Norme internationale
IEC/TR 80001-2-1:2012
Application du management du risque aux réseaux des technologies de l'information contenant les dispositifs médicaux — Partie 2-1: Management du risque étape par étape des réseaux des technologies de l'information médicaux — Applications pratiques et exemples
Numéro de référence
IEC/TR 80001-2-1:2012
Edition 1
Norme internationale
IEC/TR 80001-2-1:2012
Indisponible en français
Publiée (Edition 1, 2012)

IEC/TR 80001-2-1:2012

IEC/TR 80001-2-1:2012
CHF 345
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IEC/TR 80001-2-1:2012(E), which is a technical report, is a step-by-step guide to help in the application of risk management when creating or changing a medical IT-network. It provides easy to apply steps, examples, and information helping in the identification and control of risks. All relevant requirements in IEC 80001-1:2010 are addressed and links to other clauses and subclauses of IEC 80001-1 are addressed where appropriate (e.g. handover to release management and monitoring). This technical report focuses on practical risk management. It is not intended to provide a full outline or explanation of all requirements that are satisfactorily covered by IEC 80001-1. This step-by-step guidance follows a 10-step process that follows subclause 4.4 of IEC 80001-1:2010, which specifically addresses risk analysis, risk evaluation and risk control. These activities are embedded within the full life cycle risk management process. They can never be the first step, as risk management follows the general process model which sets planning before any action.

Informations générales

  •  : Publiée
     : 2012-07
    : Norme internationale publiée [60.60]
  •  : 1
  • ISO/TC 215
  • RSS mises à jour

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