11.040.40 - Implants for surgery, prosthetics and orthotics
ICS 11.040.40 Details
Implants for surgery, prosthetics and orthotics
Implantate fur Chirurgie, Prothetik und Orthetik
Implants chirurgicaux, protheses et ortheses
Implantanti za kirurgijo, protetiko in ortetiko
General Information
e-Library Subscription
Create subscription and get permanent access to documents within 11.040.40 - Implants for surgery, prosthetics and orthotics
Currently subscription includes documents marked with .We are working on making all documents available within the subscription.
This document specifies a test procedure to simulate and to evaluate lumbar and cervical spinal disc prostheses wear under adverse impingement conditions.
- Standard15 pagesEnglish languagesale 15% off
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.
- Standard10 pagesEnglish languagesale 15% off
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.
- Standard10 pagesEnglish languagesale 15% off
This document extends the base nomenclature provided in ISO/IEEE 11073-10101:2020 to support terminology for implantable cardiac devices. Devices within the scope of this nomenclature are implantable devices such as pacemakers, defibrillators, devices for cardiac resynchronization therapy, and implantable cardiac monitors. This nomenclature defines the terms necessary to convey a clinically relevant summary of the information obtained during a device interrogation. The nomenclature extensions may be used in conjunction with other IEEE 11073 standard components (e.g., ISO/IEEE 11073-10201 [B2] ) or with other standards, such as Health Level Seven International (HL7).
- Standard145 pagesEnglish languagesale 10% offe-Library read for1 day
This document extends the base nomenclature provided in ISO/IEEE 11073-10101:2020 to support terminology for implantable cardiac devices. Devices within the scope of this nomenclature are implantable devices such as pacemakers, defibrillators, devices for cardiac resynchronization therapy, and implantable cardiac monitors. This nomenclature defines the terms necessary to convey a clinically relevant summary of the information obtained during a device interrogation. The nomenclature extensions may be used in conjunction with other IEEE 11073 standard components (e.g., ISO/IEEE 11073-10201 [B2] ) or with other standards, such as Health Level Seven International (HL7).
- Standard145 pagesEnglish languagesale 10% offe-Library read for1 day
This document extends the base nomenclature provided in ISO/IEEE 11073-10101:2020 to support terminology for implantable cardiac devices. Devices within the scope of this nomenclature are implantable devices such as pacemakers, defibrillators, devices for cardiac resynchronization therapy, and implantable cardiac monitors. This nomenclature defines the terms necessary to convey a clinically relevant summary of the information obtained during a device interrogation. The nomenclature extensions may be used in conjunction with other IEEE 11073 standard components (e.g., ISO/IEEE 11073-10201 [B2] ) or with other standards, such as Health Level Seven International (HL7).
- Standard128 pagesEnglish languagesale 15% off
- Standard146 pagesFrench languagesale 15% off
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.
- Standard12 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Standard11 pagesEnglish languagesale 15% off
- Standard12 pagesFrench languagesale 15% off
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.
- Standard12 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Standard68 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Standard4 pagesEnglish languagesale 15% off
- Standard4 pagesFrench languagesale 15% off
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.
- Standard68 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Standard3 pagesEnglish languagesale 15% off
- Standard3 pagesFrench languagesale 15% off
- Standard2 pagesEnglish languagesale 15% off
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.
- Standard8 pagesEnglish languagesale 15% off
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.
- Standard6 pagesEnglish languagesale 15% off
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.
- Standard4 pagesEnglish languagesale 15% off
- Standard4 pagesFrench languagesale 15% off
- Standard4 pagesFrench languagesale 15% off
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.
- Standard5 pagesEnglish languagesale 15% off
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.
- Standard4 pagesEnglish languagesale 15% off
This document primarily specifies a cyclic test procedure for ankle-foot devices and foot units of external lower limb prostheses, these differ in the potential to realistically simulate those loading conditions of the complete stance phase of walking from heel strike to toe-off which is relevant to the verification of performance requirements such as strength, durability and service life.
This potential is of particular importance for the assessment of the performance of a variety of recent designs of ankle-foot devices and foot units with specific characteristics that will only develop under realistic conditions of loading.
In addition, this document specifies a static test procedure for prosthetic ankle-foot devices and foot units, consisting of a static proof test and a static ultimate strength test, distinguished, besides other features (see NOTE), by the potential to generate heel and forefoot forces at lines of action conforming to those occurring at the instants of maximum heel and forefoot loading during the cyclic test.
These loading conditions are characterized by a loading profile determined by the resultant vector of the vertical and horizontal (A-P) ground reaction forces and by a locomotion profile determined by the tibia angle.
The test loading conditions specified in this document are characterized by standardized formats of these loading and locomotion profiles, applied by the cyclic and static test procedures to each sample of ankle-foot device or foot unit submitted for test.
This document specifies Test Ranges (R) by specifying locomotion profiles for the cyclic test in relation to the intended use. According to the concept of the tests of this document, each sample of ankle-foot device or foot unit submitted for test is, nevertheless, free to develop its individual performance under load.
This document is suitable for the assessment and testing of prosthetic ankle-foot devices and foot units with the strength requirements specified in 4.4 of ISO 22523:2006 (see NOTE). Prosthetic ankle-foot devices and foot units on the market, which have demonstrated their compliance with the strength requirements specified in 4.4 of ISO 22523:2006 through submission to the relevant tests of ISO 10328:2016, need not be retested to this document.
NOTE The lines of action of the heel and forefoot forces generated by the static test procedure for Test Range 4 (R4) specified in this document approach those determining the sagittal plane loading of the test loading conditions I and II for the principal structural tests referring to ISO 10328:2016, without changing the values of the angles of the heel and forefoot platform(s) for the structural tests on ankle-foot devices and foot units specified in ISO 10328:2016.
- Standard104 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Standard15 pagesEnglish languagesale 15% off
- Standard15 pagesFrench languagesale 15% off
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.
- Technical specification14 pagesEnglish languagesale 15% off
This document primarily specifies a cyclic test procedure for ankle-foot devices and foot units of external lower limb prostheses, these differ in the potential to realistically simulate those loading conditions of the complete stance phase of walking from heel strike to toe-off which is relevant to the verification of performance requirements such as strength, durability and service life.
This potential is of particular importance for the assessment of the performance of a variety of recent designs of ankle-foot devices and foot units with specific characteristics that will only develop under realistic conditions of loading.
In addition, this document specifies a static test procedure for prosthetic ankle-foot devices and foot units, consisting of a static proof test and a static ultimate strength test, distinguished, besides other features (see NOTE), by the potential to generate heel and forefoot forces at lines of action conforming to those occurring at the instants of maximum heel and forefoot loading during the cyclic test.
These loading conditions are characterized by a loading profile determined by the resultant vector of the vertical and horizontal (A-P) ground reaction forces and by a locomotion profile determined by the tibia angle.
The test loading conditions specified in this document are characterized by standardized formats of these loading and locomotion profiles, applied by the cyclic and static test procedures to each sample of ankle-foot device or foot unit submitted for test.
This document specifies Test Ranges (R) by specifying locomotion profiles for the cyclic test in relation to the intended use. According to the concept of the tests of this document, each sample of ankle-foot device or foot unit submitted for test is, nevertheless, free to develop its individual performance under load.
This document is suitable for the assessment and testing of prosthetic ankle-foot devices and foot units with the strength requirements specified in 4.4 of ISO 22523:2006 (see NOTE). Prosthetic ankle-foot devices and foot units on the market, which have demonstrated their compliance with the strength requirements specified in 4.4 of ISO 22523:2006 through submission to the relevant tests of ISO 10328:2016, need not be retested to this document.
NOTE The lines of action of the heel and forefoot forces generated by the static test procedure for Test Range 4 (R4) specified in this document approach those determining the sagittal plane loading of the test loading conditions I and II for the principal structural tests referring to ISO 10328:2016, without changing the values of the angles of the heel and forefoot platform(s) for the structural tests on ankle-foot devices and foot units specified in ISO 10328:2016.
- Standard104 pagesEnglish languagesale 10% offe-Library read for1 day
- Amendment11 pagesEnglish languagesale 10% offe-Library read for1 day
- Amendment8 pagesEnglish languagesale 10% offe-Library read for1 day
- Amendment9 pagesEnglish languagesale 10% offe-Library read for1 day
- Amendment9 pagesEnglish languagesale 10% offe-Library read for1 day
- Amendment11 pagesEnglish languagesale 10% offe-Library read for1 day
- Amendment8 pagesEnglish languagesale 10% offe-Library read for1 day
- Standard3 pagesEnglish languagesale 15% off
- Standard3 pagesFrench languagesale 15% off
- Standard2 pagesEnglish languagesale 15% off
- Standard2 pagesFrench languagesale 15% off
- Standard5 pagesEnglish languagesale 15% off
- Standard5 pagesFrench languagesale 15% off
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.
- Technical report19 pagesEnglish languagesale 15% off
This document specifies a method of describing and measuring the residual limb after upper limb amputation. It also defines the measurements required for the provision of a prosthesis.
- Standard18 pagesEnglish languagesale 15% off
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.
- Standard36 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Standard36 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Standard18 pagesEnglish languagesale 10% offe-Library read for1 day
This document primarily specifies a cyclic test procedure for ankle-foot devices and foot units of external lower limb prostheses, these differ in the potential to realistically simulate those loading conditions of the complete stance phase of walking from heel strike to toe-off which is relevant to the verification of performance requirements such as strength, durability and service life. This potential is of particular importance for the assessment of the performance of a variety of recent designs of ankle-foot devices and foot units with specific characteristics that will only develop under realistic conditions of loading. In addition, this document specifies a static test procedure for prosthetic ankle-foot devices and foot units, consisting of a static proof test and a static ultimate strength test, distinguished, besides other features (see NOTE), by the potential to generate heel and forefoot forces at lines of action conforming to those occurring at the instants of maximum heel and forefoot loading during the cyclic test. These loading conditions are characterized by a loading profile determined by the resultant vector of the vertical and horizontal (A-P) ground reaction forces and by a locomotion profile determined by the tibia angle. The test loading conditions specified in this document are characterized by standardized formats of these loading and locomotion profiles, applied by the cyclic and static test procedures to each sample of ankle-foot device or foot unit submitted for test. This document specifies Test Ranges (R) by specifying locomotion profiles for the cyclic test in relation to the intended use. According to the concept of the tests of this document, each sample of ankle-foot device or foot unit submitted for test is, nevertheless, free to develop its individual performance under load. This document is suitable for the assessment and testing of prosthetic ankle-foot devices and foot units with the strength requirements specified in 4.4 of ISO 22523:2006 (see NOTE). Prosthetic ankle-foot devices and foot units on the market, which have demonstrated their compliance with the strength requirements specified in 4.4 of ISO 22523:2006 through submission to the relevant tests of ISO 10328:2016, need not be retested to this document. NOTE The lines of action of the heel and forefoot forces generated by the static test procedure for Test Range 4 (R4) specified in this document approach those determining the sagittal plane loading of the test loading conditions I and II for the principal structural tests referring to ISO 10328:2016, without changing the values of the angles of the heel and forefoot platform(s) for the structural tests on ankle-foot devices and foot units specified in ISO 10328:2016.
- Standard91 pagesEnglish languagesale 15% off
- Standard100 pagesFrench languagesale 15% off
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.
- Standard53 pagesEnglish languagesale 15% off
- Standard57 pagesFrench languagesale 15% off
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.
- Standard18 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies the uses and functions of external lower limb orthoses. It classifies and describes the devices and their components. It permits the systematic classification and description of both the finished orthosis and the components from which it is assembled in a manner that clearly explains their principal characteristics. This document does not specify the materials or manufacturing methods used for the fabrication of lower limb orthoses.
- Standard10 pagesEnglish languagesale 15% off
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.
- Standard109 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Standard109 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Standard99 pagesEnglish languagesale 15% off
- Standard106 pagesFrench languagesale 15% off
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.
- Standard30 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Standard114 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Standard30 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Standard22 pagesEnglish languagesale 15% off
- Standard23 pagesFrench languagesale 15% off
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.
- Standard21 pagesEnglish languagesale 15% off
- Standard23 pagesFrench languagesale 15% off
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.
- Standard114 pagesEnglish languagesale 10% offe-Library read for1 day