ISO 8871-2:2020

ISO 8871-2:2020

May 2020
International standard Current

Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 2: Identification and characterization

This document specifies identification and characterization procedures applicable to elastomeric parts including coated stoppers used for drug containers and medical devices.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.

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Main informations

Collections

International ISO standards

Publication date

May 2020

Number of pages

23 p.

Reference

ISO 8871-2:2020

ICS Codes

11.040.20   Transfusion, infusion and injection equipment

Print number

1
Sumary
Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 2: Identification and characterization

This document specifies identification and characterization procedures applicable to elastomeric parts including coated stoppers used for drug containers and medical devices.

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.

Replaced standards (2)
ISO 8871-2:2003
October 2003
International standard Cancelled
Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 2 : identification and characterization

ISO 8871-2:2003 specifies evaluation procedures applicable to elastomeric parts used for drug containers and medical devices in order to guarantee the product identity between the samples evaluated in the (suitability test) acceptance process and the current supplies. The physical and chemical test procedures specified in this part of ISO 8871 permit the determination of the typical characteristics of rubber materials, and may serve as a basis for agreements between manufacturer and user regarding the product consistency in subsequent supplies. An appropriate set of tests is selected, depending upon the type of rubber and its application. This part of ISO 8871 does not specify other requirements for rubber materials. These are laid down in the relevant product standards.

ISO 8871-2/A1:2005
July 2005
International standard Cancelled
Amendment 1 to standard ISO 8871-2:2003

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