09/30175345 DC : 0
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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BS ISO 29701 - NANOTECHNOLOGIES - ENDOTOXIN TEST ON NANOMATERIAL SAMPLES FOR IN VITRO SYSTEMS - LIMULUS AMEBOCYTE LYSATE (LAL) TEST
Hardcopy , PDF
31-10-2010
English
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Pretest considerations
4.1 Storage of nanomaterials
4.2 Storage containers
4.3 Handling of nanomaterials
5 Test sample
5.1 Aqueous dispersion
5.2 Aqueous extract
6 Preparation of test sample
6.1 Dispersion method
6.2 Extraction method
6.3 Concentration
6.4 Storage of test sample
6.5 Laboratory environment
6.5.1 Air cleanliness
6.5.2 Equipment and laboratory-ware
6.5.3 Rinse water
7 Test methods
7.1 Principle
7.2 Alternative test methods
7.2.1 Endpoint photometric methods
7.2.2 Kinetic methods
7.3 Selection and validation of test method
7.3.1 Considerations of minimum required
sensitivity
7.3.2 Inhibition/enhancement potential to
test by test sample
7.3.3 Validation of test method
7.4 Test procedures
8 Assessment of results
8.1 General
8.2 Guidance on application of test
9 Test report
Annex A (informative) - Examples of potential
interferences to LAL test
A.1 Inhibition
A.2 Enhancement
Annex B (informative) - Gel-clot method
B.1 General
B.2 Reagents
B.3 Equipment
B.4 Preparation of standard endotoxin solution
B.5 Preparation of inhibition/enhancement
control (IEC)
B.6 Dilution of test sample
B.7 Experimental procedures
Annex C (informative) - Endpoint photometric method
C.1 General
C.2 Reagents
C.3 Equipment
C.4 Preparation of standard curve
C.5 Preparation of inhibition/enhancement
control (IEC)
C.6 Experimental procedure
C.7 Assay acceptance criteria
C.8 Calculation of endotoxin concentration in
the test sample
C.9 Validation of test method
Annex D (informative) - Kinetic method
D.1 General
D.2 Reagents
D.3 Equipment
D.4 Preparation of standard curve
D.5 Preparation of inhibition/enhancement
control (IEC)
D.6 Experimental procedure
D.7 Assay acceptance criteria
D.8 Calculation of endotoxin concentration
in the test sample
D.9 Validation of test method
Bibliography
BS ISO 29701
| Committee |
NTI/1
|
| DocumentType |
Draft
|
| Pages |
31
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| PREN ISO 29701 : DRAFT 2009 | 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/TS 27687:2008 | Nanotechnologies Terminology and definitions for nano-objects Nanoparticle, nanofibre and nanoplate |
| ISO 10993-11:2017 | Biological evaluation of medical devices — Part 11: Tests for systemic toxicity |
| 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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