ISO/NP 25746

Biotechnology — Bioprocessing — General requirements and considerations for processing decellularized extracellular matrices of soft tissues

Scope

This document provides general requirements and considerations for developing decellularized extracellular matrices (dECMs) sourced from native soft tissues of mammalian origin, including the entire process and corresponding methods from sampling to the formulation of raw dECMs.
This document is applicable to the manufacturing of dECMs in various forms, including 3D scaffolds, powders, and hydrogels, through biological processes.
This document is applicable to the researchers, developers, and manufacturers of dECMs involved in biomaterials, medical devices, and related fields.
This document does not apply to dECMs or dECM materials intended for therapeutic use in humans.
This document does not address differences in specific tissues and between species.