IEC 60601 Clause 7.1.3 - Durability of Markings - Methylated Spirits

M

MNewberry

#1
Hello,

Can anyone tell me which methylated spirit they are using for the durability of markings test of 7.1.3 b) (3rd Ed)? It seems as though any methylated spirits would do, but Annex A provides some confusing input.

Annex A states that "Ethanol 96% is defined in the European Pharmacopoeia as a reagent in the following terms: C2H6O (MW46.07)."

Does this mean that the methylated spirit used should be 96% ethanol by volume? I've been unable to find any readily available methylated spirits with this much ethanol.

Thanks,
Maxs
 
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M

MIREGMGR

#2
Re: IEC 60601 Clause 7.1.3 - Durability of Markings - Methylated Spirit

I don't know what the standard-writers were thinking or intended to say, but the technical tradition is that "methylated spirits" (European term) is the same as "denatured alcohol" (US term), and consists of 90% ethanol, ~9.5 to 10% methanol, sometimes blue or purple dye, and sometimes small amounts of odorant and/or unpleasant flavorant.
 

Ninja

Looking for Reality
Staff member
Super Moderator
#3
Re: IEC 60601 Clause 7.1.3 - Durability of Markings - Methylated Spirit

Note that denaturants vary widely in amount and type. I don't know what was specifically intended either, but the "Denatured Ethanol - Reagent Grade" I use is 96% ethanol and varies in the other 4% depending on vendor.
{MEK, MIBK, Naptha, Methanol, "Aviation Fuel", and Acetone can all be found on the various MSDS's}
 
M

MIREGMGR

#4
Re: IEC 60601 Clause 7.1.3 - Durability of Markings - Methylated Spirit

None of those formulations are "methylated spirits", though. "Spirits", a very old technical term, refers to ethanol and methanol. "Methylated" refers to addition of sufficient methanol (methyl alcohol) to ethanol (ethyl alcohol) to make the resulting mixture undrinkable ("denatured").

For the purpose at hand, i.e. label/markings testing, 90:10 methylated spirits could have a markedly different solvent behavior than any version that would include (for instance) 4% of a ketone such as acetone, MEK or MIBK, or an aromatic distillate such as naphtha. The former would be unlikely to dissolve markings applied with common thermoplastic-in-ketone silkscreen inks and many types of printing inks. The latter possibly would do so.
 

Peter Selvey

Staff member
Super Moderator
#5
Re: IEC 60601 Clause 7.1.3 - Durability of Markings - Methylated Spirit

Good discussion here on a weak point in the standard.

From a purely "legal" interpretation, it is worth to note that the information in Annex A is just for reference and not legally enforceable. Couple that with the mistake of using the term "methylated spirits", then using a different term "Ethanol 96%", then failing to define what the other 4% is, together with literature which shows "methylated spirits" is typically 90% ethanol, all together makes it very weak standards writing.

Is metho still used in practice? According to literature, isopropyl alcohol is better as it has less toxic residues. If metho is not really used in practice it's not really worth too much discussion.
 

Ninja

Looking for Reality
Staff member
Super Moderator
#7
The forthcoming amendment no longer calls for meths. The three reagents for the rub test are water, 96% ethanol and isopropyl alcohol.
Any clearer guidance on the "rest" of the 96% ethanol? What is the other 4% to be?...just curious at this point.
 
#8
Any clearer guidance on the "rest" of the 96% ethanol? What is the other 4% to be?...just curious at this point.
Answer = Water

EuropeanPharmacopoeia said:
Ethanol 96%

Definition

Content
-Ethanol (C2H6O; M 46.07) 95.1% v/v (92.6% m/m) to 96.9% v/v (95% m/m) at 20C, calculated from the relative density using the alcoholimetric tables.

-Water
Please don't ask me to explain any of that as it is much too long ago that I did any chemistry. But I'm sure that if you find a laboratory supplier then this will be a "standard" reagent.
 
#9
The test calls for rubbing with a cloth moistened with each of the three liquids "without undue pressure."

Does anyone have a way of controlling or defining what "undue pressure" constitutes?

We have been evaluating some heatshrink labels for identifying cables and the amount of pressure applied is key to whether the markings stay on or are rubbed of.
 
M

MIREGMGR

#10
We had the same question, so I rubbed "normally" on a scale, we visually averaged the rub force, and we made up a soft-faced rub weight to apply that force.
 
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