• There are no items in your cart

BS EN 80001-1:2011

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Application of risk management for IT-networks incorporating medical devices Roles, responsibilities and activities
Available format(s)

Hardcopy , PDF

Superseded date

11-01-2021

Language(s)

English

Published date

04-30-2011

INTRODUCTION
1 Scope
2 Terms and definitions
3 Roles and responsibilities
4 Life cycle RISK MANAGEMENT in MEDICAL IT-NETWORKS
5 Document control
Annex A (informative) - Rationale
Annex B (informative) - Overview of RISK MANAGEMENT
        relationships
Annex C (informative) - Guidance on field of application
Annex D (informative) - Relationship with ISO/IEC 20000-2:2005
        Information technology - Service management - Part 2:
        Code of practice
Bibliography

Describes the roles, responsibilities and activities that are necessary for RISK MANAGEMENT of IT-NETWORKS incorporating MEDICAL DEVICES to address SAFETY, EFFECTIVENESS and DATA AND SYSTEM SECURITY (the KEY PROPERTIES).

IEC 80001-1:2010 Recognizing that medical devices are incorporated into IT-networks to achieve desirable benefits (for example, interoperability), defines the roles, responsibilities and activities that are necessary for risk management of IT-networks incorporating medical devices to address safety, effectiveness and data and system security (the key properties). IEC 80001-1:2010 does not specify acceptable risk levels. IEC 80001-1:2010 applies after a medical device has been acquired by a responsible organization and is a candidate for incorporation into an IT-network. It applies throughout the life cycle of IT-networks incorporating medical devices. IEC 80001-1:2010 applies where there is no single medical device manufacturer assuming responsibility for addressing the key properties of the IT-network incorporating a medical device. IEC 80001-1:2010 applies to responsible organizations, medical device manufacturers and providers of other information technology for the purpose of risk management of an IT-network incorporating medical devices as specified by the responsible organization. It does not apply to personal use applications where the patient, operator and responsible organization are one and the same person.

Committee
CH/62/1
DevelopmentNote
Supersedes 09/30157835 DC. (04/2011)
DocumentType
Standard
Pages
46
PublisherName
British Standards Institution
Status
Superseded
SupersededBy
Supersedes

Standards Relationship
EN 80001-1:2011 Identical
IEC 80001-1:2010 Identical

BS 70000:2017 Medical physics, clinical engineering and associated scientific services in healthcare. Requirements for quality, safety and competence

ISO 16484-2:2004 Building automation and control systems (BACS) — Part 2: Hardware
IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
ISO 31000:2009 Risk management Principles and guidelines
ISO/IEC 20000-1:2011 Information technology Service management Part 1: Service management system requirements
IEC 62304:2006+AMD1:2015 CSV Medical device software - Software life cycle processes
ISO/IEC 20000-2:2012 Information technology Service management Part 2: Guidance on the application of service management systems
ISO/IEC 15026-2:2011 Systems and software engineering — Systems and software assurance — Part 2: Assurance case
ISO 9000:2015 Quality management systems — Fundamentals and vocabulary
IEC 61907:2009 Communication network dependability engineering
ISO 14971:2007 Medical devices Application of risk management to medical devices

View more information
US$313.84
Excluding Tax where applicable

Access your standards online with a subscription

Features

  • Simple online access to standards, technical information and regulations.

  • Critical updates of standards and customisable alerts and notifications.

  • Multi-user online standards collection: secure, flexible and cost effective.