NF EN ISO 29701

August 2011

Standard Current

Nanotechnologies - Endotoxin test on nanomaterial samples for in vitro systems - Limulus amebocyte lysate (LAL) test

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.

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Main informations

Collections

National standards and national normative documents

Publication date

August 2011

Number of pages

29 p.

Reference

NF EN ISO 29701

ICS Codes

07.120 Nanotechnologies

11.100.10 In vitro diagnostic test systems

Classification index

T16-301

Print number

1 - 29/07/2011

International kinship

ISO 29701:2010

European kinship

EN ISO 29701:2010

Sumary

Nanotechnologies - Endotoxin test on nanomaterial samples for in vitro systems - Limulus amebocyte lysate (LAL) test

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.

Table of contents

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Avant-propos
iv
Introduction
v
1 Domaine d'application
1
2 Termes et définitions
1
3 Termes abrégés
2
4 Considérations préalables à l'essai
3
4.1 Conservation des nanomatériaux
3
4.2 Récipients
3
4.3 Manipulation des nanomatériaux
3
5 Échantillon à soumettre à essai
3
5.1 Dispersion aqueuse
3
5.2 Extrait aqueux
3
6 Préparation de l'échantillon à soumettre à essai
3
6.1 Méthode de dispersion
3
6.2 Méthode d'extraction
4
6.3 Concentration
4
6.4 Conservation de l'échantillon à soumettre à essai
4
6.5 Environnement du laboratoire
4
7 Méthodes d'essai
5
7.1 Principe
5
7.2 Autres méthodes d'essai
5
7.3 Sélection et validation de la méthode d'essai
6
7.4 Modes opératoires de l'essai
7
8 Évaluation des résultats
7
8.1 Généralités
7
8.2 Recommandations concernant l'application de l'essai
7
9 Rapport d'essai
7
Annexe A (informative) Exemples d'interférences potentielles dans l'essai LAL
9
Annexe B (informative) Méthode dite de coagulation
10
Annexe C (informative) Méthode photométrique
14
Annexe D (informative) Méthode cinétique
17
Bibliographie
20

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