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Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications
Automaticky přeložený název:
Standardní specifikace pro Polyetheretherketon (PEEK) Polymery pro chirurgický implantát aplikace
NORMA vydána dne 1.3.2014
Označení normy: ASTM F2026-14
Poznámka: NEPLATNÁ
Datum vydání normy: 1.3.2014
Kód zboží: NS-52500
Počet stran: 5
Přibližná hmotnost: 15 g (0.03 liber)
Země: Americká technická norma
Kategorie: Technické normy ASTM
Keywords:
PEEK, polyetheretherketone, ICS Number Code 11.040.30 (Surgical instruments and materials)
1. Scope | ||||||||||||||||||||||||||||||||||
1.1 This specification covers polyetheretherketone (PEEK) polymer in virgin forms as supplied by a vendor (pellets, powder, fabricated forms, 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 The properties included in this specification are those applicable for PEEK polymers only. Indicated properties are for fabricated forms. Materials or forms containing colorants, fillers, processing aids, or other additives, as well as polymer blends which contain PEEK, or reclaimed materials, are not covered by this specification. 1.3 This specification is designed to recommend physical, chemical, and biological test methods to establish a reasonable level of confidence concerning the performance of virgin PEEK polymers for use in medical implant devices. 1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.5 When evaluating material in accordance with 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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