Pharmaceutical pumps

USP VI approved materials (OPTION)
U.S. Pharmacopeial Convention (USP) class I to VI defines how a plastic or rubber material may be exposed of human tissue. Class VI requires the most stringent testing and such materials may be used for example in implant devices.

FDA §21 CFR 177 materials
FDA (U.S. Food and Drug Administration) §21 CFR 177 lists polymers, e.g. rubber and plastic materials approved for equipment in contact with food products.

EN 10204 material traceability
The EN 10204 norm gives you a checklist and traceability of materials used in the equipment. 2.1 is a general statement of compliance with material specifications, while 3.1 provides specific track records all the way to the steel mill batch (normally only on metals in contact with the product).

EC 1935/2004 regulation
This EU regulation applies to all food contact materials, e.g. metals, plastics and rubber materials. It requires that these materials are safe, are labeled with the glass-and-fork symbol, are traceable throughout the production chain (according to above EN 10204) and that they are produced according to good manufacturing practice (GMP).

CE conformance
A product classified as machinery that carries the CE mark fulfill the essential health and safety requirements of the EC Machinery Directive 2006/42/EEC.

ATEX Directive 94/9/EC
Equipment intended and approved for safe operation in potentially explosive atmospheres. The equipment is divided in main groups, categories, apparatus groups and temperature classes to define its suitability in the actual zone.