ISO/TC 150/SC 7/WG 1 - Management of risk
Gestion des risques
General Information
Frequently Asked Questions
ISO/TC 150/SC 7/WG 1 is a Subcommittee within the International Organization for Standardization (ISO). It is named "Management of risk". This committee has published 1 standards.
ISO/TC 150/SC 7/WG 1 develops ISO standards in the area of Information technology. Currently, there are 1 published standards from this subcommittee.
The International Organization for Standardization (ISO) is an independent, non-governmental international organization that develops and publishes international standards. Founded in 1947 and headquartered in Geneva, Switzerland, ISO brings together experts from 170+ member countries to share knowledge and develop voluntary, consensus-based standards that support innovation and provide solutions to global challenges.
A Subcommittee (SC) in ISO operates under a Technical Committee and focuses on a specific subset of the TC's scope. Subcommittees develop standards and technical specifications in their specialized area, reporting to their parent Technical Committee. They may also have working groups for detailed technical work.
This document specifies general requirements for tissue-engineered medical products (TEMPs), which are used in regenerative medicine. With regard to safety, this document outlines requirements for materials, manufacture, quality control, and unintentional biological effects elicited by TEMPs. This document does not address requirements for clinical trials and efficacy. This document is not applicable to tissue-engineered products used for diagnosis, ex-vivo testing or extracorporeal treatments of patients (e.g. dialysis with TEMP components). TEMPs containing viable xenogenic cells, genetically modified cells, or cells derived from abnormal cells or tissues (e.g. cancerous tissues) are also excluded from the scope. The combination of TEMPs with medical devices, with the exception 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 to specific topics covered in this document.
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