SBS - The best value in QMS software

IEC 62366 vs. FDA Human Factors Requirements

Elsmar Forum Sponsor

Stijloor

Staff member
Super Moderator
#2
A Quick Bump!

Can someone help?

If your questions were answered here, please consider helping others.

Thank you very much!
 

Mark Meer

Trusted Information Resource
#3
As far as using IEC 62366 as a consensus standard, you can lookup the standard here, and it will tell you which parts are not recognized by the FDA.

If you lookup IEC 62366, you will get the following exceptions:
  • Clause 5.5 (USABILITY SPECIFICATION) Note 1 is not recognized
  • Table D.5 (Examples of objective USABILITY goals) is not recognized
  • Table D.6 (Examples of subjective USABILITY goals) is not recognized
  • Annex G (USABILITY goals: Illustrative example for a home parenteral infusion pump) is not recognized.
 
Thread starter Similar threads Forum Replies Date
M IEC 62366:2007 - Is FDA Usability Engineering Standard a Requirement in Canada? Canada Medical Device Regulations 5
adir88 Amendment 1 of IEC 62366-1 - Details yet? IEC 62366 - Medical Device Usability Engineering 2
K Primary Operating Functions (POF) in IEC 62366-1:2015. IEC 62366 - Medical Device Usability Engineering 7
V Applicability of IEC 62366-1 usability to resorbable bone substitutes IEC 62366 - Medical Device Usability Engineering 9
pashah Looking for Usability File Template acc. IEC 62366-1 and IEC 60601-1-6 IEC 62366 - Medical Device Usability Engineering 4
C Usability IEC 62366-1:2015 and MDR 2017/745 - Risk based approach IEC 62366 - Medical Device Usability Engineering 1
E Usability Process - Looking for a template (IEC 62366) IEC 62366 - Medical Device Usability Engineering 1
J IEC 62366 - Ethical approval IEC 62366 - Medical Device Usability Engineering 5
J IEC 62366 - Summative Evaluation IEC 62366 - Medical Device Usability Engineering 3
T I need to make test reports according IEC 62304 & IEC 62366 IEC 62366 - Medical Device Usability Engineering 2
C IEC 60601-1-6 2010 maps to IEC 62366:2007 - What about 62366-1:2015? IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
K Usability of ME Equipment - IEC-62366-1:2015 IEC 62366 - Medical Device Usability Engineering 3
T IEC 62366 Test Report Form IEC 62366 - Medical Device Usability Engineering 20
M IEC 62366-1:2015 Usability Verification / Validation Plan example wanted IEC 62366 - Medical Device Usability Engineering 20
T IEC 62366:2015 Annex C - changed parts from 5.1-5.8 --> but what about 5.9? IEC 62366 - Medical Device Usability Engineering 3
S IEC 62366 - Usability Test Protocol format Imported Legacy Blogs 0
M IEC 62366-1 published - March 2015 IEC 62366 - Medical Device Usability Engineering 7
Z Final Validation Unit Requirements - Annex D of IEC 62366 IEC 62366 - Medical Device Usability Engineering 6
Z IEC 62366 and Medical Device Usability Validation IEC 62366 - Medical Device Usability Engineering 10
C Application of IEC 62366 - Usability of Non-Active Medical Devices IEC 62366 - Medical Device Usability Engineering 15
T IEC 62366 included in 3rd ed IEC 60601? IEC 62366 - Medical Device Usability Engineering 1
S IEC 62366 - Embedded Software in separate Usability Engineering File? IEC 62366 - Medical Device Usability Engineering 1
J Where to buy standards such as IEC 62366:2007 Other Medical Device Related Standards 2
S IEC 62366 for Stand-Alone Medical Device Software and Usability Engineering IEC 62366 - Medical Device Usability Engineering 16
D Training on IEC 62366 (Medical Device Usability Engineering) for CE Mark? IEC 62366 - Medical Device Usability Engineering 5
M What do you think the revision of IEC 62366 should bring? IEC 62366 - Medical Device Usability Engineering 16
A IEC 60601-1-6 last release or IEC 62366? IEC 62366 - Medical Device Usability Engineering 17
K How to apply IEC 62366 and what shall be changed in establishing a Technical File ISO 13485:2016 - Medical Device Quality Management Systems 2
D IEC EN 62366 Usability Retroactive Compliance Other Medical Device Related Standards 1
R ISO IEC EN 62366 Usability Engineering Essential Requirements IEC 62366 - Medical Device Usability Engineering 8
P IEC 62366 vs. IEC 60601-1-6 - Has IEC 62366 now replaced IEC 60601-1-6? IEC 62366 - Medical Device Usability Engineering 19
R IEC 60601-1 Clause 15.3.2, Push test IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
Le Chiffre Online training available for ISO/IEC 17021-1: Requirements for bodies providing audit and certification of management systems Training - Internal, External, Online and Distance Learning 3
E Any sample of a full software life cycle IEC 62304 report ( any class )? IEC 62304 - Medical Device Software Life Cycle Processes 1
A Defining a lower ESD test level in IEC 60601 safety test IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
J IEC 60601-1-11 Home Class II With Ballasts IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
T Relationship between ISO 9001 and ISO – IEC BS EN 870079- 34 2020 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
T Help with BS EN ISO - IEC 80079-34 2020 (Explosive atmospheres QMS) Other ISO and International Standards and European Regulations 0
A Coverage and differences: EN 60601-1:2006+A12:2014 Vs AAMI/IEC 60601-1:2005+AMD1:2012 IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
E IEC 62353 normalization IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
T IEC 60601-1-8:2020 Is it necessary to change the alarm melody? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
G Adopting old product - compliance with IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 9
M Is it normal / sufficient to have only the IEC 60601-1-2 test report without indicating IEC 60601-1? IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
S IEC 60601-2-30 - Is it mandatory to claim alarms? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
Y Auditory alarm standard IEC 60601-1-8 Reliability Analysis - Predictions, Testing and Standards 0
M IEC 61010-1 requirements for motors Other Medical Device Related Standards 0
R IEC 60601-1 - Power Supply Cords (Section 8.11.3.1) IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
A Outsourcing IEC 60601-1 Ed 3.2 Testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
R Complex IEC 60601-1 gap assessment IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
D SINGLE FAULT CONDITION, short circuit and open circuit of any component (IEC 60601-1 3.1) IEC 60601 - Medical Electrical Equipment Safety Standards Series 9

Similar threads

Top Bottom