NF EN ISO 8871-5

NF EN ISO 8871-5

November 2014
Standard Cancelled

Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 5 : functional requirements and testing

ISO 8871-5:2005 specifies requirements and test methods for functional parameters of elastomeric closures used in combination with vials and when pierced by an injection needle.

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Main informations

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National standards and national normative documents

Publication date

November 2014

Number of pages

18 p.

Reference

NF EN ISO 8871-5

ICS Codes

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

Classification index

S93-102-5

Print number

1

International kinship

ISO 8871-5:2005

European kinship

EN ISO 8871-5:2014
Sumary
Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 5 : functional requirements and testing

ISO 8871-5:2005 specifies requirements and test methods for functional parameters of elastomeric closures used in combination with vials and when pierced by an injection needle.

Standard replaced by (1)
NF EN ISO 8871-5
January 2017
Standard Current
Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 5 : functional requirements and testing

ISO 8871-5:2016 specifies requirements and test methods for functional parameters of elastomeric closures used in combination with vials and when pierced by an injection needle. NOTE Functional testing with spikes is specified in ISO 8536‑2 and in ISO 8536‑6.

Table of contents
  • Avant-propos
  • 1 Domaine d'application
  • 2 Références normatives
  • 3 Termes et définitions
  • 4 Exigences
  • 5 Préparation des fermetures en élastomère pour les essais
  • Annexe A (normative) Essai de pénétrabilité
  • Annexe B (normative) Essai de fragmentation
  • Annexe C (normative) Essai d'auto-obturation et essai d'intégrité de fermeture des récipients
  • Annexe D (normative) Essai d'intégrité de fermeture des récipients
  • Bibliographie
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