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每頁顯示20 條，共找到 2008 條結果 <101/101>
標準編號 標準名稱 發布部門 發布日期 狀態
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 現行
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 現行
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 現行
DIN EN 62366 (2016-05) Medical Devices - Application Of Usability Engineering To Medical Devices (iec 62366:2007 + A1:2014) German Ins.. 2016-05-01 現行
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 現行
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 現行
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 現行
I.S. EN ISO 15225:2016 Medical Devices - Quality Management - Medical Device Nomenclature Data Structure (iso 15225:2016) National S.. 2016-04-24 現行
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 現行
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 現行
I.S. EN ISO 11197:2016 Medical Supply Units (iso 11197:2016) National S.. 2016-03-27 現行
I.S. EN ISO 13485:2016 Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes (iso 13485:2016) National S.. 2016-03-20 現行
ISO 15225:2016 Medical devices - Quality management - Medical device nomenclature data structure Internatio.. 2016-03-18 廢止
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 現行
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 現行
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 現行
AS 1071:2015 Placement and presentation of hand hygiene materials in relation to the basin in healthcare settings Standards .. 2015-11-17 現行
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 現行
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 現行
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 現行
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