Agree with Brian in his YAID [Yet Another It Depends] But if you are in the real scope of IEC 60601 series standards that also means you will have a regulatory submission to the likes of FDA, Health Canada, EU Notified Bodies, etc. There is a lot more overhead for these regulatory submissions over just the 60601 series of standards. Like needing a quality system that meets ISO 13485, Risk MAnagement Process per ISO 14971, Usability Engineering Process under IEC 62366-1 (for FDA already), IEC 62304 (software lifecycle process for med dvcs - includes more than real s/w, etc.). Then you need to put together a much more extensive technical file / design history file, your production records need to be more in control, etc.
Focusing in on the IEC 60601 standards there are some significant differences between 60601 Series & 60950-1 Essential Performance (not well understood still after 13 years since 3rd ed. out and 6 yrs since ed. 3.1 out) and Risk Management File requirements (based on ISO 14971 Risk Mgmt for Med Dvcs) is a heavy lift even for many in the med dvc industry There are about 70 standards in the Series plus related life cycle standards: such as IEC 62304 software lifecycle process for med dvcs + IEC 62366 or IEC 62366-1 Usability Engineering Process for med dvcs (FDA already is expecting this version but not linked on the CB side yet and won’t be til IEC 60601-1, ed. 3.2 is released which likely will be sometime in 2020) IEC 60950-1 is linked to 60601-1 currently for Means of Operator Protection only. Means of Patient Protection has higher Creepage, Air Clearance and Dielectric limits. There are additional Leakage Current Tests past Earth and Touch Current related to Patient Leakage Limits which are much more stringent Most CB labs (even if not getting a CB cert & rprt) will require 60601-1, 60601-1-6 (Usability linked to IEC 62366), IEC 60601-1-8 (Alarms, if applicable) and any particular standard(s) that apply to the device. You will need to test to IEC 60601-1-2 (EMC) and at this point I would highly recommend doing 4th ed. (major change from 3rd ed) but will be required for all new submissions and change submissions to FDA & Health Canada by end of this year. For EU mandated for all products (new or old products as of Jan 1 2019). Note that IEC 62368-1, 3rd ed. ( I know in FDIS currently) is being worked on for inclusion into 60601-1 ed. 3.2 (I am on the ad hoc committee for this work). Basically we are just starting our analysis into how we will integrate into IEC 60601-1 and we will keep the IEC 60950-1 references, etc. for this work. I suspect when we go to 4th ed of IEC 60601-1 we may take out some of the IEC 60950-1 sources and text, etc. And much more in differences between the standards. Some additional resources around IEC 60601-1 and it’s series. I have provided a webinar (free) on how to be successful on IEC 60601-1 projects https://www.greenlight.guru/webinar/iec-60601-1 <https://www.greenlight.guru/webinar/iec-60601-1> InCompliance in June published an article I wrote about using standards to keep up to date on changes to requirements https://incompliancemag.com/article/how-to-stay-up-to-date-on-the-ever-changing-landscape-of-the-medical-electrical-device-regulatory-world/ <https://incompliancemag.com/article/how-to-stay-up-to-date-on-the-ever-changing-landscape-of-the-medical-electrical-device-regulatory-world/> I spoke at the FDA in May at their ASCA (Accreditation Scheme for Conformity Assessment) Workshop from the manufacturer’s perspective related to IEC 60601 testing at test labs and how FDA looks at test reports (usually CB Scheme report formats) https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm592094.htm <https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm592094.htm> Hope this all helps, Leonard (Leo) Eisner, P.E. Principal Consultant, Eisner Safety Consultants Phone: (503) 244-6151 <tel:(503) 244-6151> Mobile: (503) 709-8328 <tel:(503) 709-8328> Email: [email protected] <mailto:[email protected]> Website: www.EisnerSafety.com <http://www.eisnersafety.com/> <http://www.eisnersafety.com/Industry_News/> <http://us.linkedin.com/in/leoeisnersafetyconsultants> <http://www.twitter.com/EisnerSafety> <http://skype:Eisner_Safety_Consultants/> <http://plus.google.com/+LeoEisner> <http://www.youtube.com/channel/UC6obaID27sjS-bbk0qv0AmQ> *************** Internet E-mail Confidentiality Disclaimer *************** This e-mail message may contain privileged or confidential information. If you are not the intended recipient, you may not disclose, use, disseminate, distribute, copy or rely upon this message or attachment in any way. If you received this e-mail message in error, please return by forwarding the message and its attachments to the sender. Eisner Safety Consultants do not accept liability for any errors, omissions, corruption or virus in the contents of this message or any attachments that arise as a result of e-mail transmission. ******************************************************************************* > On Jun 11, 2018, at 11:03 PM, Amund Westin <[email protected]> wrote: > > When doing safety testing according to IEC60950-1 and IEC60601-1, are there > big differences in the practical process at the test laboratories? > For those test engineers who do both standards, what are the similarities and > what are the biggest differences. > > Thanks. > Best regards Amund > > > > > > - > ---------------------------------------------------------------- > This message is from the IEEE Product Safety Engineering Society emc-pstc > discussion list. 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To post a message to the list, send your e-mail to <[email protected]> All emc-pstc postings are archived and searchable on the web at: http://www.ieee-pses.org/emc-pstc.html Attachments are not permitted but the IEEE PSES Online Communities site at http://product-compliance.oc.ieee.org/ can be used for graphics (in well-used formats), large files, etc. Website: http://www.ieee-pses.org/ Instructions: http://www.ieee-pses.org/list.html (including how to unsubscribe) List rules: http://www.ieee-pses.org/listrules.html For help, send mail to the list administrators: Scott Douglas <[email protected]> Mike Cantwell <[email protected]> For policy questions, send mail to: Jim Bacher: <[email protected]> David Heald: <[email protected]>
