Difficulty in demonstrating Compliance to Many EMC Standards specified!

M

mr.mike

#1
Hi Everyone,

I've got a small problem here... The person who drafted the system-requirements document for our device went and listed just about every EMC standard there is. Specifically, the document states:

"The system shall conform to EMC standards FCC Part 15, Directive 89/336/EEC*, IEC 60601-1-2, ICES 003, EN6100-3-2, EN61000-3-3...."

(* I believe this Directive has since been superceded by 2004/108/EC, correct?)

...anyway, it goes on and on...
The point is, though, that now that design is complete we now have to demonstrate compliance to these original requirements laid out.

So my question is, is there a simple way to demonstrate conformity to all these EMC standards? I presume that there's a ton of overlap amonst them...in which case a single battery of tests might suffice (wishful thinking)?

...Of course, this document IS under our control, and we could always revise the original requirements to make it more feasable to verify? ...but in this case, I wouldn't know what to include and what not to.

I think the intent of the person who wrote the original system requirements was to cover all bases, so that the device would conform to as many country-specific requirements as possible. But it seems to me that this requirement statement is totally overkill, and quite infeasable to verify...

Any advice here?
Thanks in advance,
MM.
 
Elsmar Forum Sponsor
#2
Hello.

You are correct, there will be a lot of overlap.

Where is 60601-1?

I would suggest you remove them all and add 60601-1 and 14971...those together with your QMS should be sufficient and compliance with these will be required for countries such as Russia & Brazil.

If you are not interested in other global markets, you could drop them altogether.

Get your products tested and certified.
Complete your essential requirements to show how you are in compliance with the directives. I think that's about it?
 
#3
The EMC standard for medical devices is 60601-1-2, and that is accepted as THE standard just about everywhere.

If you look at the details of the tests in that standard you will see reference to the 61000 series. So under clause 6.2.2 - Immunity to electro-sttic discharge you will see "The tests of IEC 61000-4-2 apply". So if you show compliance to 60601-1-2 you are, effectively, also showing compliance to the 61000 series.
 
M

mr.mike

#4
Thanks Pads38, that simplifies the list tremendously!

But what about Directive 89/336/EEC (2004/108/EC) and ICES-003? Is compliance to these not required for EU and Canadian markets, respectively?

(P.S. Also thanks to the moderator who changed the thread title to something more descriptive! :) )
 
M

mr.mike

#5
:eek:...I think I may have answered one of my own questions...
(but if someone could confirm this is correct, that'd be great!)

So Directive 2004/108/EC states in Annex IV that reference to the Directive must be included in the EC Declaration of Conformity. ...I take this to mean that compliance with this Directive IS required.

But the essential requirements in Annex I of this Directive are pretty straight forward. Namely (for non-fixed installations):

(a) the electromagnetic disturbance generated does not exceed the level above which radio and telecommunications
equipment or other equipment cannot operate as intended;
(b) it has a level of immunity to the electromagnetic disturbance to be expected in its intended use which allows it
to operate without unacceptable degradation of its intended use.
So, I'm assuming that it is then left up to the manufacturer to declare conformity to the above and provide sufficient evidence. This can be done by demonstrating conformance to any relevant EMC harmonized standards.
But note that as per Article 6 of this Directive: "Compliance with a 'harmonised standard' is not compulsory".

So, in summary:
- Compliance to EMC Directive 2004/108/EC is required and must be sited in the Declaration of Conformity.
- To conform to this Directive (for non-fixed installations), the essential requirements are to demonstrate sufficiently low emmissions, and adequate immunity.
- While compliance to EMC harmonized standards is NOT compulsory, they are a good way to provided evidence for the above essential requirements.

Do I have this correct?
 
#6
So, in summary:
- Compliance to EMC Directive 2004/108/EC is required and must be sited in the Declaration of Conformity.
- To conform to this Directive (for non-fixed installations), the essential requirements are to demonstrate sufficiently low emmissions, and adequate immunity.
- While compliance to EMC harmonized standards is NOT compulsory, they are a good way to provided evidence for the above essential requirements.

Do I have this correct?
Yes it's correct. (I am guessing you are including your QMS and 93/42 as well?)
Some devices don't need EMC testing either.
What is your product?
 
#7
I can't remember the 'correct' words but the medical device directive 'trumps' the EMC directive. EMC is part of the Essential Requirements of the MDD (ER 12.5). If you show compliance with the MDD you do not need to seperatley show compliance to the EMC directive.
 
M

mr.mike

#8
Yes! Thanks Pads38, I just discovered this myself!

For those interested, here are the relevant Directive Excerpts:

From Article 1(7) of MDD 93/42/EEC:
7. This Directive is a specific Directive within the meaning of Article 1(4) of Directive 2004/108/EC of the European Parliament and of the Council (21).

And the Article 1(4) of Directive 2004/108/EC referenced above:

4. Where, for the equipment referred to in paragraph 1, the essential requirements referred to in Annex I are wholly or partly laid down more specifically by other Community directives, this Directive shall not apply, or shall cease to apply, to that equipment in respect of such requirements from the date of implementation of those directives.
So, I guess in the end, if we are demonstrating conformance to MDD 93/42/EEC, we can ignore Directive 2004/108/EC.
 
Last edited by a moderator:
Q

QA Rod

#9
Hello everyone, this is my 1st time, if I am doing something incorrectly, please let me know. I did a search for "ICES-003" which brought me here. My question is: our customer states we must have certification to this particular standard in order to import monitors into Canada. Our monitors are imported from Asia and are primarily used in security situations. We have shipped to Canada for 40 plus years and this is the 1st time we have heard of this? Customer states they know nothing of the requirements just that they were told that they needed this certification. Can anyone help steer me in the right direction.
Thanks
 
Thread starter Similar threads Forum Replies Date
Q Is that any difficulty to do software DFMEA and PFMEA in ISO 13485? ISO 13485:2016 - Medical Device Quality Management Systems 5
S Difficulty Finding A Notified Body for CE Marking - No Capacity Registrars and Notified Bodies 5
I Difficulty with calculated t-value for Linearity Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 7
A IMDS DIFFICULTY: Our customer requires the Wildcard portion MUST be < 0.1 % RoHS, REACH, ELV, IMDS and Restricted Substances 5
P Difficulty in Detecting Within Lot Variation when using Zbar W (Normalize) Chart Statistical Analysis Tools, Techniques and SPC 14
I Difficulty in creating a Quality Manual Quality Management System (QMS) Manuals 4
C 5S - Difficulty in Standardization Lean in Manufacturing and Service Industries 11
Wes Bucey "In the middle of difficulty lies opportunity." - Einstein Career and Occupation Discussions 2
Antonio Vieira Difficulty ?passing? Quality audits - Number of Major / Minor Nonconformances Allowed General Auditing Discussions 12
S Training Evaluation Form - Evaluator feel difficulty to fill this form Training - Internal, External, Online and Distance Learning 12
J CQE Study Guide Indicative of Test Difficulty? Professional Certifications and Degrees 1
J Difficulty with cell phone reception in House with Aluminum Siding Coffee Break and Water Cooler Discussions 23
D Organisational Structure - Difficulty with a business stream approach Misc. Quality Assurance and Business Systems Related Topics 4
B Oil/water separators - Difficulty meeting state wastewater standards Miscellaneous Environmental Standards and EMS Related Discussions 4
S QOS for Tooling and Equipment - Having difficulty selecting a measurable QS-9000 - American Automotive Manufacturers Standard 2
M Demonstrating battery safety in 510(K) submission for the FDA Other US Medical Device Regulations 9
B Demonstrating Leadership Skills in a Job Interview Career and Occupation Discussions 7
S Best method for Demonstrating Employee Motivation (6.2.2.4) Compliance IATF 16949 - Automotive Quality Systems Standard 2
M Demonstrating Substantial Equivalence - Requesting 510(k) data from company 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 17
I Cl 4.3.1 (c&d) Demonstrating fulfillment of requirements in HIRA register Occupational Health & Safety Management Standards 1
T OHSAS 18001 - Demonstrating and Auditing Management Commitment. Occupational Health & Safety Management Standards 9
S Demonstrating Capability in 'Goalpost' World Statistical Analysis Tools, Techniques and SPC 25
E Test report to certify compliance with IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 1
E Accredited vs. non-accredited labs for 60601 compliance in the US IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
E Accredited vs. non-accredited labs for 60601 compliance in the US Other Medical Device Related Standards 0
M Class II type machine , and its compliance with 60601-1 IEC 60601 - Medical Electrical Equipment Safety Standards Series 14
C ISO 14001:2015 6.1.3 Compliance Obligations - Legal requirements monitoring ISO 14001:2015 Specific Discussions 0
H Automotive wires - Compliance with USCAR21-4 & USCAR38-1 Various Other Specifications, Standards, and related Requirements 0
M FULFILMENT of compliance obligation versus COMPLY with compliance obligations ISO 14001:2015 Specific Discussions 2
K ISO 13485 and compliance of electronic signature ISO 13485:2016 - Medical Device Quality Management Systems 5
L Medical device HIPAA compliance in encryption Medical Information Technology, Medical Software and Health Informatics 1
J Strategy for MDR Regulatory Compliance Procedure ISO 13485:2016 - Medical Device Quality Management Systems 4
G Adopting old product - compliance with IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 9
M Advice needed for SEH Compliance Software and ISNETWord Compatabiliy Occupational Health & Safety Management Standards 2
D HIPAA, HITECH and Interoperability compliance route Medical Device and FDA Regulations and Standards News 2
A Environmental Compliance obligations and risks (ISO 14001:2015 6.1.3) ISO 14001:2015 Specific Discussions 3
M Tracking Expiration dates on compliance certifications REACH and RoHS Conversations 2
T Training recommendations? Bringing our RoHS and REACH compliance efforts in-house REACH and RoHS Conversations 2
optomist1 Informational Training IMDS - Management of Product Chemical Regulatory Compliance RoHS, REACH, ELV, IMDS and Restricted Substances 2
G ISO 14001 - 6.1.3 Compliance Obligations ISO 14001:2015 Specific Discussions 1
Ed Panek Compliance with Standards? When a standard is updated/revised CE Marking (Conformité Européene) / CB Scheme 3
K IEC 62304 compliance - Code reviews as part of verification strategy IEC 62304 - Medical Device Software Life Cycle Processes 5
N Which EN ISO 17664 version compliance to EU MDR? Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 3
N Audit non-compliance API Q1 - Use of External Documents 4.4.4 in Product Realization Oil and Gas Industry Standards and Regulations 8
C Compliance with ISO 17025 requirement 8.4.2 - Controls - Records recovery ISO 17025 related Discussions 4
J Management Representative and PRRC (Person Responsible for Regulatory Compliance) ISO 13485:2016 - Medical Device Quality Management Systems 10
N Audit non-compliance - API Spec Q1 9th Ed 5.6.1.2 b Oil and Gas Industry Standards and Regulations 10
J Interesting Discussion Compliance with regulations in exceptional circumstances EU Medical Device Regulations 5
L Wearables 21 CFR Part 11 compliance Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 1
V Preparing the IFU in compliance with MDR 745, Chapter III EU Medical Device Regulations 2

Similar threads

Top Bottom