SBS - The best value in QMS software

Calibrating Biomed equipment in an ISO 17025 accredited calibration laboratory

ScottBP

Involved In Discussions
#1
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?
 
Elsmar Forum Sponsor

Hershal

Metrologist-Auditor
Staff member
Super Moderator
#2
Re: Calibrating Biomed equipment

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

Hershal
 

Al Rosen

Staff member
Super Moderator
#3
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.
 

BradM

Staff member
Admin
#5
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

#6
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
 
Thread starter Similar threads Forum Replies Date
F Calibrating Taper Sleev/Plug Gauge General Measurement Device and Calibration Topics 0
F Calibrating Gagemaker Products General Measurement Device and Calibration Topics 1
S Calibrating our own equipment, can we? Micrometers to calibrate vernier calipers General Measurement Device and Calibration Topics 13
R Feeler Gauge Calibration - What tolerance is used for calibrating feeler gauges? General Measurement Device and Calibration Topics 4
I Tool maintenance and calibration procedure - Calibrating tools/equipment AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
Crusader Interval for Self-Calibrating Measurement Device? Calibration Frequency (Interval) 15
A Calibrating a PRT sensor - Temperature Sensitivity Coefficient General Measurement Device and Calibration Topics 2
M Calibrating Digital Pressure Gages In-House General Measurement Device and Calibration Topics 10
F OEM has no procedure for calibrating their device General Measurement Device and Calibration Topics 4
N Verifying Calibration of Hardness Gauge vs Actually Calibrating It General Measurement Device and Calibration Topics 2
B Problem Calibrating a Krautkramer DMS 2 Ultrasonic Thickness Meter Calibration Frequency (Interval) 2
J Calibrating an 80,000 psi Fluid Pressure Gauge General Measurement Device and Calibration Topics 6
S Calibrating Thermometer with Simulated Output Temperature from Fluke 5520A General Measurement Device and Calibration Topics 6
hogheavenfarm Is there a relatively inexpensive method of Calibrating our Torque Wrenches? General Measurement Device and Calibration Topics 7
L Calibrating Tool Makers Personal Tools General Measurement Device and Calibration Topics 9
P Exempt from Calibrating our Tape Measures and Micrometers ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 32
L Calibrating a Template Gage General Measurement Device and Calibration Topics 7
C Best Method for Calibrating Multimeters General Measurement Device and Calibration Topics 8
D How much Deviation is Acceptable when Calibrating a Hygrometer? General Measurement Device and Calibration Topics 3
K Calibrating Plain Tapered Bores at the Small End Diameter General Measurement Device and Calibration Topics 7
M Calibrating a Weight Scale in a Laboratory Calibration Frequency (Interval) 4
S Calibrating Panel Mounted Pressure Gauges located on Hydraulic Test Stands General Measurement Device and Calibration Topics 3
D Calibrating a Thermometer for use in Cold Rooms - ISO 9001 Clause 7.6 General Measurement Device and Calibration Topics 8
T Hands-On training on calibrating equipment General Measurement Device and Calibration Topics 2
L Calibrating Press Brakes, How to do? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
H Calibrating a Matheson Flowmeter-help appreciated General Measurement Device and Calibration Topics 2
Jerry Eldred Calibrating Mitutoyo SJ-201P Surface Roughness Testers General Measurement Device and Calibration Topics 4
O Calibrating a Gage Block In-house with Calibrated Digital Calipers General Measurement Device and Calibration Topics 7
L Smallest Gage block - What is the smallest gage block for calibrating micrometers? General Measurement Device and Calibration Topics 10
S Calibrating a 1/8-27 NPT thread gage General Measurement Device and Calibration Topics 4
J Calibrating Electronic Equipment Tester Software - ISO 9001 Clause 7.6 Benchmarking 1
M Calibrating 1/2-20 UNF 2B STI Threaded Plug Gage General Measurement Device and Calibration Topics 3
A Calibrating 4" and larger Micrometers General Measurement Device and Calibration Topics 6
R Checking (Calibrating) Truncated Thread Set Plugs General Measurement Device and Calibration Topics 11
G Calibrating a reflectometer - Scale uncertainty with reading? Measurement Uncertainty (MU) 1
D Calibrating Lufkin ID Micrometer ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
Z Calibrating Sunnen PG800 precision bore gage & PG700 setting fixtures General Measurement Device and Calibration Topics 1
C Gage pin calibration procedure for accurately calibrating gage pins General Measurement Device and Calibration Topics 18
Crusader Self-Calibrating Furnace does not require calibration General Measurement Device and Calibration Topics 15
B Using & Calibrating Ultrasonic Micrometer General Measurement Device and Calibration Topics 4
M Calibrating Angle Gage Blocks General Measurement Device and Calibration Topics 2
R Validation of A Procedure for Calibrating Dial Calipers using Traceable Gauge Blocks General Measurement Device and Calibration Topics 6
J Measurement Uncertainty for Calibrating Custom Check Fixtures with a Portable CMM Measurement Uncertainty (MU) 3
T Calibrating or Verifying Metal or Steel Tape Measures General Measurement Device and Calibration Topics 195
T Calibrating the calibrator (torque test) - Electronic torque tester CDI 4001-0-ETT General Measurement Device and Calibration Topics 3
R Calibrating Leak Testers - Old fashioned water tank type tester General Measurement Device and Calibration Topics 2
P Calibrating Density Cups & Viscosity Cups In-House - Seeking Procedure / Help General Measurement Device and Calibration Topics 2
R Micrometer resolution for calibrating thread plug gages General Measurement Device and Calibration Topics 7
J Thread Wire Chart to use when Calibrating a particular size Thread Gage General Measurement Device and Calibration Topics 16
S Calibrating some of our equipment in house - Where do I start? General Measurement Device and Calibration Topics 19

Similar threads

Top Bottom