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CSA C22.2 NO 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

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Organization: CSA
Publication Date: 1 January 2009
Status: active
Page Count: 102
ICS Code (Medical equipment): 11.040
scope:

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 collateral standard specifies requirements for the development (analysis, design, VERIFICATION and VALIDATION) of a PHYSIOLOGIC CLOSED-LOOP CONTROLLER (PCLC) as part of a PHYSIOLOGIC CLOSED-LOOP CONTROL SYSTEM (PCLCS) in ME EQUIPMENT and ME SYSTEMS to control a PHYSIOLOGIC VARIABLE.

NOTE A PHYSIOLOGIC VARIABLE can be a body chemistry (e.g. electrolytes, blood glucose), a physical property (e.g. PATIENT temperature, electrophysiologic, hemodynamic), or a pharmaceutical concentration.

This collateral standard applies to various types of PCLC, e.g. linear and non-linear, adaptive, fuzzy, neural networks.

This collateral standard does not specify:

− additional mechanical requirements; or

− additional electrical requirements.

This collateral standard applies to a closed-loop controller (see Figure 1) that sets the CONTROLLER OUTPUT VARIABLE in order to adjust (i.e., change or maintain) the measured 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.

Document History

Amendment 1 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
- "the general standard" designates IEC 60601-1 alone (IEC 60601-1:2005+A1:2012); – "this collateral standard" designates IEC 60601-1-10 alone (IEC 60601-1- 10:2007+A1:2013)
January 1, 2014
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
– "the general standard" designates IEC 60601-1 alone (IEC 60601-1:2005+A1:2012); – "this collateral standard" designates IEC 60601-1-10 alone (IEC 60601-1- 10:2007+A1:2013)
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....
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.
CSA C22.2 NO 60601-1-10
January 1, 2009
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....

References

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