(a) Values shown are averages and are not to be considered as specifications.
(b) ASTM test methods are the latest under the Society’s current procedures. All molded specimens are prepared by injection molding.
Note: Due to the fact that different regulations in each country set different details of compliance, users of Clyrell RC213M are recommended to undertake their own investigation of the requirements and comply with each regulation set forth, for instance, in applicable local F&DA requirements. Ultimately the users must make their own determination that their use of Clyrell RC213M is safe, lawful and technically suitable in their intended applications. Unless specifically indicated, the grades mentioned are not suitable for applications in the pharmaceutical/medical sector.
This product(s) may not be used in the manufacture of any of the following, without prior written approval by Seller for each specific product and application:
(i) U.S. FDA Class I or II Medical Devices; Health Canada Class I, II or III Medical Devices; European Union Class I or II Medical Devices;
(ii) film, overwrap and/or product packaging that is considered a part or component of one of the aforementioned medical devices;
(iii) packaging in direct contact with a pharmaceutical active ingredient and/or dosage form that is intended for inhalation, injection, intravenous, nasal, ophthalmic (eye), digestive, or topical (skin) administration;
(iv) tobacco related products and applications, electronic cigarettes and similar devices.
(v) safety components in automotive applications, for example: air bags, air bag unit housings and covers, seat belt mechanisms, brake systems, pedals and pedal supports, steering systems.
The product(s) may not be used in:
(i) U.S. FDA Class III Medical Devices; Health Canada Class IV Medical Devices; European Class III Medical Devices;
(ii) applications involving permanent implantation into the body;
(iii) life-sustaining medical applications.
All references to U.S. FDA, Health Canada, and European Union regulations include another country’s equivalent regulatory classification.