ISO/TR 80001-2-6:2014

Status : Published

	Format	Language
std 1 92	PDF
std 2 92	Paper

CHF92

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Abstract

ISO/TR 80001-2-6:2014 provides guidance on implementing RESPONSIBILITY AGREEMENTS, which are described in IEC 80001-1 as used to establish the roles and responsibilities among the stakeholders engaged in the incorporation of a MEDICAL DEVICE into an IT-NETWORK in order to support compliance to IEC 80001-1. Stakeholders may include RESPONSIBLE ORGANIZATIONS, IT suppliers, MEDICAL DEVICE manufacturers and others. The goal of the RESPONSIBILITY AGREEMENT is that these roles and responsibilities should cover the complete lifecycle of the resulting MEDICAL IT-NETWORK.

General information

Status
: Published

Publication date
: 2014-12

Stage
: International Standard published [60.60]
Edition
: 1

Number of pages
: 15
Technical Committee :
ISO/TC 215

ICS :
11.040.01 35.240.80
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