Citing EN standards

pseudoazurin

Involved In Discussions
#1
Hi just want to check with the general opinions about the citing format (the actual standard no. is irrelvant). An old product, say was tested to comply with EN 60601-1 (ed.2) ages ago, and now in my IFU, should I say that it is comply with EN60601-1 (ed.2) or IEC 60601-1 (ed.2), disregard the whether (ed.2) is still useful or recognized or not, the thing is the standard (e.g. 60601-1) is no longer EN now (however it was), and the testing and the test report or documentation-wise were all EN 60601-1.

Have a nice weekend.
 
Elsmar Forum Sponsor

yodon

Staff member
Super Moderator
#2
Compliance to the harmonized standards (EN) is what gives you presumption of conformity to the regulatory requirements. If you use a different version, you'll likely need to explain the differences between the harmonized version and what you tested to and why the version you tested to meets the requirements.
 

pseudoazurin

Involved In Discussions
#3
Thanks, but that did not answer the question about citing the standard in IFU. I don't think any company would retest the product. It was tested to comply with the then EN 1234:5678 standard, then time flies, the current version is EN 1234:5689, so in my IFU I inclined to continoue to stay that it is comply with EN1234:5678, rather than IEC:1234:5678, as my test report and TD all said so (disregard MDD to MDR dissusion here).
 

yodon

Staff member
Super Moderator
#4
Ack... sorry, completely missed the IFU part. :-/ Honestly, I don't think it matters if you include the revision in the IFU. I can see cases where the revision changes (and you possibly re-test) but wouldn't need to update the IFU. None of the IFUs I've seen include revision info for a standards reference. In fact, the ones I've seen don't even mention the EN part, just the base standard (e.g., IEC 60601-1). Don't expect that many users would have much interest in versions and such.
 

pseudoazurin

Involved In Discussions
#5
Thanks, I may be the few that would like to be as correct as possible.
I can see that stating EN seems to help my claim of compliance to "MDD", but on the other, what is the point of stating and outdating"ex-EN" EN.
 

Mark Meer

Trusted Information Resource
#6
Here's what I'd suggest: create a table in your technical documentation explaining what was tested, the current harmonised version, and notes about compliance. A 4-column table might have the following entry:
  • Standard: IEC 12345
  • Tested: IEC 12345:2003
  • Harmonised: EN 12345:2004
  • Compliance Notes: Main text of standard unchanged between IEC & EN versions.
Such a table is also useful when standards get updated, you do a gap analysis, and find that your previous test results are still applicable. Such an entry might look like:
  • Standard: IEC 12345
  • Tested: EN 12345:2004
  • Harmonised: EN 12345:2004/AM1:2009
  • Compliance Notes: Amendment does not affect tested results. Criteria for all documented tests is unchanged in harmonised version.
In the IFU cite what was tested, and in your CE declaration cite the EN versions that you comply with (table above in your TD will explain any differences).
 

levatorsuperioris

Involved In Discussions
#7
Remember, with state of the art requirements you are expected to fulfill all the latest standards EN versions. You would do this by comparing different revisions and gap analysis and remediation. Hence by default you comply to the newest standard and that can be in your IFU.

If you do not comply to the newest standard you should be remediating and working towards compliance, the IFU would be changed then after your are finished.

Finally if you do not comply and you do not intend to remediate to state of the art, then you should pull the product from markets utilizing your CE mark and in which case IFU changes are not necessary.
 
Thread starter Similar threads Forum Replies Date
V Standards and Copyrights wrt citing them in Procedures Quality Manager and Management Related Issues 1
Sam Lazzara Citing Revision Dates for External Documents including Standards Other ISO and International Standards and European Regulations 8
G ISO Registrars/CBs citing for use of "Detection" in Risk Management ISO 14971 - Medical Device Risk Management 27
G Marketing Promotional Materials and citing FDA Approval Other US Medical Device Regulations 12
B Exclusions or justification for non-applicability of IEC standards Reliability Analysis - Predictions, Testing and Standards 1
Ed Panek Compliance with Standards? When a standard is updated/revised CE Marking (Conformité Européene) / CB Scheme 3
N Harmonized Standards for MDR Certification EU Medical Device Regulations 6
A Some questions about voluntary consensus standards in traditional 510(k) submission US Food and Drug Administration (FDA) 6
D Imaging/Image Quality Standards Other Medical Device Related Standards 1
R ECG Risk Analysis Standards ISO 14971 - Medical Device Risk Management 2
I Management review in conformity assessment standards - Certification Bodies Management Review Meetings and related Processes 6
Govind Informational ISO COVID-19 response: freely available ISO standards Other ISO and International Standards and European Regulations 1
C Does a CE mark infer meeting all applicable standards? CE Marking (Conformité Européene) / CB Scheme 4
T Assessing Hazard-Related Use Scenarios where control measures exist through standards IEC 62366 - Medical Device Usability Engineering 25
Richard Regalado Informational ISO makes available relevant BCMS standards free for online access Business Continuity & Resiliency Planning (BCRP) 5
A Technical File - Updating Applied Standards EU Medical Device Regulations 4
A NB (Notified Body) Audit of Standards ISO 13485:2016 - Medical Device Quality Management Systems 3
R Applicability of new non-harmonized standards (MDD/MDR) EU Medical Device Regulations 8
dgrainger Informational EU published new Harmonised Standards List for the Directives (25/3/2020) Medical Device and FDA Regulations and Standards News 0
P Static Electricity/Pacemaker - Standards for static electricity generation CE Marking (Conformité Européene) / CB Scheme 3
M Referencing Harmonised Standards in Declarations of Conformity EU Medical Device Regulations 4
Pmarszal External Standards and Regulations Management Process Document Control Systems, Procedures, Forms and Templates 10
S IVF medical devices standards and test methods Medical Device and FDA Regulations and Standards News 4
M What are the standards for malls management? ISO 14001:2015 Specific Discussions 1
A Complaint alert levels - Industry standards pertaining to alert levels for complaints Customer Complaints 5
R MDR standards - which standards to comply with ? EU Medical Device Regulations 3
D Why does Official Journal list superseded standards? EU Medical Device Regulations 6
M MDR "Common Specifications" (CS) - If not standards, then what? EU Medical Device Regulations 5
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
F AS9100D, raw material standards are a requirement for manufacturing? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
S Industry Labelling Standards - non medical Manufacturing and Related Processes 0
J Medical device related standards or regulations - Disposed records log ISO 13485:2016 - Medical Device Quality Management Systems 2
S How many mandays required for the below mentioned standards IEC 27001 - Information Security Management Systems (ISMS) 3
M Standards Subscription Service and Standards Tracking Service Pros and Cons? Other US Medical Device Regulations 3
P European versions of standards - ISO 10993-1 and ISO 11607-1 EU Medical Device Regulations 6
Q Interpreting China Medical Device regulations/standards China Medical Device Regulations 1
M Informational US FDA – Modifications to the List of Recognized Standards, Recognition List Number: 052 Medical Device and FDA Regulations and Standards News 0
M EMC Directive and product safety standards CE Marking (Conformité Européene) / CB Scheme 1
M Referenced Standards and/or "State of the Art"? IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
Sidney Vianna Informational List of ISO Management System Standards Other ISO and International Standards and European Regulations 0
C How medical device manufacturers are implementing standards like GDPR and HIPAA Other ISO and International Standards and European Regulations 5
R Rationale for changes to ISO Standards Other Medical Device Related Standards 4
D IEC EN 61326 Dated Standards - Dated standards for test protocols CE Marking (Conformité Européene) / CB Scheme 3
M Microbiological Testing Lab - Layout & Standards Other Medical Device Regulations World-Wide 0
M Different procedure templates for different standards - We have two different management systems ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
DuncanGibbons Are there aerospace standards for the development and manufacture of euipment and tools? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
W ISO standards /Social Audit Franchise (Accredited & Non Accredited) Service Industry Specific Topics 7
S How to consider the relevant standards during development of ISO13482:2016 for IVD manufacturing Blood grouping Other Medical Device Related Standards 6
S Standards for real time stability for medical devices Other Medical Device Related Standards 2
S Mammography standards or regulations for radiology software (no hardware)? Other Medical Device and Orthopedic Related Topics 0

Similar threads

Top Bottom