Certified IT components in Medical devices, class IIa (EU)

J

Jerome

#1
Dear Covers,

I'm currently facing a problem which I guess many other Medical device manufacturers have had.
It concerns a medical device, classified as IIa (for EU), containing some IT components.
For the CE approval our Test laboratory has performed testing and an assesment according IEC60601-1 and stumbled upon the following:
The single board computer and the LCD with inverter have documents or certificates claiming they are electrically safe according a standard such as IEC-EN 60950 or UL 1950.
I've tried to get the information from our supplier but they could not help me. Only specification sheets and EMC test reports and declarations but nothing on electrical safety.
I've also tried the manufacturers directly but I got the same info.
The Test Lab then suggested we get the schematics from the manufacturers so the lab can judge the electrical circuits of the High Voltage part of the LCD and inverter and the same for the battery on the single board computer.
Surprisingly :bonk: the manufacturers are not very keen on sharing their schematics...
Or the certificates/declarations of our competitors tests showing the components are safe.:lmao:

Now, I've been trying to get some form of evidence that these components are tested, produced or even designed electrically safe for almost two months now.
No luck!! :nope:
Though the components are from really large international electrical components manufacturers???
They do have comprehensive reports and certificates regarding EMI, EMC, mechenicas shock testing etc...
But nothing on electrical sagety or compliance to the Low voltage directive?

Can anybody comment please or share their experience on this?

:thanx:

Not being sure if this is the right sub forum to post this question, moderators could perhaps move it to a forum with more expertise if needed.:confused:

Regards, Jerome
 
Elsmar Forum Sponsor
G

Gert Sorensen

#2
Anybody with knowledge of this subject? Could be interesting to see some input on how to handle this kind of challenge :cool:
 
K

krishna007

#3
May be or Is there a cross reference in one of the Electrical safety standard of IEC 60601 for the other standards you mentioned "IEC-EN 60950 or UL 1950"?

Good Luck

Krishna.
 
J

Jerome

#5
IEC EN60950 is the harmonized safety standard for IT equipment under the LVD. I never had a problem when using a power supply in my product that complied with that standard. What is your NB looking for?
Thanks Al,
But I don't have a problem with the power supply (which is a medical type with respect to leakage current etc.).
It is the electrical design around the battery on the computer board and the high voltage circuit of the LCD display and inverter.
Our Test Lab (who is testing and assessing it acc IEC60601-1) keeps nagging about evidence if these components are designed in accordance to IEC-EN60950 / UL1950 standards.:argue:
It just seems not reasonable to me as these are components of a device with a proper medical power supply and net filter.

It must be I'm not seeing something here.:read:
The manufacturers have proper QMS (ISO9001), detailed info on tests and certificates regarding EMC compatibility, just no info on electrical safety.
Come to think of it, I can't find proof of electrical safety for computer boards or LCD components at any manufacturer or supplier :nope:

So I'm still a bit puzzled on this one.
Any more experiences out there? :thanks:
 
S

seywerd

#6
As a manufacturer of "Electrical Medical Equipment" you are required to comply with IEC 60601. 60601 has many requirements on electrical parts of the system: Leakage currents, protective devices (fuses, circuit breakers), temperatures, flammability, creepage and clearances are some examples. 60601 also has requirements for mechanics, software and other things. If you built everything from scratch, then the 60601 inspection would test everything (and you would pay a lot for the testing). So it is easier to use components that have in their turn been certified; these components include everything from power supplies, transformers, connectors and wiring. If all of these components were in their turn certified to 60601 again you would be fine, but again you would pay a lot for these components to meet 60601. So they make it a bit easier and allow you to use 60950 certified components for many parts of the system. 60950 is a looser standard and is used principally for IT equipment. The scope of 60950 is much smaller, and is looser on things like leakage current. So what many people do is put 60950 certified components after an isolation transformer which ensures that the leakage current requirement is satisfied.

The specific problem with using components that have no certification at all, is that although you may meet the leakage current requirement due to use of a certified power supply, there is no guarantee that any of the other requirements - flammability, creepage/clearance are met. Use of 60950 certified components helps ensure that this is the case.

We spent some time actually trying to find a CPU board that had the 60950 certification on it, about 80% of boards did not.

Hope this helps
 
J

Jerome

#7
Many, Many Thanks

So there are certified boards (somewhere) available.
Not many but still.
I find it amazing that so many suppliers and manufacturers (which I approached) didn't have a clue what I wanted.
In the end when you look realy hard they did do the required tests or have their components UL registered, but they don't even know it themselves.
The use of certified or registered components often implies compliance to required directives I noticed.
I wonder how other covers search effectively for these components.
I found a search tool from UL at:
http://database.ul.com/cgi-bin/XYV/template/LISEXT/1FRAME/index.htm
One from IECEE at:
http://certificates.iecee.org/cbtestcert/cbtestcert.nsf/Home?OpenForm
And one from CSA at:
http://directories.csa-international.org/

But it is hard to search this way as you first find some component with the right specs, then you look for it in one of these certification directories, and whe your very lucky it's in there.
But most of the time you end up puzzled wondering if you searched the right directory.
So I try finding a different component and start over again.
Highly ineficient and time consuming (and tremendously frustrating).

Anyone got something to share on their approach to find certified or registered (IT or electrical) components for their Medical Electronic Equipment?

:thanks:
 

Marcelo

Inactive Registered Visitor
#8
Truth is, what you are facing is a challenge that everyone will be facing sometime soon (and should have already face it from some time, but who knows).

Seywerd did a wonderful job in explaining the concept in a friendly way.

But i think that there´s some misunderstangins in you problem and i´ll try to explain this in a more precise way.

To be a little more especific, the IEC 60601-1 standard a concept on components that is used in two cases:

- first, components that are means of protection (eg. isolation) shall be reliable, reliable meaning complying with the applicable safety requirements of the relevant IEC or ISO standard, or, if no specific standard exist, the requirements of IEC 60601-1. In the case of components meeting specific standards, you need "evidence" that the component meets the relevant safety requirements (see Figure 5 of the standard has a flowchart for componente qualification). This evidence, in my opinion, can be only two things: the certificate of a notified body or similar institution that says the component is in accordance with standard X, or the test report of a laboratory which shows that the component complies with standard X.

(Just take care in one point: the certificate doesn´t mean that the component doesn´t have to pass additional tests; in fact, it means that the component alone, is adequate, but it doesn´t guarantee that, using the component is an equipment, the equipment will be adequate; these certificates usually have a note saying that the component has to be tested with the equipment it´s used with, i.e., the combination has to be tested. This bring on the problem of the schematics...because another requirement of IEC 60601-1 is that components whose failure could result in a hazardous situation shall be used according to their specification, if you don´t have the specification or schematics you can´t test to see if the conditions of the combination are adequate to the specifications)

- the second way IEC 60601-1 see components is: if a fault in a component can generate an unnacceptable risk, you have to use components with high-integrity characteristics (this means - fault-safe in the conditions of use in the equipment; these are a little worse, because they
shall be selected and evaluated consistent with their conditions of use and
reasonably foreseeable misuse during the expected of the me equipment.
This clearly has nothing to to with the fact that the component complies to any standard..this has to to with the reliabily of the combination alone. In these cases you have to conduct first a risk analysis to discover which components have to be high-integrity, after that an analysis of the charateristics that have to be guaranteed according to the conditions of use and misuse in the service life (in this case you can use standards to determine these characteristics - see rationale for 4.9 which has the full explanation - i´m only explaining it lightly :)). Then, you have to type test these characteristics (and remeber, these components have to function as intended in your equipment, not as the component manufacturer intended it to function alone)! Easy, isn´t?


Now, returning to your case:

- the single board computer and the LCD with inverter have to be used according to their declared characteristics, because a fault on them could cause a hazardous situation (i´m assuming this, but that´s generally the case. This can only be tested knowing the characteristics (and the schematics in this case are fundamental) of the components. But it has nothing to to with whether they are according to 950 or not.

- second - are they means of protection? If they are, then they would have to comply with the relevant standards, in this case 950, and, yes, there shall be evidence on that (not just a claim).

- third - if they fail, thare could be an unacceptable risk? If so, they shall be high-integrity components, and you have to follow the process i told you. Surely, you can use the fact that they comply with the relevant standards to prove that some characteristics are reliable, but others, and specially the ones related to misuse, have to be proven in another way.

This is reaaaaaaaally complicated, but nobody said life of a medical device manufacturer would be easy. That´s way i stick to consulting :)))

Cheers.
 
Thread starter Similar threads Forum Replies Date
V Certified Auditor - Need of additional certification specific to industry ( GMPs) ASQ vs ECA vs others Professional Certifications and Degrees 1
JoCam Certified QMS for MDR - Class I medical device manufacturers EU Medical Device Regulations 4
J ODM not 13485-certified ISO 13485:2016 - Medical Device Quality Management Systems 2
A ASL requirement when the supplier is certified for ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 6
J Possible to get ISO 13485 certified with only OEM Product? ISO 13485:2016 - Medical Device Quality Management Systems 4
Marcel DS How do I know if my product is required be RoHS certified? REACH and RoHS Conversations 6
S National registrations for MDR certified devices in absence of EUDAMED EU Medical Device Regulations 2
S Can assembly manufacturing sub-supplier be certified IATF 16949? IATF 16949 - Automotive Quality Systems Standard 6
B Can we be ISO 9001 certified without a physical office? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
JoCam Certified Body Audit of MDR requirements EU Medical Device Regulations 4
F ISO Certified companies - Is there a list of certified companies that I can access ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
N Can a (class I) medical device be manufactured in a GMP certified site with no ISO13485? EU Medical Device Regulations 18
bryan willemot Looking for a certified test report for aerospace parts AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
L In house calibration - Our CMM's are outside certified can I use them to certify our standards General Measurement Device and Calibration Topics 4
Nicole Desouza The Difference of being AS 9100D Compliant vs.Certified AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 13
K Intended Use-Class I Self Certified - Intended Use and Indications for Use statements EU Medical Device Regulations 1
P ASQ Certified Biomedical Auditor (CBA) Certification Preparation 2019 ASQ - American Society for Quality 3
M Informational From RAPS – Novartis Inhaler is First Device to be Certified Under MDR Medical Device and FDA Regulations and Standards News 0
M Device CE certified under MDD / MDR > new GTIN? EU Medical Device Regulations 7
A Does Class 1 Medical Device need to be certified to MDSAP? Canada Medical Device Regulations 5
N When is "placing on the market"? MDD certified medical devices EU Medical Device Regulations 32
A Changes to an already certified product (IIb, MDR) EU Medical Device Regulations 1
C CE marking for general IVD (self-certified) & ISO 13485 QMS requirements - auditing EU Medical Device Regulations 6
P IATF 16949 Clause 8.4.2.3 - Justification for non-certified suppliers IATF 16949 - Automotive Quality Systems Standard 14
M Is it possible to get iso 13485:2016 certified as a one man band ISO 13485:2016 - Medical Device Quality Management Systems 1
D Who are the accredited Certified Bodies for CE Mark for Medical Devices? CE Marking (Conformité Européene) / CB Scheme 7
J Can subsidiaries use the holding company's ISO 9001 QMS and be classified as ISO 9001 certified? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
S IATF 16949: Is "Certified" Internal Auditor mandatory? IATF 16949 - Automotive Quality Systems Standard 9
Q Does our material suppliers’ supplier have to be at least ISO 9001 certified? IATF 16949 - Automotive Quality Systems Standard 3
C Acquiring an IATF 16949 Certified Company - What happens at the next audit? IATF 16949 - Automotive Quality Systems Standard 4
M Case study - If the restaurant (ISO 9001:2015 certified) was run by 2 persons covering cooking and purchasing processes (Mother and Father) supported ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
M ISO 80079-34 certified contract manufacturer needed Other ISO and International Standards and European Regulations 2
S Critical supplier - Obligated to have an ISO-certified QMS? ISO 13485:2016 - Medical Device Quality Management Systems 8
I Imaging Services - Which standard should we be certified to? ISO 13485:2016 - Medical Device Quality Management Systems 4
tony s An organization's Internal Audit Office certified to ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 28
L Please help me with the process of getting ISO 9001 certified Quality Management System (QMS) Manuals 15
C Must your reference standard provider be ISO17034 certified to meet your testing lab's ISO 17025 certification requirements? Other ISO and International Standards and European Regulations 2
H 8.4.2.4.1 Supplier Audit - Supplier with IATF certified loss IATF 16949 - Automotive Quality Systems Standard 4
T From certified QMS to certified integrated MS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
C ISO 13485 certified as precursor to regulatory compliance to 21 CRF Part 820? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
shimonv Products certified by one of the less familiar NRTL labs Other US Medical Device Regulations 1
M Are Medical device Raw material suppliers required to be ISO 13485 certified ISO 13485:2016 - Medical Device Quality Management Systems 13
R Medical devices certified by different notified bodies EU Medical Device Regulations 6
L Part 11 Certified to legally binding of hand written signatures Other Medical Device Regulations World-Wide 3
D Help identify a Nationally Recognized Testing Laboratory (NRTL) (UL) certified lab General Measurement Device and Calibration Topics 3
F It is required that External labs be also certified to ISO 9001? IATF 16949 - Automotive Quality Systems Standard 37
L How many of you are Certified to IATF 16949 IATF 16949 - Automotive Quality Systems Standard 12
P The suspension rule and de-registration rule for a certified organization Registrars and Notified Bodies 0
S GDPR (General Data Protection Regulation) - My company is ISMS certified IEC 27001 - Information Security Management Systems (ISMS) 3
M Thank you, thank you, thank you - we are ISO 9001:2015 certified! Covegratulations 8

Similar threads

Top Bottom