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Search Serbian, European and international standards. Identify the standard organization, select the standard number or keyword, and complete the search you want. You can also add a standard drafting stage or a committee / national committee that drafted the standard

Guidance on the relationship between EN ISO 13485: 2016 (Medical devices - Quality management systems - Requirements for regulatory purposes) and European Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation

50.60 Close of voting. Proof returned by secretariat

Z076 more

Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads or mattresses and intended for heating in medical use

50.60 Close of voting. Proof returned by secretariat

N062 more

Medical electrical equipment - Part 2-75: Particular requirements for the basic safety and essential performance of photodynamic therapy and photodynamic diagnosis equipment

50.60 Close of voting. Proof returned by secretariat

N062 more

Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs

50.60 Close of voting. Proof returned by secretariat

N062 more

Medical electrical equipment - Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment

50.60 Close of voting. Proof returned by secretariat

N062 more

Medical electrical equipment - Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation

50.60 Close of voting. Proof returned by secretariat

N062 more

Systems for evacuation of plume generated by medical devices (ISO 16571:2024)

50.60 Close of voting. Proof returned by secretariat

Z076 more

Refurbishment of medical electrical equipment, medical electrical systems and sub-assemblies and reuse of components as part of the extended life-cycle

40.60 Close of voting

N062 more

Medical supply units (ISO/DIS 11197:2024)

40.20 DIS ballot initiated: 12 weeks

Z076 more

Medical devices - Guidance on the application of ISO 14971 (ISO/TR 24971:2020)

10.99 New project approved

Z210 more

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

10.99 New project approved

N062 more

Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source

10.99 New project approved

N062 more

Medical electrical equipment - Part 2-36: Particular requirements for the basic safety and essential performance of equipment for extracorporeally induced lithotripsy

10.99 New project approved

N062 more

Medical electrical equipment - Part 2-62: Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound (HITU) equipment

10.99 New project approved

N062 more

Medical electrical equipment - Part 2-XX: Particular requirements for the basic safety and essential performance of MRI based image guided radiotherapy equipment for use with electron accelerators

10.99 New project approved

N062 more

Ultrasonics - Surgical systems - Measurement and declaration of the basic output characteristics

10.99 New project approved

N062 more

Medical device software - Software life cycle processes

10.99 New project approved

N062 more

Machine learning-enabled medical device - Performance evaluation process

10.99 New project approved

N062 more