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CENELEC - 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

inactive
Organization: CENELEC
Publication Date: 1 April 2008
Status: inactive
Page Count: 44
ICS Code (Medical equipment): 11.040
scope:

This I nternational Standard a pplies to t he BASIC SAFETY a nd ESSENTIAL PERFORMANCE o f MEDICAL ELECTRICAL E QUIPMENT and MEDICAL ELECTRICAL S YSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS.

This collateral standard specifies requirements for the development (analysis, design, VERIFICATION a nd VALIDATION) of a PHYSIOLOGIC CLOSED-LOOP C ONTROLLER (PCLC) as part o f a PHYSIOLOGIC CLOSED-LOOP CONTROL SYSTEM (PCLCS) in ME EQUIPMENT a nd ME SYSTEMS t o control a PHYSIOLOGIC VARIABLE.

NOTE A PHYSIOLOGIC VARIABLE c an be a body c hemistry (e.g. electrolytes, blood glucose), a p hysical property (e.g. PATIENT temperature, electrophysiologic, hemodynamic), or a pharmaceutical concentration.

This collateral standard a pplies t o various t ypes o f PCLC, e.g. linear and n on-linear, adaptive, fuzzy, neural networks.

This collateral standard does not specify:

− additional mechanical requirements; or

− additional electrical requirements.

This c ollateral standard a pplies to a closed-loop controller (see Figure 1 ) that sets the CONTROLLER OUTPUT VARIABLE in order t o adjust (i.e., change or maintain) t he m easured PHYSIOLOGIC VARIABLE by relating it to the REFERENCE VARIABLE.

A closed-loop controller that maintains a physical or chemical VARIABLE, using feedback that is not measured from a PATIENT, is outside the scope of this standard.

Object

The object o f this c ollateral s tandard is to s pecify general r equirements that are in addition t o those of the general standard and to serve as the basis for particular standards.

Document History

April 1, 2008
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
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....
April 1, 2008
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
A description is not available for this item.
EN 60601-1-10
April 1, 2008
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
This I nternational Standard a pplies to t he BASIC SAFETY a nd ESSENTIAL PERFORMANCE o f MEDICAL ELECTRICAL E QUIPMENT and MEDICAL ELECTRICAL S YSTEMS, hereafter referred to as ME EQUIPMENT and ME...

References

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