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ASTM F639-98a(2003)
Standard Specification for Polyethylene Plastics for Medical Applications (Includes all amendments And changes 12/31/2010).
Automaticky přeložený název:
Standardní specifikace pro polyetylénové plasty pro lékařské účely
NORMA vydána dne 10.4.2003
Informace o normě:
Označení normy: ASTM F639-98a(2003)
Poznámka: NEPLATNÁ
Datum vydání normy: 10.4.2003
Kód zboží: NS-55978
Počet stran: 4
Přibližná hmotnost: 12 g (0.03 liber)
Země: Americká technická norma
Kategorie: Technické normy ASTM
Anotace textu normy ASTM F639-98a(2003) :
Keywords:
plastic surgical devices/applications, polyethylene (PE) plastics-surgical implant applications, polymers-surgical applications, ICS Number Code 11.100.99 (Other standards related to laboratory medicine), 83.080.20 (Thermoplastic materials)
Doplňující informace
| 1. Scope | ||||||||||||||||||||||||||
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1.1 This specification covers polyethylene plastics (as defined in Terminology D 883) 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 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. |
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| 2. Referenced Documents | ||||||||||||||||||||||||||
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