SBS - The best value in QMS software

IEC EN 61010 3rd Edition Safety Design Checklist

C

craig-c

#1
Hello,

Does anyone have a safety design checklist based on EN 61010 3rd Edition that they are willing to share?

Craig
 
Elsmar Forum Sponsor

yodon

Staff member
Super Moderator
#2
I can't provide a checklist but we had one client recently go through the test effort and the test lab provided the following checklists (for an electronic device containing software to be used in the home environment):
* Alarms IEC 60601-1-8 (2012).doc
* Alarms, IEC 60601-1-8 (2006).doc
* Home Edition RMF IEC, 60601-1-11 Ed. 1.doc
* PEMS, IEC 60601-1 Ed. 3.0, Clause 14 (TRF G) ver. July ....doc
* PEMS, IEC 60601-1 Ed. 3.1, Clause 14 (TRF J), ver. April....doc
* Risk Process ISO 14971-1 (2007) (1).doc
* Risk Process ISO 14971-1 (2007) (2).doc
* Risk Process ISO 14971-1 (2007).doc
* Risk Process ISO 14971-1 (2000) (3).doc
* Risk Process ISO 14971-1 (2000).doc
* RMF IEC 60601-1 Ed 3.1 ver April 2014 TRF J.DOC
* RMF, IEC 60601-1 Ed. 3.0 (TRF G), ver. Dec. 2013.doc
* Software IEC 62304 (2006) Checklist.doc
* Usability IEC 60601-1-6 (2010) and 62366 (2007).doc
* Usability IEC 60601-1-6 (2013) and 62366 (2014).doc
* Usability IEC 62366 (2015) 11182015.doc
* ISO 14971-1 (2007) Checklist.doc
* ISO 14971-1 (2000) Checklist.doc
* Usability Checklist 62366-1.doc

Obviously, what's needed will depend on the type of device and the intended use environment. Point is that you might check with the test lab you use (presuming you use one) and see if they can provide applicable checklists.
 

Hershal

Metrologist-Auditor
Staff member
Super Moderator
#3
Having done several assessments of the 61010 standard (including the harmonized versions), there are a few things to note.

The test labs (TLs) that support the certification bodies (CBs) rarely share their checklists with anyone but the accrediting bodies (ABs), even though due to a peer review process the others see them. Hence, between them they are generally fairly consistent. As an example, between UL, CSA, and ITS, the checklists will have differences for their own systems, but the technical content will be the same.

The technical content is based directly from the standard(s) to include the applicable -2s and any other required standards and goes test by test. Typically includes listing any and all standards applicable for that test, whether there are any already-certified components, what is under test, the test equipment (e.g., fixtures), calibrated equipment, personnel, environmental conditions, conditioning requirements if any, descriptions (beginning, end, and others points of significance), often pictures also, decision whether it meets that specific requirement, and engineering sign-offs at appropriate points. All this for every test. The CB takes all the information and determines if the item can receive the mark, and also whether a post-certification inspection requirement is needed and at what frequency.

That is why test test/certification process takes so long and is so expensive. The TLs will be accredited under ISO/IEC 17025. CBs will be accredited under ISO/IEC 17065. Inspection bodies (IBs), if post-certification inspection is required, will be accredited under ISO/IEC 17020.

Hope this helps.
 
Thread starter Similar threads Forum Replies Date
T List of Tests - IEC 61010-1, 3rd edition and IEC 60601-1, 3.1 edition IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
P IEC 61010 3rd Edition - When devices are listed to the 2nd edition CE Marking (Conformité Européene) / CB Scheme 5
M IEC 61010-1 requirements for motors Other Medical Device Related Standards 0
B IEC 61010, Touch currents related to burns at higher frequencies (cl. 6.3, A.3) Other Medical Device Related Standards 0
B IEC 61010-1 - Voltage / Dielectric strength tests IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
J Universal Power Cord with Adapters - IVD IEC 61010-2-101 CE Marking (Conformité Européene) / CB Scheme 6
E IEC 61010-1 Dielectric strength test of inner power supply Other ISO and International Standards and European Regulations 0
G IEC 61010 - Single Fault Condition - Protective Impedance Implementation IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
I IEC 61010-1 and Flammable Liquids Other ISO and International Standards and European Regulations 1
K IEC 61010-2-100 Labeling question - IVD equipment Other ISO and International Standards and European Regulations 1
F IEC 61010 Creepage and Clearence Requirements Other ISO and International Standards and European Regulations 2
G IEC 61010 Humidity Preconditioning and Condensation CE Marking (Conformité Européene) / CB Scheme 4
O IEC 61010-1 Ed 2: "Automatic Disconnection of the supply" CE Marking (Conformité Européene) / CB Scheme 3
T Is IEC 61010 needed for a populated PCB within a unit? CE Marking (Conformité Européene) / CB Scheme 2
L Does IEC 61010-1 apply for Surgical Microscopes? IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
L Temperature - IEC 61010-1 ed2 & ed3 at chapter 10 IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
S IEC 61010-1 and IEC 60601 - Borderline Medical Device IEC 60601 - Medical Electrical Equipment Safety Standards Series 10
B IEC 61010-1 Certification Requirements, and External Supply/ELV questions CE Marking (Conformité Européene) / CB Scheme 4
S Advantages of IEC 60601-1 over IEC 61010 IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
R Is IEC 61010-1 required for my silly little device? IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
M IEC 60601 vs. IEC 61010 - CE Mark for our IVD medical device IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
R IEC 61010 vs IEC 60601-1 to ISO 15197 - Blood glucose monitoring device IEC 60601 - Medical Electrical Equipment Safety Standards Series 6
T CB Scheme IEC 61010 / IEC 60601...+ NRTL mark IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
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
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
A IEC 62304 safety classification, External Controls and off-label use related risks IEC 62304 - Medical Device Software Life Cycle Processes 5
H IEC 60601-1 ME equipment or ME system IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
M How does IEC-60601-1 apply to a non-medical device in the patient vicinity? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
R IEC 60601-1 - 11.1.3 e) Test criteria - Temperature Measurements IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
R IEC 60601-1 - Magnesium oxide used for the electrical insulation of heating elements IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
C ISO/IEC 17021-1 clause 7.1.2 - Determination of competence criteria Document Control Systems, Procedures, Forms and Templates 2
M Is IEC 60601-1-2 required by FDA for all electronic medical devices? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
C ISO/ IEC 17021 Resource requirement (need help) Document Control Systems, Procedures, Forms and Templates 5
Z IEC 60601-2-25; Frequency response test Medical Device and FDA Regulations and Standards News 1
S IEC 62304 software costs and time Medical Device and FDA Regulations and Standards News 3
S IEC 62304 - Software verification cost IEC 62304 - Medical Device Software Life Cycle Processes 3
Sravan Manchikanti Software Risk Management & probability of occurrence as per IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 8
M IEC 62304 Software changes - Minor labeling changes on the GUI IEC 62304 - Medical Device Software Life Cycle Processes 3
N IEC 60601-1-1 - Stress test, reference voltage IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
K IEC 62304 - Testing Independance IEC 62304 - Medical Device Software Life Cycle Processes 5
R IEC 60601-1:2005+AMD1:2012+AMD2:2020 CSV IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
B Exclusions or justification for non-applicability of IEC standards Reliability Analysis - Predictions, Testing and Standards 1
B IEC 60601 - Creepage Distance - Relay that acts as a means of physical mechanical protection Process Maps, Process Mapping and Turtle Diagrams 0
T Single Fault Condition IEC 60601 Clause 8.7.1 shorting Cr/Cl in Patient Applied Part IEC 60601 - Medical Electrical Equipment Safety Standards Series 7

Similar threads

Top Bottom