NF EN ISO 8871-2

NF EN ISO 8871-2

June 2020
Standard Current

Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 2 : identification and characterization

This document specifies identification and characterization procedures applicable to elastomeric parts including coated stoppers used for drug containers and medical devices. The physical and chemical test procedures specified in this document permit the determination of the typical characteristics of elastomeric parts including coatings and surface treatments and can serve as a basis for agreements between manufacturer and user regarding the product consistency in subsequent supplies. Depending upon the type of elastomer and its application, an appropriate set of tests is selected.

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Main informations

Collections

National standards and national normative documents

Publication date

June 2020

Number of pages

32 p.

Reference

NF EN ISO 8871-2

ICS Codes

11.040.20   Transfusion, infusion and injection equipment

Classification index

S93-102-2

Print number

1

International kinship

ISO 8871-2:2020

European kinship

EN ISO 8871-2:2020
Sumary
Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 2 : identification and characterization

This document specifies identification and characterization procedures applicable to elastomeric parts including coated stoppers used for drug containers and medical devices.

The physical and chemical test procedures specified in this document permit the determination of the typical characteristics of elastomeric parts including coatings and surface treatments and can serve as a basis for agreements between manufacturer and user regarding the product consistency in subsequent supplies. Depending upon the type of elastomer and its application, an appropriate set of tests is selected.

Replaced standards (2)
NF EN ISO 8871-2
April 2005
Standard Cancelled
Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 2 : identification and characterization

<p>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.</p> <p>This part of ISO 8871 does not specify other requirements for rubber materials. These are laid down in the relevant product standards.</p>

NF EN ISO 8871-2/A1
July 2014
Standard Cancelled
Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 2 : identification and characterization - Amendment 1

Le présent document amende la norme homologuée NF EN ISO 8871-2:2005. Les modifications sont les suivantes : - page 2, remplacement du paragraphe 3.5 "Spectre infrarouge" ; - ajout d'une annexe H "Détermination d'une "empreinte" par spectroscopie à infrarouge en surface (ATR, réflexion totale atténuée).

Table of contents
View the extract
  • 1 Domaine d'application
  • 2 Références normatives
  • 3 Termes et définitions
  • 4 Essais
  • 5 Préparation des échantillons pour essais
  • 6 Réactifs et appareillage
  • Annexe A Identification de l'élastomère par pyrolyse IR
  • Annexe B Détermination de la déformation rémanente après compression
  • Annexe C Gonflement dans l'huile
  • Annexe D Développement d'une "empreinte" par chromatographie en phase gazeuse
  • Annexe E Analyse des substances volatiles par chromatographie en phase gazeuse selon la méthode de l'espace de tête
  • Annexe F Détermination de l'humidité résiduelle
  • Annexe G Détermination d'une "empreinte" par thermogravimétrie
  • Annexe H Détermination de l'identité de l'élastomère et vérification de la présence d'un revêtement par spectroscopie à infrarouge en surface (ATR, réflexion totale atténuée)
  • Bibliographie
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