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
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- Standard4 pagesEnglish languagesale 15% off
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.
- Standard17 pagesEnglish languagesale 15% off
This document specifies a method for testing the reliability of microprocessor-controlled ankle moment units of ankle-foot orthosis, moving in plantar- and dorsiflexion direction. This document specifies categories of locomotion profiles to be applied together with appropriate loading profiles, to generate plantar- and dorsiflexion ankle moment loads for the microprocessor-controlled ankle moment units. It also defines which measured outcome of the test allows to claim compliance to this document, and how the compliance is documented in the IFU. This document solely addresses the resistance of microprocessor-controlled ankle moment units in motion. Geometrical constrains like end stops, where motion is stopped instead of sustaining it, can be tested in repetitive quasi static tests instead. A method to derive test parameters for the reliability test of microprocessor-controlled ankle moment units is described. This document is applicable to unilateral ankle-foot orthoses and to bilateral jointed orthoses where either both joints are controlled or where one joint is controlled and the other is not controlled.
- Technical specification15 pagesEnglish languagesale 15% off
- Draft15 pagesEnglish languagesale 15% off
- Draft15 pagesEnglish languagesale 15% off
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.
- Standard23 pagesEnglish languagesale 15% off
- Standard25 pagesFrench languagesale 15% off
- Draft34 pagesEnglish languagesale 15% off
- Draft34 pagesEnglish languagesale 15% off
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.
- Standard27 pagesEnglish languagesale 15% off
- Standard29 pagesFrench languagesale 15% off
- Draft38 pagesEnglish languagesale 15% off
- Draft38 pagesEnglish languagesale 15% off
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.
- Technical specification10 pagesEnglish languagesale 15% off
- Draft10 pagesEnglish languagesale 15% off
- Draft10 pagesEnglish languagesale 15% off
ISO 14708-3:2008 is applicable to active implantable medical devices intended for electrical stimulation of the central or peripheral nervous system.
ISO 14708-3:2008 is also applicable to all non-implantable parts and accessories of the devices.
The tests that are specified in ISO 14708-3:2008 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.
- Standard63 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft46 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies performance requirements for voice prostheses including requirements for marking, packaging and information to be provided by the manufacturer as well as test methods for the evaluation of physical characteristics of voice prostheses.
NOTE There is guidance or rationale for this list item contained in A.2.
- Standard20 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft17 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies requirements that are applicable to those active implantable medical devices that are intended to treat hearing impairment via electrical stimulation of the auditory pathways. Devices which treat hearing impairment via means other than electrical stimulation are not covered by this document.
The tests that are specified in this document are type tests and are to be carried out on samples of a device to show compliance.
This document is also applicable to non-implantable parts and accessories of the devices (see NOTE).
The electrical characteristics of the implantable part are determined by either the appropriate method detailed in this document or by any other method demonstrated to have an accuracy equal to, or better than, the method specified. In the case of dispute, the method detailed in this document applies.
NOTE A device that is commonly referred to as an active implantable medical device can in fact be a single device, a combination of devices, or a combination of a device or devices and one or more accessories. Not all of these parts are required to be either partially or totally implantable, this document specifies those requirements of non-implantable parts and accessories which could affect the safety or performance of the implantable part.
- Standard77 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft74 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies requirements for safety and performance of active implantable circulatory support devices, including type tests, animal studies and clinical evaluation requirements.
NOTE The device that is commonly referred to as an active implantable medical device can in fact be a single device, a combination of devices, or a combination of a device or devices and one or more accessories. Not all of these parts are required to be either partially or totally implantable, but there is a need to specify main requirements of non-implantable parts and accessories if they could affect the safety or performance of the implantable device.
The tests that are specified in this document are type tests and are to be carried out on a sample of a device to assess device behavioural responses and are not intended to be used for the routine testing of manufactured products.
Included in the scope of this document are:
— ventricular assist devices (VAD), left or right heart support;
— total artificial hearts (TAH);
— biventricular assist devices (biVAD);
— percutaneous assist devices;
— paediatric assist devices.
- Standard79 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft82 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Standard68 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft74 pagesEnglish languagesale 10% offe-Library read for1 day
ISO 14708-3:2017 is applicable to active implantable medical devices intended for electrical stimulation of the central or peripheral nervous system.
The tests that are specified in this document are type tests and are to be carried out on a sample of a device to assess device behavioural responses, and are not intended to be used for the routine testing of manufactured products.
- Standard63 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft46 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies requirements that are applicable to those active implantable medical devices intended to treat bradyarrhythmias and devices that provide therapies for cardiac resynchronization.
The tests that are specified in this document are type tests, and are to be carried out on samples of a device to show compliance.
This document was designed for bradyarrhythmia pulse generators used with endocardial leads or epicardial leads. At the time of this edition, the authors recognized the emergence of leadless technologies for which adaptations of this part will be required. Such adaptations are left to the discretion of manufacturers incorporating these technologies.
This document is also applicable to some non-implantable parts and accessories of the devices (see Note 1).
The electrical characteristics of the implantable pulse generator or lead are determined either by the appropriate method detailed in this particular standard or by any other method demonstrated to have an accuracy equal to, or better than, the method specified. In case of dispute, the method detailed in this particular standard applies.
Any features of an active implantable medical device intended to treat tachyarrhythmias are covered by ISO 14708-6.
NOTE 1 The device that is commonly referred to as an active implantable medical device can in fact be a single device, a combination of devices, or a combination of a device or devices and one or more accessories. Not all of these parts are required to be either partially or totally implantable, but there is a need to specify some requirements of non-implantable parts and accessories if they could affect the safety or performance of the implantable device.
NOTE 2 In this document, terms printed in italics are used as defined in Clause 3. Where a defined term is used as a qualifier in another term, it is not printed in italics unless the concept thus qualified is also defined.
- Standard80 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft77 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies requirements that are applicable to implantable cardioverter defibrillators and CRT-Ds and the functions of active implantable medical devices intended to treat tachyarrhythmia.
The tests that are specified in ISO 14708 are type tests and are to be carried out on samples of a device to show compliance.
This document was designed for tachyarrhythmia pulse generators used with either endocardial leads or epicardial leads. At the time of this edition, the authors recognized the emergence of technologies that do not use endocardial or epicardial leads for which adaptations of this part will be required. Such adaptations are left to the discretion of manufacturers incorporating these technologies.
This document is also applicable to some non-implantable parts and accessories of the devices (see Note 1).
The characteristics of the implantable pulse generator or lead shall be determined by either the appropriate method detailed in this document or by any other method demonstrated to have accuracy equal to, or better than, the method specified. In the case of dispute, the method detailed in this document shall apply.
Any aspect of an active implantable medical device intended to treat bradyarrhythmias or cardiac resynchronization is covered by ISO 14708-2.
NOTE 1 The device that is commonly referred to as an active implantable medical device can in fact be a single device, a combination of devices, or a combination of a device or devices and one or more accessories. Not all of these parts are required to be either partially or totally implantable, but there is a need to specify some requirements of non-implantable parts and accessories if they could affect the safety or performance of the implantable device.
NOTE 2 In this document, terms printed in italics are used as defined in Clause 3. Where a defined term is used as a qualifier in another term, it is not printed in italics unless the concept thus qualified is also defined.
- Standard75 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft82 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies performance requirements for voice prostheses including requirements for marking, packaging and information to be provided by the manufacturer as well as test methods for the evaluation of physical characteristics of voice prostheses.
NOTE There is guidance or rationale for this list item contained in A.2.
- Standard20 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft17 pagesEnglish languagesale 10% offe-Library read for1 day
This document lists factors to be considered when specifying a prosthesis for a person who has had a lower limb amputation.
- Standard5 pagesEnglish languagesale 15% off
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.
- Standard11 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft8 pagesEnglish languagesale 10% offe-Library read for1 day
ISO 14708-4:2008 is applicable to active implantable medical devices intended to deliver medicinal substances to site-specific locations within the human body.
ISO 14708-4:2008 is also applicable to some non-implantable parts and accessories of the devices.
The tests that are specified in ISO 14708-4:2008 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.
- Standard68 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft74 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies requirements that are applicable to those active implantable medical devices
intended to treat bradyarrhythmias and devices that provide therapies for cardiac resynchronization.
The tests that are specified in this document are type tests, and are to be carried out on samples of a
device to show compliance.
This document was designed for bradyarrhythmia pulse generators used with endocardial leads
or epicardial leads. At the time of this edition, the authors recognized the emergence of leadless
technologies for which adaptations of this part will be required. Such adaptations are left to the
discretion of manufacturers incorporating these technologies.
This document is also applicable to some non-implantable parts and accessories of the devices (see
Note 1).
The electrical characteristics of the implantable pulse generator or lead are determined either by the
appropriate method detailed in this particular standard or by any other method demonstrated to have
an accuracy equal to, or better than, the method specified. In case of dispute, the method detailed in
this particular standard applies.
Any features of an active implantable medical device intended to treat tachyarrhythmias are covered
by ISO 14708-6.
NOTE 1 The device that is commonly referred to as an active implantable medical device can in fact be
a single device, a combination of devices, or a combination of a device or devices and one or more accessories.
Not all of these parts are required to be either partially or totally implantable, but there is a need to specify
some requirements of non-implantable parts and accessories if they could affect the safety or performance of the
implantable device.
NOTE 2 In this document, terms printed in italics are used as defined in Clause 3. Where a defined term is
used as a qualifier in another term, it is not printed in italics unless the concept thus qualified is also defined
- Standard80 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft77 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies requirements that are applicable to those active implantable medical devices
that are intended to treat hearing impairment via electrical stimulation of the auditory pathways.
Devices which treat hearing impairment via means other than electrical stimulation are not covered by
this document.
The tests that are specified in this document are type tests and are to be carried out on samples of a
device to show compliance.
This document is also applicable to non-implantable parts and accessories of the devices (see NOTE).
The electrical characteristics of the implantable part are determined by either the appropriate method
detailed in this document or by any other method demonstrated to have an accuracy equal to, or better
than, the method specified. In the case of dispute, the method detailed in this document applies.
NOTE A device that is commonly referred to as an active implantable medical device can in fact be a single
device, a combination of devices, or a combination of a device or devices and one or more accessories. Not all of
these parts are required to be either partially or totally implantable, this document specifies those requirements
of non-implantable parts and accessories which could affect the safety or performance of the implantable part.
- Standard77 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft74 pagesEnglish languagesale 10% offe-Library read for1 day
ISO 14708-5:2010 specifies requirements for safety and performance of active implantable circulatory support devices. It is not applicable to extracorporeal perfusion devices, cardiomyoplasty, heart restraint devices and counter-pulsation devices, such as extra- or intra-aortic balloon pumps.
ISO 14708-5:2010 specifies type tests, animal studies and clinical evaluation requirements.
- Standard79 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft82 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies requirements that are applicable to implantable cardioverter defibrillators and
CRT-Ds and the functions of active implantable medical devices intended to treat tachyarrhythmia.
The tests that are specified in ISO 14708 are type tests and are to be carried out on samples of a device
to show compliance.
This document was designed for tachyarrhythmia pulse generators used with either endocardial leads
or epicardial leads. At the time of this edition, the authors recognized the emergence of technologies
that do not use endocardial or epicardial leads for which adaptations of this part will be required. Such
adaptations are left to the discretion of manufacturers incorporating these technologies.
This document is also applicable to some non-implantable parts and accessories of the devices (see
Note 1).
The characteristics of the implantable pulse generator or lead shall be determined by either the
appropriate method detailed in this document or by any other method demonstrated to have accuracy
equal to, or better than, the method specified. In the case of dispute, the method detailed in this
document shall apply.
Any aspect of an active implantable medical device intended to treat bradyarrhythmias or cardiac
resynchronization is covered by ISO 14708-2.
NOTE 1 The device that is commonly referred to as an active implantable medical device can in fact be
a single device, a combination of devices, or a combination of a device or devices and one or more accessories.
Not all of these parts are required to be either partially or totally implantable, but there is a need to specify
some requirements of non-implantable parts and accessories if they could affect the safety or performance of the
implantable device.
NOTE 2 In this document, terms printed in italics are used as defined in Clause 3. Where a defined term is
used as a qualifier in another term, it is not printed in italics unless the concept thus qualified is also defined.
- Standard75 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft82 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Standard17 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft15 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Technical specification31 pagesEnglish languagesale 15% off
- Draft31 pagesEnglish languagesale 15% off
- Draft31 pagesEnglish languagesale 15% off
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.
- Technical report29 pagesEnglish languagesale 15% off
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.
- Standard16 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft12 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies the characteristics of, and corresponding test methods for, wrought cobaltnickel 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
- Standard11 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft8 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Standard17 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft15 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Standard3 pagesEnglish languagesale 15% off
- Standard3 pagesFrench languagesale 15% off
- Draft3 pagesEnglish languagesale 15% off
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.
- Standard3 pagesEnglish languagesale 15% off
- Draft3 pagesEnglish languagesale 15% off
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.
- Standard58 pagesEnglish languagesale 15% off
- Standard64 pagesFrench languagesale 15% off
- Draft69 pagesEnglish languagesale 15% off
- Draft70 pagesFrench languagesale 15% off
This document specifies dimensions of the adult modular systems adapters used in lower limb prosthetic.
- Standard3 pagesEnglish languagesale 15% off
- Standard3 pagesFrench languagesale 15% off
- Draft3 pagesEnglish languagesale 15% off
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.
- Standard16 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft12 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Standard9 pagesEnglish languagesale 15% off
- Standard9 pagesFrench languagesale 15% off
This European Standard provides the procedure for the specific assessment required in Annex A of EN 50527 1:2015 for workers with implanted neurostimulators (e.g. spinal cord, deep-brain, retinal, bladder). It offers different approaches for doing the risk assessment. The most suitable one shall be used. If the worker has other Active Implantable Medical Devices (AIMDs) implanted additionally, they have to be assessed separately.
- Standard106 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft71 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies important in vitro tests including functional and durability characteristics of transcatheter cardiac occluders, and their delivery systems and accessories. This document does not specify exact test methods for functional and durability testing, but it offers requirements and recommendations for performance tests of the cardiac occluder system. Surgical occluders have been omitted from the scope of this document given their significant differences in device geometry, materials, implantation methods, and test methods as compared to transcatheter cardiac occluders. This document is applicable to all intracardiac occluders intended for transcatheter implantation in humans (e.g. atrial septal occluder, ventricular septal occluder, patent foramen ovale occluder, left atrial appendage occluder, and paravalvular leak occluders). This document does not cover non-cardiac occluders, but elements of this document can be applicable to patent ductus arteriosus occluders. The following devices and components are outside the scope of this document: surgical devices, cardiac shunt devices, atrial flow regulators, active components (such as sensors), or degradable or animal tissue components. This document is applicable to both newly developed and modified cardiac occluders, their accessory devices, packaging, and labelling. This document defines operational conditions and performance requirements for cardiac occluders where either adequate scientific or clinical evidence, or both, exists for their justification. NOTE At the time of this document, it is impossible to take all future and emerging technologies into consideration. The cardiac occluder systems based on these new technologies can benefit from evaluation based on the basic requirements of this document. Testing beyond the scope of this document can also be necessary in order to verify and validate these cardiac occluder systems.
- Standard72 pagesEnglish languagesale 15% off
- Draft72 pagesEnglish languagesale 15% off
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.
- Standard8 pagesEnglish languagesale 15% off
- Standard8 pagesFrench languagesale 15% off
- Draft8 pagesEnglish languagesale 15% off
This document specifies the appropriate application of ISO 17327-1:2018 to coated endovascular prostheses, vascular stents, and vena cava filters. This document is intended to be used as a supplement to ISO 25539-1, ISO 25539-2, ISO 25539-3, ISO 12417-1 and ISO/TS 17137. The following coatings are within the scope of ISO 17327-1 and addressed in this document for endovascular devices: drug coatings (eluting and non-eluting), non-drug coatings (absorbable and non-absorbable), and chemistry-related surface modifications (oxide, such as TiO2, and non-oxide, such as amorphous silicon carbide and diamond-like carbon). This document is not applicable to coated delivery systems or coated ancillary devices (e.g. guidewires), as these coatings are not within the scope of ISO 17327-1, which is specifically directed to implant coatings. This document is not applicable to coverings of endovascular devices; however, if the covering of a device is coated, it is within the scope of this document. This document does not address the requirements for, and the evaluation of, viable tissues and non-viable biologic materials used as implant coatings.
- Standard11 pagesEnglish languagesale 15% off
This document provides the procedure for the specific assessment required in EN 50527 1:2016, Annex A, for workers with implanted neurostimulator systems (NS), specifically of the type used for spinal cord stimulation (SCS). It is recognized that implantable neurostimulators have been developed for a wide variety of clinical applications, however the SCS devices within the scope of this document represent the largest segment of the implantable neurostimulator applications thus far. NOTE 1 If the worker has other Active Implantable Medical Devices (AIMDs) implanted additionally, they are assessed separately according to EN 50527 1 or other particular standards within the EN 50527 series. The purpose of the specific assessment is to determine the risk for workers with implanted SCS devices arising from exposure to electromagnetic fields (EMF) at the workplace. The assessment includes the likelihood of clinically significant effects. NOTE 2 This document does not address risks from contact currents, or the effects upon any associated non-implantable devices (e.g. Patient Programmers). The techniques described in the different approaches can also be used for the assessment of publicly accessible areas. The frequency range to be observed is from 0 Hz to 3 GHz. Above 3 GHz no interference with the devices within the scope of this document is expected to occur. NOTE 3 The rationale for limiting the observation range to 3 GHz can be found in ISO 14708 3 [1]. NOTE 4 Further information concerning the functions of neurostimulator systems can be found at https://www.aans.org/Patients/Neurosurgical-Conditions-and-Treatments/Spinal-Cord-Stimulation.
- Standard106 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft71 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies general requirements for plasma-sprayed titanium coatings on metallic surgical implants. This document applies to atmospheric plasma spraying and vacuum plasma spraying. This document does not apply to coatings made of other materials than titanium or titanium-6 aluminum-4 vanadium alloy or to coatings realized by another technology than plasma spraying. NOTE A quality management system can be useful, e.g. as described in ISO 13485. Requirements for the competence of testing laboratories can be found in ISO/IEC 17025.
- Standard6 pagesEnglish languagesale 15% off
- Standard6 pagesFrench languagesale 15% off
- Draft6 pagesEnglish languagesale 15% off
- Draft6 pagesFrench languagesale 15% off
This document specifies the general requirements for instruments to be used in association with non-active surgical implants. These requirements apply to instruments when they are manufactured and when they are supplied after refurbishment.
NOTE In this document, unless otherwise specified, the term "instrument" refers to an instrument for use in association with non-active surgical implants.
This document also applies to instruments which can be connected to power-driven systems, but it does not apply to the power-driven systems themselves.
With regard to safety, this document gives the requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging, and information supplied by the instrument manufacturer, hereafter referred to as the manufacturer.
This document is not applicable to instruments associated with dental implants, transendodontic and transradicular implants and ophthalmic implants.
- Standard23 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft19 pagesEnglish languagesale 10% offe-Library read for1 day
This document establishes design evaluation requirements and recommendations for absorbable cardiovascular implants used to treat vessels and/or the vascular space within the circulatory system, including the heart and all vasculature. This document is intended to supplement device-specific standards by providing guidelines specific for either absorbable implants or components, or both. This document is applicable to implants in direct contact with the cardiovascular system, where the intended action is upon the circulatory system. This document does not address the specific evaluation of issues associated with viable tissues, viable cells, and/or implants with non-viable biological materials and their derivatives. Additionally, procedures and devices used prior to and following the introduction of the absorbable cardiovascular implant (e.g. balloon angioplasty devices) are excluded from the scope of this document if they do not affect the absorption aspects of the implant. A cardiovascular absorbable implant can incorporate substance(s) which, if used separately, can be considered to be a medicinal product (drug product) but the action of the medicinal substance is ancillary to that of the implant and supports the primary mode of action of the implant. NOTE 1 Some aspects of absorbable components of cardiovascular device-drug combination products (e.g. coatings) in their connection with drug-related aspects of the device are addressed in ISO 12417-1. NOTE 2 An explanation of the nomenclature of absorb, degrade and related terms can be found in Annex A.
- Technical specification36 pagesEnglish languagesale 15% off
- Draft36 pagesEnglish languagesale 15% off
This document is applicable to heart valve substitutes intended for implantation in human hearts, generally requiring cardiopulmonary bypass and generally with direct visualization. See Annex E for examples of surgical heart valve substitutes and their components.
This document is applicable to both newly developed and modified surgical heart valve substitutes and to the accessory devices, packaging, and labelling required for their implantation and for determining the appropriate size of the surgical heart valve substitute to be implanted.
This document establishes an approach for verifying/validating the design and manufacture of a surgical heart valve substitute through risk management. The selection of appropriate qualification tests and methods are derived from the risk assessment. The tests can include those to assess the physical, chemical, biological, and mechanical properties of surgical heart valve substitutes and of their materials and components. The tests can also include those for pre-clinical in vivo evaluation and clinical evaluation of the finished surgical heart valve substitute.
This document defines operational conditions and performance requirements for surgical heart valve substitutes where adequate scientific and/or clinical evidence exists for their justification.
For some heart valve substitutes (e.g. sutureless), the requirements of both this document and ISO 5840-3:2021 can be relevant and are considered as applicable to the specific device design and are based on the results of the risk analysis.
- Standard60 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft53 pagesEnglish languagesale 10% offe-Library read for1 day
This document is applicable to all devices intended for implantation as a transcatheter heart valve substitute.
This document is applicable to transcatheter heart valve substitutes and to the accessory devices, packaging and labelling required for their implantation and for determining the appropriate size of heart valve substitute to be implanted.
This document establishes an approach for verifying/validating the design and manufacture of a transcatheter heart valve substitute through risk management. The selection of appropriate verification/validation tests and methods are to be derived from the risk assessment. The tests can include those to assess the physical, chemical, biological and mechanical properties of heart valve substitutes and of their materials and components. The tests can also include those for preclinical in vivo evaluation and clinical evaluation of the finished heart valve substitute.
This document defines operational conditions and performance requirements for transcatheter heart valve substitutes where adequate scientific and/or clinical evidence exists for their justification.
This document includes considerations for implantation of a transcatheter heart valve substitute inside a pre-existing prosthetic device (e.g. valve-in-valve and valve-in-ring configurations).
- Standard66 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft92 pagesEnglish languagesale 10% offe-Library read for1 day
This document is applicable to heart valve substitutes intended for implantation and provides general requirements. Subsequent parts of the ISO 5840 series provide specific requirements.
This document is applicable to newly developed and modified heart valve substitutes and to the accessory devices, packaging, and labelling required for their implantation and for determining the appropriate size of the heart valve substitute to be implanted.
ISO 5840-1 outlines an approach for verifying/validating the design and manufacture of a heart valve substitute through risk management. The selection of appropriate qualification tests and methods are derived from the risk assessment. The tests can include those to assess the physical, chemical, biological, and mechanical properties of heart valve substitutes and of their materials and components. The tests can also include those for preclinical in vivo evaluation and clinical evaluation of the finished heart valve substitute.
ISO 5840-1 defines operational conditions for heart valve substitutes.
ISO 5840-1 furthermore defines terms that are also applicable to ISO 5840-2 and ISO 5840-3.
ISO 5840-1 does not provide requirements specific to homografts, tissue engineered heart valves (e.g. valves intended to regenerate in vivo), and heart valve substitutes designed for implantation in circulatory support devices. Some of the provisions of ISO 5840-1 can be applied to valves made from human tissue that is rendered non-viable.
NOTE A rationale for the provisions of ISO 5840-1 is given in Annex A.
- Standard87 pagesEnglish languagesale 10% offe-Library read for1 day
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This document specifies requirements for the blood circuit for devices used in extracorporeal blood filtration therapies such as, but not limited to, haemodialysis, haemodiafiltration, haemofiltration and transducer protectors (integral and non-integral) intended for use in such circuits.
This document does not apply to:
— haemodialysers, haemodiafilters or haemofilters;
— plasmafilters;
— haemoperfusion devices;
— vascular access devices;
— blood pumps;
— pressure monitors for the extracorporeal blood circuit;
— air detection devices;
— systems to prepare, maintain or monitor dialysis fluid;
— systems or equipment intended to perform haemodialysis, haemodiafiltration, haemofiltration or haemoconcentration.
NOTE 1 Requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators are specified in ISO 8637‑1, and requirements for plasmafilters are specified in ISO 8637‑3.
NOTE 2 Extracorporeal blood tubing sets can also be used for other extracorporeal therapies such as haemoperfusion, plasmafiltration and plasma adsorption.
- Standard27 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies requirements for sterile, single-use cannulae for removal and delivery of patients’ blood during cardiopulmonary bypass (CPB) up to 6 h duration, extracorporeal lung assist (ECLA with VV, VAV, or AV cannulation strategies), left or right heart bypass (LHB, RHB), cardiopulmonary support (CPS), extracorporeal life support (ECLS with VA cannulation strategy), extracorporeal carbon dioxide removal (ECCO2R), and other extracorporeal circulation techniques. This standard does not apply to: — introducers (e.g., guidewires) as addressed in ISO 11070, — isolated organ perfusion cannulae, and — intravascular catheters as addressed in ISO 10555-3.
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This document specifies performance requirements for voice prostheses including requirements for marking, packaging and information to be provided by the manufacturer as well as test methods for the evaluation of physical characteristics of voice prostheses. NOTE There is guidance or rationale for this list item contained in A.2.
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- Standard13 pagesFrench languagesale 15% off
- Standard13 pagesFrench languagesale 15% off
- Draft12 pagesEnglish languagesale 15% off
This document specifies requirements for the mechanical assessment of spinal intervertebral body fusion devices (IBFDs) used in spinal arthrodesis procedures. This document focuses on mechanical requirements and does not intend to cover all assessments for various types of IBFDs.
- Standard5 pagesEnglish languagesale 15% off
- Draft5 pagesEnglish languagesale 15% off