Elastomeric parts for parenterals and for devices for pharmaceutical use Biological requirements and test methods

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

29-09-2006

Publisher

British Standards Institution

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.

This part of ISO8871 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	CH/212
DocumentType	Standard
Pages	18
PublisherName	British Standards Institution
Status	Current

Standards	Relationship
NEN EN ISO 8871-4 : 2006	Identical
EN ISO 8871-4:2006	Identical
NS EN ISO 8871-4 : 1ED 2006	Identical
NF EN ISO 8871-4 : 2006	Identical
I.S. EN ISO 8871-4:2006	Identical
DIN EN ISO 8871-4:2006-09	Identical
ISO 8871-4:2006	Identical
SN EN ISO 8871-4 : 2006	Identical
UNE-EN ISO 8871-4:2007	Identical
UNI EN ISO 8871-4 : 2006	Identical

ISO 11737-1:2006

Sterilization of medical devices Microbiological methods Part 1: Determination of a population of microorganisms on products

View more information

£134.00

Excluding VAT

Product format

I agree to the DRM document license rules apply against the PDF selection made.

Please confirm that you agree to the document license rules for this document.

I agree to the document license rules .

Please confirm that you agree to the document license rules for this document.

Access your standards online with a subscription

Features

Simple online access to standards, technical information and regulations.
Critical updates of standards and customisable alerts and notifications.
Multi-user online standards collection: secure, flexible and cost effective.

Learn more on subscription solutions

Get in touch with us

Log into your Account

BS EN ISO 8871-4:2006

Current

Table of Contents

Abstract

Scope

General Product Information

International Equivalents

Standards Referencing This Book

Category

Subcategory

Access your standards online with a subscription