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)
General Information
- Abstract
- Status
- Withdrawn
- Publication Date
- 14-Jul-2011
- Withdrawal Date
- 22-Sep-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
- 23-Sep-2026
- Directive
- Not Harmonized90/385/EEC - Active implantable medical devicesOJ Ref: C, C 389 OJ Date: 17-Nov-2017
Not Harmonized93/42/EEC - Medical devicesOJ Ref: C, C 389 OJ Date: 17-Nov-2017
Relations
- Effective Date
- 26-Aug-2020
- Effective Date
- 28-Jan-2023
- Effective Date
- 08-Jun-2022
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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.
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