ISO 12100:2010 - Machine Safety Requirements

TommmD

Starting to get Involved
#1
As a mechanical engineer, I'm trying to find the physical safety section that applies to a lab installed piece of equipment. 60601 states it is specifically directed towards home health care, where I previously had thought it applied as a general safety guide for all med devices.
We are now looking at the machine safety directive as a guide to evaluating physical safety for moving parts. This is an expansive document with no med device sections, so I'm not all clear as to whether I'm headed in the right direction.

Ideally I'm looking for direction for pinch points and guarding from mechanical motion and would appreciate the help.
 
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Ronen E

Problem Solver
Staff member
Moderator
#3
Which clause in 60601 made you conclude that it only applies to home health care?

1.1 * Scope
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS.
If the equipment is placed in a lab in the EU, the Machinery directive applies too (provided that we are indeed discussing a piece of machinery).
 

TommmD

Starting to get Involved
#4
hmmm ... Going back, I think I was looking at 60601-1-11, which is where I got the 'home health care' from.

I was shown a section from 61010-1 that addresses mechanical safety, so I think thats where we're going to start. We'll use the RHA to flesh out whether hazards actually exist that require use of the Machine Safety Directive.
 

Ronen E

Problem Solver
Staff member
Moderator
#5
hmmm ... Going back, I think I was looking at 60601-1-11, which is where I got the 'home health care' from.

I was shown a section from 61010-1 that addresses mechanical safety, so I think thats where we're going to start. We'll use the RHA to flesh out whether hazards actually exist that require use of the Machine Safety Directive.
After my previous posting, IEC 61010 did come to my mind... however, I think you might be looking at this from the wrong end. Is your primary goal regulatory compliance? If so, what is the relevant jurisdiction? Is it the EU? Or are you looking to apply published standards merely to guide you, voluntarily?

BTW, I’m not sure what you refer to by “the Machinery Safety Directive”. I was referring to the EU’s 2006/42/EC directive on machinery, nicknamed commonly “the Machinery Directive”.

Following is the scope statement from IEC 61010-1:2010. Lab equipment is indeed within the scope, unless the equipment also falls under IEC 60601 (and a bunch of other conditions...):

[emphasis not in the original]

1.1 Scope
1.1.1 Equipment included in scope
This part of IEC 61010 specifies general safety requirements for the following types of electrical equipment and their accessories, wherever they are intended to be used.
a) Electrical test and measurement equipment
This is equipment which by electromagnetic means tests, measures, indicates or records one or more electrical or physical quantities, also non-measuring equipment such as signal generators, measurement standards, power supplies for laboratory use, transducers, transmitters, etc. NOTE 1 This includes bench-top power supplies intended to aid a testing or measuring operation on another piece of equipment. Power supplies intended to power equipment are within the scope of IEC 61558 (see 1.1.2 h)).
This standard also applies to test equipment integrated into manufacturing processes and intended for testing manufactured devices. NOTE 2 Manufacturing test equipment is likely to be installed adjacent to and interconnected with industrial machinery in this application.
b) Electrical industrial process-control equipment
This is equipment which controls one or more output quantities to specific values, with each value determined by manual setting, by local or remote programming, or by one or more input variables.
c) Electrical laboratory equipment
This is equipment which measures, indicates, monitors, inspects or analyses materials, or is used to prepare materials, and includes in vitro diagnostic (IVD) equipment.
This equipment may also be used in areas other than laboratories; examples include self-test IVD equipment to be used in the home and inspection equipment to be used to check people or material during transportation.
1.1.2 Equipment excluded from scope
This standard does not apply to equipment within the scope of:
a) IEC 60065 (Audio, video and similar electronic apparatus);
b) IEC 60204 (Safety of machinery – Electrical equipment of machines);
c) IEC 60335 (Household and similar electrical appliances);
d) IEC 60364 (Electrical installations of buildings);
e) IEC 60439 (Low-voltage switchgear and controlgear assemblies);
f) IEC 60601 (Medical electrical equipment);
g) IEC 60950 (Information technology equipment including electrical business equipment, except as specified in 1.1.3);
h) IEC 61558 (Power transformers, power supply units and similar);
i) IEC 61010-031 (Hand-held probe assemblies);
j) IEC 61243-3 (Live working – Voltage detectors – Part 3: Two-pole low-voltage type).
1.1.3 Computing equipment
This standard applies only to computers, processors, etc. which form part of equipment within the scope of this standard or are designed for use exclusively with the equipment.
NOTE Computing devices and similar equipment within the scope of IEC 60950 and conforming to its requirements are considered to be suitable for use with equipment within the scope of this standard. However, some of the requirements of IEC 60950for resistance to moisture and liquids are less stringent than those in this standard (see 5.4.4 second paragraph)).
1.1.4DV Addition of the following referencing the National Electrical Code and the Canadian Electrical Code:
This standard applies to equipment:
a) To be employed in accordance with ANSI/NFPA 70, National Electrical Code® (NEC);
b) Designed to comply with the general requirements of CAN/CSA C22.2 No. 0 and to be installed in accordance with the Canadian Electrical Code (CEC), Part I, CSA C22.1; or
c) Both (a) and (b).
 

TommmD

Starting to get Involved
#6
Thx for including the scope. i'm sure I ad libbed 'Safety' since thats whats on my mind. I don't have the Declaration here. Mechanical safety for IVD lab equipment in the EU is precisely what we're addressing. The difference in scope between 60601 & 61010-1 is where I'm getting twisted up. We're being directed to provide the test results & the NRTL we're using is pretty much saying 'we'll test what you want'.

Historically we have not used a CB scheme, & I'm wondering if that would offer a more comprehensive (+$) review from the NRTL.
 

Ronen E

Problem Solver
Staff member
Moderator
#7
I'm trying to find the physical safety section that applies to a lab installed piece of equipment.
Mechanical safety for IVD lab equipment in the EU is precisely what we're addressing.
OK, so we’ve established that the jurisdiction is EU. Obviously some regulation applies, but let’s take it one step back so that I can better direct you.

Are you concerned with a single installation, already up and running, or are you dealing with ongoing/future sales/installations (“placing on the EU market”) of a type of IVD lab equipment? Where do your concerns originate from? Have you been approached by the EU authorities (which)? By a past / existing / furture customer? By another section/function inside you org? Other?

I can guide you with regards to EU regulations (and associated published standards) but I’m not an expert on NRTL / CB scheme. Hopefully others will chime in soon.
 

TommmD

Starting to get Involved
#8
Well, w/o particulars, we were notified by an EU customer about concerns on an existing installation re mechanical safety, far from the first install,
& are reconstructing the original process for certification. Equipment is from an acquisition that is now several years old. We believe we have the basis for defending the original decisions, but are being cautious. Sorry for being a little vague, but I'm sure you understand the need to be a little circumspect.
 

Ronen E

Problem Solver
Staff member
Moderator
#9
Well, w/o particulars, we were notified by an EU customer about concerns on an existing installation re mechanical safety, far from the first install,
& are reconstructing the original process for certification. Equipment is from an acquisition that is now several years old. We believe we have the basis for defending the original decisions, but are being cautious. Sorry for being a little vague, but I'm sure you understand the need to be a little circumspect.
Look, as far as I’m concerned you can be as vague as you like... it’s just that my ability to help decreases exponentially with your vagueness... I’m not interested in names or any other such particulars and I haven’t asked you to disclose anything about any problems or decisions made in the past regarding the product. If it can make things simpler for you, you’re welcome to send me a PM with relevant clarifications. FWIW.

Further, your brevity of “speech” doesn’t serve your cause well. If you could please try to make your sentences less ambiguous (I suppose you’re not doing it on purpose), I might be able to actually understand the situation much quicker.

Now, to the point -

Were the “concerns” you were notified about the cusomer’s own, or were they picked by some EU authority? Were any claims made that the product / installation was not in line with some official safety requirements (or regulation), or was it a “common sense” judgement, that there might be a safety issue? “far from the first install” - does that mean that the specific piece of equipment has been installed / in use for a long time now, or that your org has been selling / installing that model for a long time? “Equipment is from an acquisition that is now several years old” - do you mean the units being sold / installed, or a production line that is yielding new units now? Something else?

“reconstructing the original process for certification”
“have the basis for defending the original decisions”
In terms of EU regulations, what was the original clearance route?
 
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