The Cove Business Standards Discussion Forums
Go Back   The Elsmar Cove Business Systems and Standards Discussion Forums > > >
Forum Username

Elsmar Cove Forum Visitor Notice(s)

Wooden Line

IEC 60601-1 - Label Physical Requirements for Disposable (Single Use) Medical Devices

Monitor the Elsmar Forum
Courtesy Quick Links

Links Elsmar Cove visitors will find useful in the quest for knowledge and support:

Jennifer Kirley's
Conway Business Services

International Quality Services

Marcelo Antunes'
SQR Consulting, and
Medical Devices Expert Forum

Bob Doering
Bob Doering's Blogs and,
Correct SPC - Precision Machining

Ajit Basrur
Claritas Consulting, LLC

International Standards Bodies - World Wide Standards Bodies

AIAG - Automotive Industry Action Group

ASQ - American Society for Quality

International Organization for Standardization - ISO Standards and Information

NIST's Engineering Statistics Handbook

IRCA - International Register of Certified Auditors

SAE - Society of Automotive Engineers

Quality Digest

IEST - Institute of Environmental Sciences and Technology

Some Related Topic Tags
iec 60601 - medical electrical equipment, labeling requirements, labels and labeling (general), medical devices (disposable), single use devices (sud)
Thread Tools Search this Thread Rate Thread Content Display Modes
  Post Number #1  
Old 4th January 2017, 09:55 AM

Total Posts: 21
Please Help! IEC 60601-1 - Label Physical Requirements for Disposable (Single Use) Medical Devices

We have a medical device accessory (say electrode) needed for a medical device to work. It has its own packaging (and label). The packaging has print (text/instructions).
Since this is a single use accessory, does the package print need to be fully compliant with section 7.1.3 Durability of markings?
We have problems with the print because of the material of the packaging.

Big thanks for any help!!

Sponsored Links
  Post Number #2  
Old 4th January 2017, 10:36 AM

Total Posts: 771
Re: 60601-1 label physical requirements for disposable (single use) devices

It may be useful to realise that the rub tests of 7.1.3 only applies to those markings as required by 7.2, 7.4, 7.5 and 7.6.

Each of those relates to markings/symbols/signs that are on the outside of the device itself. They are not requirements for packaging labelling / information.
  Post Number #3  
Old 10th January 2017, 10:45 AM
Peter Selvey

Total Posts: 907
Re: IEC 60601-1 - Label Physical Requirements for Disposable (Single Use) Medical Dev

It's a good point and appears to be a mistake in the standard, something for the committee to consider.

There are a number of requirements in 7.2 which are permitted to be marked on the packaging if justified, but there is no mention of any exclusion for the durability tests.

Note that it makes sense that the marking is durable, the problem is not the requirement but the test being not representative of normal use (packaging would not normally be cleaned with alcohol). There should still be some minimum level of durability e.g. poor quality marking that easily flakes or rubs off with handling would not be OK even for packaging.

Maybe a water only test would be reasonable?

The other option would be to exclude accessories from the scope of evaluation. The standard is wrong for this point as well: accessories that are placed on the market as a separate medical device should be treated separately and only considered for the system related aspects. Non-system aspects such as marking should be outside of the scope of IEC 60601-1. These are covered by other standards.
Thanks to Peter Selvey for your informative Post and/or Attachment!
  Post Number #4  
Old 11th January 2017, 05:11 AM

Total Posts: 771
Re: IEC 60601-1 - Label Physical Requirements for Disposable (Single Use) Medical Dev

We recently had our shipping cartons tested, to ASTM D4169-14. They came back rather "second hand".
If we did have required markings on the carton we could repeat the legibility test of 7.1.2

In the case of packaging, such as double peel pouches often used for sterile items, I can't think what tests you could perform to replace the (7.1.3) durability tests. Perhaps pre-printed pouches could survive the rub tests even though the test is not really relevant. But paper self adhesive labels would need something different.
  Post Number #5  
Old 14th June 2017, 07:50 PM

Total Posts: 1
Re: IEC 60601-1 - Label Physical Requirements for Disposable (Single Use) Medical Dev

Have this same question at our company. Is there an industry standard practice for the testing of (IEC 60601-1) 7.1.3. Durability of Markings on disposable ME accessory packaging?

Is it the conservative approach which is to apply the tests outlined in 7.1.3 a & b which appear to be designed with the intent to test permanently affixed labels to ME equipment?

Lower Navigation Bar
Go Back   The Elsmar Cove Business Systems and Standards Discussion Forums > > >


Visitors Currently Viewing this Thread: 1 (0 Registered Visitors (Members) and 1 Unregistered Guest Visitors)
Thread Tools Search this Thread
Search this Thread:

Advanced Forum Search
Display Modes Rate Thread Content
Rate Thread Content:

Forum Posting Settings
You may not post new threads
You may not post replies
You may not post attachments
You may not edit your posts

BB code is On
Emoticons are On
[IMG] code is On
HTML code is Off

Similar Discussion Threads
Discussion Thread Title Thread Starter Forum Replies Last Post or Poll Vote
Reliability Testing of a Single-Use (Disposable) Medical Device NicoleinFlorida Reliability Analysis - Predictions, Testing and Standards 4 25th October 2016 11:39 AM
Customer Requirements for Single Use Medical Devices muzammil21ad Other Medical Device and Orthopedic Related Topics 3 6th December 2014 07:12 PM
Class II Disposable Medical Device Label Content Requirements dwayneq 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3 21st May 2014 11:25 AM
Manufacturing of sterile single use disposable devices in a single plant? Ajit Basrur ISO 13485:2016 - Medical Device Quality Management Systems 4 18th April 2011 08:49 PM
Distributor Requirements for Sterile Disposable Medical Devices Watchwait EU Medical Device Regulations 8 31st December 2008 01:14 PM

The time now is 10:54 PM. All times are GMT -4.
Your time zone can be changed in your UserCP --> Options.

Misc. Internal Links

NOTE: This forum uses "Cookies"