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ASTM F639-09
Standard Specification for Polyethylene Plastics for Medical Applications
Automaticky přeložený název:
Standard Specification pro polyetylénové plasty pro lékařské účely
NORMA vydána dne 1.8.2009
Informace o normě:
Označení normy: ASTM F639-09
Poznámka: NEPLATNÁ
Datum vydání normy: 1.8.2009
Kód zboží: NS-55977
Počet stran: 3
Přibližná hmotnost: 9 g (0.02 liber)
Země: Americká technická norma
Kategorie: Technické normy ASTM
Anotace textu normy ASTM F639-09 :
Keywords:
plastic surgical devices/applications, polyethylene (PE) plastics´surgical implant applications, polymers´surgical applications, Plastic surgical devices/applications--specifications, Polyethylene (PE) surgical implant applications--specifications, Polymers (surgical applications)--specifications, ICS Number Code 11.120.01 (Pharmaceutics in general), 83.080.20 (Thermoplastic materials)
Doplňující informace
| Significance and Use | ||||||||||||||||||||||||||
SignificanceTop
X1.2.1 Concentrations of trace metals are measured as extracts in simulated body fluids. The metal’s concentration in extracts is based on the surface area of the plastic extracted from which the total amount of metal deliverable to the patient may be estimated. |
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| 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 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. |
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| 2. Referenced Documents | ||||||||||||||||||||||||||
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