Calibrating Biomed equipment in an ISO 17025 accredited calibration laboratory

ScottBP

Involved In Discussions
Our company is an ISO 17025 accredited calibration lab that covers many disciplines of calibration; e.g. electrical/electronic, physical/dimensional, RF/microwave, etc. in industrial settings including everything from nuke plants to oil refineries, NASA, the military, etc.; you name it. One area we are branching out into is biomedical equipment. We won't be calibrating the common equipment that touches the patients (like thermometers, blood pressure cuffs, EKG machines, ultrasound machines, defibrillators, etc.), but rather we'll be calibrating the equipment that is used to verify and certify the above equipment, such as patient simulators, temperature simulators, safety analyzers, ultrasound wattmeters, pacemaker analyzers, etc. What standards (other than 17025) would we have to comply to do the calibration of these devices?
 

Hershal

Metrologist-Auditor
Trusted Information Resource
Re: Calibrating Biomed equipment

You might check Part 11, which is what is sometimes known as GLP.

Hershal
 

Al Rosen

Leader
Super Moderator
Re: Calibrating Biomed equipment

Our company is an ISO 17025 accredited calibration lab that covers many disciplines of calibration; e.g. electrical/electronic, physical/dimensional, RF/microwave, etc. in industrial settings including everything from nuke plants to oil refineries, NASA, the military, etc.; you name it. One area we are branching out into is biomedical equipment. We won't be calibrating the common equipment that touches the patients (like thermometers, blood pressure cuffs, EKG machines, ultrasound machines, defibrillators, etc.), but rather we'll be calibrating the equipment that is used to verify and certify the above equipment, such as patient simulators, temperature simulators, safety analyzers, ultrasound wattmeters, pacemaker analyzers, etc. What standards (other than 17025) would we have to comply to do the calibration of these devices?
AFIK, the FDA does not specify a standard, only traceability to NIST.
 

Marcelo

Inactive Registered Visitor
Re: Calibrating Biomed equipment

I recommend attention regarding the calibration methods.
 

BradM

Leader
Admin
Re: Calibrating Biomed equipment

Hello, Scott!

Al and Hershal pretty well covered it. Be ready: generally your documentation will be under more scrutiny by customers during review. Saying, most companies don't even look at their calibration certificates. FDA customers must review them.

If your data is going to be handwritten, you'll need to practice Good Documentation Practices.

I would imagine most decent Biomed companies will perform some level of audit/etc. to put you on their approved vendor list. You will find out more specific requirements at that time. For the most part, they will want to establish competency before putting you on the approved vendor list. If you can demonstrate that, you should be good.
 
M

mike8119

Our company is an ISO 17025 accredited calibration lab that covers many disciplines of calibration; e.g. electrical/electronic, physical/dimensional, RF/microwave, etc. in industrial settings including everything from nuke plants to oil refineries, NASA, the military, etc.; you name it. One area we are branching out into is biomedical equipment. We won't be calibrating the common equipment that touches the patients (like thermometers, blood pressure cuffs, EKG machines, ultrasound machines, defibrillators, etc.), but rather we'll be calibrating the equipment that is used to verify and certify the above equipment, such as patient simulators, temperature simulators, safety analyzers, ultrasound wattmeters, pacemaker analyzers, etc. What standards (other than 17025) would we have to comply to do the calibration of these devices?

ScottBP
We also calibrate bio-med devices. We are an medical maintenance facility with responsibility for calibration services for the entire US Army. We are seeking 17025 (We are currently 9001:2004 registered) Can you share some of your experiences.

Mike
 
Top Bottom