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BSI - 21/30433073 DC

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

pending
Organization: BSI
Publication Date: 1 October 2021
Status: pending
Page Count: 93
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:
IEC TR 60601-4-5 - Medical electrical equipment – Part 4-5: Guidance and interpretation – Safety-related technical security specifications
Published by IEC on January 1, 2021
This document, which is a Technical Report, provides detailed technical specifications for SECURITY features of MEDICAL DEVICES used in MEDICAL IT-NETWORKS. MEDICAL DEVICES dealt with in this...
This document references:
IEC 80001-1 - Application of risk management for IT-networks incorporating medical devices – Part 1: Roles, responsibilities and activities
Published by IEC on October 1, 2010
Recognizing that MEDICAL DEVICES are incorporated into IT-NETWORKS to achieve desirable benefits (for example, INTEROPERABILITY), this international standard defines the roles, responsibilities and...
This document references:
IEC 61672-1 - Electroacoustics - Sound level meters - Part 1: Specifications
Published by IEC on September 1, 2013
This part of IEC 61672 gives electroacoustical performance specifications for three kinds of sound measuring instruments: a time-weighting sound level meter that measures exponential-time-weighted,...
This document references:
IEC 60601-2-24 - Medical electrical equipment – Part 2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers
Published by IEC on October 1, 2012
Replacement: This Particular Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of INFUSION PUMPS and VOLUMETRIC INFUSION CONTROLLERS, hereafter referred to as ME EQUIPMENT. This standard...
This document references:
IEC 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 IEC on July 1, 2020
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....
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