IEC 60601-1-10:2013 pdf download

IEC 60601-1-10:2013 pdf download.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 use of PHYSIOLOGIC CLOSED-LOOP CONTROLLERS in ME EQUIPMENT and ME SYSTEMS are expected to provide a successful strategy to improve PATIENT safety and reduce healthcare costs [9][1O][11][12}[13] 1). New RISKS that are not directly addressed by previous standards are emerging in the development of this equipment. MANUFACTURERS employ a variety of methods to validate the safety and integrity of control systems with varying degrees of success. Classical methods of software VALIDATION for PHYSIOLOGIC CLOSED-LOOP CONTROLLERS can be insufficient to ensure performance with acceptable RISKS under all clinical and physiologic conditions.
3.6
CONTROL TRANSFER ELEMENT
E
part of a PCLC that provides an output having a deterministic relationship to the FEEDBACK
VARIABLE (I) (see, for example, Figure 1, E)
3.7
CONTROLLER OUTPUT VARIABLE
x
VARIABLE of the CONTROL TRANSFER ELEMENT (E), which is also an input VARIABLE of the
ACTUATOR (A) (see, for example, Figure 1, x)
3.8
* DISTRIBUTED PCLCS
PCLCS that involves more than one item of equipment of a ME SYSTEM
NOTE The parts of a DISTRIBUTED PCLCS can be widely separated in distance.
For example, a critical care ventilator minute volume (number of breaths per minute multiplied
by the expiratory volume) can be determined by a PCLC in response to the PHYSIOLOGIC
VARIABLES end-tidal CO2 and airway pressure. The OPERATOR sets the target end-tidal CO2 to
30 mmHg and the allowable range of peak airway pressures from 15 cmH2O to 35 cmH2O.
The PCLC sets the expiratory volume and ventilation rate.
An example of a PCLCS where the COMMAND VARIABLE changes over time is one in which the
OPERATOR sets the target end-tidal CO2 to increase linearly from 25 mmHg to 45 mmHg over a
30 mm period.
There are also instances when the OPERATOR will gradually decrease the COMMAND VARIABLE to wean the PATIENT from the medication (for example to slowly awaken a PATIENT from a drug-induced coma).
Definition 3.5 — COMPARING ELEMENT
The COMPARING ELEMENT can consist of a simple subtraction, a classification within a value ranae uo to a comolex relationshiD resultina from neural network calculation. The resultina
For example, a critical care ventilator minute volume (number of breaths per minute multiplied
by the expiratory volume) can be determined by a PCLC in response to the PHYSIOLOGIC
VARIABLES end-tidal CO2 and airway pressure. The OPERATOR sets the target end-tidal CO2 to
30 mmHg and the allowable range of peak airway pressures from 15 cmH2O to 35 cmH2O.
The PCLC sets the expiratory volume and ventilation rate.
An example of a PCLCS where the COMMAND VARIABLE changes over time is one in which the
OPERATOR sets the target end-tidal CO2 to increase linearly from 25 mmHg to 45 mmHg over a
30 mm period.
There are also instances when the OPERATOR will gradually decrease the COMMAND VARIABLE to wean the PATIENT from the medication (for example to slowly awaken a PATIENT from a drug-induced coma).
Definition 3.5 — COMPARING ELEMENT
The COMPARING ELEMENT can consist of a simple subtraction, a classification within a value ranae uo to a comolex relationshiD resultina from neural network calculation. The resultina.IEC-60601-1-10-2013

Leave a Reply

Your email address will not be published.