ISO-80001-2-6 Application of risk management for IT-networks incorporating medical devices - Part 2-6: Application guidance - Guidance for responsibility agreements

ISO-80001-2-6 - 1ST EDITION - CURRENT


Document Center Inc. is an authorized dealer of ISO standards.
The following bibliographic material is provided to assist you with your purchasing decision:


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.

ORDER

Price:

$120.28        


Want this as a site license?

To find similar documents by classification:

11.040.01 (Medical equipment in general)

35.240.80 (IT applications in health care technology Including computer tomography)

This document comes with our free Notification Service, good for the life of the document.

This document is available in either Paper or PDF format.

 

Customers who bought this document also bought:

SOR/98-282
Medical Devices Regulations (Canada)

21CFR(820)
Code of Federal Regulations - FDA, Food and Drug Administration - Quality System Regulation

BS-EN-ISO-15223-1
Medical devices. Symbols to be used with information to be supplied by the manufacturer

Document Number

ISO/TR 80001-2-6:2014

Revision Level

1ST EDITION

Status

Current

Publication Date

Dec. 1, 2014

Committee Number

ISO/TC 215