SS-EN-ISO-8871-2 Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 2: Identification and characterization (ISO 8871-2:2003)

SS-EN-ISO-8871-2 - 2005 EDITION - CURRENT


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Included in this current edition are the following subparts:

 2005 EDITION - April 1, 2005
 2005/A1:2014 EDITION AMENDMENT - June 13, 2014

This part of ISO 8871 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.

To find similar documents by classification:

11.040.20 (Transfusion, infusion and injection equipment Including blood packs Syringes, needles and catheters, see 11.040.25)

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Designation Name

SS-EN ISO 8871-2:2005

Revision Level

2005 EDITION

Status

Current

Publication Date

April 1, 2005

Language(s)

English

Page Count

25

International Equivalent

EN ISO 8871-2:2004(IDT); ISO 8871-2:2003(IDT)