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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
ISO 16142-2:2017 Medical devices - Recognized essential principles of safety and performance of medical devices Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards Internatio.. 2017-08-21 现行
AS IEC 60601.1.9:2017 Medical electrical equipment General requirements for basic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design Standards .. 2017-06-28 现行
AS IEC 60601.1.11:2017 Medical electrical equipment General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment Standards .. 2017-06-23 现行
AS IEC 60601.1.12:2017 Medical electrical equipment General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment Standards .. 2017-06-23 现行
AS IEC 60601.1.2:2017 Medical electrical equipment General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests Standards .. 2017-06-23 现行
AS IEC 60601.1.10:2017 Medical electrical equipment General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers Standards .. 2017-06-23 现行
AS IEC 60601.1.8:2017 Medical electrical equipment 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 Standards .. 2017-06-08 现行
AS IEC 60601.1.6:2017 Medical electrical equipment General requirements for basic safety and essential performance - Collateral standard: Usability Standards .. 2017-06-05 现行
IEC/TR 60601-4-1 Ed. 1.0 Medical electrical equipment Part 4-1: Guidance and interpretation - Medical electrical equipment and medical electrical systems employing a degree of autonomy Internatio.. 2017-05-22 现行
DIN EN ISO 15223-1 (2017-04) Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements (ISO 15223-1:2016, Corrected version 2017-03) German Ins.. 2017-04-01 现行
JIS T 2304:2017 Medical Device Software - Software Life Cycle Processes Japanese S.. 2017-03-01 现行
IEC/TR 80001-2-9 Ed. 1.0 Application of risk management for IT-networks incorporating medical devices Part 2-9: Application guidance - Guidance for use of security assurance cases to demonstrate confidence in IEC TR 80001-2-2 security capabilities Internatio.. 2017-01-30 现行
I.S. EN ISO 15223-1:2016 Medical Devices - Symbols to be Used With Medical Device Labels, Labelling and Information to be Supplied Part 1: General Requirements (iso 15223-1:2016, Corrected Version 2017-03) National S.. 2017-01-17 现行
ISO 15223-1:2016 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements Internatio.. 2016-11-02 现行
DIN EN ISO 15225 (2016-11) Medical devices - Quality management - Medical device nomenclature data structure (ISO 15225:2016) German Ins.. 2016-11-01 现行
ASTM F1839-08(2016) Standard Specification for Rigid Polyurethane Foam for Use as a Standard Material for Testing Orthopaedic Devices and Instruments American S.. 2016-10-01 现行
I.S. EN ISO 9626:2016 Stainless Steel Needle Tubing for the Manufacture of Medical Devices - Requirements and Test Methods National S.. 2016-09-19 现行
AS/NZS 3551:2012/Amdt 2:2016 Management programs for medical equipment Standards .. 2016-09-08 现行
DIN EN ISO 11197 (2016-08) Medical Supply Units (iso 11197:2016) German Ins.. 2016-08-01 现行
DIN EN ISO 13485 (2016-08) Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016) German Ins.. 2016-08-01 现行
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