Which standard is applicable for IR LED in conjunction with medical devices?

NewRegMan

Starting to get Involved
#1
Hi everybody,

I was wondering which standard is applicable for IR LED in conjunction with medical devices.
According to my knowledge we have to consider IEC 60825-1 laser safety requirements and/or IEC 62741 Photobiological safety of lamps and lamp systems.
Can anybody bring light into my darkness please?!

Many thanks in advance!:thanx:

Cheers,
Guido
 
Elsmar Forum Sponsor

Marcelo

Inactive Registered Visitor
#2
What exactly is the device?

There´s some particular standards from the IEC 60601-1 series which can be applied.

I think you´re looking for IEC 60601-2-22 on lasers, which explicitly includes LEDs (when there´s the word "laser" in the standard it should read as including LEDs).
 

NewRegMan

Starting to get Involved
#3
What exactly is the device?

There´s some particular standards from the IEC 60601-1 series which can be applied.

I think you´re looking for IEC 60601-2-22 on lasers, which explicitly includes LEDs (when there´s the word "laser" in the standard it should read as including LEDs).
Hi Marcelo,
thanks for your answer but I should have been more specific. I don't think that the IEC 60601-2-22 is applicable because we want to use the IR LED for a position detecting system, It is a simple assistive device for the upper extremeties.
 
W

Watchwait

#6
RE: EN standards...I've come across two more: EN 31252 & EN 11252.

So including the aforementioned EN 60601-2-22 & BS 60825 there seems to be 4 standards that apply, in come fashion, to lasers.

Also, does the inclusion of a laser in a medical device have any impact whatsoever on it's classification in 93/42/EEC Annex IX? We have a non-invasive active medical device that contains a low-power, non-medical laser. I see this as falling under Rule 12 as a Class I device.
 
Thread starter Similar threads Forum Replies Date
D Control chart applicable? Percentage of compliance with a standard Statistical Analysis Tools, Techniques and SPC 2
P Is Internal and external audit of Account Department applicable to any ISO standard Internal Auditing 5
M Who has the final say on which subclauses are applicable from a given standard? EU Medical Device Regulations 1
C AS9100, ISO Standard Applicable to Lighting for Workstations and Inspection Stations AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 5
W What is the applicable standard for Chair Mounted Dental Unit for CE IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
C Device 'A' has no applicable Standard, but a very similar product 'B' does Other Medical Device Related Standards 6
D FMEA with 2 or 3 criteria? Standard applicable to the Medical Device industry ISO 14971 - Medical Device Risk Management 13
Q ISO 9001 vs. TL9000 - Which standard is more applicable? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
Raffy ISO22000:2005 Food Safety Management System - Applicable Internal Audit standard? General Auditing Discussions 7
B AS9100D Standard in Japanese AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 0
O In addition to the standard, what other ISO 13485 sources do people recommend? ISO 13485:2016 - Medical Device Quality Management Systems 5
B ASTM E18-2020 - Rockwell testing standard changes? General Measurement Device and Calibration Topics 2
M Informational RoHS Standard - EN 63000:2018 to replace EN 50581:2012 Medical Device and FDA Regulations and Standards News 11
M IEC 60601-1 1988 - Device developed in 2012 with standard of 1988 IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
D Recent changes to ISO 14971 - SOP required for managing standard revisions ISO 13485:2016 - Medical Device Quality Management Systems 1
P Cenelec updated standard information CE Marking (Conformité Européene) / CB Scheme 1
S Is there a standard for sample size during R&D phase Other ISO and International Standards and European Regulations 18
J Standard used to determine if check fixture gauge is acceptable Reliability Analysis - Predictions, Testing and Standards 2
N Program or application for standard time measurement in industry from video surveillance? Human Factors and Ergonomics in Engineering 1
I Where can I beg, steal (just kidding of course) or borrow good training material on the ISO 9001:2015 standard? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
K Question on whether IEC 60601-2-62 standard is applied IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
B Clause 5.1.12 of Technical Standard IEC 62304/A1 IEC 62304 - Medical Device Software Life Cycle Processes 4
M Viable count Measurement ISO Standard Other Medical Device Related Standards 1
I When exactly was "competence" added to the ISO-9001 standard? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
S Managing specification changes on standard parts purchased through trading companies Document Control Systems, Procedures, Forms and Templates 2
MDD_QNA QR Code Standard ISO/IEC 15417:2007 - Does anyone use it? Other Medical Device Related Standards 3
S Average and standard deviation of Cumulative Data Statistical Analysis Tools, Techniques and SPC 5
R Standard Filter for Calibration Colorimeter ISO 17025 related Discussions 1
B Standard for Dielectric Strength Test IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
M Specific Absorption Rate (SAR) Testing - What Standard to Use? Other ISO and International Standards and European Regulations 1
M Harmonised RED Standard ETSI EN 440 - Which Version? Other ISO and International Standards and European Regulations 0
R QMS Standard appilications on different Defense Sector Quality Management System (QMS) Manuals 1
A Supplier Quality Standard vs Senior Management Direction Supplier Quality Assurance and other Supplier Issues 2
B To detect the non standard variable IATF 16949 - Automotive Quality Systems Standard 5
J What is the minimum standard for automotive component traceability? Manufacturing and Related Processes 2
B Need For BIS Standard Mark? Imported OEM's Power supply,Li-Ion Battery Other Medical Device Regulations World-Wide 0
C On spontaneous but non-standard rankings FMEA and Control Plans 3
E Post Market Surveillance Standard Various Other Specifications, Standards, and related Requirements 4
A IEC 60601-2-2 - Defib-proof test amendment to base standard IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
N Is there a standard / rules pertaining to eating in medical device manufacturing area? Manufacturing and Related Processes 5
M Performance Standard for Balloon Trocars Other Medical Device Related Standards 2
D Standard guide for shelf life determination of non sterile component with degradation materials Reliability Analysis - Predictions, Testing and Standards 1
D Using "Particle Size Standard" templates as gauges - How to avoid giving a gauge # while using for process control? General Measurement Device and Calibration Topics 2
S Where to get online AS standard audit certification classes? AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 5
P ISO 10993-1:2018 - When will the European equivalent become a Harmonized Standard? Other Medical Device Related Standards 13
M Informational From AAMI – FDA Recognizes AAMI Standard and TIR Medical Device and FDA Regulations and Standards News 0
S Implementing a 45001 Health & Safety standard - Internal audit plan wanted Internal Auditing 1
S CTS/CSE Waveforms Testing - Partial Recognition of IEC 60601-2-25 Standard by FDA IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
M Informational TGA – Guidance on Therapeutic Goods (Conformity Assessment Standard for Quality Management Systems) Order 2019 Medical Device and FDA Regulations and Standards News 0
C Does the company violates any regulation/standard by selling device without warranty ISO 13485:2016 - Medical Device Quality Management Systems 5
Similar threads


















































Top Bottom