- EC Machinery Directive 98/37/EC
- EC Machinery Directive 2006/42/EEC
- Low Voltage Directive 2014/35/EU
- Electromagnetic Compatibility Directive 2014/30/EU
- RoHS 2 Directive 2011/65/EU
- EN 809:1998+A1:2009
- EN 60204-1:2006+A1:2009
- EN 61000-6-2:2005
- EN 61000-6-4:2007+A1:2011
- EN ISO 4414:2010
USP Class VI 認証
The United States Pharmacopeia (USP) is a non-government organization that is concerned with the pharmaceutical and bio-technology industries. The USP establishes standards for quality, purity, strength and consistency to safeguard the quality of medicines and other health care technologies. USP Class VI compounds must be made from ingredients with clear histories of biocompatibility that meet tight requirements for leachates.
Samples of Teflon® PTFE, Copolymer PTFE and PFA provided by White Knight Fluid Handling have been tested for compliance to USP Class VI (70°C) plastic. Testing was performed by Pacific BioLabs on September 16, 2015 in compliance with the standards published in the USP Biocompatibility Testing standards (USP<88>).
The qualification of these materials qualifies the following White Knight products in applications requiring USP Class VI certifications: