<p>This document specifies identification and characterization procedures applicable to elastomeric parts including coated stoppers used for drug containers and medical devices.</p>
<p>The physical and chemical test procedures specified in this document permit the determination of the typical characteristics of elastomeric parts including coatings and surface treatments and can serve as a basis for agreements between manufacturer and user regarding the product consistency in subsequent supplies. Depending upon the type of elastomer and its application, an appropriate set of tests is selected.</p>
Registration number (WIID)
76110
Scope
<p>This document specifies identification and characterization procedures applicable to elastomeric parts including coated stoppers used for drug containers and medical devices.</p>
<p>The physical and chemical test procedures specified in this document permit the determination of the typical characteristics of elastomeric parts including coatings and surface treatments and can serve as a basis for agreements between manufacturer and user regarding the product consistency in subsequent supplies. Depending upon the type of elastomer and its application, an appropriate set of tests is selected.</p>
