What is this standard about?
Medical device standards are a tool to demonstrate that a medical device is clinically effective and performs in a safe manner, where the medical benefits of the use of the device outweigh the risk of its use to the patient. They represent a consensus on the requirements that foster innovation while at the same time protecting public health.
The essential principles of safety and performance of medical devices are high-level requirements that when complied with ensure a medical device is safe and performs as intended. They were revised in 2012 to harmonize regulatory requirements for medical devices worldwide.
This standard describes the relationship between the essential principles and medical device standards.
Who is this standard for?
This standard will be useful to those who are looking for a better understanding of how to use standards and how they fit with the essential principles. It may be of particular interest to new starts and small medical device manufacturers.
Why should you use this standard?
It will help you understand:
- Background on the development of standards and the use of terminology
- The types of standards useful to demonstrate compliance
- How to use standards during the medical device life-cycle phases
BS ISO 16142-1 also provides a table of standards that can be considered a starting point to determine which standards or which parts of a standard might be applicable to demonstrate conformity to the essential principles for all medical devices.
There is also a list of additional principles for all non-IVD medical devices. This is a thorough mapping of published reference standards to the essential principles.
What’s changed since the last update?
This standard has been updated to reflect changes to the revised principles (previously published as a technical report).