Lux Level for Orthopaedic Implant Factory

[mpfizer]

does any one know what should be the lux levels in qc , cleanroom and cnc machining room for an orthopaedic device factory manufacturing implants and joints ,are there any ISO / ASTM standards for this.

Thanks

michelle

 

[Marc]

I'm not a medical device person so I can't help with any specifics. I can say that there have been discussions here and elsewhere on specific lighting requirements for different industries in specific operations areas. One popular one asked about is assembly areas.

I do not remember seeing any requirements stated in Lux. When lighting requirements are stated what I have seen has always been a statement which in essence said that "appropriate" lighting shall be provided.

However, in the US OSHA does have some specifics such as http://ledlightingmanagement.com/led-lighting-management/content/osha-minimum-lighting-requirements - I know this is not directly related to your specific question, but it might be a help as "food for thought".

 

[pkost]

I held off replying to this thread because I am also not in the best position to answer it accurately, I worked in orthopaedics but had no direct manufacturing responsibility

I was not specifically aware of any of our suppliers maintaining lighting levels, in cleanrooms there was a general expectation of it being bright for adequate inspection of parts that were being packed, but I'm not sure if that was driven by the cleanroom standard - this would not be specific for orthopaedics

I seem to recall that the labeling standard EN 1041 specified a light level for reading of labels, therefore it is reasonable to expect QC to be able to verify this - again not an orthopaedic specific requirement

My comments are from an EU perspective

 

[Pads38]

A few ideas:

IEC 60601-1 has a test of labelling over the lux range of 100 - 1500 lux, which it describes as being the "normal range where medical electrical equipment is operated".

Levels are described as:

? 100 lx to 200 lx is recommended for working spaces where visual tasks are performed only occasionally;
? 500 lx to 1000 lx is recommended for visual tasks of small size or reading medium-pencil handwriting;
? 1 000 lx to 2 000 lx is recommended for visual tasks of low contrast or very small size: e.g. reading handwriting in hard-pencil on poor-quality paper.

This, apparently, comes from SANDERS, MS. and McCORMICK, EJ., Human Factors In Engineering and Design,? 7th Ed., McGraw-Hill, Inc., ISBN 0-07-054901-X

Also, there is a guide available from the UK Health and Safety Executive (the UK equivalent of OSHA). Link here to free download:
http://books.hse.gov.uk/hse/public/saleproduct.jsf?catalogueCode=9780717612321

That guide covers lighting levels as well as other factors (galre, refelections, flicker etc).

 

[BarryTaylor]

This is interesting as I have recently been challenged regarding our requirement of 1076 LUX (100 candela) at inspection workbench level. I have experience of using this level for many years and was confident of finding my source.....but alas no! It MAY have come from corporate direction.
The level is quite high, but we are looking for scratches/abrasions and other defects in highly polished surfaces of complex geometries, it does seem appropriate.
I am aware that the automotive industry does use this lighting level for paint defects and that some of the more generic lighting matrices do point at this type of level.

Using a risk based approach, you may want to perform an experiment with variables of sample/sample defects /inspector/lighting level to determine the minimum lighting one needs to capture defects.