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ISO

ISO 33407:2024

(Main)

Guidance for the production of pure organic substance certified reference materials

Guidance for the production of pure organic substance certified reference materials

Recommandations pour la production des matériaux de référence certifiés pour des substances organiques pures

Le présent document indique les exigences de l’ISO 17034 et fournit des recommandations spécifiques sur les aspects techniques à prendre en compte pour la production de matériaux de référence certifiés (MRC) pour des substances organiques pures, que les laboratoires utilisent pour étalonner les équipements et procédures de mesure, ainsi que pour établir la traçabilité métrologique des résultats respectifs. Ces recommandations ne sont pertinentes que pour les MRC qui comportent des composés organiques dont les structures sont spécifiquement définies, les matières polymères étant exclues. Dans le présent document, la référence à un MRC se limite aux matériaux de référence certifiés pour des substances organiques pures, y compris les matériaux candidats, sauf mention contraire.

General Information

Status
Published
Publication Date
16-Jan-2024
ICS
71.040.30 - Chemical reagents
Technical Committee
ISO/TC 334 - Reference materials
Drafting Committee
ISO/TC 334 - Reference materials
Current Stage
6060 - International Standard published
Start Date
17-Jan-2024
Due Date
16-Nov-2024
Completion Date
17-Jan-2024
Ref Project

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ISO/FDIS 33407 - Guidance for the production of pure organic substance certified reference materials Released:8/22/2023ISO/FDIS 33407 - Guidance for the production of pure organic substance certified reference materials Released:8/22/2023
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Standards Content (Sample)

FINAL
INTERNATIONAL ISO/FDIS
DRAFT
STANDARD 33407
ISO/TC 334
Guidance for the production of pure
Secretariat: SABS
organic substance certified reference
Voting begins on:
2023-09-05 materials
Voting terminates on:
Recommandations pour la production des matériaux de référence
2023-10-31
certifiés pour des substances organiques pures
RECIPIENTS OF THIS DRAFT ARE INVITED TO
SUBMIT, WITH THEIR COMMENTS, NOTIFICATION
OF ANY RELEVANT PATENT RIGHTS OF WHICH
THEY ARE AWARE AND TO PROVIDE SUPPOR TING
DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
Reference number
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
ISO/FDIS 33407:2023(E)
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
OCCASION HAVE TO BE CONSIDERED IN THE
LIGHT OF THEIR POTENTIAL TO BECOME STAN-
DARDS TO WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS. © ISO 2023

---------------------- Page: 1 ----------------------
ISO/FDIS 33407:2023(E)
FINAL
INTERNATIONAL ISO/FDIS
DRAFT
STANDARD 33407
ISO/TC 334
Guidance for the production of pure
Secretariat: SABS
organic substance certified reference
Voting begins on:
materials
Voting terminates on:
Recommandations pour la production des matériaux de référence
certifiés pour des substances organiques pures
COPYRIGHT PROTECTED DOCUMENT
© ISO 2023
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.
RECIPIENTS OF THIS DRAFT ARE INVITED TO
ISO copyright office
SUBMIT, WITH THEIR COMMENTS, NOTIFICATION
OF ANY RELEVANT PATENT RIGHTS OF WHICH
CP 401 • Ch. de Blandonnet 8
THEY ARE AWARE AND TO PROVIDE SUPPOR TING
CH-1214 Vernier, Geneva
DOCUMENTATION.
Phone: +41 22 749 01 11
IN ADDITION TO THEIR EVALUATION AS
Reference number
Email: copyright@iso.org
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO­
ISO/FDIS 33407:2023(E)
Website: www.iso.org
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
Published in Switzerland
OCCASION HAVE TO BE CONSIDERED IN THE
LIGHT OF THEIR POTENTIAL TO BECOME STAN­
DARDS TO WHICH REFERENCE MAY BE MADE IN
ii
  © ISO 2023 – All rights reserved
NATIONAL REGULATIONS. © ISO 2023

---------------------- Page: 2 ----------------------
ISO/FDIS 33407:2023(E)
Contents Page
Foreword .v
Introduction . vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Technical and production requirements . 2
4.1 General . 2
4.2 Production planning . 2
4.3 Specification of the CRM and its measurand . 2
4.3.1 General . 2
4.3.2 Specification of purpose . 2
4.3.3 Specification of the measurand .
...

ISO/FDIS 33407:2023(E)
ISO/TC 334
Date: 2023-06-23
Secretariat: SABS
Date: 2023-08-22
Guidance for the production of pure organic substance certified
reference materials
Recommandations pour la production des matériaux de référence certifiés pour des substances organiques
pures
FDIS stage
© ISO 2023 – All rights reserved

---------------------- Page: 1 ----------------------
ISO/FDIS 33407:2023(E)
© ISO 2023
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this
publication may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical,
including photocopying, or posting on the internet or an intranet, without prior written permission. Permission can
be requested from either ISO at the address below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: + 41 22 749 01 11
Fax: +41 22 749 09 47
EmailE-mail: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2023 – All rights reserved

---------------------- Page: 2 ----------------------
ISO/FDIS 33407:2023(E)
Contents
Foreword . v
Introduction . vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Technical and production requirements . 2
4.1 General . 2
4.2 Production planning . 2
4.3 Specification of the CRM and its measurand . 2
4.3.1 General . 2
4.3.2 Specification of purpose . 2
4.3.3 Specification of the measurand . 3
4.3.4 Definition of the metrological reference . 3
4.3.5 Fitness for purpose . 3
4.3.6 Safety considerations . 3
4.3.7 Resources and approaches to purity analysis . 4
4.4 Candidate material sourcing and assessment of suitability, including verification of PC identity and
adequate purity . 4
4.4.1 Material sourcing . 4
4.4.2 Verification of PC identity . 4
4.4.3 Material suitability . 5
4.5 Product packaging and specification of conditions for storage and safe handling .
...

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