The Cove Business Standards Discussion Forums
Medical device non sterile packaging requirement
Please read this thread...
Software update
Medical device non sterile packaging requirement
Go Back   The Elsmar Cove Business Systems and Standards Discussion Forums > >
Forum Username

Elsmar Cove Forum Visitor Notice(s)

Wooden Line

Medical device non sterile packaging requirement

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
class ii medical device, medical devices, non-sterile medical devices, packaging (general), packaging standards and specifications
Thread Tools Search this Thread Rate Thread Content Display Modes
  Post Number #1  
Old 23rd March 2018, 08:24 AM

Total Posts: 16
Please Help! Medical device non sterile packaging requirement

Hello everyone,
We are kind of stuck in determining the packaging requirements as per MDD and IEC standards.
1. How do we determine Max and min storage temperature and humidity range for a class 2a non-sterile medical device? Is there a test criteria or we directly go with what is mentioned in the IEC standards.
2. Do we have to justify these range of temperature and humidity that we select if so are there any tests ? IEC 60601-1 does not specify any tests for packaging.

If anyone has info on this please share.

Thank you

Sponsored Links
  Post Number #2  
Old 4th April 2018, 05:24 PM

Total Posts: 1,144
Re: Medical device non sterile packaging requirement

First off, look at each component to find the most limited ranges. Second, consider a risk analysis for temperature / humidity excursions (what happens to the device - do you lose basic safety / essential performance?).

Yes, there are temperature and humidity soak tests as part of 60601.

Packaging requirements are just to protect your device during transport and is, indeed, outside the scope of 60601. The requirement originates from the regulations / standards.
Thanks to yodon for your informative Post and/or Attachment!

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
Medical Implant Sterile Packaging Design SRavi EU Medical Device Regulations 6 2nd January 2013 06:18 AM
Symbol for Medical Device Sterile Packaging - "Inspect Seal Before Opening" Nancy Allen Other Medical Device Related Standards 5 21st June 2012 11:28 AM
Sterile Product Ship Testing (Medical Device Packaging) SK Vision EU Medical Device Regulations 3 28th September 2009 10:54 AM
Is there a requirement for country of origin on packaging of class 2a medical device? Pauling Other Medical Device and Orthopedic Related Topics 17 15th September 2009 03:51 AM

The time now is 09:08 AM. All times are GMT -4.
Your time zone can be changed in your UserCP --> Options.

Misc. Internal Links

NOTE: This forum uses "Cookies"