11.040.40 (Implants for surgery, prothetics and or 标准查询与下载

ASTM F543-13 医用金属接骨螺钉的标准规范和试验方法

A1.1. Significance and Use A1.1.1 This test method is used to measure the torsional yield strength, maximum torque, and breaking angle of the bone screw under standard conditions. The results obtained in this test method are not intended to predict the torque encountered while inserting or removing a bone screw in human or animal bone. This test method is intended only to measure the uniformity of the product tested or to compare the mechanical properties of different, yet similarly sized, products. 1.1 This specification provides requirements for materials, finish and marking, care and handling, and the acceptable dimensions and tolerances for metallic bone screws that are implanted into bone. The dimensions and tolerances in this specification are applicable only to metallic bone screws described in this specification. 1.2 This specification provides performance considerations and standard test methods for measuring mechanical properties in torsion of metallic bone screws that are implanted into bone. These test methods may also be applicable to other screws besides those whose dimensions and tolerances are specified here. The following annexes are included: 1.2.1 Annex A1—Test Method for Determining the Torsional Properties of Metallic Bone Screws. 1.2.2 Annex A2—Test Method for Driving Torque of Medical Bone Screws. 1.2.3 Annex A3—Test Method for Determining the Axial Pullout Strength of Medical Bone Screws. 1.2.4 Annex A4—Test Method for Determining the Self-Tapping Performance of Self-Tapping Medical Bone Screws. 1.2.5 Annex A5—Specifications for Type HA and Type HB Metallic Bone Screws. 1.2.6 Annex A6—Specifications for Type HC and Type HD Metallic Bone Screws. 1.2.7 Annex A7—Specifications for Metallic Bone Screw Drive Connections. 1.3 This specification is based, in part, upon ISO 5835, ISO 6475, and ISO 9268. 1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.5 Multiple test methods are included in this standard. However, it must be noted that the user is not obligated to test using all of the described ......

Standard Specification and Test Methods for Metallic Medical Bone Screws

ASTM F138-13 外科植入物用锻制18铬-14镍-2.5钼不锈钢棒材及线材的标准规范 (UNS S31673)

1.1 This specification covers the chemical, mechanical, and metallurgical requirements for wrought 18chromium-14nickel-2.5molybdenum stainless steel bar and wire used for the manufacture of surgical implants. 1.2 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in non-conformance with the standard.

Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)

ASTM F543-13e1 医用金属接骨螺钉的标准规范和试验方法

A1.1. Significance and Use A1.1.1 This test method is used to measure the torsional yield strength, maximum torque, and breaking angle of the bone screw under standard conditions. The results obtained in this test method are not intended to predict the torque encountered while inserting or removing a bone screw in human or animal bone. This test method is intended only to measure the uniformity of the product tested or to compare the mechanical properties of different, yet similarly sized, products. 1.1 This specification provides requirements for materials, finish and marking, care and handling, and the acceptable dimensions and tolerances for metallic bone screws that are implanted into bone. The dimensions and tolerances in this specification are applicable only to metallic bone screws described in this specification. 1.2 This specification provides performance considerations and standard test methods for measuring mechanical properties in torsion of metallic bone screws that are implanted into bone. These test methods may also be applicable to other screws besides those whose dimensions and tolerances are specified here. The following annexes are included: 1.2.1 Annex A1—Test Method for Determining the Torsional Properties of Metallic Bone Screws. 1.2.2 Annex A2—Test Method for Driving Torque of Medical Bone Screws. 1.2.3 Annex A3—Test Method for Determining the Axial Pullout Strength of Medical Bone Screws. 1.2.4 Annex A4—Test Method for Determining the Self-Tapping Performance of Self-Tapping Medical Bone Screws. 1.2.5 Annex A5—Specifications for Type HA and Type HB Metallic Bone Screws. 1.2.6 Annex A6—Specifications for Type HC and Type HD Metallic Bone Screws. 1.2.7 Annex A7—Specifications for Metallic Bone Screw Drive Connections. 1.3 This specification is based, in part, upon ISO 5835, ISO 6475, and ISO 9268. 1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.5 Multiple test methods are included in this standard. However, it must be noted that the user is not obligated to test using all of the described methods. Instead, the user should only select test methods that are appropriate for a particular device design. In most instances, only a subset of the herein described test methods will be required. 1.6 This standard may involve the use of hazardous materials, operations, and equipment. 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.

Standard Specification and Test Methods for Metallic Medical Bone Screws

ASTM F560-13e1 外科植入物用非合金钽的标准规范 (UNS R05200, UNS R05400)

1.1 This specification covers the chemical, mechanical, and metallurgical requirements for unalloyed tantalum plate, sheet, strip, bar, and wire used in the manufacture of surgical implants. 1.2 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values of the two systems may result in non-conformance with this standard.

Standard Specification for Unalloyed Tantalum for Surgical Implant Applications (UNS R05200, UNS R05400)

ASTM F648-13 外科植入物用超高分子量聚乙烯粉末及组成形式的标准规范

1.1 This specification covers ultra-high molecular weight polyethylene powder (UHMWPE) and fabricated forms intended for use in surgical implants. 1.2 The requirements of this specification apply to UHMWPE in two forms. One is virgin polymer powder (Section 4). The second is any form fabricated from this powder from which a finished product is subsequently produced (Section 5). This specification addresses material characteristics and does not apply to the packaged and sterilized finished implant. 1.3 The requirements of this specification do not apply to UHMWPE virgin powder or fabricated forms intentionally crosslinked or blended with other additives, for example, antioxidants. 1.4 The biological response to polyethylene in soft tissue and bone has been well characterized by a history of clinical use (1, 2, 3)2 and by laboratory studies (4, 5, 6). 1.5 The values stated in SI units are to be regarded as standard. 1.6 The following precautionary caveat pertains only to the test method portion, Section 7, of this specification: 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.

Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants

ASTM F560/F560M-13 外科植入物应用非合金钽(UNS R05200, UNS R05400)的标准规范

1.1 This specification covers the chemical, mechanical, and metallurgical requirements for unalloyed tantalum plate, sheet, strip, bar, and wire used in the manufacture of surgical implants. 1.2 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values of the two systems may result in non-conformance with this standard.

Standard Specification for Unalloyed Tantalum for Surgical Implant Applications (UNS R05200, UNS R05400)

ASTM F136-13 外科植入物用锻制钛-6铝-4钒ELI (超低间质) 合金的标准规范 (UNS R56401)

1.1 This specification covers the chemical, mechanical, and metallurgical requirements for wrought annealed titanium-6aluminum-4vanadium ELI (extra low interstitial) alloy (R56401) to be used in the manufacture of surgical implants. 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.

Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401)

ASTM F138-13a 外科植入物;UNS S31673用锻造18铬-14镍-2.5钼不锈钢棒材和线材的标准规范

1.1 This specification covers the chemical, mechanical, and metallurgical requirements for wrought 18chromium-14nickel-2.5molybdenum stainless steel bar and wire used for the manufacture of surgical implants. 1.2 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in non-conformance with the standard.

Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants lpar;UNS S31673rpar;

ASTM F86-13 金属外科植入物表面制备和标记的标准实施规程

3.1 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. 3.2 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. 3.3 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. 3.4 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.

Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants

ASTM F2102-13 评估预期供外科植入物使用的聚乙烯制品氧化程度的标准指南

1.1 This guide covers a method for the measurement of the relative extent of oxidation present in HDPE homopolymers and ultra-high-molecular-weight polyethylene (UHMWPE) intended for use in medical implants. The material is analyzed by infrared spectroscopy. The intensity (area) of the carbonyl absorptions (gt;C=O) centered near 1720 cm-1 is related to the amount of chemically bound oxygen present in the material. Other forms of chemically bound oxygen (C-O-C, C-O-O-C, C-O-H, and so forth) are not captured by this guide. 1.2 Although this guide may give the investigator a means to compare the relative extent of carbonyl oxidation present in various UHMWPE samples, it is recognized that other forms of chemically bound oxygen may be important contributors to these materials' characteristics. 1.3 FIG. 1 Typical FTIR Spectra of Oxidized UHMWPE, Showing the Definition of an Area-Based Oxidation Index Based on Normalization Using the 1370-cm -1 PeakFIG. 2 FTIR Spectra Showing the Carbonyl Absorption Bands Note 1—Note that both reagents effectively extracted the lipids (the lipid absorption peak is centered at approximately 1740 cm-1). The tibial insert was fabricated from highly crosslinked and remelted UHMWPE followed by terminal sterilization in EtO gas (Ref. 1).The applicability of the infrared method has been demonstrated by many literature reports. This particular method, using the intensity (area) of the C-H absorption centered near 1370 cm-1 to normalize for the sample's thickness, has been validated by an Interlaboratory Study (ILS) conducted according to Practice E691. 1.4 The following precautionary caveat pertains only to the test method portion, Section 5, of this specification: This standard may involve hazardous materials, operations, and equipment. 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 requirements prior to use.

Standard Guide for Evaluating the Extent of Oxidation in Polyethylene Fabricated Forms Intended for Surgical Implants

ASTM F1314-13ae1 外科植入物用锻制氮增强22铬-13镍-5锰-2.5钼不锈钢合金棒材及线材的标准规范 (UNS S20910)

1.1 This specification covers the chemical, mechanical, and metallurgical requirements for wrought nitrogen strengthened 22 chromium – 13 nickel – 5 manganese – 2.5 molybdenum stainless steel alloy bar and wire for surgical implants. 1.2 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in non-conformance with the standard.

Standard Specification for Wrought Nitrogen Strengthened 22 Chromiumndash;13 Nickelndash;5 Manganesendash;2.5 Molybdenum Stainless Steel Alloy Bar and Wire for Surgical Implants (UNS S20910)

ASTM F1800-12 整体膝关节替代物的医疗胫骨盘部件的周期疲劳测试的标准实施规程

4.1 This practice can be used to describe the effects of materials, manufacturing, and design variables on the fatigue performance of metallic tibial trays subject to cyclic loading for relatively large numbers of cycles. 4.2 The loading of tibial tray designs in vivo will, in general, differ from the loading defined in this practice. The results obtained here cannot be used to directly predict in vivo performance. However, this practice is designed to allow for comparisons between the fatigue performance of different metallic tibial tray designs, when tested under similar conditions. 4.3 In order for fatigue data on tibial trays to be comparable, reproducible, and capable of being correlated among laboratories, it is essential that uniform procedures be established. 1.1 This practice covers a procedure for the fatigue testing of metallic tibial trays used in knee joint replacements. This practice covers the procedures for the performance of fatigue tests on metallic tibial components using a cyclic, constant-amplitude force. It applies to tibial trays which cover both the medial and lateral plateaus of the tibia. This practice may require modifications to accommodate other tibial tray designs. 1.2 This practice is intended to provide useful, consistent, and reproducible information about the fatigue performance of metallic tibial trays with one unsupported condyle. 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 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.

Standard Practice for Cyclic Fatigue Testing of Metal Tibial Tray Components of Total Knee Joint Replacements

ASTM F2624-12 额外盘单层脊柱结构静态, 动态和磨损评定的标准试验方法

This test method is designed to quantify the static and dynamic characteristics of different designs of single level spinal constructs. Wear may also be assessed for implants that allow motion using testing medium (see 6.1) for simulating the physiologic environment at 37°C. Wear is assessed using a weight loss method in addition to dimensional analyses. Weight loss is determined after subjecting the implants to dynamic profiles specified in this test method. This information will allow the manufacturer or end user of the product to understand how the specific device in question performs under the test conditions prescribed in this test method. This test method is intended to be applicable for single level extra-discal spinal constructs. Three different types of fixtures are specified for testing single level extra-discal spinal constructs (See Fig. 2, Fig. 4, and Fig. 5). See also Table 1. Implants may be designed using a variety of materials (for example, ceramics, metals, polymers, or combinations thereof), and it is the goal of this test method to enable a comparison of the static, dynamic, and wear properties generated by these devices, regardless of material and type of device. TABLE 1 Loading Modes and Associated Apparatus Listing Possible Tests That May Be Conducted (see 1.9) Note 18212;For all loading modes, static, dynamic, and wear tests are described in this test method. Note 28212;“Offset” refers to 8 mm of offset induced in the spinal construct (see Fig. 6) before subjecting the construct to rotational flexion/extension moments (see Fig. 2). Associated ApparatusAssociated FigureLoading Mode RotationalFig. 2Flexion Extension Lateral Bending Axial Rotation Fig. 2 and Fig. 6Offset Flexion and Offset Extension ShearFig. 4Anterior/Posterior Shear Compression BendingFig. 5Compression Bending FIG. 4 Schematic of Anterior/Posterior Shear Testing Apparatus FIG. 5 Schematic of Single Level Compression Bending Test1.1 This test method describes methods to assess the static and dynamic properties of single l......

Standard Test Method for Static, Dynamic, and Wear Assessment of Extra-Discal Single Level Spinal Constructs

ASTM F1717-12a 脊柱植入物结构在脊柱切除术模型上的标准试验方法

1.1 These test methods cover the materials and methods for the static and fatigue testing of spinal implant assemblies in a vertebrectomy model. The test materials for most combinations of spinal implant components can be specific, depending on the intended spinal location and intended method of application to the spine. 1.2 These test methods are intended to provide a basis for the mechanical comparison among past, present, and future spinal implant assemblies. They allow comparison of spinal implant constructs with different intended spinal loca......

Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model

ASTM F1091-12 外科植入物用锻制钴-20铬-15钨-10镍合金的标准规范 (UNS R30605)

1.1 This specification covers the chemical, mechanical, and metallurgical requirements for the manufacture of wrought cobalt-20chromium-15tungsten-10nickel surgical fixation wire. 1.2 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in non-conformance with the standard.

Standard Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy Surgical Fixation Wire (UNS R30605)

ASTM F2902-12 可吸收聚合植入物评估的标准指南

4.1 This guide is aimed at providing guidance for assessments and evaluations to aid in preclinical research and development of various absorbable components and devices. 4.2 This guide includes brief descriptions of various intended uses, processing conditions, assessments, and both qualitative and quantitative analyses for raw materials to finished product components. 4.3 The user is encouraged to utilize appropriate ASTM and other standards to conduct the physical, chemical, mechanical, biocompatibility, and preclinical tests on absorbable materials, device components, or devices prior to assessment in an in vivo model. 4.4 Whenever an absorbable material is mixed or coated with other substances (bioactive, polymeric, or otherwise), the physical and degradation properties of the resulting composite may differ significantly from the base polymer. Thus, unless prior experience can justify otherwise, performance characterizations described herein should be conducted on the composite construct rather than on individual components. 4.5 Assessments of absorbable materials should be performed in accordance with the provisions of the FDA Good Laboratories Practices Regulations 21 CFR 58, where feasible. 4.6 Studies to support regulatory approval for clinical or commercial use, or both, should conform to appropriate nationally adopted directives or guidelines, or both, for the development of medical devices [for example, CE approval; US-FDA Investigational Device Exemption (IDE), Pre- Market Approval (PMA), or 510K submission]. 4.7 Assessments based upon data from physical, chemical, mechanical, biocompatibility, and preclinical testing models are highly valuable but carry inherent limitations. Thus, the clinical relevance of each assessment needs to be carefully considered and the user is cautioned that pre-clinical evaluations may not be predictive of human clinical performance. 1.1 This guide describes general guidelines for the chemical, physical, mechanical, biocompatibility, and preclinical assessments of implantable synthetic polymeric absorbable devices. This guide also describes evaluation methods that are potentially useful and should be considered when assessing absorbable implants or implant components. 1.2 The described evaluations may assist a manufacturer in establishing the safety and effectiveness of an absorbable implant device. This listing of assessment methods may also be utilized to assist in establishing substantial equivalence to an existing commercially marketed device. However, these polymeric material-oriented guidelines do not necessarily reflect the total needs for any particular implant application (for example, orthopedic, cardiovascular), which may require additional and potentially essential application-specific evaluations. 1.3 This guide is intended to cover all forms of absorbable polymeric components and devices, including solid (for example, injection-molded) and porous (for example, fibrous) forms. This guide is also intended to cover devices fabricated from amorphous and/or semi-crystalline absorbable polymer ......

Standard Guide for Assessment of Absorbable Polymeric Implants

ASTM F86-12a 金属外科植入物表面制备和标记的标准操作规程

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.

Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants

ASTM F136-12a 外科植入物用锻制钛-6铝-4钒ELI (超低间质) 合金的标准规范 (UNS R56401)

1.1 This specification covers the chemical, mechanical, and metallurgical requirements for wrought annealed titanium-6aluminum-4vanadium ELI (extra low interstitial) alloy (R56401) to be used in the manufacture of surgical implants. 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.

Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401)

ASTM F2989-12 外科植入物应用的金属注射成型的非合金钛部件的标准规范

1.1 This specification covers the chemical, mechanical, and metallurgical requirements for three grades of metal injection molded (MIM) unalloyed titanium components in two types to be used in the manufacture of surgical implants. 1.2 The Type 1 MIM components covered by this specification may have been densified beyond their as-sintered density by post-sinter processing. 1.3 Values in either inch-pound or SI are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore each system shall be used independent of the other. Combining values from the two systems may result in non-conformance with the specification. 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.

Standard Specification for Metal Injection Molded Unalloyed Titanium Components for Surgical Implant Applications

ASTM F2581-12 外科植入物用锻制氮增强11锰-17铬-3钼低镍不锈钢合金棒材及线材的标准规范 (UNS S29225)

1.1 This specification covers the chemical, mechanical, and metallurgical requirements for wrought nitrogen strengthened 11manganese-17chromium-3molybdenum low-nickel stainless steel alloy bar and wire for surgical implants. 1.2 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in non-conformance with the 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.

Standard Specification for Wrought Nitrogen Strengthened 11Manganese-17Chromium-3Molybdenum Low-Nickel Stainless Steel Alloy Bar and Wire for Surgical Implants (UNS S29225)