I.S. EN ISO 29701:2010
Current
The latest, up-to-date edition.
NANOTECHNOLOGIES - ENDOTOXIN TEST ON NANOMATERIAL SAMPLES FOR IN VITRO SYSTEMS - LIMULUS AMEBOCYTE LYSATE (LAL) TEST
Hardcopy , PDF
English
01-01-2010
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 Terms and definitions
3 Abbreviated terms
4 Pre-test considerations
5 Test sample
6 Preparation of test sample
7 Test methods
8 Assessment of results
9 Test report
Annex A (informative) - Examples of potential interferences
to LAL test
Annex B (informative) - Gel-clot method
Annex C (informative) - Endpoint photometric method
Annex D (informative) - Kinetic method
Bibliography
Specifies the application of a test using Limulus amebocyte lysate (LAL) reagent for the evaluation of nanomaterials intended for cell-based in vitro biological test systems.
| DocumentType |
Standard
|
| Pages |
35
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Standards | Relationship |
| EN ISO 29701:2010 | Identical |
| ISO 29701:2010 | Identical |
| ISO 14644-2:2015 | Cleanrooms and associated controlled environments Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration |
| ISO 10993-12:2012 | Biological evaluation of medical devices Part 12: Sample preparation and reference materials |
| ISO 14644-7:2004 | Cleanrooms and associated controlled environments — Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments) |
| ISO 14644-1:2015 | Cleanrooms and associated controlled environments Part 1: Classification of air cleanliness by particle concentration |
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