I.S. EN ISO 8871-4:2006
Current
The latest, up-to-date edition.
ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE - PART 4: BIOLOGICAL REQUIREMENTS AND TEST METHODS
Hardcopy , PDF
English
01-01-2006
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.
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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 |
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