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Document ASTM F 1980 is offered by IHS as part of an online subscription. This subscription contains many documents on the same topic.
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ASTM F 1980 Document Information:
Title
Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
ASTM International
Publication Date:
Apr 1, 2007
Scope:
This guide provides information for developing accelerated aging
protocols to rapidly determine the effects, if any, due to the
passage of time on the sterile integrity of the sterile barrier
system (SBS), as defined in ANSI/AAMI/ISO 11607–1:2006 and the
physical properties of their component packaging materials.
Information obtained using this guide may be used to support
expiration date claims for medical device sterile barrier
systems.
The accelerated aging guideline addresses the sterile barrier
systems in whole with or without devices. The sterile barrier
system material and device interaction compatibility that may be
required for new product development or the resulting evaluation is
not addressed in this guide.
Real-time aging protocols are not addressed in this guide;
however, it is essential that real-time aging studies be performed
to confirm the accelerated aging test results using the same
methods of evaluation.
Methods used for sterile barrier system validation, which
include the machine process, the effects of the sterilization
process, environmental challenge, distribution, handling, and
shipping events, are beyond the scope of this guide.
This guide does not address environmental challenging that
stimulates extreme climactic conditions that may exist in the
shipping and handling environment. Refer to Practice D 4332 for
standard conditions that may be used to challenge the sterile
barrier system to realistic extremes in temperature and humidity
conditions. See Terminology F 1327 for a definition of
"environmental challenging."
This standard does not purport to address all of the safety
concerns, if any, associated with its use. It is the responsibility
of the user of this standard to establish appropriate safety and
health practices and determine the applicability of regulatory
limitations prior to use.
Keywords:
- accelerated aging
- Arrhenius reaction rate
- Q10
- shelf-life
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