Elenco
delle varie norme tecniche relative alla Dialisi
NORME TECNICHE. Disposizioni per gli usi comuni e ripetitivi di prodotti o servizi, relativamente a problemi effettivi e potenziali, miranti ad ottenere l'ordine migliore in un determinato contesto. Sono di applicazione consigliata ma non obbligatoria. Esse devono essere: accessibili al pubblico; messe a punto con la cooperazione e il consenso di tutte le parti interessate (produttori, utenti, Autorità); fondate sui risultati di scienza, tecnologia, esperienza; rappresentative dello "stato dell'arte", definito come stadio di sviluppo raggiunto in un determinato momento; tendenti al vantaggio della comunità e al progresso civile; approvate da un organismo riconosciuto sul piano nazionale o internazionale. Divengono obbligatorie solo se espressamente richiamati in Atti legali e/o amministrativi.
NORMATIVA TECNICA EUROPEA. L'insieme delle norme tecniche emesse dall'apposito organo (CEN) della Comunità europea. Più di 2000 gruppi di lavoro stanno lavorando per armonizzare le norme dei singoli Stati e definire norme comuni per ogni categoria di prodotti o servizi. Per ognuno di questi, quando è operativo un gruppo di lavoro CEN, non è ammessa l'attività normativa dei singoli Stati (stand still).
NORMATIVA TECNICA INTERNAZIONALE. Sono le norme tecniche volontarie elaborate ed emesse dall'lSO - Istituto per la normativa Internazionale. Esso è costituito da rappresentanti degli enti membri di oltre 180 Paesi.
NORMATIVA TECNICA ITALIANA. Normativa elaborata ed emessa dall'ente normatore italiano UNI (CEI per il settore elettrico). Esso ha emanato numerose norme in quasi ogni settore e partecipa in CEN all'attività di normazione europea.
TECHNICAL STANDARDS. Dispositions for
the common and repetitive uses of products and services regarding real and
potential problems, aiming to obtain the best order in a specific context.
Their application
may be suggested, not compulsory. They must be: accessible to people; drafted
with the cooperation and the permission of all the involved parts (manufacturers,
users, Authorities); based on results of science, technology, experience;
representative of "the state of the art", intended as level of
development reached on a certain moment; tending to the advantage of the
community and to civil progress; approved by an organization nationally or
internationally recognized. They become compulsory only when expressly cited
in Legal and/or administrative Acts.
EUROPEAN TECHNICAL STANDARDS
The whole of the technical standards issued by the appointed body
(CEN) of the European Community. More than 2000 work groups are working to
harmonize the standards of the
single State and define common standards for each class of products or
services. For each of these groups, when a CEN group is working, the
standardization activity of the single States is not admitted (stand still).
INTERNATIONAL TECHNICAL STANDARDS.
They are the voluntary technical standards elaborated and issued by ISO - the
Institute for the International Standardization. It is formed by
representatives of the Member Bodies of over 180 Countries.
ITALIAN TECHNICAL STANDARDS. Standards elaborated and issued by the Italian Standard Body UNI (CEI for the electrical field). It has issued many standards in almost all the areas and participates to CEN in the activity of European standardization.
Codifica CEN sullo stato di avanzamento
CEN code Codifica ISO sullo stato di avanzamento ISO code NORME
TECNICHE SUI DISPOSITIVI MEDICI MEDICAL DEVICES TECHNICAL STANDARDS Nel
seguito sono riportate in ordine alfabetico le categorie di prodotti ed
accanto a ciascuno gli Enti Normatori che hanno pubblicato Norme su quella
famiglia di prodotti.
Selezionando l'Ente desiderato si richiamano le norme, inserite in ordine
alfanumerico in base al loro stadio di sviluppo.
Products
categories are listed in alphabetic order and beside each product are inserted
the Standard Bodies that have published Standards on that product family.
Selecting the desired Body, the standards listed in alphanumeric order
according to their development stage are recalled.
EMODIALISI, EMODIALIZZATORI,CIRCUITI EXTRACORPOREI E DEFIBRILLATORI
HEMODIALYSIS, HEMODIALYZER, EXTRACORPOREAL CIRCUITS, DEFIBRILLATORS AND RELATIVE SOLUTIONS
AFNOR-BSI-CEN-CENELEC-DIN-IEC-ISO-UNI
EMODIALISI, EMODIALIZZATORI,CIRCUITI EXTRACORPOREI E DEFIBRILLATORI - NORME AFNOR
Haemodialysis, haemodializers, extracorporeal circuits and defibrillators
· NF C 74-328 Juillet 1990 Medical electrical equipment. Part 2 : particular requirements for safety infusion pumps. Status :Experimental
· NF C 74-329 Décembre 1990 Medical electrical equipment. Part 2 : particular safety requirements for separation of cells and plasma monitors by centrifugation. Status :Approved NF C 74-340 + ADDITIF 1 Octobre 1987 Electromedical equipment. Cardiac defibrillators and cardiac defibrillators. Monitors. Particular safety requirements. Status :Approved
· NF EN 1283 Juin 1996 Haemodialysers, haemodiafilters, haemofilters, haemoconcentrators and their extracorporeal circuits. Status :Approved
· NF EN 50072 Janvier 1993 Medical electrical equipment. Particular requirements for the safety of peritoneal dialysis equipment. Status :Approved
· NF EN 50072 Janvier 1993 Medical electrical equipment. Particular requirements for the safety of peritoneal dialysis equipment. Status :Approved NF C 74-322 Décembre 1986 Medical electrical equipment. Part 2 : particular requirement for safety of haemodialysis equipment. Status :Approved
· NF S 90-303 Mai 1984 Medico-surgical equipment. Dialysis apparatus. Single-use, sterile lines and connections. Status :Approved
· NF S 90-304 Octobre 1989 Medico-surgical equipment. Haemodialysis equipment. Operating data. Status :Approved
· NF S 90-305 Décembre 1986 Medico-surgical equipment. Peritoneal dialysis cycler. Functional aptitude. Status :Approved
· NF S 93-306 Décembre 1992 Extracorporeal circuits. Sterile, single-use units for filtration plasma separators (single-use, sterile plasmafilters). Status :Approved
· NF S 90-307 Décembre 1990 Medico-surgical equipment. Centrifuge-type blood cell and plasma separators (monitors and single-use kits) suitability for use. Status :Approved
· NF S 93-308 Novembre 1992 Extracorporal circuits. Identification of concentrate solutions for hemodialysis. Status :Approved
·
PR
NF EN 13867 Juillet 2000 Titre : Concentrés pour hémodialyse et thérapies
associées Indice de Classement : S93-301PR Statut : Projet de Norme
DISPOSITIVI MEDICI - DISPOSITIVI MEDICI NON ATTIVI
EMODIALISI, EMODIALIZZATORI,CIRCUITI EXTRACORPOREI E DEFIBRILLATORI - NORME BSI
Haemodialysis, haemodializers, extracorporeal circuits and defibrillators
· BS 5724:Part 2:Section 2.4:1985 - Medical electrical equipment. Particular requirements for safety.Specification for cardiac defibrillators and cardiac defibrillator-monitors
· BS 5724:Part 2:Section 2.16:1989 - Medical electrical equipment. Particular requirements for safety. Specification for haemodialysis equipment
· BS 7778 1994 Specification for connector assembly DF-1 for implantable cardiac defibrillators
· BS EN 1283 1996 Haemodialysers, haemodiafilters, haemofilters, haemoconcentrators and their extracorporeal circuits
· BS EN 12022 1999 Blood-gas exchangers
· BS EN 60601-2-16 1998 Medical electrical equipment. Particular requirements for safety. Particular requirements for the safety of haemodialysis, haemodiafiltration and haemofiltration equipment
· BS EN 60601-2-36 1997 Medical electrical equipment. Particular requirements for safety. Specification for equipment for extra-corporeally induced lithotripsy
DISPOSITIVI MEDICI - DISPOSITIVI MEDICI NON ATTIVI
EMODIALISI, EMODIALIZZATORI,CIRCUITI EXTRACORPOREI E DEFIBRILLATORI - NORME CEN
Haemodialysis, haemodializers, extracorporeal circuits and defibrillators
norme armonizzate
· EN 12022:1999 Blood gas exchangers
· EN 1283 1996 Haemodialysers, haemodiafilters, haemofilters, haemoconcentrators and their extracorporeal circuits
· EN 60601-2-16 1998 Medical electrical equipment. Particular requirements for safety. Particular requirements for the safety of haemodialysis, haemodiafiltration and haemofiltration equipment
· EN 60601-2-31 1995 Medical electrical equipment. Particular requirements for safety. Specification for external cardiac pacemakers with internal power source
· EN 60601-2-36 1997 Medical electrical equipment. Particular requirements for safety. Specification for equipment for extra-corporeally induced lithotripsy
· EN 61846 1999 Ultrasonics. Pressure pulse lithotripters. Characteristics of fields
· prEN 45502-2-2 - Active implantable medical devices - Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators) - (90/385/EEC)
· prEN 45502-2-X Active implantable medical devices -- Part 2-X: Implantable pumps ((Under development)
DISPOSITIVI MEDICI - DISPOSITIVI MEDICI NON ATTIVI
EMODIALISI, EMODIALIZZATORI,CIRCUITI EXTRACORPOREI E DEFIBRILLATORI - NORME CENELEC
Haemodialysis, haemodializers, extracorporeal circuits and defibrillators
norme armonizzate
· EN 50072:1992 Medical electrical equipment - Particular requirements for the safety of peritoneal dialysis equipment
· EN 60601-2-16:1998 IEC 60601-2-16:1998 Medical electrical equipment -- Part 2-16: Particular requirements for the safety of haemodialysis, haemodiafiltration and haemofiltration equipment 93/42/EEC
· HD 395.2.16 S1:1989 IEC 60601-2-16:1989 Medical electrical equipment -- Part 2: Particular requirements for the safety of haemodialysis equipment
· prEN 45502-2-2:1998 Active implantable medical devices -- Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (Includes implantable defibrillators)
DISPOSITIVI MEDICI - DISPOSITIVI MEDICI NON ATTIVI
EMODIALISI, EMODIALIZZATORI,CIRCUITI EXTRACORPOREI E DEFIBRILLATORI - NORME DIN
Haemodialysis, haemodializers, extracorporeal circuits and defibrillators
norme armonizzate
· DIN EN 1283, Publication date:1996-06 Haemodialysers, haemodiafilters, haemofilters, haemoconcentrators and their extracorporeal circuits
· DIN EN 45502-2-2, 1998: Active implantable medical devices - Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrythmia (includes implantable defibrillators)
· DIN EN 60601-2-16, 1999: Medical electrical equipment - Part 2-16: Particular requirements for the safety of haemodialysis, haemodiafiltration and haemofiltration equipment (IEC 60601-2-16:1998)
· DIN IEC 62D/181/CD, 1997: Medical electrical equipment - Part 2: Particular requirements for the safety of cardiac defibrillators (IEC62D/181/CD:1995)
· DIN VDE 0750-201, 1985: Medical electrical equipment; particular requirements for the safety of cardiac defibrillators and cardiac defibrillators-monitors; identical with IEC 60601-2-4, edition 1983
· DIN VDE 0750-213, 1989: Medical electrical equipment; equipment for single-needle and bicarbonate haemodialysis; particular requirements for safety
· DIN VDE 0753-4, 1986: Rules of application for haemodialysis equipment
DISPOSITIVI MEDICI - DISPOSITIVI MEDICI NON ATTIVI
EMODIALISI, EMODIALIZZATORI,CIRCUITI EXTRACORPOREI E DEFIBRILLATORI - NORME IEC
Haemodialysis, haemodializers, extracorporeal circuits and defibrillators
· IEC 1288-1: 1993, Cardiac defibrillators - Cardiac defibrillators-monitors - Part 1: Operation
· IEC 1288-2: 1993, Cardiac defibrillators - Cardiac defibrillators-monitors - Part 2: Maintenance
· IEC 60601-2-4 (1983-01)Medical electrical equipment. Part 2: Particular requirements for the safety of cardiac defribrillators and cardiac defribrillator-monitors
· IEC 60601-2-16 (1989-02) Medical electrical equipment. Part 2: Particular requirements for the safety of haemodialysis equipment
· IEC 60601-2-16 (1998-02) Medical electrical equipment - Part 2-16: Particular requirements for the safety of haemodialysis, haemodiafiltration and haemofiltration equipment
· IEC 60601-2-36 (1997-03) Medical electrical equipment - Part 2: Particular requirements for the safety of equipment for extracorporeally induced lithotripsy
DISPOSITIVI MEDICI - DISPOSITIVI MEDICI NON ATTIVI
EMODIALISI, EMODIALIZZATORI,CIRCUITI EXTRACORPOREI E
DEFIBRILLATORI - NORME ISO
Haemodialysis, haemodializers, extracorporeal circuits and defibrillators
TC 150 / SC 2 Cardiovascular implants
· ISO 8637 Haemodialysers, haemofilters and haemoconcentrators
· ISO 8638 Extracorporeal blood circuit for haemodialysers, haemofilters and haemoconcentrators
· ISO 11318:1993 Cardiac defibrillators -- Connector assembly for implantable defibrillators -- Dimensional and test requirements
· ISO 11318 /+A1:1993 1993 Cardiac defibrillators - Connector assembly for implantable defibrillators - Dimensional and test requirements
· ISO 11318 AMD 1, 1996: Cardiac defibrillators - Connector assembly for implantable defibrillators - Dimensional and test requirements; Amendment 1
· ISO/DIS 13958 Concentrates for haemodialysis or haemodiafiltration
· ISO/DIS 13959 Water for haemodialysis or haemodiafiltration -- Requirements
DISPOSITIVI MEDICI - DISPOSITIVI MEDICI NON ATTIVI
EMODIALISI, EMODIALIZZATORI,CIRCUITI EXTRACORPOREI E
DEFIBRILLATORI - NORME UNI
Haemodialysis, haemodializers, extracorporeal circuits and defibrillators
· UNI 8740 Soluzioni concentrate per emodialisi.
· UNI 8741 Soluzioni per emofiltrazioni.
· UNI 8742 Soluzioni per dialisi peritoneale.
· UNI 9268 Circuito extracorporeo. Emodialisi. Termini e definizioni.
· UNI 12022 - 30/06/1999 - Scambiatori gas/sangue extracorporali (Codice ICS: 11.040.10)
· UNI EN 1283, - 31-05-98 - Emodializzatori, emodiafiltri, emofiltri, emoconcentratori e loro circuiti extracorporei
· UNI EN 12022 - 30/06/1999 - Scambiatori gas/sangue extracorporali (Codice ICS: 11.040.10)
· ANSI/AAMI DF2-1996 Title: Cardiac Defibrillator Devices (revision of ANSI/AAMI DF2-1989)
· ANSI/AAMI DF39-1993 Title: Automatic External Defibrillators and Remote-Control Defibrillators (new standard)
· ANSI/AAMI RD5-1992 Title: Hemodialysis Systems (revision of ANSI/AAMI RD5-1981)
· ANSI/AAMI RD16-1996 Title: First-Use Hemodialyzers (revision of ANSI/AAMI RD16-1984)
· ANSI/AAMI RD17-1994 Title: Hemodialyzer Blood Tubing
· ANSI/AAMI/CDV-1 RD17:1994/A1 -- Amendment 1 to ANSI/AAMI RD17:1994, Hemodialyzer blood tubing
· ANSI/AAMI RD47-1993 Title: Reuse of Hemodialyzers (new standard)
· ANSI/AAMI RD61:2000 -- Concentrates for hemodialysis
DISPOSITIVI MEDICI - DISPOSITIVI MEDICI NON ATTIVI
EMODIALISI, EMODIALIZZATORI,CIRCUITI EXTRACORPOREI E DEFIBRILLATORI - NORME ASTM
Haemodialysis, haemodializers, extracorporeal circuits and defibrillators
· F1254-90(1995)e1 Standard Practice for Performance of Prehospital Manual Defibrillation
· F1255-90(1995)e1 Standard Practice for Performance of Prehospital Automated Defibrillation
DISPOSITIVI MEDICI - DISPOSITIVI MEDICI NON ATTIVI
EMODIALISI, EMODIALIZZATORI,CIRCUITI EXTRACORPOREI E DEFIBRILLATORI - NORME CEI
Haemodialysis, haemodializers, extracorporeal circuits and defibrillators
· CEI 62-46 - Guida all'utilizzo dei defibrillatori cardiaci e defibrillatori cardiaci con monitor incorporato
· CEI 62-47 - Guida per la manutenzione dei defibrillatori cardiaci e defibrillatori cardiaci con monitor incorporato