Which kind of medical equipment must comply with IEC60601-1-8?

J

Jamiechina

Hi everyone.
As we all known IEC60601-1-8 is a comprehensive international standard that specifies basic safety and essential performance requirements and tests for alarm systems in medical equipment.

But I'm not sure which kind of medical equipment must comply it.
It depends on what? Previously I think only the medical equipments that affect the safety of the user a lot should comply with the standard. But I don't it's right or not. And the definition of this kind of medical equipment.

Can someone help me out of the confusion? Thanks in advance.:)
 

Marcelo

Inactive Registered Visitor
Quoted from the standard

If the manufacturer chooses as a mean of risk control to have the equipment or system notify the operator that a hazardous situation can exist, then the equipment or system shall include an alarm system complying with this collateral standard for that purpose.

So, this depends on the means of risk control you define on your equipment and if they have to notify the operator of the need of an action (or need for no action).
 

Peter Selvey

Leader
Super Moderator
There is a related discussion here:
http://elsmar.com/Forums/showthread.php?t=47730

The underlying purpose of an "alarm" in IEC 60601-1-8 is to get the user's attention to a hazardous situation that has just been detected.

This more nuanced definition would exclude some cases such as software reminders or messages where it can be expected that the user's attention is already on the medical device in question, or the situation exists all the time.
 
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