ASTM F 2559 : 2006
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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Standard Guide for Writing a Specification for Sterilizable Peel Pouches
Hardcopy , PDF
11-11-2014
English
01-11-2006
Important note : Users cannot be edited or removed once added to your Multi user PDF.CONTAINED IN VOL. 15.09, 2009 Defines the requirements and considerations for flexible peel pouches with one open, unsealed end that are intended to be sterilized containing medical devices.
| Committee |
F 02
|
| DocumentType |
Guide
|
| Pages |
6
|
| PublisherName |
American Society for Testing and Materials
|
| Status |
Superseded
|
| SupersededBy |
1.1 This guide defines the requirements and considerations for flexible peel pouches with one open, unsealed end that are intended to be sterilized containing medical devices. These are also known as preformed sterile barrier systems.
1.2 Pouch styles are categorized as chevron, header, and corner peel. These pouches are typically manufactured by heat sealing, or in some cases, by cohesive cold sealing. The sealing bond is intended to be peeled open to aseptically dispense the contents.
1.3 Pouch materials may be either porous, nonporous, or any combination of the two.
1.4 This guide addresses some critical printing requirements on the pouch.
1.5 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.
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