NF EN ISO 8871/A1
NF EN ISO 8871/A1

NF EN ISO 8871/A1

December 1999
Standard Cancelled

Elastomeric parts for aqueous parenteral preparations

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Main informations

Collections

National standards and national normative documents

Publication date

December 1999

Number of pages

10 p.

Reference

NF EN ISO 8871/A1

ICS Codes

11.040.20   Transfusion, infusion and injection equipment
83.140.99   Other rubber and plastics products

Classification index

S93-102/A1

Print number

1 - décembre 1999

International kinship

ISO 8871/A1:1995

European kinship

EN ISO 8871/A1:1999
Standard replaced by (4)
NF EN ISO 8871-1
April 2005
Standard Current
Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 1: Extractables in aqueous autoclavates (ISO 8871-1:2003)

NF EN ISO 8871-2
April 2005
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.

NF EN ISO 8871-3
December 2004
Standard Current
Elastomeric parts for parenterals and for devices for pharmaceuticals use - Part 3: Determination of released-particle count (ISO 8871-3:2003)

NF EN ISO 8871-4
September 2006
Standard Current
Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 4: Biological requirements and test methods

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