ASTM F 2097 : 2001
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
Standard Guide for Design and Evaluation of Primary Packaging for Medical Products
Hardcopy , PDF
11-11-2014
English
10-10-2001
Important note : Users cannot be edited or removed once added to your Multi user PDF.| Committee |
F 02
|
| DocumentType |
Guide
|
| Pages |
11
|
| PublisherName |
American Society for Testing and Materials
|
| Status |
Superseded
|
| SupersededBy |
1.1 This guide provides directions for the design and evaluation of primary packages for medical products. The package materials must be selected appropriately for manufacturing process, end use, and the product being packaged.
1.2 This guide provides a compendium of test methods. 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.
1.3 This guide does not address acceptability criteria, which need to be determined jointly by the package producer and the medical products manufacturer.
1.4 This guide does not assess the product to be packaged; the sterilization method to be used; or package performance through sterilization, distribution, and handling.
| 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 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 |
| 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) |
Access your standards online with a subscription
Features
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.