Definition Critical Component Definition

RoxaneB

Change Agent and Data Storyteller
Super Moderator
#11
Re: Critical Component Defined

regarding the point that all the components are critical, I am not with you on that.
I did not say that every component is critical, but I asked HOW to determine what is critical above other aspects. I wanted you to provide more of a definition that what you originally said and your response above provided that...hopefully to the Original Poster's use. :applause:
 
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somashekar

Staff member
Admin
#12
Re: Critical Component Defined

We mfg a medical device and currently going through CE mark for a new product. I guess I am looking for a general definition of critical component. We test the product 100%. The component is an oscillator. There is no UL/Safety marks on the component.
No UL/Safety mark is fine.
Is your medical device subjected to safety tests and approvals by a recognized test house ?
When this is done, the test house along with your designers will decide which of the components are critical and list them in the report. You may then have to respect this in your purchasing and inspection controls.
This decision is taken based on safety analysis of your device. Safety concerned to the patient / user.
Usually termed as safety critical components
You can further add components to this list based on your design analysis for performance as well, and get your bunch or critical components.
.
..
Further my interpretation ...
When a component is critical to the medical device effectiveness in the sense that the lack of effectiveness could lead to death or major irreversible damage, such a component is into safety critical component.
 
Last edited:

Sullen-gent

Involved In Discussions
#13
Hoping some one responds but what Regulatory requirements is there to define parts as 'critical'? I see Critical comes up one the Electrical side and is a requirement of 60601-1. However for non-active device, what clauses would we not meet by not defining 'critical' parts components etc. Background I'm working on older devices where DFMEA were never created as part of D+D.
 
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