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标准名称
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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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