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已選條件: 醫療設備綜合
每頁顯示20 條,共找到 2008 條結果 <1/101>
標準編號 標準名稱 發布部門 發布日期 狀態
EN ISO 20417:2021 Medical devices - Information to be supplied by the manufacturer (ISO 20417:2021) Comite Eur.. 2021-09-26 現行
ISO/TR 80002-2:2017 Medical device software Part 2: Validation of software for medical device quality systems Internatio.. 2020-12-29 現行
AS/NZS 5116:2016 Microwavable heat packs - Wheat and other organic filling materials Standards .. 2020-11-20 現行
IEC 60601-1-8:2006+AMD1:2012+AMD2:2020 Medical electrical equipment – Part 1-8: General requirements for basic safety and essential performance – Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems Internatio.. 2020-09-10 現行
ISO 13485:2016 Medical devices - Quality management systems - Requirements for regulatory purposes Internatio.. 2020-04-22 現行
I.S. EN ISO 14971:2012 Medical Devices - Application of Risk Management to Medical Devices (iso 14971:2007, Corrected Version 2007-10-01) National S.. 2020-01-25 被替代
I.S. EN ISO 14971:2019 Medical devices - Application of risk management to medical devices National S.. 2020-01-25 現行
IEC 60601-1:2020 SER 醫療電氣設備(2020合集)Medical electrical equipment - ALL PARTS Internatio.. 2020-01-15 現行
AS 60601.2.5:2018 Medical electrical equipment Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment (IEC 60601-2-5:2009 (ED 3.0), MOD) Standards .. 2018-06-29 現行
AS 60601.2.3:2018 Medical electrical equipment Particular requirements for the basic safety and essential performance of short-wave therapy equipment (IEC 60601-2-3:2016 (ED.3.1), MOD) Standards .. 2018-06-29 現行
AS/NZS 3003:2018 Electrical installations - Patient areas Standards .. 2018-03-26 現行
IEC 80601-2-30 Ed. 2.0 Medical electrical equipment Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers Internatio.. 2018-03-22 現行
KS C IEC 60601-2-31:2017 Medical electrical equipment — Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source Korean Sta.. 2017-12-29 廢止
KS C IEC 60601-1-2:2017 Medical electrical equipment — Part 1-2: General requirements for basic safety and essential performance — Collateral standard:Electromagnetic disturbances — Requirements and tests Korean Sta.. 2017-12-29 廢止
AS ISO 13485:2017 Medical devices - Quality management systems - Requirements for regulatory processes Standards .. 2017-12-14 現行
NSAI/ISO Guide to ISO 13485:2016 Medical Devices Advice from ISO/TC 210 a practical guide National S.. 2017-11-17 現行
I.S. EN ISO 15378:2017 Primary Packaging Materials for Medicinal Products - Particular Requirements for the Application of iso 9001:2015, With Reference to Good Manufacturing Practice (gmp) (iso 15378:2017) National S.. 2017-11-13 現行
KS C IEC 60601-2-22:2017 Medical electrical equipment - Part 2-22:Particular requirements for basic safety and essential performance of surgical, cosmetic,therapeutic and diagnostic laser equipment Korean Sta.. 2017-09-29 廢止
AS CISPR 11:2017 Industrial, scientific and medical equipment - Radio-frequency disturbance characteristics - Limits and methods of measurement (CISPR 11:2015+AMD1:2016 (ED.6.1) MOD) Standards .. 2017-09-15 現行
ISO 15378:2017 Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) Internatio.. 2017-09-14 現行
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