• There are no items in your cart
We noticed you’re not on the correct regional site. Switch to our AMERICAS site for the best experience.
Dismiss alert

ASTM D 4754 : 2018

Current
Current

The latest, up-to-date edition.

Standard Test Method for Two-Sided Liquid Extraction of Plastic Materials Using FDA Migration Cell
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-05-2018

1.1This test method covers the use of the FDA migration cell in the extraction of components and permits quantitation of individual migrants from plastic materials by suitable extracting liquids, including liquid foods and food-stimulating solvents.

1.2This test method provides a two-sided, liquid extraction test for plastic materials that can be formed into film, sheet, or disks.

1.3This test method has been applied to a variety of migrant/polymer systems in contact with numerous foods and food simulants.2 Though most of the migrants examined were radiolabeled, the use of the FDA cell has been validated for migration studies of unlabeled sytrene from polystyrene.3

1.4This test method has been shown to yield reproducible results under the conditions for migration tests requested by the FDA. However, if the data is to be submitted to the FDA, it is suggested that their guidelines be consulted.

1.5Because it employs two-sided extraction, this test method may not be suitable for multi-layered plastics intended for single-sided food contact use.

1.6The size of the FDA migration cell as described may preclude its use in determining total nonvolatile extractives in some cases.

Note 1:For more information, see Practice D1898, the AOAC Methods of Analysis on Flexible Barrier Materials Exposed for Extraction, and the Guidance for Industry: Preparation of Premarket Submissions for Food Contact Substances: Chemistry Recommendations, December 2007.

1.7Analytical procedures must be available to quantitate the migrant(s) generated by this test method.

1.8The values stated in SI units are to be regarded as the standard.

1.9This 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use. Specific hazards statements are given in Section 8.

Note 2:There is no known ISO equivalent to this test method.

1.10This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

Committee
D 20
DocumentType
Test Method
Pages
5
PublisherName
American Society for Testing and Materials
Status
Current
Supersedes

ASTM F 561 : 2019 Standard Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids
ASTM F 34 : 2013 : R2018 Standard Practice for Construction of Test Cell for Liquid Extraction of Flexible Barrier Materials
ASTM F 2097 : 2016 Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products

ASTM D 883 : 2023 Standard Terminology Relating to Plastics
ASTM D 883 : 2024 Standard Terminology Relating to Plastics
ASTM D 883 : 2022 Standard Terminology Relating to Plastics
ASTM D 883 : 2020 : REV B Standard Terminology Relating to Plastics
ASTM E 691 : 2020 Standard Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method
ASTM E 691 : 2019 : EDT 1 Standard Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method
ASTM E 691 : 2023 Standard Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method
ASTM D 1898 : 1968 : R1989 Standard Practice for Sampling of Plastics (Withdrawn 1998)
ASTM E 691 : 2022 Standard Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method
ASTM E 691 : 2009 Standard Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method
ASTM E 691 : 2021 Standard Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method

View more information
£52.59
Excluding VAT

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.