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ASTM F1579-02e1
Standard Specification for Polyaryletherketone (PAEK) Polymers for Surgical Implant Applications (Withdrawn 2011) (Includes all amendments And changes 12/31/2010).
Automaticky přeložený název:
Standardní specifikace pro Polyaryletherketone ( PAEK ) Polymery pro chirurgický implantát Applications (Withdrawn 2011 )
NORMA vydána dne 10.4.2002
Informace o normě:
Označení normy: ASTM F1579-02e1
Poznámka: NEPLATNÁ
Datum vydání normy: 10.4.2002
Kód zboží: NS-50808
Počet stran: 6
Přibližná hmotnost: 18 g (0.04 liber)
Země: Americká technická norma
Kategorie: Technické normy ASTM
Anotace textu normy ASTM F1579-02e1 :
Keywords:
PAEK, PEEK, PEEKK, PEKEKK, PEKK, PEK, polyaryletherketone, ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)
Doplňující informace
| 1. Scope | ||||||||||||||||||||||||||||||||||||||||||||
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1.1 This specification covers polyaryletherketone (PAEK) polymers in virgin forms as supplied by a vendor (pellets, powder, and so forth). It provides requirements and associated test methods for these thermoplastics when they are to be used in the manufacture of intracorporeal devices such as surgical implants or components of surgical or dental devices. 1.2 As with any material, some characteristics may be altered by the processing techniques (molding, extrusion, machining, assembly, sterilization, and so forth) required for the production of a specific part or device. Therefore, properties of fabricated forms of these polymers should be evaluated using test methods that are appropriate to ensure safety and efficacy as agreed upon by the vendor, purchaser, and regulating bodies. 1.3 The properties included in this specification are those applicable for PAEK polymers only. Fabricated forms, material or forms containing colorants, fillers, processing aids, or other additives, as well as polymer blends that contain PAEK, are not covered by this specification. 1.4 This specification is designed to recommend physical, chemical, and biological test methods to establish a reasonable level of confidence concerning the performance of unfilled PAEK polymers for use in medical devices. The properties listed should be considered in selecting material according to the specific end-use requirements. 1.5 When evaluating material to this specification hazardous materials, operations, and equipment may be involved. 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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