C
craig-c
Hello,
Does anyone have a safety design checklist based on EN 61010 3rd Edition that they are willing to share?
Craig
Does anyone have a safety design checklist based on EN 61010 3rd Edition that they are willing to share?
Craig
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.
* 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.
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.
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.
You also buy a test report form here: https://webstore.iec.ch/publication/8576
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