Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants

Importancia y uso:

3.1 The objective of surface treatments as documented in this practice is to improve the corrosion resistance of metallic surgical implants including, but not limited to, those manufactured from iron, cobalt, nickel, titanium, and tantalum base materials.

3.2 Iron particles, ceramic media, and other foreign particles may become smeared over or embedded into the surface of implants during processing operations such as forming, machining, tumbling, media blasting, marking, and so forth. These particles should be removed to minimize localized corrosion and superficial blemishes.

3.3 The various chemical and electrochemical surface treatments specified by this practice are used to remove objectionable surface contaminants and to restore maximum corrosion resistance to, or promote the creation of, an inert or passive surface, such as a metal oxide film, as is applicable to the specific material. Some of these treatments are referred to as passivation treatments. The preferred surface treatment for a given application varies depending on the implant material and the nature of the surface contaminants.

3.4 Depending on the implant, its material, and the type of marking method and procedure, the marking may be applied before or after a chemical or electrochemical surface treatment. When marking is performed after the surface treatment, the localized implant surface shall be evaluated to determine if there is a need for additional surface treatment.

Note 1: The need for additional surface treatment is likely for stainless steel with all marking methods, and for nonferrous alloys when the marking method involves direct or second-hand contact with iron-based or other material that would be considered an objectionable surface contaminant.

3.5 The selection of procedures to be applied to the implants, and additional requirements which are not covered by this practice, may be included in the implant production specification.

Subcomité:

F04.12

Referida por:

F0983-86R18, F2180-24, F1611-20, F1091-20, F0452-76R22, F1801-20, F1781-21, F0366-24, F2887-23, F0897-19, F2665-21, F1357-23, F3143-20, F3047M-23, F0763-22, F1378-18E01, F0564-17, F1714-96R18, F1264-24, F0543-23, F3446-20, F0981-23, F0746-04R21, F1350-24, F1408-20A, F0732-17

Volúmen:

13.01

Número ICS:

11.040.40 (Implants for surgery, prothetics and orthotics)

Palabras clave:

alkaline cleaners; cleaning; electropolishing; final inspections; markings; metal implants; passivation; surface treatments;