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Homepage>BS Standards>11 HEALTH CARE TECHNOLOGY>11.040 Medical equipment>11.040.40 Implants for surgery, prosthetics and orthotics>PD ISO/TS 21560:2020 General requirements of tissue-engineered medical products
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immediate downloadReleased: 2020-10-02
PD ISO/TS 21560:2020 General requirements of tissue-engineered medical products

PD ISO/TS 21560:2020

General requirements of tissue-engineered medical products

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Standard number:PD ISO/TS 21560:2020
Pages:20
Released:2020-10-02
ISBN:978 0 580 95816 8
Status:Standard
DESCRIPTION

PD ISO/TS 21560:2020


This standard PD ISO/TS 21560:2020 General requirements of tissue-engineered medical products is classified in these ICS categories:
  • 11.040.40 Implants for surgery, prosthetics and orthotics

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.