EN ISO 10993-1:2009/AC:2010
(Corrigendum)Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process - Technical Corrigendum 1 (ISO 10993-1:2009/Cor 1:2010)
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process - Technical Corrigendum 1 (ISO 10993-1:2009/Cor 1:2010)
2010-05-19 EMA: Consultant added following e-mail from PM sent to dataservice on 2010-05-17.
Biologische Beurteilung von Medizinprodukten - Teil 1: Beurteilung und Prüfungen im Rahmen eines Risikomanagementsystems (ISO 10993-1:2009/Cor 1:2010)
Évaluation biologique des dispositifs médicaux - Partie 1: Évaluation et essais au sein d'un processus de gestion du risque - Rectificatif technique 1 (ISO 10993-1:2009/Cor 1:2010)
Biološko ovrednotenje medicinskih pripomočkov - 1. del: Ocena in preskušanje znotraj procesa obvladovanja tveganja - Popravek 1 (ISO 10993-1:2009/Cor 1:2010)
Ta del ISO 10993 opisuje:
a) splošna načela, ki upravljajo biološko ovrednotenje medicinskih pripomočkov znotraj okvira za obvladovanje tveganja;
b) splošno kategorizacijo naprav, osnovano na njihovi naravi in dolžini njihovega kontakta z telesom;
c) ovrednotenje obstoječih ustreznih podatkov iz vseh virov;
d) določevanje vrzeli v razpoložljivem naboru podatkov na osnovi analiz tveganja;
e) določevanje dodatnih naborov podatkov, potrebnih za analizo biološke varnosti medicinskega pripomočka;
f) oceno biološke varnosti medicinskega pripomočka.
Ta del standarda ISO 10993 ne zajema preskušanja materialov in pripomočkov, ki ne prihajajo v neposreden ali posreden stik z bolnikovim telesom, ter ne zajema bioloških nevarnosti, ki izhajajo iz kakršne koli mehanske okvare. Drugi deli standarda ISO 10993 zajemajo posebne preskuse, navedene v predgovoru.
General Information
- Status
- Withdrawn
- Publication Date
- 14-Jun-2010
- 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
- 16-Dec-2020
- Completion Date
- 28-Jan-2026
Relations
- Effective Date
- 23-Dec-2020
- 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 10993-1:2009/AC:2010 is a corrigendum published by the European Committee for Standardization (CEN). Its full title is "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process - Technical Corrigendum 1 (ISO 10993-1:2009/Cor 1:2010)". This standard covers: 2010-05-19 EMA: Consultant added following e-mail from PM sent to dataservice on 2010-05-17.
2010-05-19 EMA: Consultant added following e-mail from PM sent to dataservice on 2010-05-17.
EN ISO 10993-1:2009/AC:2010 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 10993-1:2009/AC:2010 has the following relationships with other standards: It is inter standard links to EN ISO 10993-1:2020, EN ISO 10993-1:2009. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN ISO 10993-1:2009/AC:2010 is associated with the following European legislation: EU Directives/Regulations: 2007/47/EC, 90/385/EEC, 93/42/EEC; Standardization Mandates: M/BC/CEN/89/9. 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 10993-1:2009/AC:2010 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.SUHVNXãDQMHBiologische Beurteilung von Medizinprodukten - Teil 1: Beurteilung und Prüfung im Rahmen eines Risikomanagementverfahrens (ISO 10993-1:2009/Cor 1:2010)Évaluation biologique des dispositifs médicaux - Partie 1: Évaluation et essais au sein d'un processus de gestion du risque - Rectificatif technique 1 (ISO 10993-1:2009/Cor 1:2010)Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process - Technical Corrigendum 1 (ISO 10993-1:2009/Cor 1:2010)11.100.20Biological evaluation of medical devicesICS:Ta slovenski standard je istoveten z:EN ISO 10993-1:2009/AC:2010SIST EN ISO 10993-1:2010/AC:2010en01-november-2010SIST EN ISO 10993-1:2010/AC:2010SLOVENSKI
STANDARD
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN ISO 10993-1:2009/AC
June 2010
Juin 2010
Juni 2010 ICS 11.100.20 English version Version Française Deutsche Fassung
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process - Technical Corrigendum 1 (ISO 10993-1:2009/Cor 1:2010)
Évaluation biologique des dispositifs médicaux - Partie 1: Évaluation et essais au sein d'un processus de gestion du risque - Rectificatif technique 1 (ISO 10993-1:2009/Cor 1:2010)
Biologische Beurteilung von Medizinprodukten - Teil 1: Beurteilung und Prüfung im Rahmen eines Risikomanagementverfahrens (ISO 10993-1:2009/Cor 1:2010) This corrigendum becomes effective on 15 June 2010 for incorporation in the three official language versions of the EN.
Ce corrigendum prendra effet le 15 juin 2010 pour incorporation dans les trois versions linguistiques officielles de la EN.
Die Berichtigung tritt am 15.Juni 2010 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 © 2010 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Tous droits d'exploitation sous quelque forme et de quelque manière que ce soit réservés dans le monde entier aux membres nation
...
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...