ISO/TC 150 - Implants for surgery

This document provides a method for quantification of marker peptide of type I collagen which was purified products extracted from bovine tissues with liquid chromatography - tandem mass spectrometry (LC-MS/MS). The method described in this document is intended to be used for marker peptide detection of purified bovine type I collagen which will be used for constructing tissue-engineered medical products (TEMPs) or other collagen-based biomaterials, for product quality control. This method also can be used for qualitative analysis and quantitative detection of bovine-specific and/or type I-specific collagen in the samples mixed with other animal sources and/or other type collagen. This document does not exclude other possible methods for quantifying type I collagen, such as hydroxyproline quantification, that can evaluate the total amount of collagen regardless of type. NOTE 1 The collagen has been known there are greater than 28 types and with the different property in each one. This document focuses on the quantification of marker peptide of purified bovine type I collagen. Type I collagen isolated from skin, tendon, bone, etc., can contain other types of collagen, for example, type III and type V. And type I collagen can be sourced from bovine, swine, etc. For quantification of other types of collagens or type I collagen sourced from other species of animals can use this document as a template, but need to design collagen type-specific or/and animal species-specific characteristic peptides for LC-MS/MS method, as well as optimize the determination conditions. NOTE 2 For quantification of the collagen marker peptide of scaffold which combined with other materials, or type I collagen contained in ECM materials of tissues or type I collagen-based regenerative tissues, can refer to this document, but need to isolate or/and purify the type I collagen with a reasonable and verified method at first (9,10), and then quantify it by referring to the method provided in this document.

This document specifies a test method for determining short-term deformation of a press-fit acetabular component for total hip joint replacement under specific laboratory conditions. This document also defines the conditions of testing so that the important parameters that affect the components are taken into account and it describes how the specimen is set up for testing. The described method is intended to be used to measure the amount of deformation under load and plastic deformation after unloading of various designs and materials used for acetabular components in total hip joint replacement. These measurements are then used in an evaluation of risks associated with acetabular cup deformation for the acetabular component under evaluation to determine if its performance can be adversely affected. In the evaluation of risks associated with acetabular component deformation, it can be useful to take into consideration various design, material and surgical implantation factors (e.g. those identified in REF Section_sec_8 \r \h Clause 8 08D0C9EA79F9BACE118C8200AA004BA90B02000000080000000E000000530065006300740069006F006E005F007300650063005F0038000000 ), and, if necessary, a comparison of results to a reference implant tested under the same conditions. Depending on this evaluation, either additional testing or clinical data, or both, which is outside the scope of this document, can be necessary. The loading of the acetabular components in vivo differs, in general, from the loading defined in this test method. The results obtained here cannot be used to directly predict in vivo performance. This document does not cover methods that examine the test specimens.

This document specifies a test procedure to simulate and to evaluate lumbar and cervical spinal disc prostheses wear under adverse impingement conditions.

This document identifies factors that affect the safety and performance of surgical implants due to the fact that these implants are manufactured additively. This document applies to non-active implants manufactured additively, including custom-made implants and patient-matched implants. This document also applies to instrumentation for use in association with non-active surgical implants manufactured by additive manufacturing (AM). While this document is not intended to apply to active implants, certain clauses or subclauses of this document can potentially still be used in the context of active implants. This document identifies factors which are either unique to additively manufactured implants or which require additional consideration for additively manufactured implants. These factors have not always been included within existing implant specific standards. This document is not applicable to implants which contain or incorporate tissues or cells, or their derivates, of animal or human origin.

This document 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 conform with those specified in this document.

This document specifies surface finish requirements for the articulating surfaces of total and partial knee joint prostheses classified in ISO 7207-1. This document is intended to provide guidance for periodic validation of production processes.

This document specifies the requirements and corresponding test methods for moulded forms (e.g. sheets, rods and near net shape bars) made from ultra-high-molecular-weight polyethylene (UHMWPE) powder for use in the manufacture of surgical implants. This document is not applicable to moulded forms that were intentionally irradiated, that were made from UHMWPE blended with additives or UHMWPE blended with different forms of polyethylene, and the packaged and sterilized finished implant.

This document specifies the requirements and corresponding test methods for ultra-high-molecular-weight polyethylene (UHMWPE) powder moulding materials for use in the manufacturing of moulded forms that are subsequently used in the manufacturing of surgical implants. This document is not applicable to UHMWPE moulding materials that were blended with any additives or different forms of polyethylene.

This document specifies the test method for assessing the morphology of ultra-high-molecular-weight polyethylene (UHMWPE) moulded forms as defined in ISO 5834-2. The assessment of morphology of UHMWPE moulded forms is not required in routine monitoring of validated moulding process because alternative test methods defined in ISO 5834-2, such as density and mechanical properties, already provide reasonable, redundant assurance of successful consolidation. This document 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 test method for investigating the oxidative stability of ultra-high-molecular-weight polyethylene (UHMWPE) moulded forms as a function of processing and sterilization method. This document describes a laboratory method for accelerated ageing of specimens taken from UHMWPE moulded forms or forms fabricated from these for use in the manufacture of surgical implants. The specimens are 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 a method for the measurement of the relative extent of oxidation present in ultra-high-molecular-weight polyethylene (UHMWPE) moulded forms or forms fabricated for use in the manufacture of surgical implants.

This document specifies a procedure for preparing the simulated body fluid (SBF) and a test method for use as an initial screening tool in the evaluation of apatite formation on the surfaces of bone-contacting implant materials. NOTE 1 The results of this SBF test (see REF Section_sec_7 \r \h Clause 7) alone do not establish bone-bonding ability. The test can be used along with other in vitro and in vivo confirmatory tests to establish an implant material’s ability to bond with bone tissue in vivo. This document is limited to an assessment of the in vitro apatite-forming ability of bulky solid materials used for bone-contacting implants and is not intended to be used to evaluate this ability of porous materials, particulate materials or solute molecules or ions. NOTE 2 Porous materials are excluded from test specimens because they require a large volume of SBF due to high surface area, and often have difficulty in penetration of SBF into their porous bodies. Furthermore, analysis of the inner surfaces of porous materials is difficult by the method described in this document.

This document establishes the currently recognized approaches and special considerations needed when evaluating the in vitro and in vivo performance of absorbable metals and implants fabricated, in whole or in part, from them. This document describes how the evaluation of these metals can differ from those utilized for permanent non-absorbable implantable implants (or subcomponents), in that absorbable metal implants (or subcomponents) are – by design – intended to be absorbed in their entirety by the host. This document provides guidance regarding the materials considerations, in vitro degradation/fatigue characterization, and biological evaluation of medical implants made of absorbable metals. The provided content is intended to deliver added clarity to the evaluation of these materials and implants to increase awareness of critical factors and reduce potential for generation of erroneous or misleading test results. While this document and the herein described referenced standards contain many suggested alterations or modifications to currently practiced procedures or specifications, the provided content is intended to complement, and not replace, current conventions regarding the assessment of implantable implants. This document covers the evaluation of absorbable metal specific attributes in general and is not intended to cover application or implant specific considerations. Thus, it is important to consult relevant implant and/or application specific standards. This document does not apply to non-absorbable or non-metallic components (e.g. polymeric coatings, pharmaceuticals, non-absorbable metals) used in conjunction with absorbable metal implants.

This document illustrates the implementation of the risk management process to the total product life cycle of cardiac valve replacement and repair systems. It provides specific examples of how risk management requirements and concepts can be applied to new or modified cardiac valve replacement and repair systems. The informative examples included herein are not exhaustive.

This document specifies specific requirements for mammary implants. With regard to safety, this document specifies requirements for intended performance, design attributes, materials, design evaluation, manufacturing, packaging, sterilization and information supplied by the manufacturer.

This document specifies the requirements for the evaluation of vena cava filter systems (filters and delivery systems) and the requirements with respect to nomenclature, design attributes and information supplied by the manufacturer. Guidance for the development of in vitro test methods is included in Annex D. This document is intended to be used in conjunction with ISO 14630, which specifies general requirements for the performance of non-active surgical implants. NOTE 1 Due to the variations in the design of implants covered by this document, and in some cases due to the emergence of novel types of such implants, acceptable standardized in vitro tests and clinical results are not always available. As further scientific and clinical data become available, a revision of this document will be necessary. This document is applicable to vena cava filters intended to prevent symptomatic pulmonary embolism by capturing blood clots in the inferior vena cava (IVC). While this document can be useful with respect to filters implanted in other venous locations (e.g. superior vena cava, iliac veins), it does not specifically address the use of filters in other implantation sites. This document is also applicable to permanent filters together with their associated delivery systems, optional filters that can be retrieved and their associated retrieval systems, and convertible filters and their associated conversion systems. While this document can be useful with respect to the evaluation of repositioning filters after chronic implantation, it does not specifically address filter repositioning. This document is not applicable to — temporary filters (e.g. tethered) that need to be removed after a defined period of time, — issues associated with viable tissues and non-viable biological materials, and — procedures and devices (e.g. venous entry needle) used prior to the vena cava filter procedure. Although absorbable filters and filters with absorbable coatings are within the scope of this document, this document is not comprehensive with respect to the absorbable properties of these devices. NOTE 2 Absorbable implants are covered in ISO/TS 17137. Although coated filters and coated filter systems are within the scope of this document, this document is not comprehensive with respect to coatings. NOTE 3 Vascular device-drug combination products are covered in ISO 12417-1 and some coating properties are covered in ISO 25539-4.

This document specifies requirements for sterile, single-use, extracorporeal blood-gas exchangers (oxygenators) intended for the supply of oxygen to, and the removal of carbon dioxide from, human blood, during cardiopulmonary bypass (CPB) for up to 6 h, extracorporeal lung assist [ECLA with veno-venous (VV), veno-arterial (VA) or veno-arterial-venous (VAV) cannulation strategies], cardiopulmonary support (CPS), extracorporeal life support (ECLS with VA cannulation strategy), extracorporeal carbon dioxide removal (ECCO2R), and other extracorporeal circulation techniques requiring blood-gas exchange. This document also applies to heat exchangers and arterial filters that are integral parts of the oxygenator. This document also applies to external equipment unique to the use of the oxygenator. This document does not apply to — implanted oxygenators, — liquid oxygenators, — extracorporeal circuits (blood tubing), — separate heat exchangers, — separate ancillary devices, and — separate arterial line filters.

This document specifies general requirements for non-active surgical implants, hereafter referred to as implants. This document is not applicable to dental implants, dental restorative materials, transendodontic and transradicular implants, intra-ocular lenses and implants utilizing viable animal or human tissue. With regard to safety, this document specifies requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging and information supplied by the manufacturer, and tests to demonstrate compliance with these requirements. Additional requirements applicable to specific implants or implant families are given or referred to in Level 2 and Level 3 standards. NOTE 1 This document does not require that the manufacturer have a quality management system in place. However, many regulatory authorities require the application of a quality management system, such as that described in ISO 13485, to ensure that the implant achieves its intended performance and safety. NOTE 2 In this document, when not otherwise specified, the term "implant" refers to each individual component of a system or a modular implant, provided separately or as a set of components, as well as to all ancillary implants or associated implants designed for improving the intended performance.

This document specifies the general requirements for the preparation of fluids for haemodialysis and related therapies and substitution fluid for use in online therapies, such as haemodiafiltration and haemofiltration, for dialysis practitioners. This document gives guidance on the user's responsibility for fluids used in haemodialysis and related therapies once the equipment used in its preparation has been delivered and installed. As dialysis water used to prepare dialysis fluid can also be used to reprocess dialysers not marked intended for single use, this aspect of water use is also covered by this document. This document is applicable to — the quality management of equipment used to treat and distribute water used for the preparation of dialysis fluid and substitution fluid, from the point at which municipal water enters the dialysis facility to the point at which the final dialysis fluid enters the dialyser or the point at which substitution fluid is infused. — the quality management of the equipment used to prepare acid and bicarbonate concentrate from powdered or other highly concentrated media at a dialysis facility, and — the preparation of the final dialysis fluid or substitution fluid from dialysis water and concentrates. This document does not apply to — sorbent-based dialysis fluid regeneration systems that regenerate and recirculate small volumes of dialysis fluid, — systems for continuous renal replacement therapy that use pre-packaged solutions, and — systems and solutions for peritoneal dialysis. This document does not address clinical issues associated with inappropriate usage of such fluids.

This document specifies the performance requirements for sterile, single-use non-active hydrocephalus shunts. This includes not only the valve, but also additional components such as tubes and reservoirs. This document does not provide any recommendations on which type of valve is most suitable for any specific context of use. This document specifies the mechanical and technical requirements to manufacture shunts and the technical information of the valve to be supplied by the manufacturer. This document does not apply to active implants for the treatment of hydrocephalus.

This document specifies requirements and recommendations for individual water treatment devices and water treatment systems assembled from one or more of such devices. This document is directed at the individual or company that specifies the complete water treatment system and, the supplier who assembles and installs the system. Since systems can be assembled from a number of individual water treatment devices, the provisions of this document are also directed at the manufacturers of these devices, provided that the manufacturer indicates that the device is intended to be used to supply water for haemodialysis and related therapies. This document is applicable to all devices, piping and fittings between the point at which water is delivered to the water purification system and the point of use of the purified water. Such components include but are not necessarily limited to water purification devices, online water quality monitors (such as conductivity monitors) and piping systems for the distribution of purified water. This document does not apply to — equipment used in the preparation of concentrates from powder or other highly concentrated media at a dialysis facility either for a single patient or multiple patients, — dialysis fluid supply systems that proportion water and concentrates to produce dialysis fluid, — sorbent dialysis fluid regeneration systems that regenerate and recirculate small volumes of the dialysis fluid, — dialysis concentrates, — haemodiafiltration or haemofiltration systems, — systems that process dialysers for multiple uses, and — peritoneal dialysis systems. Requirements for the ongoing monitoring of water purity in terms of chemical and microbiological quality are given in ISO 23500-3.

1.1 This document specifies an approach for verifying and validating the design and manufacture of a heart valve repair system through risk management. The selection of appropriate verification and validation tests and methods are derived from the risk assessment. The tests include assessments of the physical, chemical, biological and mechanical properties of components and materials of heart valve repair systems. The tests also include preclinical in vivo evaluation and clinical investigation of the finished heart valve repair system to assess the safety and effectiveness of the heart valve repair system. NOTE For the purposes of this document, effectiveness end point includes clinical performance and benefits. 1.2 This document defines operational conditions and performance requirements for heart valve repair systems where adequate scientific and/or clinical evidence exists for their justification. It also describes the labels and packaging of the device. 1.3 This document applies to all heart valve repair systems that have an intended use to repair and/or improve the function of native human heart valves by acting either on the valve apparatus or on the adjacent anatomy (e.g. ventricle, coronary sinus). 1.4 This document does not apply to cardiac resynchronization therapy (CRT) devices, paravalvular leakage closure devices, systems that do not leave an implant in place (e.g. ablation, radio frequency annuloplasty), apical conduits and devices with components containing viable cells. This document also excludes materials not intended for repairing and/or improving the function of human heart valves according to its intended use (e.g. patch material and sutures used in general surgical practice). NOTE A rationale for the provisions of this document is given in Annex A.

This document specifies requirements and test methods for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators, hereinafter collectively referred to as “the device”, for use in humans. This document does not apply to: — extracorporeal blood circuits; — plasmafilters; — haemoperfusion devices; — vascular access devices; — blood pumps; — systems to prepare, maintain or monitor dialysis fluid; — systems or equipment intended to perform haemodialysis, haemodiafiltration, haemofiltration or haemoconcentration; — reprocessing procedures and equipment. NOTE 1 Requirements for extracorporeal blood circuits for haemodialysers, haemodiafilters and haemofilters are specified in ISO 8637-2. NOTE 2 Requirements for plasmafilters are specified in ISO 8637-3.

This document specifies requirements and test methods for plasmafilters, which are devices intended to separate plasma from blood in therapeutic plasmapheresis therapy. This document specifies the requirements for sterile, single-use plasmafilters, intended for use on humans, hereinafter collectively referred to as “the device”, for use in humans. This document does not apply to; — extracorporeal blood circuits; — haemodialysers, haemodiafilters, haemofilters and haemoconcentrators; — haemoperfusion devices; — vascular access devices; — blood pumps; — systems or equipment intended to perform plasma separation. NOTE 1 Requirements for the extracorporeal blood circuit are specified in ISO 8637-2. NOTE 2 Requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators are specified in ISO 8637-1.

This document specifies the chemical and microbiological requirements for concentrates used for haemodialysis and related therapies and applies to the manufacturer of such concentrates. This document is applicable to: — concentrates in both liquid and powder forms; — additives, also called spikes, which are chemicals that can be added to the concentrate to supplement or increase the concentration of one or more of the existing ions in the concentrate and thus in the final dialysis fluid; — equipment used to mix acid and bicarbonate powders into concentrate at the user's facility. This document does not apply to: — concentrates prepared from pre-packaged salts and water at a dialysis facility for use in that facility; — pre-packaged and sterile dialysis fluid; — sorbent dialysis fluid regeneration systems that regenerate and recirculate small volumes of the dialysis fluid; — equipment to perform patient treatment; this is addressed IEC 60601-2-16. This document does not cover the dialysis fluid that is used to clinically dialyse patients. Dialysis fluid is covered in ISO 23500-5. The making of dialysis fluid involves the proportioning of concentrate and water at the bedside or in a central dialysis fluid delivery system. Although the label requirements for dialysis fluid are placed on the labelling of the concentrate, it is the user's responsibility to ensure proper use.

This document specifies the minimum chemical and microbiological quality requirements, for water used for preparation of dialysis fluids, concentrates, and for the reprocessing of haemodialysers, together with the necessary steps to ensure conformity with the requirements. The document also provides guidance for the ongoing monitoring of the purity of such water in terms of chemical and microbiological quality. This document is applicable to — water used in the preparation of dialysis fluids for haemodialysis, haemodiafiltration and haemofiltration and the reprocessing of haemodialysers, and — water used in the preparation of concentrates. This document does not apply to dialysis fluid regenerating systems. The operation of water treatment equipment and the final mixing of treated water with concentrates to produce dialysis fluid are the sole responsibility of dialysis professionals.

This document specifies the minimum chemical and microbiological quality requirements for dialysis fluids used in haemodialysis and related therapies. This document applies to — dialysis fluids used for haemodialysis and haemodiafiltration, — substitution fluid produced online for haemodiafiltration and haemofiltration based on dialysis fluid This document does not apply to — the water and concentrates used to prepare dialysis fluid or the equipment to produce dialysis fluid — sorbent-based dialysis fluid regeneration systems that regenerate and recirculate small volumes of dialysis fluid, — systems for continuous renal replacement therapy that use pre-packaged solutions, and — systems and solutions for peritoneal dialysis. The delivery and monitoring of the dialysis fluid composition and its permitted deviation from set points is governed by protective systems defined in IEC 60601-2-16.

This document specifies requirements for disposable extracorporeal blood and fluid circuits and accessories used in combination with haemodialysis equipment intended for extracorporeal blood treatment therapies such as, but not limited to, haemodialysis, haemodiafiltration, haemofiltration. This document does not apply to: — haemodialysers, haemodiafilters or haemofilters; — plasmafilters; — haemoperfusion devices; — vascular access devices. NOTE 1 Requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators are specified in ISO 8637-1. NOTE 2 Requirements for plasmafilters are specified in ISO 8637-3.

This document 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. 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 the characteristics of, and corresponding test methods for, cobalt-chromium-molybdenum casting 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 can differ from those given in this document.

This document 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 document. NOTE 2 The alloy described in this document corresponds to UNS S31673 in ASTM F138 and ASTM F139.

This document specifies the characteristics of, and corresponding test methods for, the wrought titanium alloy known as titanium 6-aluminium 7-niobium alloy (Ti-6Al-7Nb) for use in the manufacture of surgical implants. 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 requirements for vascular device-drug combination products (VDDCPs). With regard to safety, this document outlines requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information supplied by the manufacturer. For implanted products, this document is intended to be used as a supplement to ISO 14630, which specifies general requirements for the performance of non-active surgical implants. This document is intended to be used as a supplement to relevant device-specific standards, such as the ISO 25539 series specifying requirements for endovascular devices. Requirements listed in this document also address VDDCPs that are not permanent implants. NOTE 1 Due to variations in the design of combination products covered by this document and due to the relatively recent development of some of these combination products, acceptable standardized in vitro test results and clinical study results are not always available. As further scientific and clinical data become available, appropriate revision of this document can be necessary. This document applies to delivery systems or parts of the delivery system that are an integral component of the vascular device and that are drug-covered (e.g. drug-covered balloon catheters and drug-covered guidewires). This document does not apply to devices whose PMOA provide a conduit for delivery of a drug (e.g. infusion catheters), unless they contain a drug component that is intended to have an ancillary action to the device part (e.g. antimicrobial coated infusion catheter). This document does not apply to procedures and devices used prior to and following the introduction of the VDDCP (e.g. balloon angioplasty devices) that do not affect the drug-related aspects of the device. This document does not provide a comprehensive pharmacological evaluation of VDDCPs. NOTE 2 Some information about the requirements of certain national and regional authorities is given in Annex B. The connection of absorbable components of VDDCPs (e.g. coatings) with drug-related aspects of the device are addressed in this document. This document does not provide an exhaustive list of the degradation and other time-dependent aspects of absorbable implants and coatings. NOTE 3 For more information on absorbable coatings, refer to ISO/TS 17137 and ASTM F3036-13. This document does not address issues associated with viable or non-viable biological materials such as tissues, cells or proteins. This document does not address issues associated with active surgical implants (i.e. implants that require power not generated by the human body or gravity).

This document establishes a method for detecting and evaluating internal imperfections of cast metallic surgical implants and related weldments. The procedures established in this document apply to film-based methods. The recommendations on the acceptance limits for internal imperfections in cast metallic surgical implants are given in Annex A. NOTE In this document, when not otherwise specified, the term “manufacturer” refers to the “implant manufacturer”, and the term “product” refers to the “metallic cast implant for surgery” or to the “component of metallic cast implant for surgery”.

This document provides requirements and recommendations for specification and verification of synthetic anatomical bone models for use in testing of implants. The anatomical source of the synthetic model can be digital data from computed tomography (CT) scanning or any other sources such as from cadaveric specimens or statistically determined shape data. The specifications covered in this document are 3D shape and mechanical characteristics. Other characteristics, such as colour or cosmetic features, are not considered in this document.

This document specifies requirements for knee-joint replacement implants. Regarding safety, this document specifies requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging, information supplied by the manufacturer and methods of test. This document applies to both total and partial knee joint replacement implants. It applies to these replacements both with and without the replacement of the patella-femoral joint. It applies to components made of metallic and non-metallic materials. This document applies to a wide variety of knee replacement implants, but for some specific knee replacement implant types, some considerations, not specifically covered in this document, can be applicable. Further details are given in 7.2.1.2. The requirements which are specified in this document are not intended to require the re-design or re-testing of implants which have been legally marketed and for which there is a history of sufficient and safe clinical use. For such implants, compliance with this document can be demonstrated by providing evidence of the implant’s sufficient and safe clinical use.

This document specifies requirements for hip-joint replacement implants. With regard to safety, this document specifies requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging, information supplied by the manufacturer and methods of test. This document applies to both total and partial hip joint replacement implants. It applies to components made of metallic and non-metallic materials. This document applies to a wide variety of hip replacement implants, but for some specific hip replacement implant types, some considerations, not specifically covered in this document, can be applicable. Further details are given in 7.2.1.2. The requirements which are specified in this document are not intended to require the re-design or re-testing of implants which have been legally marketed and for which there is a history of sufficient and safe clinical use. For such implants, compliance with this document can be demonstrated by providing evidence of the implant’s sufficient and safe clinical use.

This document describes in vitro methods of measurement of the sizing parameters for surgical valves (referring to mechanical and stented bioprosthetic valves only here and hereafter). It represents a consensus reached among manufacturers, independent bioengineers and clinicians, and is underpinned by interlaboratory studies. This document relates to surgical heart valve prostheses and is intended to be used in conjunction with ISO 5840-1:2021 and ISO 5840-2:2021. Where noted, the requirements of this document clarify certain requirements of ISO 5840-1 and/or ISO 5840-2. Specific methodologies are included for flexible leaflet (bioprosthetic) and rigid (mechanical) valves. Sutureless valves, stentless valves and valved conduits are not included.

This document provides a principle to determine the parameter settings and operating methods for the evaluation of the composition and structure of articular cartilage by dGEMRIC and T2-mapping MRI in humans with a typical example of the methods; each are distinct MRI technologies that allow for noninvasive observation of soft tissue characteristics. The methods provided in this document are intended for application in the evaluation of the clinical effects of tissue-engineered cartilage or other cartilage regeneration products used in the knee joint, and are also applicable for the evaluation of regenerative cartilage in other joints, although some modification of parameters is needed. This document describes a longitudinal evaluation of the water content, the glycosaminoglycan (GAG) concentration, and the concentration and orientation of collagen fibres in regenerative cartilage when using dGEMRIC and T2-mapping techniques in 1,5 T or 3,0 T magnetic resonance imaging equipment.

This document provides region-specific information for: — local submissions and approvals for vascular device-drug combination products (VDDCPs) in countries and regions around the world; — changes related to the drug-containing part and how they are evaluated by different local regions. For implanted products, this document is considered as a supplement to ISO 14630, which specifies general requirements for the performance of non-active surgical implants. This document is considered also as a supplement to ISO 12417-1, and any relevant device-specific standards, such as the ISO 25539 series specifying requirements for endovascular devices. This document also addresses VDDCPs that are not necessarily permanent implants.

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 particular requirements for active implantable medical devices intended to deliver a medicinal substance to site-specific locations within the human body, to provide basic assurance of safety for both patients and users. It amends and supplements ISO 14708-1:2014. The requirements of this document take priority over those of ISO 14708-1. This document is applicable to active implantable medical devices intended to deliver medicinal substances to site-specific locations within the human body. This document is also applicable to some non-implantable parts and accessories of the devices defined in Clause 3. The tests that are specified in this document are type tests intended to be carried out on a sample of a device to show compliance and are not intended to be used for the routine testing of manufactured products. NOTE This document is not intended to apply to non-implantable infusion systems.

This document establishes the characteristics of self-closing aneurysm clips intended for permanent intracranial implantation and specifies requirements for their marking, packaging, sterilization and for labelling and accompanying documentation. In addition, it gives a method for the measurement of closing force. This document is not applicable to malleable clips, or clips intended to be used during the course of surgery and removed before wound closure (temporary clips). NOTE In this document when not otherwise established, the term “implant” refers to the self-closing intracranial aneurysm clips.