ISO/TS 21560:2020

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

General Information

• Status: Published
• Publication Date: 30-Aug-2020
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: ISO/TC 150/SC 7 - Tissue-engineered medical products
• Drafting Committee: ISO/TC 150/SC 7/WG 1 - Management of risk
• Current Stage: 9093 - International Standard confirmed
• Completion Date: 17-May-2024

Standards Content (Sample)

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

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ISO/TS 21560:2020(E)

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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
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