BS 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
31-10-2010
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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.
| Committee |
NTI/1
|
| DevelopmentNote |
Supersedes 09/30175345 DC. (11/2010)
|
| DocumentType |
Standard
|
| Pages |
32
|
| PublisherName |
British Standards Institution
|
| Status |
Current
|
| SupersededBy | |
| Supersedes |
This International Standard 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.
This International Standard 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.
| 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 |
| ISO/TS 80004-1:2015 | Nanotechnologies — Vocabulary — Part 1: Core terms |
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