Szabványkereső

Hivatkozási szám, azonosító jelzet, vagy a szabványcímben előforduló kulcsszó szerinti keresés:


ICS (a szabványok nemzetközi osztályozási rendszere) szerinti keresés

Nettó ár: 17420 Ft
Kosárba tesz
Alapadatok
Hivatkozási szám
MSZ EN ISO 12417-1:2016
Dokumentumazonosító
162477
Cím
Szív- és érrendszeri implantátumok és extrakorporális rendszerek. Gyógyszerrel kombinált érrendszeri eszközök. 1. rész: Általános követelmények (ISO 12417-1:2015)
Angol cím
Cardiovascular implants and extracorporeal systems. Vascular device-drug combination products. Part 1: General requirements (ISO 12417-1:2015)
Alkalmazási terület
This part of ISO 12417 specifies requirements for vascular device-drug combination products (VDDCPs) based upon current technical and medical knowledge. VDDCPs are medical devices with various clinical indications for use in the human vascular blood system. A VDDCP incorporates, as an integral part, substance(s) which, if used separately, can be considered to be a medicinal substance or product (drug substance, drug product) but the action of the medicinal substance is ancillary to that of the device and supports the primary mode of action (PMOA) of the device. With regard to safety, this part of ISO 12417 outlines requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging, and information supplied by the manufacturer. For implanted products, this International Standard should be considered as a supplement to ISO 14630, which specifies general requirements for the performance of non-active surgical implants. This International Standard should also be considered as a supplement to relevant device-specific standards, such as the ISO 25539-series specifying requirements for endovascular devices. Requirements listed in this part of ISO 12417 also address VDDCPs that are not permanent implants. NOTE Due to variations in the design of combination products covered by this part of ISO 12417 and due to the relatively recent development of some of these combination products, acceptable standardized in vitro test results and clinical study results are not always available. As further scientific and clinical data become available, appropriate revision of this part of ISO 12417 might be necessary. Delivery systems or parts of the delivery system are included in the scope of this part of ISO 12417, if they comprise an integral component of the vascular device and if they are drug-covered (e.g. drugcovered balloon catheters and drug-covered guidewires). Devices whose PMOA is to provide a conduit for delivery of a drug, are excluded from the scope of this part of ISO 12417 (e.g. infusion catheters), unless they contain a drug component that is intended to have an ancillary action to the device part (e.g. antimicrobial coated infusion catheter). Procedures and devices used prior to and following the introduction of the VDDCP (e.g. balloon angioplasty devices) are excluded from the scope of this part of ISO 12417 if they do not affect the drugrelated aspects of the device. This part of ISO 12417 is not comprehensive with respect to the pharmacological evaluation of VDDCPs. Some information on the requirements of different national and regional authorities is given in Annex B. Absorbable components of VDDCPs (e.g. coatings) are addressed by this part of ISO 12417 in their connection with drug-related aspects of the device. Degradation and other time-dependent aspects of absorbable implants and coatings are not completely addressed by this part of ISO 12417. NOTE See also ISO/TS 17137 and ASTM F3036-13. This part of ISO 12417 does not address issues associated with viable or non-viable biological materials such as tissues, cells, or proteins. This part of ISO 12417 does not address issues associated with active surgical implants (i.e. implants that require power not generated by the human body or gravity). INTERNATIONAL STANDARD ISO 12417-1:2015€
ICS
11.040.40 Sebészeti implantátumok, protézisek és ortézisek
Műszaki Bizottság
A szabvány nyelve
angol
Az érvényesség kezdete
2016-04-01
További adatok
Forrás
idt EN ISO 12417-1:2015; idt ISO 12417-1:2015
Előd
Utód
Módosítás
Kiegészítő információk
SZK-közlemények
Kapcsolódó európai jogszabály
93/42/EGK A TANÁCS 93/42/EGK IRÁNYELVE (1993. június 14.) az orvostechnikai eszközökről (MDV93)
Kereskedelmi adatok
A szabvány
kapható formátuma
Papír ,
PDF (letöltés) (a fájl mérete: 947191) ,
oldalszáma
59 oldal; U kategória
ára
Nettó: 17420 Ft
Bruttó:
Papír formátum esetén (5% Áfával): 21949 Ft
PDF (letöltés) formátum esetén (27% Áfával): 22123 Ft
Szabvány életútja
Elődök

Jelenleg nincsenek előzmények

Megtekintett szabvány

MSZ EN ISO 12417-1:2016

2016-04-01

Utódok

Jelenleg nincsenek utódok