1. Scope

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.

2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.

ASTM Standards

D4332 Practice for Conditioning Containers, Packages, or Packaging Components for Testing

E337 Test Method for Measuring Humidity with a Psychrometer (the Measurement of Wet- and Dry-Bulb Temperatures)

F17 Terminology Relating to Flexible Barrier Packaging

F1327 Terminology Relating to Barrier Materials for Medical Packaging

F2097 Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products

Keywords

accelerated aging; Arrhenius reaction rate; Q ₁₀ ; shelf-life: Accelerated aging/testing--surgical devices/applications; Arrhenius kinetic constants; Medical/surgical packaging materials; Shelf life Q 10 ; Sterile medical device packages; Surgical implants; Testing methods--surgical implants;

ICS Code

ICS Number Code 11.080.30 (Sterilized packages)

DOI: 10.1520/F1980-07

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