F0639-09R15
Standard Specification for Polyethylene Plastics for Medical Applications
| Označení normy: | F0639-09R15 |
| Vydáno: | 01.03.2015 |
| Status: | Active |
| Počet stran: | 3 |
| Sekce: | 13.01 |
| Označení: |  plastic surgical devices/applications; polyethylene (PE) plastics—surgical implant applications; polymers—surgical applications ; |
1.1 This specification covers polyethylene plastics (as defined in Terminology D883) intended for use in medical device applications involving human tissue contact devices, short-term indwellings of 30 days or less, and fluid transfer devices. The biocompatibility of these materials as a class has not been established. Biocompatibility tests must be conducted on the final product.
1.2 This specification is not applicable to ultra-high molecular weight polyethylenes (UHMWPE) plastics, such as those used in joint implants, and so forth.
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.