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).

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Main informations

Collections

National standards and national normative documents

Publication date

July 2014

Number of pages

9 p.

Reference

NF EN ISO 8871-2/A1

ICS Codes

11.040.20 Transfusion, infusion and injection equipment

Classification index

S93-102-2/A1

Print number

International kinship

ISO 8871-2/A1:2005

European kinship

EN ISO 8871-2/A1:2014

Sumary

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).

Standard replaced by (1)

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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