ISO/TC 150/SC 1 - Materials

This document specifies the characteristics of, and corresponding test methods for, wrought cobalt-nickel chromium-molybdenum alloy for use in the manufacture of surgical implants. NOTE The tensile properties of a sample obtained from a finished product made of this alloy do not necessarily comply with those specified in this document.

This document specifies the characteristics of, and corresponding test methods for, wrought cobalt-chromium-tungsten-nickel alloy for use in the manufacture of surgical implants. NOTE The tensile properties of a sample obtained from a finished product made of this alloy do not necessarily comply with those specified in this document.

This document specifies the characteristics of, and corresponding test methods for, the wrought titanium alloy known as titanium 6-aluminium 4-vanadium alloy (Ti-6Al-4V alloy) for use in the manufacture of surgical implants. NOTE The mechanical properties of a sample obtained from a finished product made of this alloy might not necessarily comply with the specifications given in this document.

This document specifies the characteristics of, and corresponding test methods for, unalloyed tantalum sheet, rod and wire used in the manufacture of surgical implants. NOTE 1 Provision is made for two grades of tantalum.

This document specifies the characteristics of, and corresponding test methods for bio-stable ceramic-bone-substitute material based on a zirconia-reinforced, high-purity alumina matrix composite for use as bone spacers, bone replacements and components in orthopaedic joint prostheses. This document is intended for composite materials which are based on an alumina matrix, i.e. alumina as the dominating phase in the composite with a mass fraction of >60 %, similar to the material described in ISO 6474‑1, but extended by means of a certain amount of zirconia and other defined ingredients. NOTE The required properties in this document differ from those in ISO 6474‑1 with respect to strength and fracture toughness. Furthermore, there are requirements specifically applicable for zirconia-containing materials (see ISO 13356). In the material composition as defined in this document, additional additives are listed. Typical additives for alumina or zirconia ceramics are Mg, Y, Ce and others. Such additives can be useful in order to improve the mechanical properties and/or the chemical stability of the alumina-zirconia composite material. This document does not cover biocompatibility (see ISO 10993‑1). It is the responsibility of the manufacturer to evaluate the biocompatibility of the specific ceramic composite material which is produced within the framework of this document.

This document specifies the characteristics of, and corresponding test methods for bio-stable ceramic bone substitute material based on high purity alumina for use as bone spacers, bone replacements and components of orthopaedic joint prostheses. This document does not cover biocompatibility (see ISO 10993-1). It is the responsibility of the manufacturer to evaluate the biocompatibility of ceramic materials which are produced within the framework of this document.

This document specifies a test method for investigating the oxidative stability of ultra-high-molecular-weight polyethylene (UHMWPE) materials as a function of processing and sterilization method. This document describes a laboratory method for accelerated ageing of UHMWPE specimens and components for total joint prostheses. The UHMWPE is aged at elevated temperature and at elevated oxygen pressure, to accelerate oxidation of the material and thereby allow for the evaluation of its potential long-term chemical and mechanical stability.

This document specifies the test method for assessing the morphology of UHMWPE moulded forms, which are described in ISO 5834‑2. It is not applicable to UHMWPE powder forms, which are described in ISO 5834‑1. NOTE Performance requirements for this test method have not been established.

This document specifies a method for the measurement of the relative extent of oxidation present in ultra-high molecular weight polyethylene (UHMWPE). It is applicable to ultra-high molecular weight polyethylene (UHMWPE) intended for use in surgical implants.

This document specifies the requirements and corresponding test methods for moulding materials in powder form made from ultra-high-molecular-weight polyethylene (UHMWPE) for use in the manufacture of surgical implants. It is not applicable to finished products.

This document specifies the requirements and corresponding test methods for moulded forms, e.g. sheets and rods, made from ultra-high-molecular-weight polyethylene (UHMWPE) for use in the manufacture of surgical implants. This document is not applicable to direct-moulded (near net shape), irradiated or finished products or products manufactured from polyethylene blended with additives or by blending different forms of polyethylene.

This document specifies the requirements for two wrought cobalt 28-chromium 6-molybdenum alloys used for surgical implants. The properties apply specifically to wrought bar, rod and wire. NOTE 1 The mechanical properties of a sample obtained from a finished product made of this alloy can differ from those specified in this document. NOTE 2 The high carbon content of this alloy produces a structure containing a significant carbide distribution. This can be adjusted either in the production of the bar or in subsequent thermomechanical processing to produce the final device. Carbide distribution in the final device is not included as part of this document.

This document specifies the characteristics of, and corresponding test methods for, wrought stainless steel containing a mass fraction of 0,25 % to 0,50 % nitrogen for use in the manufacture of surgical implants for which high levels of strength and corrosion resistance are required. NOTE 1 The mechanical properties of a sample obtained from a finished product made of this alloy can differ from those specified in this document. NOTE 2 Requirements for other stainless steels for implants for surgery can be found in ISO 5832-1.

This document specifies the characteristics of, and corresponding test methods for, the wrought titanium 15-molybdenum 5-zirconium 3-aluminium alloy for use in the manufacture of surgical implants. This document applies to materials in bar form up to a maximum diameter of 100 mm. NOTE The mechanical properties of a sample obtained from a finished product made of this alloy can differ from those specified in this document.

This document specifies methods of test for the chemical analysis, assessment of crystallinity ratio and phase composition of hydroxyapatite-based materials such as powders, coating or bulk products. NOTE These tests are intended to describe properties of the material and to communicate these between organizations. These tests are not written with the objective of replacing a company's internal operational and assessment tests although they could be used as such.

This document specifies requirements for single layer thermally sprayed hydroxyapatite coatings applied to metallic surgical implants. These requirements are intended to describe properties of the materials and to communicate these between organizations. These requirements are not written with the objective of replacing a company's internal operational and assessment requirements although they could be used as such. NOTE 1 For thin coatings with a thickness of less than 50 µm, some of the test methods described in this document might be difficult to apply without modification. NOTE 2 The requirements of the hydroxyapatite layer of dual-layer coatings (consisting of a lower layer of metallic coating and an upper layer of hydroxyapatite coating) can follow this document; however, testing methods referred to in this document cannot be applied to dual layer coatings. If this document is taken in reference for the requirements of the hydroxyapatite layer of dual layer coatings, a rationale on how the single-layer tested coupons are representative of the dual-layer coated implant might be considered necessary. This document does not cover coatings made from glasses, glass ceramics, alpha- and beta-tricalcium phosphate, biphasic calcium phosphate or other forms of calcium phosphate. NOTE 3 While the requirements in this document are intended to be used as specifications of a thermally sprayed coating of hydroxyapatite, it might be necessary to establish routine control procedures specifying control tests and their time intervals to make sure the characteristics of the coating stay within specified limits. NOTE 4 This document was developed with a focus on plasma sprayed coating of hydroxyapatite. It might also be used to characterize other thermally sprayed coatings of hydroxyapatite. However, thermally sprayed coatings that do not have a history of clinical use might present different risks and might need additional characterizations beyond those identified in this document.

This document specifies a test method for measurement of the adhesion strength of hydroxyapatite coatings intended for use on metallic-substrate components of surgical implants. NOTE Requirements for the competence of testing laboratories can be found in ISO/IEC 17025.

ISO 5832-2:2018 specifies the characteristics of, and corresponding test methods for, unalloyed titanium for use in the manufacture of surgical implants. Six grades of titanium based on tensile strength are listed in Table 2. NOTE The mechanical properties of a sample obtained from a finished product made of this metal do not necessarily comply with those specified in ISO 5832-2:2018.

ISO 13781:2017 describes methods for the determination of chemical and mechanical changes in poly(lactide)-based homopolymers, copolymers and/or blends induced under in vitro degradation testing conditions. This document covers polymers based on L-lactide, D-lactide, and/or D, L-lactide monomeric units. The purpose of this document is to compare and/or evaluate materials or processing conditions. This document also describes the fundamental physical and mechanical evaluations needed for an in vitro degradation characterization of an absorbable poly(lactide) or other hydrolysable material or device. ISO 13781:2017 is applicable to poly(lactide)-based homopolymers, copolymers and/or blends in bulk or processed forms and used for the manufacture of surgical implants, including finished products (packaged and sterilized implants). The test methods specified in this document are also intended to determine the in vitro degradation rate and related changes in material properties of polylactide-based copolymers and/or blends with various other comonomers, such as glycolid, trimethylene, carbonate and/or ε-caprolactone. Unless otherwise validated for a specific device, these in vitro methods cannot be used to definitively predict device behaviour under in vivo conditions.

ISO 5832-7:2016 specifies the characteristics of, and corresponding test methods for, forgeable and cold-formed cobalt-chromium-nickel-molybdenum-iron alloy for use in the manufacture of surgical implants.

ISO 5832-1:2016 specifies the characteristics of, and corresponding test methods for, wrought stainless steel for use in the manufacture of surgical implants. NOTE 1 The mechanical properties of a sample obtained from a finished product made of this alloy can differ from those specified in this part of ISO 5832. NOTE 2 The alloy described in this part of ISO 5832 corresponds to UNS S31673 referred to in ASTM F138/ASTM F139 and to alloy code 1.4441 given in the withdrawn DIN 17443.

ISO 13356:2015 specifies the requirements and corresponding test methods for a biocompatible and biostable ceramic bone-substitute material based on yttria-stabilized tetragonal zirconia (yttria tetragonal zirconia polycrystal, Y-TZP) for use as a material for surgical implants.

ISO 13779-6:2015 specifies requirements for hydroxyapatite powders used as a raw material for the manufacturing of surgical implants or coating of surgical implants. ISO 13779-6:2015 does not apply to hydroxyapatite coatings, ceramic hydroxyapatite, glass ceramics, α- and β-tricalcium phosphate, or other forms of calcium phosphate.

ISO 5832-4:2014 specifies the characteristics of, and corresponding test methods for, cobalt-chromium-molybdenum casting alloy for use in the manufacture of surgical implants.

ISO 5832-11:2014 specifies the characteristics of, and corresponding test methods for, the wrought titanium alloy known as titanium 6-aluminium 7-niobium alloy (Ti-6-Al 7-Nb) for use in the manufacture of surgical implants.

ISO 23317:2014 specifies a method for detecting apatite formed on a surface of a material in simulated body fluid (SBF). It is applicable to implant surfaces intended to come into direct bone contact.

ISO 15309:2013 specifies a method for the thermal analysis of Poly Ether Ether Ketone (PEEK) that is for use in the manufacture of implantable medical devices, using differential scanning calorimetry (DSC). The transition temperatures to be determined are the glass transition temperature (Tg), the melting temperature (Tm) and the crystallization temperature on cooling (Tc).

1 Scope This part of ISO 13175 specifies requirements for monophasic hydroxyapatite bone substitutes, monophasic β-tricalcium phosphate bone substitutes and biphasic hydroxyapatite/β-tricalcium phosphate bone substitutes in the form of blocks or granules. This part of ISO 13175 is not applicable to cell-seeded bone void fillers, calcium phosphate cements or bone void fillers containing materials other than hydroxyapatite and β-tricalcium phosphate.

ISO 16402:2008 applies to resin cements based on poly(methacrylic acid esters) and specifies the procedure for determining the fatigue behaviour of the polymerized cement.

ISO 20160:2006 provides a catalogue of metallographic photomicrographs for the designation of microstructures of alpha+beta titanium alloys in the form of bars that are intended for the manufacture of surgical implants. ISO 20160:2006 is applicable to bars of diameter no greater than 100 mm or the equivalent.

ISO 16428:2005 specifies standard environmental conditions for the testing of metallic materials intended for implantation, surgical implants, and medical devices. The testing conditions described simulate physiological conditions in a simplified manner controlling the test solution, the temperature, the gaseous atmosphere and the proportions of sample size and volume of solution. These environmental testing conditions can be employed where necessary in combination with various static or dynamic tests where the effect of the physiological environment is to be considered. Typical applications are corrosion fatigue tests and selected fretting and wear tests, as well as general electrochemical tests. Typical articulating joint simulator tests and aspects particular to the dental field are not considered by ISO 16428:2005. Solutions that attempt to replicate the tribological properties of body fluids, such as those used in wear studies, are outside the scope of ISO 16428:2005.

ISO 16429:2004 specifies a test method for measurements over extended time periods of the open-circuit potential of implant materials and surgically implantable devices immersed in a test environment related to body fluid, using a standard corrosion test cell to study the electrochemical corrosion properties of the devices. This method of monitoring the open-circuit potential can also be combined with mechanical static or dynamic loading tests. ISO 16429:2004 is applicable in particular to metallic materials which form passive layers with protective properties against corrosion, as typical for surgical implant materials. This test method is intended for the investigation of single metallic materials or alloys. It is not applicable to dissimilar material combinations, which require particular considerations in measuring and interpreting the results.

This International Standard specifies the physical, mechanical, packaging and labelling requirements for curing polymerizing radio-opaque and non-radio-opaque resin cements based on poly(methacrylic acid esters). It applies to two types of cement, intended respectively for use with a syringe or in the dough state, for the fixation of internal orthopaedic prostheses and supplied as units containing premeasured amounts of sterile powder and of sterile liquid in forms suitable for mixing at the time of implantation. This International Standard does not cover the hazards associated with the use of the cement in respect of either the patient or the user of the cement. All requirements apply to, and all tests are intended to be performed on, the sterile product.

This International Standard specifies the characteristics of, and corresponding test methods for, the two-part addition-cure high consistency or liquid silicone elastomer for use in the manufacture (partially or totally) of surgical implants.

The method for detecting and evaluating internal imperfections shall be performed in accordance with the requirements in ISO 1027 and ISO 5579. Guidance on the acceptance limits for internal imperfections is given in annex A.

The method for detecting and evaluating internal imperfections shall be performed in accordance with the requirements in ISO 3452. Guidance on the acceptance limits for surface imperfections in the raw and finally treated and finished conditions is given in annex A.

ISO 5832-3:2016 specifies the characteristics of, and corresponding test methods for, the wrought titanium alloy known as titanium 6-aluminium 4-vanadium alloy (Ti 6-AI4-V alloy) for use in the manufacture of surgical implants. NOTE The mechanical properties of a sample obtained from a finished product made of this alloy may not necessarily comply with the specifications given in this part of ISO 5832.

ISO 23317:2012 specifies a method for detecting apatite formed on a surface of a material in simulated body fluid (SBF). It is applicable to implant surfaces intended to come into direct bone contact.

ISO 5834-2:2011 specifies the requirements and corresponding test methods for moulded forms, e.g. sheets and rods, made from ultra-high-molecular-weight polyethylene (UHMWPE) for use in the manufacture of surgical implants. ISO 5834-2:2011 is not applicable to direct-moulded (near net shape), irradiated or finished products or products manufactured from polyethylene blended with additives or from blending of different forms of polyethylene.

ISO 6474-1:2010 specifies the characteristics of, and corresponding test methods for, a bio-compatible and bio-stable ceramic bone substitute material based on high purity alumina for use as bone spacers, bone replacements and components of orthopaedic joint prostheses.

ISO 13779-1:2008 specifies requirements for ceramic hydroxyapatite intended for use as surgical implants. It applies to hydroxyapatite blocks. ISO 13779-1:2008 does not apply to hydroxyapatite coatings, hydroxyapatite powder or nanoparticle-type and calcium phosphate ceramics which are not mainly composed of crystalline hydroxyapatite.

ISO 13779-2:2008 specifies requirements for ceramic hydroxyapatite coatings applied to metallic or non-metallic surgical implants. ISO 13779-2:2008 does not cover coatings made from glasses, glass ceramics, alpha- and beta-calcium orthophosphate or other forms of calcium phosphate, nor does it cover coatings in which the hydroxyapatite is present in a powder form.

ISO 13356:2008 specifies the characteristics of, and corresponding test methods for, a biocompatible and biostable ceramic bone-substitute material based on yttria-stabilized tetragonal zirconia (yttria tetragonal zirconia polycrystal, Y-TZP) for use as material for surgical implants.

ISO 13779-3:2008 specifies methods of test for the chemical analysis and assessment of crystallinity and phase composition of hydroxyapatite-based materials such as coatings and sintered products.

ISO 5832-14:2007 specifies the characteristics of, and corresponding test methods for, the wrought titanium 15-molybdenum 5-zirconium 3-aluminium alloy for use in the manufacture of surgical implants. ISO 5832-14:2007 applies to materials in bar form up to a maximum diameter of 100 mm.

ISO 5832-1:2007 specifies the characteristics of, and corresponding test methods for, wrought stainless steel for use in the manufacture of surgical implants.

ISO 5832-9:2007 specifies the characteristics of, and corresponding test methods for, wrought stainless steel containing a mass fraction of 0,25 % to 0,50 % nitrogen for use in the manufacture of surgical implants for which high levels of strength and corrosion resistance are required.