Manufacture of cell-based health care products — Control of microbial risks during processing — Amendment 1

Manufacture de produits de soins de santé fondés sur les cellules — Contrôle des risques microbiaux durant le processus — Amendement 1

General Information

Status
Published
Publication Date
20-Jun-2022
Current Stage
6060 - International Standard published
Start Date
21-Jun-2022
Due Date
02-Dec-2021
Completion Date
21-Jun-2022
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ISO 18362:2016/Amd 1:2022 - Manufacture of cell-based health care products — Control of microbial risks during processing — Amendment 1 Released:21. 06. 2022
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INTERNATIONAL ISO
STANDARD 18362
First edition
2016-02-01
AMENDMENT 1
2022-06
Manufacture of cell-based health care
products — Control of microbial risks
during processing
AMENDMENT 1
Manufacture de produits de soins de santé fondés sur les cellules —
Contrôle des risques microbiaux durant le processus
AMENDEMENT 1
Reference number
ISO 18362:2016/Amd.1:2022(E)
© ISO 2022

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ISO 18362:2016/Amd.1:2022(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2022
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
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Published in Switzerland
ii
  © ISO 2022 – All rights reserved

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ISO 18362:2016/Amd.1:2022(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
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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 documents 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 drawn to the possibility that some of the elements of this document may be the subject of
patent rights. 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).
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the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see
www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 198, Sterilization of health care products.
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.
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© ISO 2022 – All rights reserved

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ISO 18362:2016/Amd.1:2022(E)
Manufacture of cell-based health care products — Control
of microbial risks during processing
AMENDMEN
...

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