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- Withdrawn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
- 20-Jan-2026
- Technical Committee
- CEN/TC 206 - Biocompatibility of medical and dental materials and devices
- Current Stage
- 9960 - Withdrawal effective - Withdrawal
- Start Date
- 19-Aug-2020
- Completion Date
- 28-Jan-2026
Relations
- Effective Date
- 26-Aug-2020
- Effective Date
- 28-Jan-2023
- Effective Date
- 08-Jun-2022
Get Certified
Connect with accredited certification bodies for this standard
BSI Group
BSI (British Standards Institution) is the business standards company that helps organizations make excellence a habit.
TÜV Rheinland
TÜV Rheinland is a leading international provider of technical services.
TÜV SÜD
TÜV SÜD is a trusted partner of choice for safety, security and sustainability solutions.
Sponsored listings
Frequently Asked Questions
EN ISO 14155:2011/AC:2011 is a corrigendum published by the European Committee for Standardization (CEN). Its full title is "Clinical investigation of medical devices for human subjects - Good clinical practice - Technical Corrigendum 1 (ISO 14155:2011/Cor 1:2011)". This standard covers: 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)
EN ISO 14155:2011/AC:2011 is classified under the following ICS (International Classification for Standards) categories: 11.100.20 - Biological evaluation of medical devices. The ICS classification helps identify the subject area and facilitates finding related standards.
EN ISO 14155:2011/AC:2011 has the following relationships with other standards: It is inter standard links to EN ISO 14155:2020, EN ISO 14155:2011, EN ISO 14155:2011. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN ISO 14155:2011/AC:2011 is associated with the following European legislation: EU Directives/Regulations: 90/385/EEC, 93/42/EEC; Standardization Mandates: M/295. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
EN ISO 14155:2011/AC:2011 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.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
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.
Loading comments...