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The international market for regenerative medicine products has recently entered a new era that will be characterised by the emergence of new ways of treating patients and curing conditions in a way that was previously not possible. Activity in the area will be based on the transformation of scientific knowledge into commercially viable clinical products.
BSI has been working closely with the UK research base, academia, regulatory bodies and other relevant organizations (in both the public and private sector) to better understand the challenges faced by this industry today. BSI is seeking to find ways of supporting UK stakeholders by providing guidance documents, codes of best practice and, ultimately, formal standards in this field.
BSI has established a new standards committee in regenerative medicine, RGM/1. The terms of reference for the committee are:
- To mirror the work of ISO/TC 150/SC7 "Tissue-engineered medical products"
- To formulate a UK strategy for standardization in regenerative medicine through a broad consultation with relevant stakeholders
- To ensure the UK view is given due consideration within the European Union, CEN, ISO and IEC
- To develop and support formal standards and other standardization documents in the area of regenerative medicine and to promote their use by industry and other potential users
- To ensure due consideration of the need for standards and standardization is given by UK regenerative networks and organisations, and to coordinate activities and actions in this area.
BS EN ISO 22442-1:2007
Medical devices utilizing animal tissues and their derivatives. Application of risk management
BS EN ISO 22442-2:2007
Medical devices utilizing animal tissues and their derivatives. Controls on sourcing, collection and handling
BS EN ISO 22442-3:2007
Medical devices utilizing animal tissues and their derivatives. Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents
Regenerative medicine. Glossary
In addition to this, BSI recently published Regenerative Medicine Glossary (PAS 84). This Publicly Available Specification (PAS) was developed to encourage the use of common terms and definitions within the field of regenerative medicine. It defines the terms commonly used in the field and provides clear guidance on the meaning of terminology currently used in the UK by industry, regulators, government and academia. This will help the key stakeholders to communicate more effectively and allow the commercialization of the new technology to take place more efficiently and safely.
Developing human cells for clinical applications in the European Union and the United States of America. Guide
In 2006 BSI published PAS 83 Guidance for cell-based therapeutics, from basic research to clinical application. This publication defines the process and overlays the current legislation and standards in order to obtain a picture of the area and identifies relevant gaps. As described by Professor Chris Mason in his editorial for the Regenerative Medicine Journal (PDF file opens in new window)
Standards for Cleanrooms
Find out more about ISO 14644 and other cleanroom standards