Consider the IEC 60721-3 series on classification of environmental conditions. It defines ranges of temperature, humidity, etc., to be used as input parameters for testing the ability of electrical equipment to withstand the expected conditions for indoor or outdoor use, storage, transportation, etc.
Or create your own definitions of what's considered "normal" in Winnipeg or Riyadh or wherever you expect your product to be.
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Anne LeBlanc
Manager, Regulatory Affairs
United States
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Original Message:
Sent: 04-Oct-2019 18:44
From: Dan O'Leary
Subject: Special handling and storage conditions
Consider ISO 13485:2016, 7.5.11 Preservation of product
There is a paragraph that requires that the organization protects product from alteration, contamination, or damage when exposed to expected conditions and hazards during processing, storage, handling, and distribution by:
a) designing and constructing suitable packaging and shipping containers;
b) documenting requirements for special conditions needed if packaging alone cannot provide preservation
The 13485 Handbook has a discussion of considerations and methods.
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Dan O'Leary CQA, CQE
Swanzey NH
United States
Original Message:
Sent: 04-Oct-2019 12:21
From: Diane King
Subject: Special handling and storage conditions
Going back to basics here...
If "special storage and/or handling conditions" apply, MDD/MDR requirements state that these conditions are included on the device label.
I'm looking for a reference that provides a "normal" set of conditions such that conditions outside of those ranges would be considered special. Any suggestions?
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Diane King RAC
Redwood City CA
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