Standards Adoption Workshop
Biomedical Standards Industry Series 2019
ISO 10993-1 : 2018
Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management

The Biomedical Standards Industry Series consists of a series of in-depth briefing sessions/workshops for biomedical-related companies that are interested and ready for standards implementation. These workshops will cover new and existing standards.

Industry experts will share how they have leveraged on standards to address some of their challenges and opportunities in the field of med-tech devices manufacturing and distribution. Participants will also obtain insight on how standards can help their organisations gain market access, improve the quality of products, services and raise in-house productivity.

For medical devices that directly or indirectly contact patients, biocompatibility testing is required to obtain regulatory approval in most markets. Biocompatibility tests help determine whether a device performs as intended without causing any adverse or harmful effects for patients or users, and mitigate any biological risks posed by the device.

ISO 10993 is the key standard used for medical device biocompatibility testing. The standard has 20 parts, but its most widely recognized component is ISO 10993-1:2009, “Biological evaluation of medical devices. Part 1: Evaluation and testing.”

Programme is tentative and is subject to change at the sole discretion of Singapore Manufacturing Federation. 

Should you require further information or assistance, kindly contact
Ms Cherie Ong at 6826 3039 / Mr She Long Huai at 6826 3102.