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

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• Status: Withdrawn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
• ICS: 11.100.20 - Biological evaluation of medical devices
• Technical Committee: VAZ - Healthcare
• Current Stage: 9900 - Withdrawal (Adopted Project)
• Start Date: 13-Jan-2021
• Due Date: 05-Feb-2021
• Completion Date: 13-Jan-2021
• Directive: 2007/47/EC - Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
• 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
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/BC/CEN/89/9 - Joint Standardization request to CEN/CENELEC concerning harmonized standards relating to horizontal aspects in the field of medical devices
• Ref Project: EN ISO 10993-1:2009/AC: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)

Relations

• Corrects: SIST EN ISO 10993-1:2010 - Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009)
• Effective Date: 01-Nov-2010
• Replaced By: SIST EN ISO 10993-1:2021 - Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018, including corrected version 2018-11)
• Effective Date: 01-Feb-2021
• Corrects: SIST EN ISO 10993-1:2010 - Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009)
• Effective Date: 08-Jun-2022

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



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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