Name: SN EN ISO 8871-4 : 2006
Brand: SNV

ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE - PART 4: BIOLOGICAL REQUIREMENTS AND TEST METHODS

Published date

12-01-2013

Publisher

Swiss Standards

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Biological requirements
Annex A (informative) Test for extractable bacterial endotoxins
Annex B (normative) Test for cytotoxicity
Annex C (normative) Test for intracutaneous toxicity
Annex D (normative) Test for systemic toxicity
Bibliography

Describes biological requirements for elastomeric parts for parenterals and for devices for pharmaceutical use. It also specifies the test methods, i.e. it offers the extraction procedures for elastomeric parts, and it makes reference to relevant biological test instructions in Pharmacopoeias and standards.

DevelopmentNote	Supersedes SNV NF EN ISO 8871 and SNV NF S93-102. (10/2006)
DocumentType	Standard
PublisherName	Swiss Standards
Status	Current
Supersedes	SNV NF EN ISO 8871 : 1997 SNV NF S93-102 : 1997

Standards	Relationship
EN ISO 8871-4:2006	Identical
BS EN ISO 8871-4:2006	Identical
UNI EN ISO 8871-4 : 2006	Identical
DIN EN ISO 8871-4:2006-09	Identical
UNE-EN ISO 8871-4:2007	Identical
ISO 8871-4:2006	Identical

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SN EN ISO 8871-4 : 2006

ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE - PART 4: BIOLOGICAL REQUIREMENTS AND TEST METHODS

Table of Contents

Abstract

General Product Information

International Equivalents

Category

Subcategory