NF EN ISO 8871-1 : 2005
Current
The latest, up-to-date edition.
ELECTROMETRIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE - PART 1: EXTRACTABLES IN AQUEOUS AUTOCLAVATES
12-01-2013
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)
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| DocumentType |
Standard
|
| PublisherName |
Association Francaise de Normalisation
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| Status |
Current
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| 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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