Flammability requirements for applied parts as per 60601-1

#1
Hi All,
Looking forward for your valuable inputs
Flammability requirement as mentioned in clause 11.3 of 60601-1 i.e
"The ENCLOSURE, and any baffle or flame barrier, shall be made of metal (except magnesium) or of non-metallic materials, except for constructions according to Table 25 and constructions with a mesh, having a flammability classification of FV-2 (or better) for TRANSPORTABLE ME EQUIPMENT and FV-1 (or better) for FIXED ME EQUIPMENT or STATIONARY ME EQUIPMENT in accordance with IEC 60695-11-10 "

According to the above requirement the flammability requirements are for Enclosure and parts within the enclosure. I need additional information on flammability requirements for any applied part connected to the same enclosure for eg. In patient monitoring device ECG , IBP,CO cables which is not specified in standard.

Should we consider the same flammability requirements as for enclosure?
I noticed in the definition of ENCLOSURE in standard which defines
"exterior surface of electrical equipment or parts thereof NOTE For the purpose of testing to this standard, metal foil, with specified dimensions, applied in contact with parts of the exterior surface made of material with low conductivity or made of insulating material is considered a part of the ENCLOSURE (see Figure 2, Figure 3 and Figure 4). "

Please help.
 
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Peter Selvey

Staff member
Super Moderator
#2
Within 11.3, the term ENCLOSURE should always be read as "fire enclosure" which is different to the normal enclosure.

A fire enclosure is always optional. In total there are four options, and designers/test labs usually take the easiest path:

- designate the enclosure as a fire enclosure (test to 11.3)
- do fault testing and prove that a fire does not start (test in 13.2)
- use the general 15VA exclusion (anything circuit under 15VA, e.g. 3A @ 5V is assumed not to have enough energy to start a fire)
- use the 100VA exclusion for secondary circuits, if the wiring/PCBs are flame proof

The details of the 15VA/100VA exclusions are in 13.1.2.

In theory, if the 15VA or 100VA exclusions are used, it should be documented/tested about how the power is limited. However, in practice small electronic circuits like ECG, IBP etc are powered by dc/dc converters that are way below 15W, so it's not really worth the effort and usually not documented.
 
#3
Hi Peter,

Thank yo very much for your comments , It was very helpful . In summarizing to meet the flammability ratings , either it shall be complying to 11.3 ( flammability requirements ) or to fulfill single fault condition ( 13.1.2 ) along with Risk Management.
 

Peter Selvey

Staff member
Super Moderator
#4
I think the requirements and criteria are objective, so no need to involve risk management.

I the test report, for completeness:

  • In Clause 11.3, in the remarks column state that applied part circuits (ECG, IBP etc.) are covered by the exclusion in 13.1.2
  • In 13.1.2 there should be an associated table for measuring VA of such circuits. In that table, in the supplementary information I would write something like "Applied part circuits (ECG, IBP, Temp etc.) are powered by dc/dc converters that well below 15VA limit. Therefore they are excluded from fault tests associated with flammability hazards and the requirements of Clause 11.3. See table 8.1 for component details of the dc/dc converters."
However, as mentioned before it's such an obvious case that most test labs would not even bother to document this, which I think is OK.
 
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