ISO/TS 21560:2020
(Main)General requirements of tissue-engineered medical products
General requirements of tissue-engineered medical products
This document specifies general requirements for tissue-engineered medical products (TEMPs), which are used in regenerative medicine. With regard to safety, this document outlines requirements for materials, manufacture, quality control, and unintentional biological effects elicited by TEMPs. This document does not address requirements for clinical trials and efficacy. This document is not applicable to tissue-engineered products used for diagnosis, ex-vivo testing or extracorporeal treatments of patients (e.g. dialysis with TEMP components). TEMPs containing viable xenogenic cells, genetically modified cells, or cells derived from abnormal cells or tissues (e.g. cancerous tissues) are also excluded from the scope. The combination of TEMPs with medical devices, with the exception of scaffolds comprised of synthetic and/or naturally-derived (e.g. animal sourced) materials, is also excluded from the scope. NOTE International, national or regional regulations or requirements, or the Pharmacopeia also apply to specific topics covered in this document.
Exigences générales relatives aux produits médicaux issus de l'ingénierie tissulaire
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TECHNICAL ISO/TS
SPECIFICATION 21560
First edition
2020-08
General requirements of tissue-
engineered medical products
Reference number
ISO/TS 21560:2020(E)
©
ISO 2020
---------------------- Page: 1 ----------------------
ISO/TS 21560:2020(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2020
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
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved
---------------------- Page: 2 ----------------------
ISO/TS 21560:2020(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General requirements for tissue-engineered medical products .4
5 Materials . 6
5.1 General . 6
5.2 Starting materials . 6
5.2.1 Cells and tissues . 6
5.2.2 Scaffolds and other substances . 7
5.3 Ancillary materials . 7
5.4 Excipients . 8
6 Manufacturing process . 8
7 Characterization and control strategy . 8
8 Developmental studies. 9
9 Container closure system . 9
10 Transportation .10
Bibliography .11
© ISO 2020 – All rights r
...
TECHNICAL ISO/TS
SPECIFICATION 21560
First edition
General requirements of tissue
engineered medical products
Exigences générales relatives aux TEMP
PROOF/ÉPREUVE
Reference number
ISO/TS 21560:2020(E)
©
ISO 2020
---------------------- Page: 1 ----------------------
ISO/TS 21560:2020(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2020
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
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii PROOF/ÉPREUVE © ISO 2020 – All rights reserved
---------------------- Page: 2 ----------------------
ISO/TS 21560:2020(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General requirements for tissue engineered cell-based products .4
5 Materials . 6
5.1 General . 6
5.2 Starting materials . 6
5.2.1 Cells and tissues . 6
5.2.2 Scaffolds and other substances . 7
5.3 Ancillary materials . 7
5.4 Excipients . 8
6 Manufacturing process . 8
7 Characterization and control strategy . 8
8 Developmental studies. 9
9 Container closure system . 9
10 Transportation .10
Bibliography .
...
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