11.040.40 - Implants for surgery, prosthetics and orthotics

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

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...view more

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

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

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.

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.

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

This document specifies a vocabulary for the description of surgical limb amputations, amputation procedures, and persons who have had an amputation.

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

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

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

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

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

DOW = DAV + 36 months

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 ...view more

2019-11-11-JO:  CEN/TC 205 Decision 19/2019 on delinking EN ISO 7199:2017/prA1 from MDD.
DOW = DAV + 36 months

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.

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.