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Marking of Medical Electrical equipment and accessories - Cl. 7.2.2 "Identification" and Cl. 7.2.4 "Accessories"

Benjamin Weber

Involved In Discussions
#1
Dear community,

how do you interpret the following requirements regarding marking on the outside of ME equipment:

Cl. 7.2.2 "Identification" says: "- the date of manufacture or use by date, if applicable"
- Does the "if applicable" relate to the whole requirement or is it to say, either a date of manufucture AND/OR a use by date, depending on if the one or the other is applicable.
- If the serial number codes the date of manufacture (e.g.: SN 2019-02-25_001 or similar), is this compliant?
- If the serial number does not obviously code the date of manufatcure, but the manufacturer can easily trace the date of manufacture by the serial number, is an additional marking of the date of manufacture needed?

Cl. 7.2.4 "Accessories"requires accessories to be marked with the same markings as the ME equipment.
- If the accessory itself is non ME equipment (e.g. a power supply, charger, cable...), should these requirements be applied or can this be waived because the accessory complies with its own product relevant standards (e.g. IEC 60335-2-29 for house hold battery chargers) that may require less/other marking?

I hope you can help to clarify this.
 

Enternationalist

Starting to get Involved
#2
The "OR" is there for a reason. I think it's pretty simple - if your device has a use-by date, mark it as such. Otherwise, mark it with the relevant manufacture date.

Regarding encoding dates into your serial number - how is someone external meant to know if that number is the date of manufacture, the expiry date, some other date, or just a coincidental number that looks like a date? Consider this carefully.

The standard provides the following options for encoding:
"The serial number, lot or batch identifier, and the date of manufacture may be provided in a human readable code or through automatic identification tech such as barcodes or RFID"

Note that use-by date is not included in that list.

There is no provision for it just being "easily traceable" - besides, all this information is also marked for the user's benefit. If they want to know how old the stock they have is, it's not really that helpful for them to have to go through your company to be traced and provided (probably after a week of messing around, after which it'll be too late for whatever their reason was).

Regarding Accessories: an accessory is an accessory is an accessory. It doesn't stop being one just because it's also something else.

Note that the marking requirements are not perfectly identical - if marking is not practicable for an ACCESSORY, you can put them on the individual packaging.

You seem to be taking some wishful thinking and hoping it'll apply without reading the document and its definitions in full. All of what you're asking is reasonably covered by the document if you read it. I strongly recommend getting into the nitty gritty definitions and properly characterising what is and is not applicable to parts of your device. Read it like a lawyer!
 

Benjamin Weber

Involved In Discussions
#3
The "OR" is there for a reason. I think it's pretty simple - if your device has a use-by date, mark it as such. Otherwise, mark it with the relevant manufacture date.

Regarding encoding dates into your serial number - how is someone external meant to know if that number is the date of manufacture, the expiry date, some other date, or just a coincidental number that looks like a date? Consider this carefully.

The standard provides the following options for encoding:
"The serial number, lot or batch identifier, and the date of manufacture may be provided in a human readable code or through automatic identification tech such as barcodes or RFID"

Note that use-by date is not included in that list.

There is no provision for it just being "easily traceable" - besides, all this information is also marked for the user's benefit. If they want to know how old the stock they have is, it's not really that helpful for them to have to go through your company to be traced and provided (probably after a week of messing around, after which it'll be too late for whatever their reason was).

Regarding Accessories: an accessory is an accessory is an accessory. It doesn't stop being one just because it's also something else.

Note that the marking requirements are not perfectly identical - if marking is not practicable for an ACCESSORY, you can put them on the individual packaging.

You seem to be taking some wishful thinking and hoping it'll apply without reading the document and its definitions in full. All of what you're asking is reasonably covered by the document if you read it. I strongly recommend getting into the nitty gritty definitions and properly characterising what is and is not applicable to parts of your device. Read it like a lawyer!
@Enternationalist Thank your very much for your opinion. I am not a manufacturer, I am a tester and know the standard quite well. But sometime lang discussions with the manufacturer happen. During these discussions it helps a lot to understand what the standard requirements are amimg at. During these discussion the details of the definitions get lost sometimes.

But you are making some good points here that are very helpful to me.

The operator shall have an easy way to know the device's age. Therefore the date of manufacture shall be clearly marked, ond not coded somewhere else. I agree!

The option to apply minimum required markings to the packaging is actually also possible for ME equipment if it is not practical, not only for accessories (see cl. 7.2.1, first paragraph, last sentence)!

Regarding the date of manufacture of non ME equipment as an accessory: I also think, this should be marked, that's my understanding of the standard. The problem for many manufacturers is, that they buy such parts (e.g. power supplies) which are sold as "60601-1 compliant", "For medical applications"....But they don't bear such markings. So it's not my wishful thinking as a tester, but rather that of the manufacturer.
I then have to tell them, that the power supply is not compliant with 60601-1 "just because of one little marking". So I was thining, that maybe I am seeing this to critical. But obviusly I am not.
 

Enternationalist

Starting to get Involved
#4
@Enternationalist
Regarding the date of manufacture of non ME equipment as an accessory: I also think, this should be marked, that's my understanding of the standard. The problem for many manufacturers is, that they buy such parts (e.g. power supplies) which are sold as "60601-1 compliant".
If this is the case, then I would expect to be provided with documentation certifying this compliance by those manufacturers. If they have reasonable record-keeping, they should be able to obtain this from their suppliers (unless, of course, their supplier misled them).

A generous interpretation is that for some reason the markings were "not applicable" -maybe there is perhaps some risk associated with the application of the markings or some such. If you press for documentation proving this compliance, you can place a bit of pressure on whoever is advertising things as 60601-1 compliant.
 
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Peter Selvey

Staff member
Moderator
#5
I think these requirements were driven by Europe, which requires the "year of manufacturer for active devices" (which can include many accessories), see MDD Annex I, 13.3 (l).

As per the directive, it is allowed that the date can form part of the serial number, which is also confirmed in EN 1041:2008, however this must still include the four digits e.g. 2019-123456. Note: I don't have the latest amendment of EN1041, it should be checked but I think this would be unlikely to change for this point.

ISO 15223-1:2016 also refers to the use of the four digits for the year of manufacturer if the symbol is used. So all in all, not something that can be encoded in the serial number (e.g. A = 2016, B = 2017 ..), it has to be obvious to the user.

I guess finally as a non-medical device user: Japan has for a while required that many devices have year of manufacturer marked. I found this marking very useful - for example a friend gave us a kerosene heater when he left, but I could see from the marking it was more than 10 years old, and felt it was safer for my family to let it retire (of course, saying "ostukaresama" as Marie Kondo would expect). Knowing the age of the device definitely does impact decisions on use.
 
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