devices	Internatio..	2016-04-27	现行
I.S. EN ISO 15225:2016	Medical Devices - Quality Management - Medical Device Nomenclature Data Structure (iso 15225:2016)	National S..	2016-04-24	现行
DIN EN 60601-1-10 (2016-04)	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 (iec 60601-1-10:2007 + A1:2013)	Verband De..	2016-04-01	现行
AS/NZS IEC 60601.2.31:2016	Medical electrical equipment Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source	Standards ..	2016-03-29	现行
I.S. EN ISO 11197:2016	Medical Supply Units (iso 11197:2016)	National S..	2016-03-27	现行
I.S. EN ISO 13485:2016	Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes (iso 13485:2016)	National S..	2016-03-20	现行
ISO 15225:2016	Medical devices - Quality management - Medical device nomenclature data structure	Internatio..	2016-03-18	废止
ISO 16142-1:2016	Medical devices - Recognized essential principles of safety and performance of medical devices Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards	Internatio..	2016-03-09	现行
DIN EN 60601-1-6 (2016-02)	Medical Electrical Equipment - Part 1-6: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Usability (iec 60601-1-6:2010 + A1:2013)	Verband De..	2016-02-01	现行
I.S. EN ISO 15378:2015	Primary Packaging Materials for Medicinal Products - Particular Requirements for the Application of iso 9001:2008, With Reference to Good Manufacturing Practice (gmp) (iso 15378:2015)	National S..	2015-11-22	现行
AS 1071:2015	Placement and presentation of hand hygiene materials in relation to the basin in healthcare settings	Standards ..	2015-11-17	现行
AS/NZS IEC 60601.2.21:2015	Medical electrical equipment Particular requirements for the basic safety and essential performance of infant radiant warmers	Standards ..	2015-11-16	现行
AS/NZS IEC 60601.2.17:2015	Medical electrical equipment Particular requirements for the basic safety and essential performance of automatically-controlled brachytherapy afterloading equipment	Standards ..	2015-11-16	现行
AS/NZS IEC 60601.2.18:2015	Medical electrical equipment Particular requirements for basic safety and essential performance of endoscopic equipment	Standards ..	2015-11-16	现行

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