In accordance with the “The Medical Devices Directive 93/42/EEC”, any product that is Class IIa or higher shall be reviewed and approved by a “Notified Body” so as to be eligible to be marketed and sold in the EU. The requirements cover both the product and the manufacturer. This certification defines the essential requirements for medical devices that must be met before being placed on the market. The essential requirements are mandatory to minimize risks associated with these or similar products and includes aspects of both safety and performance. This certification also assures the customer that the company provides national authorities with reports and information to ensure and protect public health.
For Amon’s part, this comprehensive certification process, verifies that the company's products, SAMedical® pipes and fittings, can be safely used in complete medical gas pipeline systems for the distribution of medical, pharmaceutical grade, gases. And that the stringent requirements for product safety, and "intended use" are meet.