IEC 60601-1 - Label Physical Requirements for Disposable (Single Use) Medical Devices

S

SmallD

#1
We have a medical device accessory (say electrode) needed for a medical device to work. It has its own packaging (and label). The packaging has print (text/instructions).
Since this is a single use accessory, does the package print need to be fully compliant with section 7.1.3 Durability of markings?
We have problems with the print because of the material of the packaging.

Big thanks for any help!!
 
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Pads38

Trusted Information Resource
#2
Re: 60601-1 label physical requirements for disposable (single use) devices

It may be useful to realise that the rub tests of 7.1.3 only applies to those markings as required by 7.2, 7.4, 7.5 and 7.6.

Each of those relates to markings/symbols/signs that are on the outside of the device itself. They are not requirements for packaging labelling / information.
 

Peter Selvey

Staff member
Moderator
#3
Re: IEC 60601-1 - Label Physical Requirements for Disposable (Single Use) Medical Dev

It's a good point and appears to be a mistake in the standard, something for the committee to consider.

There are a number of requirements in 7.2 which are permitted to be marked on the packaging if justified, but there is no mention of any exclusion for the durability tests.

Note that it makes sense that the marking is durable, the problem is not the requirement but the test being not representative of normal use (packaging would not normally be cleaned with alcohol). There should still be some minimum level of durability e.g. poor quality marking that easily flakes or rubs off with handling would not be OK even for packaging.

Maybe a water only test would be reasonable?

The other option would be to exclude accessories from the scope of evaluation. The standard is wrong for this point as well: accessories that are placed on the market as a separate medical device should be treated separately and only considered for the system related aspects. Non-system aspects such as marking should be outside of the scope of IEC 60601-1. These are covered by other standards.
 

Pads38

Trusted Information Resource
#4
Re: IEC 60601-1 - Label Physical Requirements for Disposable (Single Use) Medical Dev

We recently had our shipping cartons tested, to ASTM D4169-14. They came back rather "second hand".
If we did have required markings on the carton we could repeat the legibility test of 7.1.2

In the case of packaging, such as double peel pouches often used for sterile items, I can't think what tests you could perform to replace the (7.1.3) durability tests. Perhaps pre-printed pouches could survive the rub tests even though the test is not really relevant. But paper self adhesive labels would need something different.
 
1

13lla

#5
Re: IEC 60601-1 - Label Physical Requirements for Disposable (Single Use) Medical Dev

Have this same question at our company. Is there an industry standard practice for the testing of (IEC 60601-1) 7.1.3. Durability of Markings on disposable ME accessory packaging?

Is it the conservative approach which is to apply the tests outlined in 7.1.3 a & b which appear to be designed with the intent to test permanently affixed labels to ME equipment?
 
#6
Hi,
We have the same problem, our product is an electrode single use, for intraoperative use that shall be used with a active ME for recording.
We applied the EN 45502-1 §10.3 even if it is not applicable:
The MARKINGS on the SALES PACKAGING of an ACTIVE IMPLANTABLE MEDICAL DEVICE shall be indelible.
Test: The package shall be placed so that the MARKINGS under test are uppermost and in a horizontal plane.
Ten millilitres of water shall be dispensed onto the centre of the area. After one minute, the MARKINGS shall be
wiped clear of surface water using a wet, soft cloth.
Compliance is checked by inspection to determine that all MARKINGS remain clearly legible. If the MARKINGS are
on a LABEL, the adhesive fixing the LABEL shall not have loosened and the LABEL shall not have become curled
at any edge.
 
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