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BSI - BS PAS 84

Cell therapy and regenerative medicine – Glossary

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Organization: BSI
Publication Date: 30 March 2012
Status: active
Page Count: 58
ICS Code (Health care technology (Vocabularies)): 01.040.11
ICS Code (Medical science): 11.020.20

Document History

BS PAS 84
March 30, 2012
Cell therapy and regenerative medicine – Glossary
A description is not available for this item.
BS PAS 84
April 30, 2008
Regenerative medicine - Glossary
A description is not available for this item.
PAS 84
April 30, 2008
Regenerative medicine - Glossary
A description is not available for this item.

References

This document references:
ISO/IEC GUIDE 51 - Safety aspects - Guidelines for their inclusion in standards
Published by ISO on April 1, 2014
This Guide provides requirements and recommendations for the drafters of standards for the inclusion of safety aspects in standards. It is applicable to any safety aspect related to people, property...
This document references:
ASTM F2312 - Standard Terminology Relating to Tissue Engineered Medical Products
Published by ASTM on April 1, 2011
This terminology defines basic terms and presents the relationships of the scientific fields related to Tissue Engineered Medical Products (TEMPs). Committee F04 has defined these terms for the...
This document references:
93/42/EEC - Council Directive Concerning Medical Devices
Published by EU on June 14, 1993
Definitions, scope 1. This Directive shall apply to medical devices and their accessories. For the purposes of this Directive, accessories shall be treated as medical devices in their own right. Both...
This document references:
2000/70/EC - Directive of the European Parliment and of the Council Amending Council Directive 93/42/EEC as Regards Medical Devices Incorporating Stable Derivates of Human Blood or Human Plasma
Published by EU on November 16, 2000
A description is not available for this item.
This document references:
EEC/2007/47 - DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
Published by EEC on September 5, 2007
A description is not available for this item.
This document references:
2000/70/EC - Directive of the European Parliment and of the Council Amending Council Directive 93/42/EEC as Regards Medical Devices Incorporating Stable Derivates of Human Blood or Human Plasma
Published by EU on November 16, 2000
A description is not available for this item.
This document references:
EEC/2007/47 - DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
Published by EEC on September 5, 2007
A description is not available for this item.
This document is referenced by:
BS PAS 93 - Characterization of human cells for clinical applications. Guide
Published by BSI on August 31, 2011
A description is not available for this item.
This document is referenced by:
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 is referenced by:
AAMI 13022 - Medical products containing viable human cells - Application of risk management and requirements for processing practices
Published by AAMI on January 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 is referenced by:
DIN ISO 13022 - Medical products containing viable human cells - Application of risk management and requirements for processing practices (ISO 13022:2012)
Published by DIN on June 1, 2014
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 is referenced by:
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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