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ISO 13485:2003 is recognized by regulators around the world as a good basis for addressing medical device design and manufacturing regulatory requirements. It allows us to enhance product safety by proactively identifying and managing product and project risks. Becoming ISO 13485:2003 certified has allowed us to better control the consistency of manufactured products. Download our certificate here. |
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Colder Products Company manufactures the following Life Sciences and Chemical Management product lines in a cleanroom certified by an external testing service to meet or exceed ISO Class 7 at 0.5 micrometers per ISO 14644-1 (superseding the former Federal Standard 209E Class 10,000). Certification data can be provided upon request. Please contact us with any questions you may have. |
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Life Sciences:
AseptiQuik, MPC, MPX, MPU, HFC39, SMC91, Quick Disconnect Sanitary, Steam-Thru Connections |
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Chemical Management:
CQG, CQH, CQV |
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The U.S. Food and Drug Administration publishes, through the Code of Federal Regulations, standardized criteria which govern the acceptability of materials used in food contact. The U.S. Department of Agriculture publishes similar standards that mirror FDA criteria. Neither agency approves or disapproves products for particular applications. Most of Colder's products are made using resins that comply with applicable FDA or USDA standards. When necessary, the standard o-ring seals are replaced with specific, recognized materials. |
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NSF International, based in Ann Arbor, Michigan develops and publishes consensual criteria that govern the acceptability of materials and equipment used in food and beverage processing. They also do testing to verify the performance of materials or devices to their published criteria. Colder lists many of its product lines under the criteria of NSF/ANSI Standard 169 (formerly C-2), which governs components used in food and beverage contact applications. |
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ISO 9001:2008 is a standard which assures consistency of a product ordered by customers. Organizations having ISO 9001:2008 certification have demonstrated compliance to the ISO 9001:2008 requirements by an independent registration authority. Colder Products Company's Quality Management System has been approved and certified under the ISO 9001:2008 standard. |
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The RoHS Directive stands for "the restriction of the use of certain hazardous substances in electrical and electronic equipment." This Directive bans the placing on the EU market of new electrical and electronic equipment containing more than agreed levels of lead, cadmium, mercury, hexavalent chromium, polybrominated biphenyl (PBB) and polybrominated diphenyl ether (PBDE) flame retardants. |
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REACH is the Regulation for Registration, Evaluation, Authorisation and Restriction of Chemicals. It entered into force on 1st June 2007 to streamline and improve the former legislative framework on chemicals of the European Union (EU). REACH places greater responsibility on industry to manage the risks that chemicals may pose to the health and the environment. |
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Shelf Life and Storage Conditions Statement
Colder Products Company manufactures quick disconnect couplings and connections made from a variety of metal, plastic and elastomeric raw materials. The shelf life of a connector is dependent upon the connector materials and the storage conditions. Read more about Colder's general recommendation for storage conditions.
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