Scales integrated in medical device

EMengineer

Involved In Discussions
#1
Hi,

I ran into an issue. Scales (which comply with EN 45501 standard) is incorporated into the medical bed. Does scales should be retested according to EN 45501? What I have found in EN 45501 clause 2.4: "The requirements of this standard apply to all devices performing the relevant functions, whether they are incorporated in an instrument or manufactured as separate units.". Does it mean that if scales complies with EN 45501 and then is incorporated into medical bed, there is no need to retest the scales?
 
Elsmar Forum Sponsor

Al Rosen

Holed-up in a Hotel in South Florida
Staff member
Super Moderator
#2
Hi,

I ran into an issue. Scales (which comply with EN 45501 standard) is incorporated into the medical bed. Does scales should be retested according to EN 45501? What I have found in EN 45501 clause 2.4: "The requirements of this standard apply to all devices performing the relevant functions, whether they are incorporated in an instrument or manufactured as separate units.". Does it mean that if scales complies with EN 45501 and then is incorporated into medical bed, there is no need to retest the scales?
It means that if your scale is incorporated into another instrument, in this case your bed, it is required to meet EN 45501. If EN 45501 requires retesting, then you must retest the scale as part of the bed.
 

somashekar

Staff member
Super Moderator
#3
Hi,

I ran into an issue. Scales (which comply with EN 45501 standard) is incorporated into the medical bed. Does scales should be retested according to EN 45501? What I have found in EN 45501 clause 2.4: "The requirements of this standard apply to all devices performing the relevant functions, whether they are incorporated in an instrument or manufactured as separate units.". Does it mean that if scales complies with EN 45501 and then is incorporated into medical bed, there is no need to retest the scales?
I beg to differ in this case.
The scale you are incorporating (fixing on the medical bed) is already complying to EN 45501. (manufactured as a separate unit)
In place of fixing that scale if you fix any other scale on the medical bed not known to comply with EN 45501., then that device (your medical bed) performing the relevant function (weight measurement) must apply the EN 45501.
So you are right in that there is no need to retest the scale.....
 

Jean_B

Trusted Information Resource
#4
First question is to determine whether it is simply an independent medical device scale.
Is its use as mounted to your medical device bed within the intended use of the medical device scale as sold to you?
Is it independent e.g. the result comes about and is used as if your bed isn't material to it? (The opposite is when it does factor into your intended use in a more integrated way, e.g. calculation, alarms).
If the answer to both is yes, you can probably make a case akin to procedure packs that you don't need to retest (but need to supply its IFU alongside your own, etc.). As a basic, an EN 45501 gap analysis showing no impact/impact and how it is addressed is the minimum. If you're being really fancy with the scales and your bed a full retest might be in order, but that needs so much information you'll probably head into confidential or proprietary matters and contract a consultant instead of this open forum.
 

Peter Selvey

Staff member
Moderator
#5
I would lean to Somashekar's interpretation. I would assume the logic of the directive (2014/31/EU) and the associated standard EN 45501 is around making a declaration that the "measurement module" meets the directive, full stop.

The "instructions for use" should have installation conditions which if followed means the declaration and compliance are still valid, even if installed in another device.

The alternative does not work logistically: i.e. that installing the module in another device invalidates the declaration and compliance. The reason is that ensuring weighing measurement accuracy is a complex, specialised area so the end product manufacturer (e.g. bed) is not going to have the competence or experience to take responsibility for design and production of the module. The only practical way would be to have the module manufacturer become a subcontractor of the bed manufacturer. That needs legal agreements, and means the module manufacturer gets audited with every bed manufacturer etc etc. If you consider that the module manufacturer could have 100's or 1000's of end users, it all gets messy.

Hence, it makes sense that the module manufacturer can make a one time declaration of compliance. The key here is the installation instructions that need to be robust enough to ensure compliance when installed. Then, the end use manufacturer just needs to verify that they followed the instructions.
 
Thread starter Similar threads Forum Replies Date
C Industrial scales and MSA (IATF 16949 requirement 7.1.5.1.1) IATF 16949 - Automotive Quality Systems Standard 30
Q Translating FDA Searches - Neonatal incubator weigh scales US Food and Drug Administration (FDA) 5
Manix Calibration of Scales to Traceable Standards (Clause 7.6) - Required or Not Calibration Frequency (Interval) 6
W Legality of selling parts by count - Counting Scales Quality Manager and Management Related Issues 6
A Calibration of Disposable Weight Scales General Measurement Device and Calibration Topics 2
P Applying Combined Tolerances of Two Scales - Balance Tolerance Question General Measurement Device and Calibration Topics 9
L Is calibration required for weighing scales used for shipping purposes ? Misc. Quality Assurance and Business Systems Related Topics 10
D Single-Point Scale Calibration - Very Large Scales General Measurement Device and Calibration Topics 3
N What brand of scales do you use in pharma? Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 6
WEAVER Calibration of Measuring Instrument by Adjustment of its Scales IATF 16949 - Automotive Quality Systems Standard 2
F GRR (Gage R&R) with Different Scales Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 10
F How to calculate the minimum Value of Mass needed for Scales Calibration? General Measurement Device and Calibration Topics 6
M To Calibrate or Not to Calibrate various Weight Scales ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 24
M FMEA Rating Scales for the Insurance Industry FMEA and Control Plans 4
D Scales calibrated by an ISO 17025 accredited organization? TS 16949 requirement? ISO 17025 related Discussions 44
H Less Really is More When it Comes to Response Scales The Reading Room 9
V Daily weight checks of floor scales General Measurement Device and Calibration Topics 9
S Satisfaction scales - positive to negative or negative to positive Benchmarking 6
R Calibration of Scales for Weigh Counting General Measurement Device and Calibration Topics 19
Q Weighing (Weight) Scales Verification - Blank weight of material General Measurement Device and Calibration Topics 13
T How to calibrate dial indicators, gauges and scales General Measurement Device and Calibration Topics 22
F Scales and Accuracy - Getting scale companies to give out accuracy for their scales Reliability Analysis - Predictions, Testing and Standards 2
M Weighing scales to be used at each machine on the shop floor Manufacturing and Related Processes 6
J Surface Finish Tester Recommendations with both Ra and Rz (english and metric) scales Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
A Required platform for scales (a weighty matter?) General Measurement Device and Calibration Topics 8
C SPC for calibration check data? Daily gram scales check - What is acceptable? Statistical Analysis Tools, Techniques and SPC 5
B Scales - Gage R&R, Bias, Linearity, Stability Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
B Gage R&R Study on Laboratory Scales Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 3
L Tape Measures & Scales - Part Tolerance - Gage R&R Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 24
J UPS owned shipping carton weight scales - Include this in my Calibration system? General Measurement Device and Calibration Topics 9
J Should weigh count scales be in the Calibration System? QS-9000 - American Automotive Manufacturers Standard 4
U Imagine a technology which is an artificial muscle and is integrated into textiles... Coffee Break and Water Cooler Discussions 1
M Interview question - IMS (Integrated Management Systems) a necessity or an ISO mistake? ISO 14001:2015 Specific Discussions 10
B Efficacy of Q-Das system integrated with PC-DMIS Inspection, Prints (Drawings), Testing, Sampling and Related Topics 0
B Integrated management system - ISO 9001 and ISO 14001 - Is possible to have a joint certificate covering both standards? ISO 14001:2015 Specific Discussions 6
A Integrated risk and opportunities evalution template ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 0
T From certified QMS to certified integrated MS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
A Integration of Information Security in an existent Integrated Management System IEC 27001 - Information Security Management Systems (ISMS) 4
B Integrated Quality Manual ISO 13485:2003 ISO 9001:2015 ISO 13485:2016 - Medical Device Quality Management Systems 6
G Integrated ISO EHSQ Multi-Site Certification ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
A Integrated Management Systems - ISO 50001 and ISO 9001 possible? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
M Integrated Phased Processes - AS9100D cl. 8.1 Operational Planning - Clarification AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 8
S Sample document for integrated ISO 20000 & ISO 27001 Other ISO and International Standards and European Regulations 3
W ISO 9001, ISO 14001 and 18001 Integrated Approach ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
T Guidance - Setting up an integrated quality & environmental management system Career and Occupation Discussions 12
G What to do and prepare for an Integrated Management Systems Audit ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
M IMS - Integrated ISO9001, ISO14001 & OHSAS 18001 Internal Audit Checklist Internal Auditing 2
S ISO 9001, ISO 17020 and ISO 3834 Joint (Integrated) QMS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
S GDPMD integrated with ISO9001 Other Medical Device and Orthopedic Related Topics 3
D IMS (Integrated Management Systems) for 6 standards ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
Similar threads


















































Top Bottom