We use cookies to give you the best experience and to help improve our website
Find out what cookies we use and how to disable them
Standards Development
This document specifies requirements and guidance on risk management related to the hazards typical of medical devices utilizing bioengineered biological substances, including risk management process, risk evaluation, risk control, residual risk evaluation, evaluation of overall residual risk acceptability, and production and post-production information system. The main risk categories of medical devices include structural risks of bioengineered biological substances; risks of impurities, contaminants, and additives; immunogenicity risks; and other hazards and risks.
With the development of biotechnology, an innovative class of medical devices has been created, which is prepared utilizing bioengineered biological substances and is beginning to be used worldwide. For example, currently there are at least 257 companies in 6 countries that have been approved to manufacture medical devices utilizing recombinant humanized collagen. Medical devices utilizing recombinant humanized collagen have a promising application in various fields, such as cardiovascular, gynaecology, dentistry, orthopaedics and other areas. With the expanding market and in-depth research, the market size of recombinant collagen is expected to be $108.3 billion by 2027, exceeding the market size of animal- derived collagen by $65.5 billion. In addition, bio-polymer materials prepared by bioengineering, such as polyurethane, polylactic acid, and poly-pdioxocyclohexanone, have been used in medical devices of artificial blood vessels, laminating scaffolds, artificial joints, intervertebral fusion devices, and absorbable sutures. Compared to traditional medical devices utilizing animal or human tissues, the preparation process, quality standards and regulation of the innovative class of medical devices are significantly different. There are international standards for risk management of medical devices utilizing animal tissues, while the international standards for risk management of medical devices utilizing human tissues are in the process of preparation. However they are not applicable to the medical device utilizing bioengineered biological substances. There is an urgent need for an international standard for risk management of medical devices utilizing bioengineered biological substances.
You are now following this standard. Weekly digest emails will be sent to update you on the following activities:
You can manage your follow preferences from your Account. Please check your mailbox junk folder if you don't receive the weekly email.
You have successfully unsubscribed from weekly updates for this standard.
Comment on proposal
Required form fields are indicated by an asterisk (*) character.