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ASTM F 2097 : 2014

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products
Available format(s)

Hardcopy , PDF

Superseded date

11-11-2014

Language(s)

English

Published date

04-01-2014

1.1This guide provides directions for the design and evaluation of primary flexible packages for medical products. The package materials must be selected appropriately for manufacturing process, end use, and the product being packaged.

1.2This guide provides a compendium of test methods, practices, and procedures. Specific individual test methods must be selected based on the pertinent characteristics of the specific product to be packaged and the purpose for testing, research and development, or compliance. Not all test methods will be applicable.

1.3This guide does not address acceptability criteria, which need to be determined jointly by the package producer and the medical products manufacturer.

1.4This guide does not assess the product to be packaged or the sterilization method to be used.

1.5The units cited in the referenced standard should be used.

Committee
F 02
DocumentType
Guide
Pages
18
PublisherName
American Society for Testing and Materials
Status
Superseded
SupersededBy
Supersedes

ASTM F 2902 : 2016 : EDT 1 Standard Guide for Assessment of Absorbable Polymeric Implants
ASTM F 392/F392M : 2011 : R2015 Standard Practice for Conditioning Flexible Barrier Materials for Flex Durability
ASTM F 99 : 2007 : R2015 Standard Guide for Writing a Specification for Flexible Barrier Rollstock Materials
ASTM F 2559/F2559M : 2006 : R2015 Standard Guide for Writing a Specification for Sterilizable Peel Pouches
ASTM D 8233 : 2019 Standard Guide for Packaging and Labeling of Consumer Resin Cannabis Products for Sale to Adult Consumers, Legally Authorized Medical Users, and Caregivers in a Business-to-Consumer Retail Environment (Retailers)
ASTM F 3263 : 2017 Standard Guide for Packaging Test Method Validation
ASTM F 1980 : 2016 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices

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US$83.00
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