ISO/TS 5441:2024

FINAL DRAFT
Technical
Specification
ISO/DTS 5441
ISO/TC 212
Competence requirements for
Secretariat: ANSI
biorisk management advisors
Voting begins on:
2024-02-02
Voting terminates on:
2024-03-29
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Reference number
ISO/DTS 5441:2024(en) © ISO 2024

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FINAL DRAFT
ISO/DTS 5441:2024(en)
Technical
Specification
ISO/DTS 5441
ISO/TC 212
Competence requirements for
Secretariat: ANSI
biorisk management advisors
Voting begins on:
Voting terminates on:
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT,
COPYRIGHT PROTECTED DOCUMENT
WITH THEIR COMMENTS, NOTIFICATION OF ANY
RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE
AND TO PROVIDE SUPPOR TING DOCUMENTATION.
© ISO 2024
IN ADDITION TO THEIR EVALUATION AS
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO­
LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
or ISO’s member body in the country of the requester.
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland Reference number
ISO/DTS 5441:2024(en) © ISO 2024

© ISO 2024 – All rights reserved
ii

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ISO/DTS 5441:2024(en)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Context for biorisk management advice . 4
5 Functions of biorisk management advisor(s) . 4
6 Biorisk management advisor knowledge, skills, and experience . 5
7 Competence . 5
7.1 General prerequisites .5
7.2 Range and subject matter of competencies .5
7.2.1 Scientific, technical and management background .5
7.2.2 Planning of biorisk management .6
7.2.3 Support of personnel .
...

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ISO /TS /DTS 5441:2021(E)
ISO/TC 212/WG 5
Secretariat: ANSI
Date: 2023-07-262024-01-19
Competence requirements for biorisk management advisors

DTS stage

Warning for WDs and CDs
This document is not an ISO International Standard. It is distributed for review and comment. It is subject to
change without notice and may not be referred to as an International Standard.
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 supporting documentation.

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© ISO 2022

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ISO°/TS°5441:2021(E)
© ISO 2024
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
EmailE-mail: copyright@iso.org
Website: www.iso.orgwww.iso.org
Published in Switzerland
© ISO 2022 – All rights reserved iii

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ISO°/TS°5441:2021(E)


iv © ISO 2022 – All rights reserved

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ISO°/TS°5441:2021(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organisationsorganizations, governmental and non-governmental, in liaison with ISO, also take part in
the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all
matters of electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documentsdocument should be noted. This document was drafted in accordance
with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
Attention is drawnISO draws attention to the possibility that some of the elementsimplementation of this
document may beinvolve the subjectuse of (a) patent(s). ISO takes no position concerning the evidence,
validity or applicability of any claimed patent rights. in respect thereof. As of the date of publication of
this document, ISO had not received notice of (a) patent(s) which may be required to implement this
document. However, implementers are cautioned that this may not represent the latest information,
which may be obtained from the patent database available at www.iso.org/patents. ISO shall not be held
responsible for identifying any or all such patent rights. Details of any patent rights identified during the
development of the document will be in the Introduction and/or on the ISO list of patent declarations
received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the World
Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) (see
www.iso.org/iso/foreword.html).), see www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 212, Clinical laboratory testing and in vitro
diagnostic test systems, Working group 5, Laboratory biorisk management.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.
© ISO 2022 – All rights reserved v

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ISO/DTS 5441:(en)
www.iso.org/members.html.
vi © ISO 2022 2024 – All rights reserved

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ISO/DTS 5441:(en)
Introduction
Principal factors in managing biorisks include but are not limited to:
— establishing and maintaining comprehensive biorisk management.
— ensuring that there is qualified and competent advice and support for biorisk management.
Biorisk management advisors are competent individuals who provide advice, guidance, and as
...