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NEPLATNÁ ASTM F755-99(2011) 1.12.2011 náhľad

Doplňujúce informácie

ASTM F755-99(2011)

Standard Specification for Selection of Porous Polyethylene for Use in Surgical Implants

Automaticky preložený názov:

Štandard Specification pre výber poréznych polyetylénu pre použitie v chirurgických implantátov

NORMA vydaná dňa 1.12.2011

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Prevedenie	PDF - okamžité stiahnutie - 61.70 € Tlačené - 61.70 €
Dostupnosť	SKLADOM
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61.70 €

Informácie o norme:

Označenie normy: ASTM F755-99(2011)
Poznámka: NEPLATNÁ
Dátum vydania normy: 1.12.2011
Kód tovaru: NS-56351
Počet strán: 3
Približná hmotnosť: 9 g (0.02 libier)
Krajina: Americká technická norma
Kategória: Technické normy ASTM

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Kategórie - podobné normy:

Implantáty pro chirurgii, protetiku a ortotiku

Anotácia textu normy ASTM F755-99(2011) :

Keywords:
plastic surgical devices/applications, polyethylene (PE) plastics/surgical implant applications, polymers-surgical applicant&thinsp,&thinsp, &thinsp,&thinsp, &thinsp,&thinsp, &thinsp,&thinsp, , Plastic surgical devices/applications--specifications, Polyethylene (PE) surgical implant applications--specifications, Polymers (surgical applications)--specifications, Surgical implants--specifications, ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)

Doplňujúce informácie

1. Scope

1.1 This specification covers the properties and test methods for porous high density and ultra high molecular weight polyethylenes intended for use in surgical implants. The porous polyethylene may be used as a free standing product or as a coating on a substrate in nonloaded applications.

1.2 Evaluation of tissue response to a porous polyethylene must be completed. Guidance in establishing biocompatibility may be found in the list of references.

1.3 Clinical experience and animal studies have shown that tissue will grow into the open pores of porous polyethylene. The tissue ingrowth into the pores may allow for the establishment of implant fixation.

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 This section 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

D2873-94(1999)e1	Standard Test Method for Interior Porosity of Poly(Vinyl Chloride) (PVC) Resins by Mercury Intrusion Porosimetry (Withdrawn 2003)
E562-19e1	Standard Test Method for Determining Volume Fraction by Systematic Manual Point Count (Includes all amendments and changes 8/24/2020).
F316-03(2019)	Standard Test Methods for Pore Size Characteristics of Membrane Filters by Bubble Point and Mean Flow Pore Test
D2238-22	Standard Test Methods for Absorbance of Polyethylene Due to Methyl Groups at 1378 cm?1
F648-21	Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
F748-16	Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
F763-22	Standard Practice for Short-Term Intramuscular Screening of Implantable Medical Device Materials
F981-23	Standard Practice for Assessment of Muscle and Bone Tissue Responses to Long-Term Implantable Materials Used in Medical Devices
D638-22	Standard Test Method for Tensile Properties of Plastics
D732-17	Standard Test Method for Shear Strength of Plastics by Punch Tool
D790-17	Standard Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials
D883-24	Standard Terminology Relating to Plastics
D1238-23a	Standard Test Method for Melt Flow Rates of Thermoplastics by Extrusion Plastometer (Includes all amendments and changes 12/6/2023).
D1505-18	Standard Test Method for Density of Plastics by the Density-Gradient Technique
D1621-16(2023)	Standard Test Method for Compressive Properties of Rigid Cellular Plastics
D1898-68(1989)	Standard Practice for Sampling of Plastics (Withdrawn 1998)
D1623-17(2023)	Standard Test Method for Tensile and Tensile Adhesion Properties of Rigid Cellular Plastics