医疗设备综合 -环标网

已选条件： 医疗设备综合

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每页显示20 条，共找到 2008 条结果 <1/101>

标准编号	标准名称	发布部门	发布日期	状态
EN ISO 20417:2021	Medical devices - Information to be supplied by the manufacturer (ISO 20417:2021)	Comite Eur..	2021-09-26	现行
ISO/TR 80002-2:2017	Medical device software Part 2: Validation of software for medical device quality systems	Internatio..	2020-12-29	现行
AS/NZS 5116:2016	Microwavable heat packs - Wheat and other organic filling materials	Standards ..	2020-11-20	现行
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	现行
ISO 13485:2016	Medical devices - Quality management systems - Requirements for regulatory purposes	Internatio..	2020-04-22	现行
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	现行
IEC 60601-1:2020 SER	医疗电气设备（2020合集）Medical electrical equipment - ALL PARTS	Internatio..	2020-01-15	现行
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	现行
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	现行
AS/NZS 3003:2018	Electrical installations - Patient areas	Standards ..	2018-03-26	现行
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	现行
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	废止
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	废止
AS ISO 13485:2017	Medical devices - Quality management systems - Requirements for regulatory processes	Standards ..	2017-12-14	现行
NSAI/ISO Guide to ISO 13485:2016	Medical Devices Advice from ISO/TC 210 a practical guide	National S..	2017-11-17	现行
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	现行
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	废止
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	现行
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	现行

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