SBS - The Best Value in QMS software

Applicability of Photobiological Safety Evaluation for LED used in medical devices

akp060

Involved In Discussions
#1
I have a basic question. Will photobiological safety evaluation be required in all cases where LED is used in medical devices? If not, how do we rule out its applicability in the risk analysis?
 
Elsmar Forum Sponsor

chris1price

Trusted Information Resource
#2
I don't know much about the subject, but a quick google search implies that IEC62471:2006 requires photobiological safety for all LED based lamps

StackPath

I would start with that standard and see if there are any exceptions and how they should be documented.
 

Apex Hao

Starting to get Involved
#3
Are you referring to evaluating photobiological risk in your product risk management, or just merely sending it for external testing?

For the former, my two cents is that you have to. Your risk management should cover all possible hazards during usage.

For the latter, there could be several ways on how to treat it. You may refer to manufacturer's spec sheet and justify that in all foreseeable scenarios the risk group is always Exempt etc. If your application in end product is different from manufacturer's scope, then such testing is likely needed for you to know the risk associated with your product. Eventually, the evaluation here will feed into your risk management.
 
Thread starter Similar threads Forum Replies Date
E Medical device applicability to WEEE Other ISO and International Standards and European Regulations 2
S Defibrillator Protection applicability When using Multiple applied parts IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
D ISO 14971 applicability in ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 7
F Applicability of CSR's IATF 16949 - Automotive Quality Systems Standard 1
A ISO 13485 Sterilization Clause Applicability ISO 13485:2016 - Medical Device Quality Management Systems 7
S Applicability of 60601 vs. 60335 IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
K Applicability of Cybersecurity EU MDR 2017/745 Annex 1 23.4(ab), 14.2(d) CE Marking (Conformité Européene) / CB Scheme 3
K Applicability of eIFU as per EU MDR 2017/745 Annex 1 23.1 CE Marking (Conformité Européene) / CB Scheme 0
R MDD x PPE Directive - Statement of Non-Applicability EU Medical Device Regulations 3
B Exclusions or justification for non-applicability of IEC standards Reliability Analysis - Predictions, Testing and Standards 1
DuncanGibbons Understanding the applicability of Design of Experiments to the IQ OQ PQ qualification approach Qualification and Validation (including 21 CFR Part 11) 5
A Software as Medical Device (SaMD) definition and its applicability Other Medical Device and Orthopedic Related Topics 4
N EU MDR - Applicability Article 22 Systems and Procedure Packs CE Marking (Conformité Européene) / CB Scheme 4
R Applicability of new non-harmonized standards (MDD/MDR) EU Medical Device Regulations 14
A MDR Article 22 applicability - Legal manufacturer EU Medical Device Regulations 8
K Diagnostic X-ray devices - Applicability of Biocompatibility Testing per ISO 10993-1 Manufacturing and Related Processes 7
V Applicability of IEC 62366-1 usability to resorbable bone substitutes IEC 62366 - Medical Device Usability Engineering 9
E Commission Regulation (EU) No. 207/2012 E-IFU Applicability EU Medical Device Regulations 5
M ROHS : Applicability for AIMDs RoHS, REACH, ELV, IMDS and Restricted Substances 2
L Dying a slow SCOPE death - NEW ISO APG Paper on Scope and Applicability May 2020. AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
M Applicability of Means of Protection, working voltage in an Automated External Defibrillator IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
M Applicability of IEC 60950-1 Table K2 - Minimum clearances between circuits Various Other Specifications, Standards, and related Requirements 0
R Applicability of ISO 14708-3 RF Transmitter and Implantable RF Receiver Other Medical Device Related Standards 1
R Applicability of ISO 14708-3 - RF transmitter and implantable RF receiver Other Medical Device and Orthopedic Related Topics 1
M Oxygen enriched environment applicability - Operating table used in general surgeries in hospital IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
E CB scheme applicability for battery powered medical devices CE Marking (Conformité Européene) / CB Scheme 0
I IATF 16949 - 8.4.2.3 - Applicability to Shipping Suppliers IATF 16949 - Automotive Quality Systems Standard 11
S CQI-12 - Applicability to Raw Materials Customer and Company Specific Requirements 1
C Applicability of ISO 9001:2015 Section 8.5 - Engineering company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
H Applicability of EN 13795 for Incise Drape EU Medical Device Regulations 0
S Applicability of the standard IEC 60601-2-18 to an arthroscopy pump IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
Q Partial non applicability of ISO 9001 Cl. 7.1.5 (not having services)? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
M User Interface of Unknown Provenance (UOUP) applicability IEC 62366 - Medical Device Usability Engineering 8
E Applicability of Low Voltage Directive (LVD) for 12V equipment CE Marking (Conformité Européene) / CB Scheme 4
Y Counterfeit Parts - AS9100 D Cl. 8.1.4 - Can I claim no applicability? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 10
M IEC 62304 Applicability - GUI Control Software IEC 62304 - Medical Device Software Life Cycle Processes 3
D Clarification of Applicability of TS 16949 Requirements to a Non-Automotive Business IATF 16949 - Automotive Quality Systems Standard 13
Richard Regalado Sharing a Statement of Applicability (SOA) for ISO/IEC 27001:2013 IEC 27001 - Information Security Management Systems (ISMS) 2
G Not quite old news: Statement of Applicability IEC 27001 - Information Security Management Systems (ISMS) 3
G Question on Statement of Applicability (SOA) IEC 27001 - Information Security Management Systems (ISMS) 2
L TS 16949 applicability for Supplier's Supplier IATF 16949 - Automotive Quality Systems Standard 8
R ISO 22000:2005 Clause 7.10.4 Withdrawal - Applicability and documentation required? Food Safety - ISO 22000, HACCP (21 CFR 120) 3
A Applicability of electrical safety standards to a dedicated PC IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
A Help me understand the applicability of 21 CFR Part 820.198 (Customer Complaints) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
Y New Draft FDA Guidance for Applicability of GLP in Medical Device Submission Other US Medical Device Regulations 2
G TS 16949 applicability for Bulk Material Product IATF 16949 - Automotive Quality Systems Standard 25
Q Two AS9102 Applicability and Interpretation Questions AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
R HIPAA (Health Insurance Portability and Accountability Act) applicability Other US Medical Device Regulations 3
E Applicability of Defibrillator Energy Test to Implantable Devices IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
S OEM Supplier of Accessories Registration and 21 CFR 820 QSR Controls Applicability 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 11

Similar threads

Top Bottom