Work Item
ASTM WK76565

New Test Method for Standard Test Method for Marking Indelibility

1. Scope

The scope of the Committee shall include the development of standards for physical, chemical, and barrier properties of primary barrier packaging materials and the promotion of research in this field. The committee’s focus includes the component materials, their properties, and primary package design, development, and production.

A primary barrier packaging is defined as a package constructed from porous or nonporous barrier materials and designed to control or eliminate the passage of gas vapor, humidity, liquid, microbes, and light into or out from the package and is in direct contact with the contents.

Typical primary barrier packaging materials are papers, nonwovens, plastic films, rigid plastics, glass, and metal foils, used alone, treated, or in various combinations

Typical primary barrier packages include but are not limited to bottles, vials, pouches, blisters, and trays.

Recognition shall be made of related national and international standards with the encouragement of full participation in those activities. Standards under the jurisdiction of other committees shall be used when applicable.


Package, print, artwork, legibility, indelibility


Regulations (EU) 2017/745 and 746 require that "The particulars on the label shall be indelible, easily legible and clearly comprehensible to the intended user or patient." Currently, no test method exists which explicitly claims to assess indelibility.

The title and scope are in draft form and are under development within this ASTM Committee.


Developed by Subcommittee: F02.50

Committee: F02

Staff Manager: W Scott Orthey

Work Item Status

Date Initiated: 04-15-2021

Technical Contact: Dan Burgess

Item: 000