What harmonised standards apply to the product?
Products manufactured in accordance with harmonised standards shall enjoy a presumption of conformity with the relevant essential requirements of the directives in the area covered by the standard. Demonstration of conformity with harmonised standards shall be the recommended and most accessible form of demonstration of conformity with the essential requirements of the Directive.
Although compliance with the requirements of harmonised standards is not mandatory, failure to comply with them may raise doubts as to the design of the medical device based on the latest state of the art and cause increased risks associated with the use of the device.
Examples of harmonized standards with Directive 93/42/EEC
- PN-EN ISO 14971: 2012 Medical devices – Application of risk management to medical devices.
- PN-EN ISO 10993-1: 2010 Biological evaluation of medical devices – part 1: evaluation and testing within a risk management process.
- PN EN 60601-1: 2011 Medical electrical equipment – part 1: General requirements for safety and essential functioning.