DIN EN 60601
The EN 60601 or DIN EN 60601 series of standards applicable to medical equipment technology in Germany defines the requirements that are placed on the safety and ergonomics of electrically operated medical equipment and systems in Germany and Europe. The basis for this series of standards is the IEC version, IEC 60601.
UL-CSA
In North America – the USA and Canada – much stricter product liability laws apply than in Europe. Manufacturers and distributors exporting medical device technology there require additional certification marks to satisfy regulators, retailers and users, and to demonstrate the tested safety of the products. The UL/CSA Mark identifies products for which a representative number of them have been shown to comply with certain standards of the following institutions:
- Underwriters Laboratories(R) (UL)
- CSA Group (Canadian Standards Association)
- ANSI - American National Standards Institute
- NSF International (NSF)
Because the UL and CSA differ significantly from the IEC standard commonly used in Europe, there are relatively frequent difficulties in applying or complying with all applicable standards when exporting for the North American market. The components of the ISO system used are UL-listed and thus also comply with the relevant legal regulations for international trade relations and projects.