What is ISO/TS 21560 about?
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 combination of TEMPs with medical devices, except for scaffolds comprised of synthetic and/or naturally derived materials, is excluded from ISO/TS 21560.
Who is ISO/TS 21560 for?
ISO/TS 21560 on TEMPs is applicable to:
- Pharmaceutical industry
- Medical industry
- Biomedical engineers
- Manufacturers of tissue medical products
- Tissue engineering companies
- Medical research and development bodies
- Regulatory bodies
Why should you use ISO/TS 21560?
Tissue engineering contains engineered cells or tissues which are intended to repair, regenerate, or replace human tissue.
ISO/TS 21560 covers key aspects to be considered when defining the critical quality parameters for TEMPs. Guidelines on materials, manufacturing process, characterization and control strategy, development program, container closure system and transportation are also provided by ISO/TS 21560.
As a user of ISO/TS 21560, you are provided with guidance for the manufacturing process and requirement for tissue-engineered medical products. As a result, you can establish suitable quality parameters and specifications for the final TEMPs as well as cells, critical materials, processing steps and appropriate controls ensuring the safety of TEMPs.
