SBS - The best value in QMS software

Lux Level for Orthopaedic Implant Factory

mpfizer

Involved In Discussions
#1
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
 
Elsmar Forum Sponsor

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#2
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

Trusted Information Resource
#3
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
 
#4
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).
 
B

BarryTaylor

#5
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.
 
Thread starter Similar threads Forum Replies Date
was named killer Onsite Level II N.D.T. Training in Florida Training - Internal, External, Online and Distance Learning 0
D High level understanding of EUDAMED EU Medical Device Regulations 3
D Supplier Quality level category help - high level ISO 13485:2016 - Medical Device Quality Management Systems 6
silentmonkey Rationalising the level of effort and depth of software validation based on risk ISO 13485:2016 - Medical Device Quality Management Systems 10
Y What are different Special Inspection Level 1-4 and General spesification 1-3 ? AQL - Acceptable Quality Level 0
D Supplier Quality - How to classify a supplier level Medical Device and FDA Regulations and Standards News 10
E Received a Major finding during IATF Surveillance audit for loss of BIQS Level 3 (more than 6 SPPS in 6 months)...how should we address SYSTEMIC CA? IATF 16949 - Automotive Quality Systems Standard 11
J Level 3 KPI Excel Template Manufacturing and Related Processes 1
M Informational How to perform a clinical evaluation of medical devices – Part 2 – Level of clinical evidence and what sufficient clinical evidence means Medical Device and FDA Regulations and Standards News 9
R Bottom up approach versus system level ISO 14971 - Medical Device Risk Management 2
C Failure nets - Same level effects FMEA and Control Plans 0
H Graphical analysis of results - Confidence level bands nomenclature Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
S Level of Clinical Evidence - MDR EU Medical Device Regulations 3
D GM BIQS level 5 requirements Customer and Company Specific Requirements 5
I Sampling processes - Who must define the AQL level? AQL - Acceptable Quality Level 9
R Identifying internal issues.. at what level? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
I What level of change in documentation requires re-training? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
M Level 3 PPAP submission of intentional defective parts APQP and PPAP 4
eule del ayre List of Level 3 PPAP requirements for automotive suppliers APQP and PPAP 20
I Document levels and approval requirements for lower level documents like work instructions, forms etc. Document Control Systems, Procedures, Forms and Templates 18
B AS9102 FAI & Lower Level Drawings - How should we perform the FAI? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
Rameshwar25 What is a Control Plan at "Material Level"? IATF 16949 - Automotive Quality Systems Standard 4
N How to resolve discrepancies in Level 3 PPAP supplier dimensional reports? APQP and PPAP 11
M Creating a Plant Level Value Stream Map Process Maps, Process Mapping and Turtle Diagrams 1
K Defining Acceptance Quality Level, I need clarity on AQL 1.5, 2.5, 4.0 AQL - Acceptable Quality Level 5
P GM BIQS level 5 training? Training - Internal, External, Online and Distance Learning 2
Ron Rompen Dual level holes - Measurement method suggestions wanted General Measurement Device and Calibration Topics 9
A Level of details required for Class IIb Product Verification and Validation CE Marking (Conformité Européene) / CB Scheme 1
D System Level FMEA example wanted FMEA and Control Plans 2
samer Do we have to determine Educational level for all Staff as pr 7.2 b clause? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
J What level PPAP for 5 critical parts? APQP and PPAP 8
Paul Simpson Informational The role of Annex SL - High Level Structure of ISO MSS's - Revision Update February 2019 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 26
E High level structure - Planning and operation control Occupational Health & Safety Management Standards 2
rob73 Worldwide device regulatory authorities at country level Other Medical Device Regulations World-Wide 6
K Biocompatibility Testing - Component Level or Assembled Medical Device? ISO 13485:2016 - Medical Device Quality Management Systems 7
C Example Work Instruction/Procedure for AQL (Acceptable Quality Level) AQL - Acceptable Quality Level 4
W Level of V&V in Class II Medical Device (Dialysis Machine) IEC 62304 - Medical Device Software Life Cycle Processes 10
K FDA Premarket Submissions for Embedded Software - Level of Concern Other US Medical Device Regulations 4
H Identifying Guidance on Medical Device Software Level of Concern for the EU EU Medical Device Regulations 2
R Managing Level 3 Production Documents - Document Control System Help Document Control Systems, Procedures, Forms and Templates 6
A What KPI's do you use at Shop Floor Level and Team Boards? Quality Tools, Improvement and Analysis 4
T Struggling with ISO 13485:2016 Clause 6.2 - Level of Risk Associated with Work ISO 13485:2016 - Medical Device Quality Management Systems 3
J Multi-level QMR Process Management Review Meetings and related Processes 6
N Definition Needed: High Level Acronym Buzzword Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 9
A How to rollout Security Awarness at Project Level in the Organisation IEC 27001 - Information Security Management Systems (ISMS) 1
M What level of control should be exercised on distributors? Supplier Quality Assurance and other Supplier Issues 10
M ISO 13485 and the High Level Structure (HLS) ISO 13485:2016 - Medical Device Quality Management Systems 0
P Automotive Supplier PPAP Level Requirements Supplier Quality Assurance and other Supplier Issues 6
P Is the next revision of ISO 15378 following the High Level Structure? Other ISO and International Standards and European Regulations 5
M Medical Device Software "Level of Concern" 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7

Similar threads

Top Bottom