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Medical products containing viable human cells -- Application of risk management and requirements for processing practices by ISO/TC 194 Biological and clinical evaluation of medical devices is a reference work available to read on EtoBox.
What is Medical products containing viable human cells -- Application of risk management and requirements for processing practices about?
This International Standard specifies requirements and guidance for processing practices and managing risk. associated with viable cellular components of products regulated as medicinal products, biologics, medical. devices and active implantable medical devices, or combinations thereof. It covers viable human materials of. autologous as well as allogeneic human origin, obtained from living or deceased donors. For manufacturers of medical products containing viable cells of human origin, this International Standard. specifies procedures to be used in processing and handling, as well as those to be used in identifying the. hazards and hazardous situations associated with such cells, in order to estimate and evaluate the resulting. risks, to control these risks, and to monitor the effectiveness of that control. Furthermore, this International. Standard outlines the decision process for the residual risk acceptability, taking into account the balance of. residual risk and expected medical benefit as compared to available alternatives. This International Standard provides requirements and guidance on risk management related to the hazards. typical of medical products manufactured utili
Who reads Medical products containing viable human cells -- Application of risk management and requirements for processing practices?
It is typically read by working professionals who need an authoritative practice reference.
Common subject areas: medicine, law, business, engineering.
- Author
- ISO/TC 194 Biological and clinical evaluation of medical devices
- Publisher
- ISO
- Published
- 2012
- Language
- EN
- Category
- reference
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