ISO/TS 21560 is an international standard that specifies general requirements for tissue-engineered medical products (TEMPs), which are used in regenerative medicine. About safety, ISO/TS 21560 outlines requirements for materials, manufacture, quality control, and unintentional biological effects elicited by TEMPs. Note 1: ISO/TS 21560 does not address the requirements for clinical trials and efficacy. Note 2: ISO/TS 21560 is not applicable to tissue-engineered products used for diagnosis, ex-vivo testing or extracorporeal treatments of patients. Note 3: The combi...

PD ISO/TS 21560:2020 PDF

Abstract

Похожие стандарты

PD 6605-2:1998

Guidance on methodology for assessment of stress-rupture data - Computing methods

PD ISO/TS 6226:2025

Health informatics. Reference architecture for syndromic surveillance systems for infectious diseases

PD ISO/TS 17595:2025

Solid biofuels. Characterization of wood chip fuels. Essential information for producers, suppliers and users

PD ISO/TS 4452:2025

Specification and demonstration of system reliability of single-use drug delivery systems

PD ISO/TS 25271:2026

Automation systems and integration. Industrial digital twin interface architecture

PD IEC PAS 63720:2026

Rigid circuit board. Routing parameters

PD 6620:1998

Mains communications systems. Protocol and data integrity and interfaces

PD 6640:1999

Recommendations for short term solutions to support a sevice provider access interface