🔥🔥 Don’t Miss Out on Our End of Autumn Sale. If you have any questions, feel free to click the bottom right corner to contact our customer service..

Concat us[email protected]
Shopping Cart

No products in the cart.

🔍
ASTM-F1980:2007 Edition

ASTM-F1980:2007 Edition

$40.63

F1980-07 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices

Published By Publication Date Number of Pages
ASTM 2007 7
PDF Format Searchable Printable Preview Now
Guaranteed Safe Checkout
Categories: ,

If you have any questions, feel free to reach out to our online customer service team by clicking on the bottom right corner. We’re here to assist you 24/7.
Email:[email protected]

1.1 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.

1.2 Information obtained using this guide may be used to support expiration date claims for medical device sterile barrier systems.

1.3 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.

1.4 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.

1.5 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.

1.6 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.’

1.7 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.

PDF Catalog

PDF Pages PDF Title
1 Scope
Referenced Documents
Terminology
2 Significance and Use
Apparatus
Accelerated Aging Theory
3 Accelerated Aging Plan
4 Post-Aging Testing Guidance
Report
Keywords
X1. ACCELERATED AGING OF POLYMERS
X1.1
5 X2. EXAMPLE STERILE BARRIER SYSTEM SHELF-LIFE TEST PLAN
X2.1
X2.2
X2.3
X2.4
X2.5
X2.6
X2.7
FIG. X1.1
6 X2.8
X3. USING RELATIVE HUMIDITY IN AGING PROTOCOLS
X3.1
X3.2
X3.3
TABLE X3.1
7 FIG. X3.1

Related products

ASTM-F1980
$40.63