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National standards and national normative documents

Publication date

December 1997

Number of pages

25 p.

Reference

NF EN ISO 8871

ICS Codes

11.040.20 Transfusion, infusion and injection equipment

83.140.99 Other rubber and plastics products

Classification index

S93-102

Print number

1 - octobre 1997

International kinship

ISO 8871:1990

European kinship

EN ISO 8871:1997

Replaced standards (1)

NF EN 28871

October 1993

Standard Cancelled

Elastomeric parts for aqueous parenteral preparations.

Le présent document fixe les méthodes de classification et d'identification des éléments en élastomère destinés à être directement au contact de préparations aqueuses parentérales. Il spécifie leurs caractéristiques biologiques, chimiques et physiques, ainsi que les méthodes d'essai correspondantes.

Standard replaced by (4)

NF EN ISO 8871-1

April 2005

Standard Current

Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 1: Extractables in aqueous autoclavates (ISO 8871-1:2003)

NF EN ISO 8871-2

April 2005

Standard Cancelled

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

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

NF EN ISO 8871-3

December 2004

Standard Current

Elastomeric parts for parenterals and for devices for pharmaceuticals use - Part 3: Determination of released-particle count (ISO 8871-3:2003)

NF EN ISO 8871-4

September 2006

Standard Current

Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 4: Biological requirements and test methods

Table of contents

1 Domaine d'application
1
2 Références normatives
1
3 Classification
1
4 Identification
2
5 Prescriptions
2
6 Essais
3
7 Emballage
3
8 Stockage
3
9 Marquage et étiquetage
3
Annexes
A Spectrométrie en ultraviolet des extraits
4
B Spectrométrie en infrarouge des pyrolysats
5
C Détermination des substances réductrices extraites (oxydables)
6
D Détermination des métaux lourds extraits
7
E Détermination de l'ammoniaque extraite
8
F Détermination des ions halogénures extraits
9
G Détermination de l'acidité et de l'alcalinité
10
H Détermination des extraits secs non volatils
11
J Détermination des sulfures volatils
12
K Détermination du zinc extrait
13
L Détermination de la conductivité
14
M Détermination de la turbidité
15

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