Regulations concerning Calibration of Stop Watches used for Testing Medical Devices

P

Phalcon

#1
I am trying to find regulations concering the need for calibration of stop watches used for testing medical devices. There is some debate in my organization if it is required or not. Any information would be very helpful.
 
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rob73

looking for answers
#2
Re: Regulations concerning Calibration of Stop Watches used for Testing Medical Devic

If you are using the stopwatches for inspection/verification/production purposes then they should be calibrated as should any instrument used for measuring. A calibration procedure should be easy enough,our NB once suggested that if we needed to calilbrate we could use either radar controlled clocks (traceable to national standards) or use the speaking clock and write our own procedure.
We did away with the timing issue so we never had to pursue it;)
Rob
 

ScottK

Not out of the crisis
Staff member
Super Moderator
#3
Re: Regulations concerning Calibration of Stop Watches used for Testing Medical Devic

What Rob73 says above - if you are using it for verification of product/process or for validation of a process it should probably be calibrated whether you're in medical devices or not.

As far as a program - You can get a digital stopwatch with a NIST traceable cert for under $40.00 from Cole Parmer.
I'd probably buy one and replace with another on an annual basis.

(I used to have a couple really good calibrated Meylan stopwatches. Wish I knew what happened to them)
 

ScottK

Not out of the crisis
Staff member
Super Moderator
#4
Re: Regulations concerning Calibration of Stop Watches used for Testing Medical Devic

What Rob73 says above - if you are using it for verification of product/process or for validation of a process it should probably be calibrated whether you're in medical devices or not.

As far as a program - You can get a digital stopwatch with a NIST traceable cert for under $40.00 from Cole Parmer.
I'd probably buy one and replace with another on an annual basis.

(I used to have a couple really good calibrated Meylan stopwatches. Wish I knew what happened to them)
PS - as far as regulations... ISO13485, for example, requires measurement equipment to be calibrated or verified at specified intervals....etc...

You need to determine determine if the device is use "to provide evidence of conformity of product to the determined requirments"
That's whether it's a watch, caliper, balance, etc.

If you're making something that dispenses X ml of fluid per hour and you're using a stopwatch to verify... I'd say "yes"
 
P

Phalcon

#5
Re: Regulations concerning Calibration of Stop Watches used for Testing Medical Devic

Thanks Rob73 & ScottK, these are the exact points I have been making. I appreciate the help.
 
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