Understanding Versions of Collateral and Particular Standards

Mark Meer

Trusted Information Resource
#1
Hi Everyone,

I'm trying to get my head around how versions of collateral and particular standards of relate to the general 60601-1 version...

Is there a simple relationship?

For example:

Europe currently has "EN 60601-1:2006/AC:2010 (IEC 60601-1:2005 Mod)" and "EN 60601-2-10:2000 (IEC 60601-2-10:1987)" listed as harmonized standards.

Whereas the FDA has "AAMI / ANSI ES60601-1:2005/(R)2012 And C1:2009/(R)2012 And, A2:2010/(R)2012 (IEC 60601-1:2005, Mod)" and "IEC 60601-2-10 Edition 2.0 2012-06" listed as consensus standards.

So, both seem to be recognizing a 3rd-edition variant of the general standard, but for the particular standard (-2-10), Europe is recognizing the 1st edition (1987), whereas the US FDA is recognizing the 2nd edition (2012).

Is this correct? If so, it appears that the version of the general standard has no bearing on the versions of particulars and collaterals you choose... :confused:
 
Elsmar Forum Sponsor
P

PaulGr

#2
From IEC60601-1:2012: Applicable collateral standards ... shall apply together with this [IEC60601-1] standard. (...) A requirement of a particular standard takes priority over this [IEC60601-1] standard.

So check the references of applicable particulars and collaterals to decide which version of the general standard IEC60601-1 should be used. You can only select versions of the general standard, collaterals and particulars that belong together and you have to start with the version of applicable particular(s).

The issue i.m.o. is with the adoption of new standards by the authorities. Looking at the lists of harmonized (EU) we have not seen an update of the list of harmonized standards since January 2013. As a result, specific particulars aligned with 60601-1 3rd edition or 3.1 are available on IEC level but for a CE conformity assessment we still have to use particulars aligned with the 2nd edition and as a result also the 2nd edition of the main standard.

Any other thoughts on this subject?
 

Mark Meer

Trusted Information Resource
#3
...we still have to use particulars aligned with the 2nd edition and as a result also the 2nd edition of the main standard.
This is precisely what is confusing me.

IEC 60601-2-10:2012 (2nd Ed.) clearly states it is aligned with IEC 60601-1:2005+A1:2012 (3rd Ed.)

IEC 60601-2-10:1987+Am1:2001 (1st) states alignment with the 2nd edition of the general standard.

So: if the EU is presently listing only 60601-2-10 (1st edition) as harmonized, but is NOT listing the edition of the general standard to which it is aligned (i.e. 60601-1 2nd Ed.), what are you supposed to do??
 
M

medgar

#4
Hi

Care needs to be taken when using the 60601 series if your 'end game' is conformity to the MDD because there are now a number of 'current' stds in the 60601 series referencing different versions of each other (some of which do not give a presumption of conformity to the MDD).

For example, the OJEU now annotates EN 60601-1 (3rd Ed) as 'compliance with this standard may not give a presumption of conformity to the MDD'.

The consensus with my colleagues is that, in this case, it is most likely due to the 3rd edition reliance on ISO 14971:2007 rather than EN 14971:2012 => the treatment of risk is quite different between these standards.

We've found that we need to check that the standard is hamonised AND still gives a presumption of conformity if we are looking for conformity to the MDD.
 

Mark Meer

Trusted Information Resource
#5
Thanks for the tip medgar, I'll pay close attention to which harmonized standards are expired or have notes regarding presumption of MDD conformity...

EN 60601-1:2006/AC:2010 seems to be ok...

But my real concern here is with versions. If applicable, we are supposed to start with an applicable particular standard, in this case -2-10.

Now we find that only the 1st edition (ammended) is harmonized. ...and this aligns with the 2nd edition of the general standard, which is no longer harmonized.

So, what to do? Do we:
1. Go with the harmonized particular, and then test to the 2nd edition of the general standard assuming that because it is aligned with the harmonized particular this will be ok.
OR
2. Go with the latest (not-yet-harmonized) particular that is aligned with the 3rd edition (harmonized) of the general standard.
OR
3. Do both 2nd and 3rd edition testing (this is what our test lab is recommending...of course)
 
P

PaulGr

#6
So, what to do? Do we:
1. Go with the harmonized particular, and then test to the 2nd edition of the general standard assuming that because it is aligned with the harmonized particular this will be ok.
For MDD compliance, this might be a safe option as long as you don't need compliance with IEC 3rd edition standards in the rest of the world. This is also conform the NB-MED recommendation (see 60601-1 FAQ 3.5.4).

2. Go with the latest (not-yet-harmonized) particular that is aligned with the 3rd edition (harmonized) of the general standard.
Before choosing this route, I would discuss the approach with your notified body (if they are involved) to ensure they accept these standards as an alternative to the harmonized standards. (Because of the EU quarrel about the harmonized standards we have this strange situation without updates of the list).

3. Do both 2nd and 3rd edition testing (this is what our test lab is recommending...of course)
This will be required if you need both sets of reports to get approvals in your target countries. I think currently only Canada and Brazil are to be checked if they need 3rd edition reports.
 

Pads38

Trusted Information Resource
#7
As harmonisation of 60601-2-10:2012 is long overdue I would "future proof" my testing and use the newer versions of both the particular and the general standard.

I would then highlight in my Technical Files that the -2-10 Test Report has been issued before harmonisation but that it provides an acceptable alternative approach. I don't think a Notified Body would argue much with that. You could even do a side-by-side clause comparisons to show that there is not a great deal of technical difference.

Remember ALL standards are voluntary.
The "Essential Requirements" are the compulsory thing.
 

Peter Selvey

Staff member
Moderator
#8
Technically, when a particular standard exists, there is no "general standard" as such. The particular is merged with the general standard to create a single standard e.g. IEC 60601-2-10:1987. Therefore, there is no need for Europe to keep the old version of general standards (e.g. EN 60601-1:1990) in the list of harmonized standards.

But anyway in this particular case I would go with the latest edition if possible, even though not harmonized.

The problem is that change from old to new is so dramatic that it would be difficult to try to cover both old and new editions. Also we can expect the new standard to be harmonized soon.

For Europe, it is misleading or simplistic to say that "all standards are voluntary". The law states that if you do not use harmonized standards you need to document your "alternate solutions" against the essential requirements. There is no obligation to do this when harmonized standards are used. Although most manufacturers will have a "essential requirements checklist" these are usually poorly prepared and lacking any detail, which is fine as long as harmonized standards are used, since it is not required anyway. The minute you decide to go "off-road" so to speak, this becomes a formal legal document, so it needs to be prepared carefully.

The key point in this case would be to identify any area in which the older standard is more strict than the latest standard. In that case you would need to show the alternate solution (e.g. new standard) meets the essential requirement.

For some standards, Europe has genuine concerns so they may be deliberately holding back on harmonization. ISO 80601-2-56 for thermometers has been around for nearly 5 years but not yet harmonized, and there are some serious conflicts with the existing older standards.

However for IEC 60601-2-10, I don't know of any such conflict, it may be just a delay for the committee to get around to the IEC version, and Europe would like give a period of grace (e.g. 3 years) before harmonizing. Why no period of grace for FDA? The answer is that standards are not part of the law in the US, they are just guidance for smoother applications. So the FDA can change the list quickly without any legal impact.

In summary I would go with the latest standards, and for Europe I would prepare a short report that outlines any significant changes between 1987 edition and the 2012 edition. For any point where the 1987 edition is more strict than the 2012 edition, explain why the related essential requirement(s) is/are met. In your essential requirements checklist, make reference to the actual reports for the standards and also the report on the assessment of significant changes.

Don't ask the NB if this is OK. Just do it.
 
Thread starter Similar threads Forum Replies Date
D Surface Roughness understanding Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
P Understanding DFMEA and PFMEA - Supplier Related IATF 16949 - Automotive Quality Systems Standard 21
DuncanGibbons Understanding the applicability of Design of Experiments to the IQ OQ PQ qualification approach Reliability Analysis - Predictions, Testing and Standards 0
B Measuring and monitoring equipment - Understanding which procedures to be compliant with ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 6
M Informational Health Canada has launched an e-Learning tool to aid in understanding the premarket regulatory requirements for medical devices in Canada Medical Device and FDA Regulations and Standards News 0
S Understanding UDI requirements - Class 2 medical device (hearing aids) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
M Informational Understanding Costs And Risks For HFE Usability Studies — Part 1: Testing In-House Medical Device and FDA Regulations and Standards News 0
P Understanding FDA draft "Management of Cybersecurity in Medical Devices" Medical Information Technology, Medical Software and Health Informatics 3
J Properly understanding SPC - Newbie SPC questions Statistical Analysis Tools, Techniques and SPC 29
S Understanding control chart and measurement capability Statistical Analysis Tools, Techniques and SPC 2
P Minitab Data Analysis - Understanding if a Process is in Control or Not Using Minitab Software 2
R Understanding a few points on ISO 9001's Design and Development Planning ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
Z Understanding Cycle Time - Why the time of the other activities are left out Lean in Manufacturing and Service Industries 11
J Understanding ISO 9001:2015 - 10.3 Continual Improvement ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
J Understanding ISO9001:2015 - 8.3: Design and Development of Products and Services ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
E Root Cause Analysis - Is Insufficient Understanding an acceptable Root Cause? General Auditing Discussions 9
E Understanding of TS 16949 Clause 7.6.2 IATF 16949 - Automotive Quality Systems Standard 5
K Understanding IEC 60601-2-68 requirements ISO 13485:2016 - Medical Device Quality Management Systems 1
A Training material for interpretation & understanding Part 11 requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
N Understanding the absolute uncertainty specification for a Fluke 5500A Measurement Uncertainty (MU) 3
N Understanding, Challenging & Approving Supplier Control Plans FMEA and Control Plans 7
M Definition Recommendations - Understanding "recommendations" and "recommended corrective action" Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 8
S Understanding UDI (Unique Device Identification) Other US Medical Device Regulations 10
T Understanding USP <1112> Water Activity as applicable to Medical Devices Other Medical Device and Orthopedic Related Topics 4
K Understanding Risk Management Requirements according to AS9100 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 11
S MIL-HDBK-217 - Understanding the various Environmental Conditions Reliability Analysis - Predictions, Testing and Standards 1
D What is your understanding or interpretation of TS16949 7.4.1.2 IATF 16949 - Automotive Quality Systems Standard 6
C Understanding the relationship between 62304 and the MDD ER IEC 62304 - Medical Device Software Life Cycle Processes 7
S Understanding Subgroup Size - Multi Cavity (Minitab) Statistical Analysis Tools, Techniques and SPC 4
R Understanding clause 15.4.2.1 d) of amendment 1:2012? IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
M Understanding accreditation, MoUs, certifications Other ISO and International Standards and European Regulations 28
L Mobile Medical App - Understanding 21 CFR Part 820 Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
D Understanding and implementing ISO 17025 ISO 17025 related Discussions 9
S Understanding, Analysis and Monitoring Quality Defects on Composite Components Statistical Analysis Tools, Techniques and SPC 3
S Understanding PMS (Post Market Surveillance) and PMCF (Vigilance and PMCF) Quality Manager and Management Related Issues 1
B Understanding why my CpK and PpK are low, and LCL Statistical Analysis Tools, Techniques and SPC 20
S Understanding Quality Objectives, Metrics and KPI ISO 13485:2016 - Medical Device Quality Management Systems 15
Q Beginner's Understanding - The Purpose and Applications of QMS/ISO Standards Philosophy, Gurus, Innovation and Evolution 12
Q Understanding Configuration Management AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 16
W Understanding PPAP Appearance Approval APQP and PPAP 22
V Understanding Automotive Coating for Seating Mechanism Components Manufacturing and Related Processes 1
M Understanding of Regression and ANOVA in Minitab Statistical Analysis Tools, Techniques and SPC 8
4 Understanding ILAC policy P14:12/2010 6.3 part a) General Measurement Device and Calibration Topics 28
H Understanding 8.2.3 M&M of Processes for our Internal Audit ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
P Understanding ISO 26262 Road Vehicle Functional Safety Other ISO and International Standards and European Regulations 2
arios Understanding adoption of a product to an existing Sterilization Cycle Other US Medical Device Regulations 1
M Learning ISO 13485 - Getting a better understanding of the requirements ISO 13485:2016 - Medical Device Quality Management Systems 6
S Understanding FDA rules regarding MDDS Status and Clinical Trials 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
G Understanding Identification of Design in QSR 21 CRF Part 820.30 Design Control (f) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
Q Understanding the general Philosophy with Complaints and CAPAs ISO 13485:2016 - Medical Device Quality Management Systems 7

Similar threads

Top Bottom