Safrene® M 6650

Drums and Industrial chemical containers up to 250 liter

Safripol will not knowingly sell or sample any product or service (“Product”) into any commercial or developmental application that is intended for:
a. permanent (Long term) contact with internal body fluids or internal body tissues. Long term is a use which exceeds 72 continuous hours.
b. use in cardiac prosthetic devices regardless of the length of time involved; (Cardiac prosthetic devices include, but are not limited to, pacemaker leads and devices, artificial hearts, heart valves, intra-aortic balloons and control systems, and ventricular bypass assisted devices);
c. use as a critical component in medical devices that support or sustain human life; or
d. use specifically by pregnant women or in applications designed specifically to promote or interfere with human reproduction.
Additionally, all Products intended for use in pharmaceutical applications, other than pharmaceutical packaging, must pass the current Pharmaceutical Liability Guidelines.
● New business opportunities require a business assessment prior to sale or sampling of Safripol products.
● Authorized distributors and resellers will adhere to this medical policy.
● Safripol does not endorse or claim suitability of their products for specific medical applications. It is the responsibility of the medical device or pharmaceutical manufacturer to determine that the Safripol product is safe, lawful, and technically suitable for the intended use.
SAFRIPOL MAKES NO WARRANTIES, EXPRESS OR IMPLIED, CONCERNING THE SUITABILITY OF ANY SAFRIPOL PRODUCT FOR USE IN MEDICAL APPLICATIONS.

Safrene® M 6650 High Density Polyethylene Resin should comply with Commission Regulation (EU) No 10/2011 and with U.S. FDA 21 CFR 177.1520(c)3.2a food contact regulations when used unmodified and processed according to good manufacturing practices for food contact applications. The purchaser remains responsible for determining whether the use complies with all relevant regulations.