I see another probably more likely interpretation of "knife edge and finger 
stock" in this context. Look up a knife edge fuse on the internet. Presumably 
the socket the fuse seats in would be the finger stock.


Mike Sherman

Graco Inc.

> On February 5, 2019 at 2:34 PM "Schmidt, Mark" <[email protected]> wrote:
> 
> 
>     Please see test below:
> 
>      
> 
>     “Safety Interlocks [21 CFR 1020.40(c)(4)(i)]:Each door of a cabinet x-ray 
> system shall have a minimum of two safety interlocks. One, but not both of 
> the required interlocks shall be such that door opening results in physical 
> disconnection of the energy supply circuit to the high-voltage generator, and 
> such disconnection shall not be dependent upon any moving part other than the 
> door. [Note: Safety interlock is defined in 21 CFR 1020.40(b)(11).]
> 
>      
> 
>     The primary door interlock should be of conventional design. The second 
> door interlock must physically disconnect the energy supply circuit to the 
> high voltage generator. Physical disconnection means opening the energy 
> supply circuit by removing a piece of the circuit. This is usually 
> accomplished with a ‘knife-edge and finger stock’ or ‘plug and socket’ type 
> connection. It is good practice to assure the primary interlock will remove 
> power from the energy supply circuit before the physical disconnection 
> occurs. Relays, micro switches, and ‘safety switches’ all contain moving 
> parts and, therefore, cannot be used to satisfy the requirement that the 
> physical disconnect interlock is "not dependent on any moving part other than 
> the door."”
> 
>      
> 
>     Compliance Guide for Cabinet X-Ray Systems  
> https://www.fda.gov/MedicalDevices/ucm094358.htm
> 
>      
> 
>      
> 
>     Mark
> 
>      
> 
>      
> 
>     From: Nyffenegger, Dave [mailto:[email protected]]
>     Sent: Tuesday, February 5, 2019 12:31 PM
>     To: [email protected]
>     Subject: Re: [PSES] A question about FDA language and interlocking devices
> 
>      
> 
>     That seems to make more sense.  I don’t know anything about X-ray 
> requirements but the FDA requirements laser interlocks are not specific, only 
> referring to “interlocks”.
> 
>     -Dave
> 
>      
> 
>     From: MIKE SHERMAN [mailto:[email protected]]
>     Sent: Tuesday, February 05, 2019 12:27 PM
>     To: [email protected] mailto:[email protected]
>     Subject: Re: [PSES] A question about FDA language and interlocking devices
> 
>      
> 
>     Doug --
> 
>      
> 
>     "knife-edge and finger stock" sounds more like the gasketing around the 
> door to keep the radiation inside. I think you'll find similar gasketing on 
> doors to EMC chambers. I've not heard of this term applied to interlock 
> switches.
> 
>      
> 
>     Mike Sherman
> 
>     Graco Inc.
> 
>      
> 
>         > > 
> >         On February 5, 2019 at 10:35 AM Doug Nix <[email protected] 
> > mailto:[email protected] > wrote:
> > 
> >         Colleagues,
> > 
> >          
> > 
> >         I had a question come my way yesterday that I need a little help 
> > with. Here’s the question:
> > 
> >          
> > 
> >             > > > 
> > >             I have a customer that produces X-ray equipment. The FDA 
> > > requires that the door that gives access to the X-ray source must have an 
> > > interlock with a ‘knife-edge and finger stock’ type connection.  Also the 
> > > FDA mentions that interlocks should be of conventional design. What is 
> > > understood by “conventional design”? 
> > > 
> > >         > > 
> >          
> > 
> >         My reading on this requirement is that any conventional 
> > electromechanical interlocking device like this:
> > 
> >         [Image result for keyed interlock switch images]
> > 
> >         will meet the basic requirements as described by the FDA as 
> > “knife-edge and fingerstock” connection, but I am concerned that this may 
> > not be at all what is meant. 
> > 
> >          
> > 
> >         As always, any guidance you can offer will be welcomed and 
> > appreciated!
> > 
> >          
> > 
> >         Best,
> > 
> >          
> > 
> >         Doug Nix
> >         [email protected] mailto:[email protected]
> >         +1 (519) 729-5704
> > 
> >          
> > 
> >     > 
> 
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