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Doplňujúce informácie

ASTM F648-07e1

Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants (Includes all amendments And changes 12/31/2010).

Automaticky preložený názov:

Štandardné špecifikácie pre Ultra - High - molekulovej hmotnosti prášku polyetylénu a kovových Formulár pre Chirurgické protézy

NORMA vydaná dňa 1.2.2007

Jazyk
Prevedenie	PDF - okamžité stiahnutie - 70.90 € Tlačené - 70.90 €
Dostupnosť	SKLADOM
Cena	70.90 € bez DPH
70.90 €

Informácie o norme:

Označenie normy: ASTM F648-07e1
Poznámka: NEPLATNÁ
Dátum vydania normy: 1.2.2007
Kód tovaru: NS-56005
Počet strán: 8
Približná hmotnosť: 24 g (0.05 libier)
Krajina: Americká technická norma
Kategória: Technické normy ASTM

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Anotácia textu normy ASTM F648-07e1 :

Keywords:

fabricated forms, powdered form, ultra-high molecular weight polyethylene, ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics), 83.080.20 (Thermoplastic materials)

Doplňujúce informácie

1. Scope

1.1 This specification covers ultra-high molecular weight polyethylene powder (UHMWPE) and fabricated forms intended for use in surgical implants.

1.2 The requirements of this specification apply to UHMWPE in two forms. One is virgin polymer powder (Section 4). The second is any form fabricated from this powder from which a finished product is subsequently produced (Section 5). This specification addresses material characteristics and does not apply to the packaged and sterilized finished implant.

1.3 The provisions of Specification D 4020 apply. Special requirements detailed in this specification are added to describe material which will be used in surgical implants.

1.4 The biological response to polyethylene in soft tissue and bone has been well characterized by a history of clinical use (1, 2, 3) and by laboratory studies (4,5 6, ).

The following precautionary caveat pertains only to the test method portion, Section 7, of this specification: 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.<>

2. Referenced Documents

D1898-68(1989)	Standard Practice for Sampling of Plastics (Withdrawn 1998)
F619-20	Standard Practice for Extraction of Materials Used in Medical Devices
F748-16	Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
F749-20	Standard Practice for Evaluating Material Extracts by Intracutaneous Injection in the Rabbit
F895-11(2016)	Standard Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity
F981-23	Standard Practice for Assessment of Muscle and Bone Tissue Responses to Long-Term Implantable Materials Used in Medical Devices
D1505-18	Standard Test Method for Density of Plastics by the Density-Gradient Technique
D256-23e1	Standard Test Methods for Determining the Izod Pendulum Impact Resistance of Plastics (Includes all amendments and changes 4/7/2023).
D792-20	Standard Test Methods for Density and Specific Gravity (Relative Density) of Plastics by Displacement
D790-17	Standard Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials
D648-18	Standard Test Method for Deflection Temperature of Plastics Under Flexural Load in the Edgewise Position
D638-22	Standard Test Method for Tensile Properties of Plastics
F763-22	Standard Practice for Short-Term Intramuscular Screening of Implantable Medical Device Materials
F756-17	Standard Practice for Assessment of Hemolytic Properties of Materials
F813-20	Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices
D4020-18	Standard Specification for Ultra-High-Molecular-Weight Polyethylene Molding and Extrusion Materials

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