Usability Standard - The difference between IEC 60601-1-6 to IEC 62336

M

mvroops

Starting to get Involved
#1
#1
Dear All,

Please help me to understand the difference between 60601-1-6 to 62336.
what are the clause included and removed etc.
 
GAGEpack - Gage & Calibration Management
Elsmar Forum Sponsor
T

tazer

Involved In Discussions
#2
#2
The latest edition 3.1 of 2013-10 contains 19 pages, including introduction, appendices, ...
The only clause in the standard says that you have to apply much of the 62366 and that's it.
In other words, the 60601-1-6 is moribund.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
P Usability/human factors engineering requirement (standard) for IVD medical device Other Medical Device Related Standards 2
R What is the typical industry standard for documenting Usability Risk? Human Factors and Ergonomics in Engineering 16
M IEC 62366:2007 - Is FDA Usability Engineering Standard a Requirement in Canada? Canada Medical Device Regulations 5
S Usability standard IEC 60601-1-6 in the Medical Device Industry IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
I "Usability" for technical documentation EU Medical Device Regulations 1
Q Summative Usability Evaluation Testing: prior or during Clinical Investigation? Human Factors and Ergonomics in Engineering 9
K Usability for custom made medical devices IEC 62366 - Medical Device Usability Engineering 5
P Human Factors / Usability validation in the time of COVID Human Factors and Ergonomics in Engineering 17
N Usability testing required for FDA IDE (investigational device exemption)? Human Factors and Ergonomics in Engineering 8
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
T MDR article 22 - System of 2 CE products and validation / usability? EU Medical Device Regulations 10
M Informational Understanding Costs And Risks For HFE Usability Studies — Part 1: Testing In-House Medical Device and FDA Regulations and Standards News 0
P Global medical device human factors/usability requirement IEC 62366 - Medical Device Usability Engineering 3
E Usability Process - Looking for a template (IEC 62366) IEC 62366 - Medical Device Usability Engineering 1
S Usability procedure - looking for a template IEC 62366 - Medical Device Usability Engineering 3
K Usability of ME Equipment - IEC-62366-1:2015 IEC 62366 - Medical Device Usability Engineering 3
V 510(k) vs. CE Marking Summative Usability Testing Expectations IEC 62366 - Medical Device Usability Engineering 4
M IEC 62366-1:2015 Usability Verification / Validation Plan example wanted IEC 62366 - Medical Device Usability Engineering 20
Q EU ROHS and GUI Usability Trial Requirements EU Medical Device Regulations 10
M New MHRA guidance on Human Factors - Usability Engineering IEC 62366 - Medical Device Usability Engineering 1
S IEC 62366 - Usability Test Protocol format Imported Legacy Blogs 0
M Does Medical Device Usability Study = Clinical Trial? Other Medical Device and Orthopedic Related Topics 26
L BSI White Paper on Human Factors/Usability Engineering IEC 62366 - Medical Device Usability Engineering 12
F Usability Objectives and Verification & Validation Plan IEC 62366 - Medical Device Usability Engineering 7
Z IEC 62366 and Medical Device Usability Validation IEC 62366 - Medical Device Usability Engineering 10
P Number of Participants - Usability Validation IEC 62366 - Medical Device Usability Engineering 3
C Application of IEC 62366 - Usability of Non-Active Medical Devices IEC 62366 - Medical Device Usability Engineering 15
P Usability Plan for Existing Equipment IEC 62366 - Medical Device Usability Engineering 5
Ronen E Can Usability Studies save lives? Other Medical Device and Orthopedic Related Topics 1
L Patient Monitor Viewing Distance Usability Requirements IEC 60601 - Medical Electrical Equipment Safety Standards Series 11
S IEC 62366 - Embedded Software in separate Usability Engineering File? IEC 62366 - Medical Device Usability Engineering 1
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
Y Applying Human Factors and Usability Engineering - FDA Guidance Document 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
S New Draft FDA Guidance - Human Factors & Usability Engineering for Med Device Design US Food and Drug Administration (FDA) 0
C Understanding Design Decisions relating to Safety and Usability Human Factors and Ergonomics in Engineering 3
M Employees Awareness, Usability & Effectiveness of the ISO QMS - Survey needed ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
D IEC EN 62366 Usability Retroactive Compliance Other Medical Device Related Standards 1
N Usability Formula to Predict Use Error Reduction IEC 62366 - Medical Device Usability Engineering 6
R ISO IEC EN 62366 Usability Engineering Essential Requirements IEC 62366 - Medical Device Usability Engineering 8
M Link between Risk Management, Usability Engineering and R&D in Medical Devices ISO 14971 - Medical Device Risk Management 2
W Usability Engineering ISO 62366:2008 - Medical Devices IEC 62366 - Medical Device Usability Engineering 124
C Usability Engineering File - Looking for an example/template IEC 62366 - Medical Device Usability Engineering 3
lanley liao Confusion between national standard and API related standard. Oil and Gas Industry Standards and Regulations 8
E Comparison of Respiratory Protective Equipment Standards (China Standard Compare with EU standard of EN149 Occupational Health & Safety Management Standards 2
Ajit Basrur Any ISO standard or guidance documents on barcode and scanning? Other Medical Device Related Standards 1
J External Standard Services Document Control Systems, Procedures, Forms and Templates 12
B IVDR Electrical safety standard EU Medical Device Regulations 0

Similar threads

Top Bottom