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.

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This document provides lists of reference standards which contain general information, implant device or application-specific information, material specifications, or test methods related to coatings. These reference standards can be used to develop product coatings for specified applications when using ISO 17327-1 to address general coating requirements. This document is applicable to coatings on non-active surgical implants.

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    • Technical report
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      English language
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      12 pages
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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 no...view more

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    • Standard
      14 pages
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      16 pages
      French language
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      14 pages
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This document specifies the requirements for the evaluation of absorbable medical devices during a biological risk assessment based on ISO 10993-1, including a clarification of the terms "absorb", "degrade" and other related terms (see Annex A).

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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/val...
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      87 pages
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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 t...
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      60 pages
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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 mana...view more

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    • Standard
      57 pages
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      57 pages
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    • Standard
      61 pages
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      61 pages
      French language
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    • Draft
      56 pages
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    • Draft
      61 pages
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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/validati...view more

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    • Standard
      79 pages
      English language
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    • Standard
      79 pages
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    • Standard
      82 pages
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      82 pages
      French language
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      79 pages
      English language
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      82 pages
      French language

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 su...view more

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    • Standard
      51 pages
      English language
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      51 pages
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    • Standard
      56 pages
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      51 pages
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This document specifies a four-pole connector system for implantable cardiac rhythm management (CRM) devices which have pacing, electrogram sensing and/or defibrillation functions. This document includes requirements for the connector portion of an implantable lead as well as for the mating connector cavity attached to an implantable pulse generator. Essential dimensions and performance requirements are specified together with appropriate test methods. NOTE The safety, reliability, biocompatibil...view more

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    • Standard
      81 pages
      English language
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      81 pages
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This document specifies requirements for the evaluation of stent systems (vascular stents and delivery
systems) and requirements with respect to nomenclature, design attributes and information supplied
by the manufacturer, based upon current medical knowledge. Guidance for the development of in vitro
test methods is included in Annex D. This document is supplemental to ISO 14630, which specifies
general requirements for the performance of non-active surgical implants.
NOTE 1 Due to the vari...
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    • Standard
      124 pages
      English language
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This document specifies requirements for the evaluation of stent systems (vascular stents and delivery systems) and requirements with respect to nomenclature, design attributes and information supplied by the manufacturer, based upon current medical knowledge. Guidance for the development of in vitro test methods is included in Annex D. This document is supplemental to ISO 14630, which specifies general requirements for the performance of non-active surgical implants. NOTE 1 Due to the variation...view more

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    • Standard
      114 pages
      English language
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      123 pages
      French language
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      115 pages
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This document defines general terms used to describe external limb prostheses and orthoses, and the personnel involved in the practice of prosthetics and orthotics. NOTE 1 The complete range of levels of limb amputation are listed and defined in ISO 8549-2. The complete range of classes of orthoses are listed and defined in ISO 8549-3. This document does not apply to breast, ocular or other external prostheses used to replace other parts of the human body, nor to dental prostheses or orthoses. N...view more

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      5 pages
      English language

This document defines terms used to describe external limb prostheses and the wearers of external limb prostheses. NOTE 1 The types of component used in the construction of prostheses are classified and described in the ISO 13405 series. NOTE 2 For the purposes of this document, the abbreviated term ?prosthetics' and its derivatives only apply to external limb prosthetics.

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      5 pages
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This document defines terms relating to orthoses. This document does not include terms for orthoses that only encompass limb segments, as these orthoses are limited mainly to use in the treatment of fractures and in sports medicine. NOTE 1 The types of components used in the construction of orthoses are classified and described in ISO 13404. NOTE 2 For the purposes of this document the abbreviated term ?orthotics' and its derivatives only apply to external orthotics.

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    • Standard
      8 pages
      English language

This document established 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 ...view more

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    • Technical specification
      14 pages
      English language
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      14 pages
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This document specifies a vocabulary for the description of surgical limb amputations, amputation procedures, and persons who have had an amputation.

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      5 pages
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This document specifies general requirements for tissue-engineered medical products (TEMPs), which are used in regenerative medicine. With regard to safety, this document outlines requirements for materials, manufacture, quality control, and unintentional biological effects elicited by TEMPs. This document does not address requirements for clinical trials and efficacy. This document is not applicable to tissue-engineered products used for diagnosis, ex-vivo testing or extracorporeal treatments o...view more

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    • Technical specification
      11 pages
      English language
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      11 pages
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This document specifies a test method for determining the endurance properties, under specified laboratory conditions, of tibial trays used in knee-joint prostheses to support and secure the plastic articulating surface. It applies to tibial trays which cover both the medial and lateral plateaux of the tibia. The test method does not apply to tibial components manufactured solely from plastic materials. This document does not cover methods of examining and reporting the final condition of the te...view more

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    • Standard
      9 pages
      English language
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    • Standard
      10 pages
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      9 pages
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      2 pages
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EN-ISO 8637-1 specifies requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators, hereinafter collectively referred to as “the device”, for use in humans. This document does not apply to: - extracorporeal blood circuits; - plasmafilters; - haemoperfusion devices; - vascular access devices; - blood pumps; - pressure monitors for the extracorporeal blood circuit; - air detection devices; - systems to prepare, maintain or monitor dialysis fluid; - systems or equipment i...view more

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      30 pages
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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 ...view more

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    • Standard
      69 pages
      English language
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    • Standard
      74 pages
      French language

This document specifies methods for the analysis of retrieved surgical implants. This document describes the analysis of retrieved metallic, polymeric and ceramic implants. The analysis is divided into three stages which are increasingly destructive. This document can also be applied to other materials, e.g. animal tissue implants. NOTE National regulations or legal requirements regarding the handling and analysis of retrieved implants and tissues and associated biological material can also appl...view more

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    • Standard
      25 pages
      English language

DOW = DAV + 36 months

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ISO 8637-1:2017 specifies requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators, hereinafter collectively referred to as "the device", for use in humans.
ISO 8637-1:2017 does not apply to:
- extracorporeal blood circuits;
- 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 ...
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2019-11-11-JO:  CEN/TC 205 Decision 19/2019 on delinking EN ISO 7199:2017/prA1 from MDD.
DOW = DAV + 36 months

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This document establishes a method of describing and measuring lower limb amputation stumps. It also lists the measurements required for the provision of a prosthesis.

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    • Standard
      19 pages
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    • Standard
      9 pages
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      9 pages
      French language

This document establishes a method of describing the person to be treated with an orthosis, the clinical objectives of treatment and the functional requirements of the orthosis.

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      7 pages
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      10 pages
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      2 pages
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      2 pages
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    • Standard
      2 pages
      English language
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      2 pages
      French language

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 p...view more

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    • Standard
      68 pages
      English language
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      68 pages
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    • Standard
      74 pages
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      75 pages
      French language
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      10 pages
      English language

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

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

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      11 pages
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This part of ISO 5832 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 mechanical properties of a Sample obtained from a finished product made of this alloy may not necessarily
comply with the specifications given in this part of ISO 5832.

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    • Standard
      9 pages
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This part of ISO 5832 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 mechanical properties of a Sample obtained from a finished product made of this alloy may not necessarily
comply with the specifications given in this part of ISO 5832.

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

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

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    • Standard
      14 pages
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This document defines minimum data sets for implants to facilitate recording and international
exchange of data for the purposes of implant tracking systems. This data can also be used to support
retrieval analysis and implant registry.
This document is applicable to the manufacturers and distributors of medical devices intended
for implant via a surgical procedure and to those hospitals and other medical facilities which carry
out implant or explant procedures. It specifies requirements fo...
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This document outlines design evaluation guidelines 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 meant to supplement device-specific standards by providing guidelines specific for absorbable implants and/or components This document is applicable to implants in direct contact with the cardiovascular system, where the intended action is upon the circulatory system. Thi...view more

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    • Technical specification
      29 pages
      English language

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 ...view more

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    • Standard
      66 pages
      English language
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    • Standard
      75 pages
      French language

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 th...view more

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    • Standard
      71 pages
      English language
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    • Standard
      77 pages
      French language

This document specifies test methodologies for the evaluation of the electromagnetic compatibility (EMC) of active implantable cardiovascular devices that provide one or more therapies for bradycardia, tachycardia and cardiac resynchronization in conjunction with transvenous lead systems. NOTE This document was designed for pulse generators used with endocardial leads or epicardial leads. At the time of this edition, the authors recognized the emergence of technologies that do not use endocardia...view more

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    • Standard
      134 pages
      English language

This document specifies the relative angular movement between articulating components, the pattern of the applied force, speed and duration of testing, sample configuration and test environment to be used for the wear testing of total ankle-joint prostheses in wear-testing machines with load or displacement control. NOTE This document is based on the method described by ISO 14243‑1 and ISO 14243‑3 and allows for the use of the same test equipment as for total knee replacement wear testing.

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    • Standard
      25 pages
      English language
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    • Standard
      24 pages
      French language