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BSI - BS EN IEC 60601-2-16

Medical electrical equipment Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment

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Organization: BSI
Publication Date: 30 June 2019
Status: active
Page Count: 82
ICS Code (Transfusion, infusion and injection equipment): 11.040.20
ICS Code (Syringes, needles and catheters): 11.040.25

Document History

21/30433073 DC
October 1, 2021
Draft BS EN IEC 60601-2-16 Medical electrical equipment. Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
A description is not available for this item.
BS EN IEC 60601-2-16
June 30, 2019
Medical electrical equipment Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
A description is not available for this item.
BS EN 60601-2-16
July 31, 2015
Medical electrical equipment Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
A description is not available for this item.
BS EN 60601-2-16
July 15, 1998
Medical Electrical Equipment - Part 2: Particular Requirements for the Safety of Haemodialysis, Haemodiafiltration and Haemofiltration Equipment
A description is not available for this item.
BS EN 60601-2-16
July 15, 1998
Medical Electrical Equipment - Part 2: Particular Requirements for the Safety of Haemodialysis, Haemodiafiltration and Haemofiltration Equipment
A description is not available for this item.

References

This document references:
EN 60601-1-10 - Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers
Published by CENELEC on April 1, 2008
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS....
This document references:
EN IEC 80001-1 - Application of risk management for IT-networks incorporating medical devices - Part 1: Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software
Published by CENELEC on October 1, 2021
This document specifies general requirements for ORGANIZATIONS in the application of RISK MANAGEMENT before, during and after the connection of a HEALTH IT SYSTEM within a HEALTH IT INFRASTRUCTURE,...
This document references:
EN ISO 11197 - Medical supply units
Published by CEN on November 1, 2019
This document applies to the basic safety and essential performance of medical supply units, hereafter also referred to as ME equipment. This document applies to medical supply units manufactured...
This document references:
EN ISO 14971 - Medical devices - Application of risk management to medical devices
Published by CEN on December 1, 2019
This document specifies terminology, principles and a process for risk management of medical devices, including software as a medical device and in vitro diagnostic medical devices. The process...
This document references:
EN ISO 23500-1 - Preparation and quality management of fluids for haemodialysis and related therapies - Part 1: General requirements
Published by CEN on March 1, 2019
General This document is the base standard for a number of other standards dealing with water treatment equipment, water, dialysis water, concentrates, and dialysis fluid (ISO 23500 series) and...
This document references:
EN ISO 23500-1 - Preparation and quality management of fluids for haemodialysis and related therapies - Part 1: General requirements
Published by CEN on March 1, 2019
General This document is the base standard for a number of other standards dealing with water treatment equipment, water, dialysis water, concentrates, and dialysis fluid (ISO 23500 series) and...
This document references:
EN ISO 14971 - Medical devices - Application of risk management to medical devices
Published by CEN on December 1, 2019
This document specifies terminology, principles and a process for risk management of medical devices, including software as a medical device and in vitro diagnostic medical devices. The process...
This document references:
EN IEC 80001-1 - Application of risk management for IT-networks incorporating medical devices - Part 1: Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software
Published by CENELEC on October 1, 2021
This document specifies general requirements for ORGANIZATIONS in the application of RISK MANAGEMENT before, during and after the connection of a HEALTH IT SYSTEM within a HEALTH IT INFRASTRUCTURE,...
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