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ASTM F983-86(2018)
Standard Practice for Permanent Marking of Orthopaedic Implant Components
Přeložit název
NORMA vydána dne 1.2.2018
Informace o normě:
Označení normy: ASTM F983-86(2018)
Datum vydání normy: 1.2.2018
Kód zboží: NS-845318
Počet stran: 2
Přibližná hmotnost: 6 g (0.01 liber)
Země: Americká technická norma
Kategorie: Technické normy ASTM
Kategorie - podobné normy:
Anotace textu normy ASTM F983-86(2018) :
This practice covers recommendations on permanent marking of metallic and nonmetallic orthopaedic implant components. The practical amounts of information that should be included in the marking are specified. Where implant size and shape allow, it is recommended that the following standard information be included in the permanent marking: (1) manufacturer, (2) material, (3) implant component catalog number or model number, and (4) implant component serial number or lot number. For smaller implants, it is recommended that the following minimum information be included in the permanent marking: symbols or letters selected by the manufacturer which identify (1) the manufacturer and (2) the material from which the component is made. The system of symbols or letters shall be described in the manufacturer’s product literature. Optional information may be included in the permanent marking, such as implant size and whether an implant is intended for right limb or left limb reconstruction.
Keywords:
ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)
Doplňující informace
| 1. Scope | ||
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1.1 It is common practice for orthopaedic implant manufacturers to apply permanent identification to implant components. In this regard, Practice F86 describes recommended locations and methods of marking for metallic implants. 1.2 The purpose of this practice is to (1.3 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 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. |
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| 2. Referenced Documents | ||
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