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 (ISO 29701:2010)
15-09-2010
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
ISO 29701:2010 describes 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. The test is suitable for use with nanomaterial samples dispersed in aqueous media, e.g. water, serum or reaction medium, and to such media incubated with nanomaterials for an appropriate duration at 37 °C.ISO 29701:2010 is restricted to test samples for in vitro systems, but the methods can also be adapted to nanomaterials to be administered to animals by parenteral routes.
| Committee |
CEN/TC 352
|
| DevelopmentNote |
Supersedes PREN ISO 29701. (11/2010)
|
| DocumentType |
Standard
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Current
|
| Standards | Relationship |
| UNE-EN ISO 29701:2010 | Identical |
| I.S. EN ISO 29701:2010 | Identical |
| NS EN ISO 29701 : 1ED 2010 | Identical |
| NBN EN ISO 29701 : 2010 | Identical |
| SN EN ISO 29701:2010 | Identical |
| NF EN ISO 29701 : 2011 | Identical |
| DIN EN ISO 29701:2011-01 | Identical |
| NEN EN ISO 29701 : 2010 | Identical |
| PN EN ISO 29701 : 2011 | Identical |
| ISO 29701:2010 | Identical |
| BS EN ISO 29701:2010 | Identical |
| PNE-prEN ISO 29701 | 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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