ISO/TS 21560-2020 pdf free.General requirements of tissue-engineered medical products.
This document specifies general requirements for tissue-engineered medical products (TEMPs), whichare used in regenerative medicine. With regard to safety, this document outlines requirements formaterials, manufacture, quality control, and unintentional biological effects elicited by TEMPs. Thisdocument does not address requirements for clinical trials and efficacy.
This document is not applicable to tissue-engineered products used for diagnosis, ex-vivo testing orextracorporeal treatments of patients (e.g. dialysis with TEMP components).TEMPs containing viablexenogenic cells,genetically modified cells, or cells derived from abnormal cells or tissues (e.g.canceroustissues) are also excluded from the scope. The combination of TEMPs with medical devices,with theexception 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 tospecific topics covered in this document.
The following documents are referred to in the text in such a way that some or all of their contentconstitutes requirements of this document. For dated references, only the edition cited applies. Forundated references, the latest edition of the referenced document(including any amendments) applies.
ISO 13022，Medical products containing viable human cells — Application of risk management andrequirements for processing practices
ISO/TS 20399-1, Biotechnology —Ancillary materials present during the production of cellular therapeuticproducts — Part 1: General requirements
ISO/Ts 20399-2,Biotechnology —Ancillary materials present during the production of cellular therapeuticproducts —Part 2: Best practice guidance for ancillary material suppliers
ISO/TS20399-3,Biotechnology—Ancillary materials present during the production of cellular therapeuticproducts — Part 3: Best practice guidance for ancillary material users
ISO 22442-1,Medical devices utilizing animal tissues and their derivatives — Part 1: Application of riskmanagement
ISO 22442-2, Medical devices utilizing animal tissues and their derivatives —Part 2:Controls on sourcing,collection and handling
ISO 22442-3,Medical devices utilizing animal tissues and their derivatives — Part 3: Validation of theelimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents
ISO/TR 22442-4,Medical devices utilizing animal tissues and their derivatives — Part 4: Principles forelimination and/or inactivation of transmissible spongiform encephalopathy (TSE) agents and validationassays for those processes.
For the purposes of this document, the following terms and definitions apply.ISO/TS 21560 pdf download.