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BSI - BS PD ISO/TS 21560

General requirements of tissueengineered medical products

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Organization: BSI
Publication Date: 31 October 2020
Status: active
Page Count: 20
ICS Code (Implants for surgery, prosthetics and orthotics): 11.040.40

Document History

BS PD ISO/TS 21560
October 31, 2020
General requirements of tissueengineered medical products
A description is not available for this item.

References

This document references:
ISO 13022 - Medical products containing viable human cells - Application of risk management and requirements for processing practices
Published by ISO on April 1, 2012
This International Standard specifies requirements and guidance for processing practices and managing risk associated with viable cellular components of products regulated as medicinal products,...
This document references:
ISO 18362 - Manufacture of cell-based health care products - Control of microbial risks during processing
Published by ISO on February 1, 2016
This International Standard specifies the minimum requirements for, and provides guidance on, a risk-based approach for the processing of cell-based health care products (CBHPs) requiring control of...
This document references:
ISO 19108 - Geographic information — Temporal schema
Published by ISO on October 15, 2006
A description is not available for this item.
This document references:
ISO TR 22442-4 - Medical devices utilizing animal tissues and their derivatives — Part 4: Principles for elimination and/or inactivation of transmissible spongiform encephalopathy (TSE) agents and validation assays for those processes
Published by ISO on December 1, 2010
This Technical Report offers suggestions for designing and conducting validation assays to help determine if processes used in the manufacture of medical devices derived from non-viable animal...
This document references:
ISO TS 20399-1 - Biotechnology - Ancillary materials present during the production of cellular therapeutic products - Part 1: General requirements
Published by ISO on November 1, 2018
This document specifies definitions and general requirements for ancillary materials (AMs) used in cell processing of cellular therapeutic products. This document is applicable to cellular...
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