EN 1283:1996
(Main)Haemodialysers, haemodiafilters, haemofilters, haemoconcentrators and their extracorporeal circuits
Haemodialysers, haemodiafilters, haemofilters, haemoconcentrators and their extracorporeal circuits
This European Standard specifies requirements for sterile, single use hemodialysers, hemodiafilters, hemofilters, hemoconcentrators and the extracorporeal circuits for these devices (including any integral accessory lines, such as fluid and infusion lines and lines for connection to pressure monitors) intended for renal care and cardiovascular use on humans.
Hämodialysatoren, Hämodiafilter, Hämofilter, Hämokonzentratoren und dazugehörige Blutschlauchsysteme
Diese Europäische Norm legt Anforderungen fest für sterile Hämodialysatoren, Hämodiafilter, Hämofilter, Hämokonzentratoren und extrakorporale Blutschlauchsysteme für diese Geräte, soweit sie zur einmaligen Verwendung bestimmt sind (einschließlich aller integrierter Zusatzleitungen, wie Leitungen für Flüssigkeiten und Infusionen sowie Leitungen, die an Druckmonitore angeschlossen werden) und die für die Nierenbehandlung und cardiovaskuläre Anwendung am Menschen vorgesehen sind.
Hémodialyseurs, hémodiafiltres, hémofiltres, hémoconcentrateurs et leurs circuits extracorporels
La présente norme européenne spécifie les exigences relatives aux hémodialyseurs, hémodiafiltres, hémofiltres et hémoconcentrateurs non réutilisables et stériles ainsi qu'aux circuits extracorporels de ce matériel (y compris toutes les lignes auxiliaires intégrées, telles que les lignes pour liquides et pour perfusion et les lignes permettant de connecter à des moniteurs de pression) destinés aux soins rénaux et aux usages cardio- vasculaires chez l'homme.
Hemodializatorji, hemodiafiltri, hemofiltri, hemokoncentratorji in izventelesni pretočni sistemi
General Information
- Status
- Withdrawn
- Publication Date
- 16-Apr-1996
- Withdrawal Date
- 14-Jan-2014
- Technical Committee
- CEN/TC 205 - Non-active medical devices
- Drafting Committee
- CEN/TC 205/WG 11 - Transfusion, infusion and injection equipment
- Current Stage
- 9960 - Withdrawal effective - Withdrawal
- Start Date
- 15-Jan-2014
- Completion Date
- 15-Jan-2014
Relations
- Effective Date
- 08-Jun-2022
- Effective Date
- 08-Jun-2022
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Frequently Asked Questions
EN 1283:1996 is a standard published by the European Committee for Standardization (CEN). Its full title is "Haemodialysers, haemodiafilters, haemofilters, haemoconcentrators and their extracorporeal circuits". This standard covers: This European Standard specifies requirements for sterile, single use hemodialysers, hemodiafilters, hemofilters, hemoconcentrators and the extracorporeal circuits for these devices (including any integral accessory lines, such as fluid and infusion lines and lines for connection to pressure monitors) intended for renal care and cardiovascular use on humans.
This European Standard specifies requirements for sterile, single use hemodialysers, hemodiafilters, hemofilters, hemoconcentrators and the extracorporeal circuits for these devices (including any integral accessory lines, such as fluid and infusion lines and lines for connection to pressure monitors) intended for renal care and cardiovascular use on humans.
EN 1283:1996 is classified under the following ICS (International Classification for Standards) categories: 11.040.20 - Transfusion, infusion and injection equipment. The ICS classification helps identify the subject area and facilitates finding related standards.
EN 1283:1996 has the following relationships with other standards: It is inter standard links to EN ISO 8637:2014, EN ISO 8638:2014. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN 1283:1996 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Hämodialysatoren, Hämodiafilter, Hämofilter, Hämokonzentratoren und dazugehörige BlutschlauchsystemeHémodialyseurs, hémodiafiltres, hémofiltres, hémoconcentrateurs et leurs circuits extracorporelsHaemodialysers, haemodiafilters, haemofilters, haemoconcentrators and their extracorporeal circuits11.040.20Transfuzijska, infuzijska in injekcijska opremaTransfusion, infusion and injection equipmentICS:Ta slovenski standard je istoveten z:EN 1283:1996SIST EN 1283:2000en01-januar-2000SIST EN 1283:200
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