EN 60601-1-10

from Wikipedia, the free encyclopedia
Logo of the German Institute for Standardization DIN EN 60601-1-10
Area Medical technology
title Medical electrical equipment - Part 1-10: General requirements for safety including the essential performance characteristics - Collateral standard: Requirements for the development of physiological closed-loop control systems.
Latest edition 11/2008
ISO IEC 60601-1-10: 2007

The EN 60601-1-10 titled "Electrical Medical devices - Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop" is part of the series of standards EN 60601 .

The German Institute for Standardization is the publisher of the DIN standard DIN EN 60601-1-10 .

The standard is based on the international version IEC 60601-1-10. Within the framework of the VDE standards, the standard is classified as VDE 0750-1-10 , see DIN-VDE standards part 7 .

This supplementary standard regulates general specifications for safety, tests and guidelines for physiologically closed control loops.

validity

The German edition 11.2008 has been accepted as a German standard from the date of its publication .

  • The current version (11.2008) is to be used in accordance with the 3rd edition of DIN EN 60601-1.
  • This standard cannot be used with the 2nd edition of DIN EN 60601-1.

scope of application

This international standard applies to the basic safety and essential performance characteristics of medical electrical devices and medical electrical systems.

This supplementary standard specifies the requirements for the development (analysis, construction, verification and validation) of physiologically closed control loops (PCLC) as part of a physiological closed control system (PCLCS) in medical electrical devices and medical electrical systems for regulating a physiological variable.

A physiological quantity can relate to the chemistry of the body (e.g. electrolytes, blood sugar), to a physical property (e.g. the patient's temperature, electrophysiology, blood flow) or a drug concentration.

This collateral standard applies to different types of PCLC, e.g. B. linear and non-linear, adaptive, fuzzy, neural networks. It does not specify any additional mechanical requirements or additional electrical requirements.

The supplementary standard applies to a closed control loop that sets the controller output variable in order to compare the measured physiological variable with a reference variable. A closed control loop that maintains a physiological variable based on a feedback variable not measured on the patient is outside the scope of this standard.

extra information

The following changed requirements are contained in EN 60601-1-10 (extract):

  • accuracy
  • Protection against dangerous output values