Identifying Standard Elements
In order to examine the different elements of a standard, we're going to take a closer look at a standard commonly used in medical device design: ISO 11607-1:2020 Packaging of terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems Links to an external site.
Each standard has basic elements that can help you identify if it is relevant to your project. These elements include:
- Scope
- Referenced Documents
- Definitions
Pictured below are the first page of this standard with these sections circled and labeled. The next part of this module will define each element of a standard, and explain its purpose.