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EN ISO 8871-4:2006

Current

Current

The latest, up-to-date edition.

Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 4: Biological requirements and test methods (ISO 8871-4:2006)

Published date

15-06-2006

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

ISO 8871-4:2006 specifies 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.

Committee
CEN/TC 205
DevelopmentNote
Supersedes EN ISO 8871. (08/2006)
DocumentType
Standard
PublisherName
Comite Europeen de Normalisation
Status
Current
Supersedes

ISO 11737-1:2006 Sterilization of medical devices Microbiological methods Part 1: Determination of a population of microorganisms on products

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