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prEN ISO 7198 Viešoji apklausa

Komentavimo iki data 2026-07-30

Širdies ir kraujagyslių implantai bei ekstrakorporinės sistemos. Kraujagyslių protezai. Vamzdiniai kraujagyslių transplantantai ir kraujagyslių lopai (ISO/DIS 7198:2026)

ISO 7198:2016 specifies requirements for the evaluation of vascular prostheses 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 an informative annex to ISO 7198:2016. It can be considered as a supplement to ISO 14630:2012, which specifies general requirements for the performance of non-active surgical implants. NOTE Due to the variations in the design of implants covered by ISO 7198 :2016 and, in some cases, due to the relatively recent development of some of these implants (e.g. bioabsorbable vascular prostheses, cell based tissue engineered vascular prostheses), acceptable standardized in vitro tests and clinical results are not always available. As further scientific and clinical data become available, appropriate revision of ISO 7198 :2016 will be necessary. It is applicable to sterile tubular vascular grafts implanted by direct visualization surgical techniques as opposed to fluoroscopic or other non-direct imaging (e.g. computerized tomography or magnetic resonance imaging), intended to replace, bypass, or form shunts between segments of the vascular system in humans and vascular patches intended for repair and reconstruction of the vascular system. Vascular prostheses that are made of synthetic textile materials and synthetic non-textile materials are within the scope of ISO 7198:2016. While vascular prostheses that are made wholly or partly of materials of non-viable biological origin, including tissue engineered vascular prostheses are within the scope, ISO 7198:2016 does not address sourcing, harvesting, manufacturing and all testing requirements for biological materials. It is further noted that different regulatory requirements might exist for tissues from human and animal sources. Compound, coated, composite, and externally reinforced vascular prostheses are within the scope of ISO 7198:2016. Endovascular prostheses implanted using catheter delivery and non-direct visualization are excluded from the scope of ISO 7198:2016. It includes information on the development of appropriate test methods for graft materials, referenced in ISO 25539‑1 for materials used in the construction of endovascular prostheses (i.e. stent-grafts). NOTE Requirements for endovascular prostheses are specified in ISO 25539‑1. The valve component of valved conduits constructed with a tubular vascular graft component, and the combination of the valved component and the tubular vascular graft component, are excluded from the scope of ISO 7198:2016. It can be helpful in identifying the appropriate evaluation of the tubular vascular graft component of a valved conduit but specific requirements and testing are not described for these devices. Cardiac and pericardial patches, vascular stents, accessory devices such as anastomotic devices, staplers, tunnelers and sutures, and pledgets are excluded from the scope of ISO 7198:2016. NOTE Requirements for vascular stents are specified in ISO 25539‑2. Requirements regarding cell seeding are excluded from the scope of ISO 7198:2016. Tissue engineered vascular prostheses that contain or are manufactured using cells present many distinct manufacturing (e.g. aseptic processing, cell seeding, etc.) and testing issues than those produced with synthetic or non-viable biological materials. The in vitro testing requirements that are outlined in ISO 7198:201

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prEN 17984-5 Viešoji apklausa

Komentavimo iki data 2026-07-07

Šunys pagalbininkai. 5 dalis. Šunų pagalbininkų komandų sudarymas ir išlaikymas

This document provides expectations for assistance dog service providers and assistance dog handlers to protect the interests of all stakeholders. It focuses on the creation of successful assistance dog teams by ensuring transparent and fair eligibility for service, matching applicant beneficiaries with available dogs, thoroughly training the teams to become a partnership and sustaining the team by offering lifetime aftercare support as required. The purpose of this document is to help create competent and well-functioning teams, maintaining team quality over the years provided that transparency and responsibilities of all stakeholders to one another are met. Related elements include the following: — application; — applicant - dog matching; — team instruction; — assessing competency of assistance dog teams; — aftercare; — taking a dog out of service (including retirement); — complaints, appeals and disputes; — general rights.

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