At present, no formal standards have been developed to specifically address products and processes in the field of regenerative medicine. However new work is scheduled to begin in late 2007 within ISO in the area of tissue engineering. BSI are keen to ensure that the UK is at the forefront of the standards development process, thereby ensuring that UK companies can compete successfully with others in the global marketplace. If you would like to contribute to this process, please see our get involved section. We will be actively recruiting new expertise to ensure the UK is well represented in this new ISO work.
A small number of existing formal standards have been published which apply to the quality and safety of medical devices using animal tissues, but to date these standards specifically exclude human tissues. There are a handful of UK, European and ISO (World) committees who have produced broadly applicable formal standards which fall into one or more of the following categories:
- medical device standards
- quality management
- risk management
- general requirements for the competence of testing and calibration laboratories
- general laboratory operations, health, signage and safety requirements
- active implantable medical devices
- quality management systems standards.
The majority of the standards most relevant to this industry are drafted at the ISO level, with UK contributions provided by British committees and European committees with UK representation.
BSI committees active in areas relating to regenerative medicine:
British Committee on Medical Devices Utilizing Tissues (Committee No. CH/194/100)
This subcommittee is responsible for standardization, both national and international, in the field of animal tissues, used in medical devices. The committee shadows the activities of European Committee on Medical Devices Utilizing Tissues and ISO Committee on Tissue Product Safety.
British Committee on Implants for Surgery (Committe No. CH/150)
This technical committee is responsible for standardization in the field of implants for surgery. The committee provides UK input into the European committee on Non-Active Surgical Implants and the ISO committee on Implants For Surgery (including tissue engineered implants).
For further information, please contact:
Simon Alcock
BSI Group Headquarters
389 Chiswick High Road, London W4 4AL
T: +44 (0)20 8996 7203
F: +44 (0)20 8996 7143
E: simon.alcock@bsi-global.com
