IEC 60601-1 4th Edition - Is a "Red-line" version available?

R

RCW

Quite Involved in Discussions
Is anyone aware of the availability of a red-lined version of 60601-1 that compares 4th edition against 3rd edition? (To purchase, not an illegal copy)

OR

Has anybody run across any comparison of these available on the web? I did find something from Intertek (http://www.intertek.com/blog/2015-07-22-medical-emc/) but that was just a general "what's changing" article.
 
P

Pads38

Moderator
Re: 60601-1 4th Edition - red-line available?

Red line versions are only available for amended standards - that is, ones where the basic structure is maintained but some lines or paragraphs are changed. The new 60601-1-2 Edition 4 of the EMC standard is a completely new standard.

I'm just now looking through Ed 4 - and getting worried!

(I have a 15 page guide to Ed 4, from Intertek, but cannot seem to find it on their web-site. It is titled 'IEC60601-1-2 Edition 4: New Requirements for Medical EMC')
 
Last edited:
  • Like
Reactions: RCW
P

Pads38

Moderator
Perhaps we should have been a little clearer:-

The Edition 4 standard referred to above was the EMC standard 60601-1-2:2015

Not the amended 60601:1 Edition 3.1
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
T IEC 60601-1 vs IEC 60601-1-2 4th Edition Other ISO and International Standards and European Regulations 1
Ed Panek Transition to IEC 60601 4th Edition - Risk Analysis and test submissions CE Marking (Conformité Européene) / CB Scheme 2
O IEC 60601-1-2 4th edition transition deadline Dec 31 2018 CE Marking (Conformité Européene) / CB Scheme 1
O Standards used for IEC 60601-1-2 3rd ed. Vs. 4th ed. CE Marking (Conformité Européene) / CB Scheme 1
O Suggestions for templates for formulating test plan for IEC 60601-1-2 4th ed CE Marking (Conformité Européene) / CB Scheme 0
B When is Compliance required for 4th edition IEC 60601-1-2 IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
F Defining the need to perform the Proximity magnetic fields immunity tests (IEC 61000-4-39) according to the IEC 60601-1-2 ed.4.1 IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
M IEC 60601-1-8 clause 6.4.1 (statistics of the distribution of the sum of the maximum ALARM CONDITION + SIGNAL GENERATION DELAY) IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
O ESD Testing IEC 60601 IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
E Meaning of ALARM PRESETS (subclause 6.5.1 of IEC 60601-1-8:2020) IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
Franky Zhang123 The Electrical Standards GB9706.1:2020 (same as IEC 60601-1:2012) etc. will be implemented on May 1st, 2023 in China. China Medical Device Regulations 0
H IEC 62368-1 used in IEC 60601-1 IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
E Artificial hand (IEC 60601-1-2) IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
L Differences between IEC 60601-1-2 and IEC TR 60601-4-2 US Food and Drug Administration (FDA) 3
S PDF version of IEC 60601-1 IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
P IEC 60601-2-25 requirements IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
F IEC 60601-2-54:2009 Accuracy of CURRENT TIME PRODUCT IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
C Sample qualification to be IEC 60601-1 series tested IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
H Is testing according to IEC 60601-1 & IEC 60601-1-2 mandatory for a device being registered under MDR? IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
XRAY_3121 Class II heating pad - does the power supply have to have IEC 60601-1 testing?? US Medical Device Regulations 5
G History of IEC 60601-1:2005 IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
J IEC 60601-1-2 IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
J IEC 60601-1 Clause 7.9.3.1 IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
S Safety testing IEC 60601 series Medical Device and FDA Regulations and Standards News 2
F Battery overload in IEC 60601-1 vs 62133-2 IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
S Mandatory tests for IEC 60601-1 IEC 60601 - Medical Electrical Equipment Safety Standards Series 11
D IEC 60601-1-2: Is EMC immunity testing required for a device without essential performance? IEC 60601 - Medical Electrical Equipment Safety Standards Series 25
E Clause 8.9.1.2 of AMD2:2020 of IEC 60601-1 IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
P IEC 60601-1-2 RF wireless technology IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
A IEC 60601-2-8 cl.201.10.1.2.101 and cl.201.10.1.2.104 IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
G Risk Management for IEC 60601-1 and IEC 60601-1-2 IEC 60601 - Medical Electrical Equipment Safety Standards Series 15
J IEC 60601 Applied Part - Probes intended to be covered by sheaths IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
S IEC 60601-1-11 Requirements related to Storage and Distribution IEC 60601 - Medical Electrical Equipment Safety Standards Series 6
shimonv IEC 60601-1-2:2014+A1:2020 (Ed. 4.1) IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
G IEC 60601 Compliance IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
W IEC 60601-1 clause 8.8.3 - Dielectric Strength IEC 60601 - Medical Electrical Equipment Safety Standards Series 8
B IEC 60601-1 Clause 14.8 - Architecture IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
R IEC 60601-2-57 light source classification IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
L Top opening of enclsoure against fire in IEC 60601-1 IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
C EN 45502 vs IEC 60601-1-8 Other Medical Device Related Standards 0
JoCam IEC 60601-1 and 60601-1-2 retest after PCBA change IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
K IEC 60601-1:2005/AMD2:2020, Why this standard version is 3.0? IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
C IEC 60601 - 8.8.3 Dielectric Strength test. 4kv being applied to the ground conductor?! IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
R IEC 60601-1 Clause 15.3.2, Push test IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
A Defining a lower ESD test level in IEC 60601 safety test IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
J IEC 60601-1-11 Home Class II With Ballasts IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
A Coverage and differences: EN 60601-1:2006+A12:2014 Vs AAMI/IEC 60601-1:2005+AMD1:2012 IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
T IEC 60601-1-8:2020 Is it necessary to change the alarm melody? IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
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

Similar threads

Top Bottom