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AFNOR
NF EN ISO 8871-1 : 2005

NF EN ISO 8871-1 : 2005

Current

Current

The latest, up-to-date edition.

ELECTROMETRIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE - PART 1: EXTRACTABLES IN AQUEOUS AUTOCLAVATES

Published date

12-01-2013

Publisher

Association Francaise de Normalisation

Avant-propos
Introduction
1 Domaine d'application
2 Références normatives
3 Classification
4 Exigences
5 Échantillonnage
6 Appareillage et réactifs
7 Préparation des solutions pour essai
Annexe A (normative) Aspect de la solution
Annexe B (normative) Acidité ou alcalinité
Annexe C (normative) Absorbance
Annexe D (normative) Substances réductrices
Annexe E (normative) Métaux lourds extractibles
Annexe F (normative) Zinc extractible
Annexe G (normative) Ammoniaque extractible
Annexe H (normative) Résidus d'évaporation
Annexe I (normative) Sulfures volatils
Annexe J (informative) Détermination de la conductivité
Bibliographie

Describes procedures for classifying elastomeric parts for primary packs and medical devices used in direct contact with preparations for parenteral use, including both aqueous preparations and dry preparations which have to be dissolved before use.

DevelopmentNote
Indice de classement: S93-102-1. (04/2005) Supersedes NF EN ISO 8871. (11/2006)
DocumentType
Standard
PublisherName
Association Francaise de Normalisation
Status
Current

Standards Relationship
ISO 8871-1:2003 Identical
EN ISO 8871-1 : 2004 Identical
BS EN ISO 8871-1:2004 Identical
DIN EN ISO 8871-1:2004-11 Identical
UNE-EN ISO 8871-1:2005 Identical
UNI EN ISO 8871-1 : 2006 Identical

NF ISO 8362-5 : 2008 INJECTION CONTAINERS AND ACCESSORIES - PART 5: FREEZE DRYING CLOSURES FOR INJECTION VIALS
NF EN ISO 8871-2 : 2005 AMD 1 2014 ELECTROMETRIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE - PART 2: IDENTIFICATION AND CHARACTERIZATION

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