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Doplňujúce informácie

ASTM F1781-21

Standard Specification for Elastomeric Flexible Hinge Finger Total Joint Implants

NORMA vydaná dňa 1.9.2021

Jazyk
Prevedenie	Online zabezpečené PDF - 63.00 € Norma a Redline - Online zabezpečené PDF - 75.60 € Tlačené - 63.00 € Tlač + redline - 75.60 €
Dostupnosť	SKLADOM
Cena	63.00 € bez DPH
63.00 €

Informácie o norme:

Označenie normy: ASTM F1781-21
Dátum vydania normy: 1.9.2021
Kód tovaru: NS-1034336
Počet strán: 6
Približná hmotnosť: 18 g (0.04 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 F1781-21 :

This specification covers the biocompatibility and other performance requirements, and associated test methods for elastomeric flexible hinge finger total joint implants, used with and without metal grommets in the reconstruction of the metacarpophalangeal (MCP) and proximal interphalangeal (PIP) joints. This specification excludes those implants that do not have an across-the-joint elastomeric linkage, and is limited to implants made from one material in a single one-step molding procedure.

Keywords:

elastomer, finger, implant,, ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)

Doplňujúce informácie

1. Scope

1.1?This specification covers elastomeric flexible hinge finger total joint implants, used with and without metal grommets, in the reconstruction of the metacarpophalangeal (MCP) and proximal interphalangeal (PIP) joints.

1.2?This specification excludes those implants that do not have an across-the-joint elastomeric linkage. This specification is limited to implants made from one material in a single, one-step molding procedure.

1.3?The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

1.4?This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

2. Referenced Documents

D412-16(2021)	Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers—Tension
MIL STD 177A	Rubber Products, Terms for Visible Defects
F86-21(2026)	Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants
F2042-18	Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II´Crosslinking and Fabrication
F2038-18	Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part I´Formulations and Uncured Materials
F983-24	Standard Practice for Permanent Marking of Orthopaedic Implant Components
F981-23	Standard Practice for Assessment of Muscle and Bone Tissue Responses to Long-Term Implantable Materials Used in Medical Devices
F748-25	Standard Practice for Selecting Biological Test Methods for Materials and Devices
F601-23	Standard Practice for Fluorescent Penetrant Inspection of Metallic Surgical Implants
F67-24	Standard Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700)
D624-00(2020)	Standard Test Method for Tear Strength of Conventional Vulcanized Rubber and Thermoplastic Elastomers
D813-07(2025)	Standard Test Method for Rubber Deterioration—Crack Growth
ISO 10993-1	Biological Evaluations of Medical Devices -- Part 1: Evaluation and testing within a risk management process
D2240-15(2021)	Standard Test Method for Rubber Property—Durometer Hardness
D1052-09(2026)	Standard Test Method for Measuring Rubber Deterioration—Cut Growth Using Ross Flexing Apparatus
21 CFR 820	Good Manufacturing Practices for Medical Devices

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