Standard Swedish standard · SS-EN ISO 8871-2:2005

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

Status: Withdrawn

· Replaced by: SS-EN ISO 8871-2:2020 Amended by: SS-EN ISO 8871-2:2005/A1:2014
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Standard Swedish standard · SS-EN ISO 8871-2:2005

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

Subjects

Transfusion, infusion and injection equipment (11.040.20)


Buy this standard

Standard Swedish standard · SS-EN ISO 8871-2:2005

Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 2: Identification and characterization (ISO 8871-2:2003)
Subscribe on standards - Read more Dölj
Price: 1 655 SEK
standard ikon pdf

PDF

Price: 1 655 SEK
standard ikon

Paper

Price: 2 648 SEK
standard ikon pdf + standard ikon

PDF + paper

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Product information

Language: English

Written by: Svenska institutet för standarder

International title:

Article no: STD-39264

Edition: 1

Approved: 4/1/2005

No of pages: 25

Replaces: SS-EN ISO 8871+A1

Replaced by: SS-EN ISO 8871-2:2020