Medical Acetal(POM) from Celaness for Healthcare Applications
This is to certify that medical acetal comply with the following requirements.
The monomers and additives used for the manufacturing of the above mentioned product complies with EU Regulation 10/2011 and its amendment 1282/2011 and 1183/2012. When manufacturing above listed product complies with the guidelines laid down in the Regulation (EC) 2023/2006.
The above mentioned product is compliant with the applicable FDA regulations for food contact subject to the limitations below. The composition of product is compliant for use in food contact applications according to the CFR Title 21 177. 2470. Any additives, that may be present, comply with appropriate, specific FDA regulations.
- Types of food : All types of food except foods containing 15% or more alcohol
- Conditions of use : Use temperature shall not exceed 120 deg C [ per CFR 177. 2470]
- Application : Repeated use articles only per 21 CFR 177. 2470
Manufacturer of the finished article or seller has to evaluate the finished article for conformance to Regulation 10/2011, FDA and other applicable requirements by themselves.
The above mentioned product meet the requirements of the USP Plastics Test Class Ⅵ - 70℃ testing per USP <88> Biological reactivity tests, in vivo. Above mentioned products also passed cytotoxicity test according to ISO 10993-5, Biological evaluation of medical devices – Tests for in vitro cytotoxicity.
Hostaform MT SlideX 1203
Acetal copolymer. Contains low residual monomers and no animal products. It has standard flow with tribological modification designed for use in demanding applications that require prevention of audible noise caused by stick-slip phenomenon and low friction as well as wear against plastics and metals. Processed by injection molding. Developed for medical industry applications.
Low level 10% PTFE filled with good flow for medical technology applications
Low level PTFE filled product with high flow for use in medical technology applications
Standard grade with good flow with optimum properties for healthcare market
Improved slip grade with good flow for medical technology applications.
Improved flow grade with optimum properties for medical technology applications
MEDICAL POM INVENTORY
|HOSTAFORM MT SlideX 1230
**any medical POM questions ,Please e-mail to: firstname.lastname@example.org