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

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2006

Publisher

National Standards Authority of Ireland

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For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.

Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

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 I.S. EN ISO 8871. (08/2006)
DocumentType	Standard
Pages	18
PublisherName	National Standards Authority of Ireland
Status	Current

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