Re: [PSES] Maintaining UL Label when Modifying Electrical Enclosures in the Field

. Typically can be done fast and in a week or so depending on the test lab you get the field evaluation from. All the best, Leonard (Leo) Eisner, P.E. The “IEC 60601 Guy” Principal Regulatory & Compliance Consultant, Eisner Safety Consultants Mobile: (503) 709-8328 Emai

Re: [PSES] Confusion about IEC 60601-1-11 Power Cord Requirements and Functional vs Protective Earth Terminals

can be class I. Also, note that the APPLIED PARTS need to be floating BF or CF (F stands for floating and so would not be able to be grounded. I would suggest you sell two different versions a professional version and home medical version. Best, Leonard (Leo) Eisner, P.E. The

Re: [PSES] IEC 60601-1-2: 2014 Testing on Device Powered from Computer USB Port

ving proper Essential Performance Requirements (which has to be the manufacturer’s responsibility) can have a huge impact on the emc testing. Cheers, Leonard (Leo) Eisner, P.E. The “IEC 60601 Guy” Principal Consultant, Eisner Safety Consultants Phone: (503) 244-6151 Mobile: (503) 709-8328 E

Re: [PSES] Part 2 - Are there regulatory requirements (like NEC / CEC or similar) for an Agency Mark (Not NRTL or SCC) for the following items

> A medical device/system (AAM ES 60601-1) & a separate wall power adapter? Thx, Leonard (Leo) Eisner, P.E. Principal Consultant, Eisner Safety Consultants Phone: (503) 244-6151 Mobile: (503) 709-8328 Email: l...@eisnersafety.com <mailto:l...@eisnersafety.co

Re: [PSES] Part 3 - What are the SCC requirements for a Canadian Agency Mark (C) next to the Agency Mark for the following items

A medical device/system (AAM ES 60601-1) & a separate wall power adapter? What are the requirements for this (in the CEC or somewhere else in Canadian law? Thx Leonard (Leo) Eisner, P.E. Principal Consultant, Eisner Safety Consultants Phone: (503) 244-6151 Mobile: (503) 709-

[PSES] What are the OSHA requirements for a NRTL Mark for the following items

A medical device/system (AAM ES 60601-1) & a separate wall power adapter? be approved via a NRTL? Where in 29 CFR or elsewhere is this mandated. I can’t find a good reference and 29 CFR seems very circuitous Thx, Leonard (Leo) Eisner, P.E. Principal Consultant, Eisner Sa

Re: [PSES] Process IEC60950-1 vs. IEC60601-1

4.htm> Hope this all helps, Leonard (Leo) Eisner, P.E. Principal Consultant, Eisner Safety Consultants Phone: (503) 244-6151 Mobile: (503) 709-8328 Email: l...@eisnersafety.com <mailto:l...@eisnersafety.com> Website: www.EisnerSafety.com <http://www.eisnersafety.com/>

Re: [PSES] Medical device risk assessment - faulty chargers

need risk management realize this is a requirement of the standard. Thx, Leonard (Leo) Eisner, P.E. Principal Consultant, Eisner Safety Consultants Phone: (503) 244-6151 Mobile: (503) 709-8328 Email: l...@eisnersafety.com <mailto:l...@eisnersafety.com> Website: www.EisnerS

Re: [PSES] Medical device risk assessment - faulty chargers

Do a thorough Risk Analysis per ISO 14971:2007 (that is what IEC 60601-1:2005 + A1:2012) or in the EU use EN 14971:2012 with the associated EN 60601-1, ed. 3.1 Hope this helps, Leonard (Leo) Eisner, P.E. Principal Consultant, Eisner Safety Consultants Phone: (503) 244-6151 Mobile: (503) 709

Re: [PSES] IEC 60601-1-2: 2014 Basic Safety and Essential Performance Pass/Fail Criteria

sts that are not EP related. Happy New Year to one and all, Leonard (Leo) Eisner, P.E. Principal Consultant, Eisner Safety Consultants Phone: (503) 244-6151 Mobile: (503) 709-8328 Email: l...@eisnersafety.com <mailto:l...@eisnersafety.com> Website: www.EisnerSa

[PSES] Fwd: [PSES] Was there ever a comparison between IEC 60950-1 and IEC 62368-1 (current edition preferable)? And any rationale for any of the changes

t and the plum don’t fit together. > > Ted - I didn’t know you were that oldd!!! :) > > Thx all and I will pass on the comments and some of the humor to my CAG. > > Cheers, > > > Leonard (Leo) Eisner, P.E. > Principal Consultant, Eisner Safety Consult

[PSES] Was there ever a comparison between IEC 60950-1 and IEC 62368-1 (current edition preferable)? And any rationale for any of the changes

all, Leonard (Leo) Eisner, P.E. Principal Consultant, Eisner Safety Consultants Phone: (503) 244-6151 Mobile: (503) 709-8328 Email: l...@eisnersafety.com <mailto:l...@eisnersafety.com> Website: www.EisnerSafety.com <http://www.eisnersafety.com/> <http://www.eisnersafety.com/Indu

Re: [PSES] Surface Creepage & Air Clearance Calculator - IEC 60601-1 3.1ed

chair for SC62D, among other Working Groups, Maintenance Teams, etc. involved in IEC 60601-1. If you want further training or details please contact me direct (see below). Thx

[PSES] Which Safety Test Agency Reports are accepted by City of LA Test Lab (please provide text of requirement or code)

code or similar would be really great to get too. Thx much, Leonard (Leo) Eisner, P.E. Principal Consultant, Eisner Safety Consultants Phone: (503) 244-6151 Mobile: (503) 709-8328 Email: l...@eisnersafety.com Website: www.EisnerSafety.com *** Internet E-mail Confidentiality

[PSES] Interpretation for RoHS2 requirement (exemption of medical devices) of CE Marked device under MDD & transfer or ownership but same product

their justification to the MDD NB nothing about parts being RoHS2 compliant in their justification. Thx much, Leonard (Leo) Eisner, P.E. Principal Consultant, Eisner Safety Consultants Phone: (503) 244-6151 Mobile: (503) 709-8328 Email: l...@eisnersafety.com Website: www.EisnerSafety.com

Re: [PSES] 60601-1-2 edition 4 acceptance dates and DOW of edition 3

Mid June. All the best, Leonard (Leo) Eisner, P.E. Principal Consultant, Eisner Safety Consultants Phone: (503) 244-6151 Mobile: (503) 709-8328 Email: l...@eisnersafety.com Website: www.EisnerSafety.com *** Internet E-mail Confidentiality Disclaimer *** This e-mail

Re: [PSES] 60601-1-2 edition 4 acceptance dates and DOW of edition 3

Hi Gary, For the US I believe from memory it is April 1, 2017 so pretty soon. I have the EU info buried somewhere so when I get a chance (may be awhile as I am only working couple hours per day max with being post knee surgery 1 week). Thx, Leonard (Leo) Eisner, P.E. Principal Consultant, Eisner

Re: [PSES] another MDD question

lps this is most of the story but there is more detail we could go into just don't have the time currently as I am digging out of a hole of e-mail since I just had a knee surgery last week on Tues to get rid of an infection that hit my knee joint & not able to drive currently. thx,

Re: [PSES] EU OJ today

roved. That as much as I can tell you without spending time digging thru things which IVD is not my area of expertise but if you have a Medical Device question under 60601 please let me know., Cheerip Leonard (Leo) Eisner, P.E. Principal Consultant, Eisner Safety Consultants Phone: (503) 244-6151 M

[PSES] Safety Test Labs Currently in and around SF Bay Area

ny of late to know which ones are still around. Thx so much for your help with this. Cheers, Leonard (Leo) Eisner, P.E. Principal Consultant, Eisner Safety Consultants Phone: (503) 244-6151 Mobile: (503) 709-8328 Email: l...@eisnersafety.com Website Consulting Service: www.EisnerSafety.c