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 part of ISO 10993 describes:
a) the general principles governing the biological evaluation of medical devices within a risk managementframework;
b) the general categorization of devices based on the nature and duration of their contact with the body;
c) the evaluation of existing relevant data from all sources;
d) the identification of gaps in the available data set on the basis of a risk analysis;
e) the identification of additional data sets necessary to analyze the biological safety of the medical device;
f) the assessment of the biological safety of the medical device.
This part of ISO 10993 does not cover testing of materials and devices that do not come into direct or indirect contact with the patient's body, nor does it cover biological hazards arising from any mechanical failure. Other parts of ISO 10993 cover specific tests as indicated in the foreword.

Biologische 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)

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Withdrawn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
13-Oct-2010
Withdrawal Date
12-Jan-2021
Technical Committee
Current Stage
9900 - Withdrawal (Adopted Project)
Start Date
13-Jan-2021
Due Date
05-Feb-2021
Completion Date
13-Jan-2021

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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



SIST EN ISO 10993-1:2010/AC:2010



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.
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