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金属外科植入物表面制备和标志的标准实施规程  
 【英文标准名称】  Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants
 【原文标准名称】  金属外科植入物表面制备和标志的标准实施规程
 【标准号】  ASTM F86-2004(2009)
 【标准状态】  Active
 【国别】  美国
 【发布日期】  2004
 【实施或试行日期】  
 【发布单位】  美国材料与试验协会(US-ASTM)
 【起草单位】  F04.12
 【标准类型】  (Practice)
 【标准水平】  ()
 【中文主题词】  
 【英文主题词】  alkaline cleaner; cleaning; electropolishing; final inspection; marking; metal implants; passivation; surface treatment; Marking; Metallic surgical implant materials--specifications; Passivation treatments; Specimen preparation (general); Surface preparat
 【摘要】  

The surface treatments documented in this practice are intended to improve the corrosion resistance of metallic surgical implants manufactured from iron, cobalt, titanium, and tantalum base materials.

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

The various chemical and electrochemical surface treatments specified in this practice are intended to remove objectionable surface contaminants and to restore maximum corrosion resistance to the passive oxide film.

The need for an additional implant surface treatment such as secondary passivation in nitric acid should be evaluated for localized implant surfaces that have electrochemical or laser product markings created after the final surface treatment.

1.1 This practice provides a description of surface characteristics, methods of surface preparation, and methods of marking for metallic surgical implants. Marking nomenclature and neutralization of endotoxin are not specified in this practice (see X1.3). Surface requirements and marking methods included in the implant specification shall take precedence over requirements listed in this practice, where appropriate.

1.2 The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical conversions to SI units that are provided for information only and are not considered standard.

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 and health practices and determine the applicability of regulatory limitations prior to use.

 【中国标准分类号】  C45
 【国际标准分类号】  11_040_40
 【页数】  3P.;A4
 【正文语种】  英语
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