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Doplňující informace

ASTM F997-10

Standard Specification for Polycarbonate Resin for Medical Applications

Automaticky přeložený název:

Standardní specifikace pro polykarbonátová pryskyřice pro lékařské účely

NORMA vydána dne 1.1.2010

Jazyk
Provedení	PDF - okamžité stažení - 1 756.20 Kč Tištěné - 1 756.20 Kč
Dostupnost	SKLADEM
Cena	1 756.20 Kč bez DPH
1 756.20 Kč

Informace o normě:

Označení normy: ASTM F997-10
Poznámka: NEPLATNÁ
Datum vydání normy: 1.1.2010
Kód zboží: NS-57213
Počet stran: 3
Přibližná hmotnost: 9 g (0.02 liber)
Země: Americká technická norma
Kategorie: Technické normy ASTM

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Kategorie - podobné normy:

Ostatní normy týkající se laboratorního lékařství
Termoplasty

Anotace textu normy ASTM F997-10 :

Keywords:

plastics (thermoplastic), plastic surgical devices/applications, polycarbonate (PC) plastics, polymers-surgical applications, resins-polycarbonate, seals, Plastic surgical devices/applications--specifications, Polycarbonate (PC)--specifications, Polymers (surgical applications)--specifications, Seals--surgical implant applications, Surgical implant resins--specifications, Thermoplastic surgical implant applications--specifications

Doplňující informace

1. Scope

1.1 This specification covers polycarbonate resin and provides requirements and associated test methods for this thermoplastic when it is to be used in the manufacture of medical devices or components of medical devices.

1.2 As with any material, some characteristics may be altered by the processing techniques (such as molding, extrusion, machining, assembly, sterilization, and so forth) required for the production of a specific part or device. Therefore, properties of fabricated forms of this resin should be evaluated using those test methods that are appropriate to assure safety and efficacy.

1.3 The properties included in this specification are those applicable for polycarbonate only. The biocompatibility of plastic compounds made up of polycarbonate resin containing colorants, fillers, processing aids, or other additives, as well as polymer blends which contain polycarbonate, should not be assumed. The biocompatibility of these modified polycarbonates must be established by testing the final (end-use) compositions using the appropriate methods of evaluation. In addition, the biocompatibility of the material depends to a large degree on the nature of the end-use application. It is, therefore, necessary to specify a set of biocompatibility test methods for each new and distinct application.

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.

2. Referenced Documents

Title 21	CFR Subpart 177.1580 Available from Standardization Documents Order Desk, Bldg. 4 Section D, 700 Robbins Ave., Philadelphia, PA 19111-5094, Attn: NPODS.
UL Standard 94	Tests and Flammability of Plastic Materials for Parts in Devices and Appliances Available from Underwriters Laboratories (UL), 333 Pfingsten Rd., Northbrook, IL 60062-2096, http://www.ul.com.
D1600-18	Standard Terminology for Abbreviated Terms Relating to Plastics (Withdrawn 2024)
ISO 10993	Biological Evaluation of Medical Devices Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http://www.ansi.org.
F748-16	Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
D3935-21	Standard Classification System and Basis for Specification for Polycarbonate (PC) Unfilled and Reinforced Material
D3892-15(2020)	Standard Practice for Packaging/Packing of Plastics
D1898-68(1989)	Standard Practice for Sampling of Plastics (Withdrawn 1998)
D1238-23a	Standard Test Method for Melt Flow Rates of Thermoplastics by Extrusion Plastometer (Includes all amendments and changes 12/6/2023).
D1003-21	Standard Test Method for Haze and Luminous Transmittance of Transparent Plastics
D955-21	Standard Test Method of Measuring Shrinkage from Mold Dimensions of Thermoplastics
D883-24	Standard Terminology Relating to Plastics
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
D570-22	Standard Test Method for Water Absorption of Plastics
D256-23e1	Standard Test Methods for Determining the Izod Pendulum Impact Resistance of Plastics (Includes all amendments and changes 4/7/2023).
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

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