SS-EN-ISO-8871-2-AM1 › Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 2: Identification and characterization - Amendment 1 (ISO 8871-2:2003/Amd 1:2005)
SS-EN-ISO-8871-2-AM1
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2005 EDITION AMENDMENT 1
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CURRENT
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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.
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Designation Name
SS-EN ISO 8871-2:2005/A1:2014
Revision Level
2005 EDITION AMENDMENT 1
Status
Current
Publication Date
June 13, 2014
Language(s)
English
Page Count
16
International Equivalent
EN ISO 8871-2:2004/A1:2014(IDT); ISO 8871-2:2003/Amd 1:2005(IDT)