ABSTRACT
Clause 3—Terms and definitions is necessary in order to clarify terms and definitions mentioned in the ISO 13485 Standard. In order to clear matters and disputes, the standard presents its interpretations and explanations regarding terms and definitions presented throughout the standard. These are an inseparable and integral part of the standard. The explanations provided are very descriptive and clear; therefore, there is no need to repeat them. Please refer to clause 3 of the ISO 13485 Standard—Terms and definitions for the exact definitions.
