White Knight’s manufacturing process is certified according to ISO 9001:2015.
ISO 9001 specifies criteria for quality management systems. It is based on quality management principles including a strong customer focus, the motivation and implication of top management, the process approach and continual improvement. ISO 9001 helps ensure that customers get consistent, good quality products and services. Visit ISO 9000 Quality Management website for more information.
CE mark signifies that products have been assessed to meet high safety, health, and environmental protection requirements. Visit European Commission CE Marking website for more information.
White Knight CE marked products include bellows pumps, diaphragm pumps, metering pumps, high-pressure pumps, mini pumps, legacy pumps, pressure regulators and filter housings. These products fulfill the demands of various applicable directives and standards. View the certificates for lists of specific models and applicable directives. White Knight CE certifications are also included in product manuals.
- 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
EU Harmonized Standards:
- 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 Certifications
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:
- PSA Series bellows pumps
- PSH Series bellows pumps
- PSU Series bellows pumps
- PFA Series bellows pumps
- PFH Series bellows pumps
- PFU Series bellows pumps
- PXA Series bellows pumps
- PXH Series bellows pumps
- PXU Series bellows pumps
- PSB Series diaphragm pumps
- PEM Series metering pumps
- PPM Series metering pumps
- PPMC Series low flow pumps