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EN ISO 14155:2011/AC:2011

(Corrigendum)

Clinical investigation of medical devices for human subjects - Good clinical practice - Technical Corrigendum 1 (ISO 14155:2011/Cor 1:2011)

Clinical investigation of medical devices for human subjects - Good clinical practice - Technical Corrigendum 1 (ISO 14155:2011/Cor 1:2011)

Klinische Prüfung von Medizinprodukten an Menschen - Gute klinische Praxis (ISO 14155:2011/Cor 1:2011)

Investigation clinique des dispositifs médicaux pour sujets humains - Bonnes pratiques cliniques - Rectificatif technique 1 (ISO 14155:2011/Cor 1:2011)

Klinične raziskave medicinskih pripomočkov za ljudi - Dobre klinične prakse - Tehnični popravek 1 (ISO 14155:2011/Cor 1:2011)

Ta mednarodni standard naslavlja dobro klinično prakso za načrtovanje, izvajanje, beleženje in poročanje o kliničnih preiskavah, izvedenih na ljudeh, za ocenjevanje varnosti ali delovanja medicinskih pripomočkov za potrebe regulacije.
Načela, določena v tem mednarodnem standardu, prav tako veljajo za vse preostale klinične raziskave in jim je treba slediti, kolikor je mogoče, upoštevajoč naravo kliničnih raziskav in zahteve državnih predpisov.
Ta mednarodni standard določa splošne zahteve za:
– zaščito pravic, varnost in dobro počutje ljudi,
– zagotavljanje znanstvenega izvajanja klinične raziskave in verodostojnost rezultatov klinične raziskave,
– opredelitev odgovornosti sponzorja in vodilnega raziskovalca ter
– pomoč sponzorjem, preiskovalcem, etičnim odborom, regulativnim organom in drugim organom, ki so vključeni v ugotavljanje skladnosti medicinskih pripomočkov.
Ne velja za diagnostične medicinske pripomočke in vitro.
OPOMBA Standardi, ki jih je razvil ISO/TC, so namenjeni uporabi pri medicinskih pripomočkih. Uporabniki tega mednarodnega standarda bodo morali upoštevati, ali drugi standardi in/ali zahteve prav tako veljajo za raziskovalne naprave, ki jih obravnavajo.

General Information

Status
Withdrawn
Publication Date
14-Jul-2011
Withdrawal Date
18-Aug-2020
ICS
11.100.20 - Biological evaluation of medical devices
Technical Committee
CEN/TC 206 - Biocompatibility of medical and dental materials and devices
Drafting Committee
CEN/TC 206 - Biocompatibility of medical and dental materials and devices
Current Stage
9960 - Withdrawal effective - Withdrawal
Completion Date
19-Aug-2020
Directive
90/385/EEC - Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices
93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
Mandate
M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
Ref Project
SIST EN ISO 14155:2011/AC:2011 - Clinical investigation of medical devices for human subjects - Good clinical practice - Technical Corrigendum 1 (ISO 14155:2011/Cor 1:2011)

Relations

Replaced By
EN ISO 14155:2020 - Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)
Effective Date
26-Aug-2020
Corrects
EN ISO 14155:2011 - Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)
Effective Date
28-Jan-2023
Corrects
EN ISO 14155:2011 - Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)
Effective Date
08-Jun-2022

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EN ISO 14155:2011/AC:2011EN ISO 14155:2011/AC:2011
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EN ISO 14155:2011/AC:2011
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Standards Content (Sample)


2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Klinische Prüfung von Medizinprodukten an Menschen - Gute klinische Praxis (ISO 14155:2011/Cor 1:2011)Investigation clinique des dispositifs médicaux pour sujets humains - Bonnes pratiques cliniques - Rectificatif technique 1 (ISO 14155:2011/Cor 1:2011)Clinical investigation of medical devices for human subjects - Good clinical practice - Technical Corrigendum 1 (ISO 14155:2011/Cor 1:2011)11.040.01Medicinska oprema na splošnoMedical equipment in generalICS:Ta slovenski standard je istoveten z:EN ISO 14155:2011/AC:2011SIST EN ISO 14155:2011/AC:2011en01-oktober-2011SIST EN ISO 14155:2011/AC:2011SLOVENSKI
STANDARD
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN ISO 14155:2011/AC
July 2011
Juillet 2011
Juli 2011 ICS 11.100.20 English version Version Française Deutsche Fassung
Clinical investigation of medical devices for human subjects - Good clinical practice - Technical Corrigendum 1 (ISO 14155:2011/Cor 1:2011)
Investigation clinique des dispositifs médicaux pour sujets humains - Bonnes pratiques cliniques -Rectificatif technique 1 (ISO 14155:2011/Cor 1:2011)
Klinische Prüfung von Medizinprodukten an Menschen - Gute klinische Praxis (ISO 14155:2011/Cor 1:2011) This corrigendum becomes effective on 15 July 2011 for incorporation in the three official language versions of the EN.
Ce corrigendum prendra effet le 15 juillet 2011 pour incorporation dans les trois versions linguistiques officielles de la EN.
Die Berichtigung tritt am 15. Juli 2011 zur Einarbeitung in die drei offiziellen Sprachfassungen der ENin Kraft.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre:
Avenue Marnix 17,
B-1000 Brussels © 2011 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Tous droits d'exploitatio
...

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