International Standards and Conformity Assessment for all electrical, electronic and related technologies

 

Project

Reference EN 80001-1:2011
Title Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities
Project Number 22607
Abstract/Scope 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.
Status
Published

Status

Current Stage code 6060
Current Stage code date 2011-03-18
Current Stage code deadline 2011-11-01
Deadline date for vote  

Legal

Directive(s)  
Mandate(s)  
Order Voucher  

Details

IEC Technical Body IEC/SC 62A
Reference Document IEC 80001-1:2010 (EQV)
ICS 11.040.01 - Medical equipment in general
35.240.80 - IT applications in health care technology
Keywords Risk management; IT; Network; Medical
Note  
A-Deviation(s)  
Special National Condition(s)  

Environment

Clause
Categories - Aspects
Product Life Cycle
Information

History

Stage
Date
Deadline Date
Documents
6060 2011-03-18 2011-11-01 export to doc file  EN  FR  DE
5099 2011-02-01 2011-04-01  
5061 2010-11-29 2011-02-01  
5060 2010-09-27 2010-10-11 export to doc file  EN
5020 2010-07-23 2010-09-24  
3090 2010-05-21 2010-07-31  
5091 2010-01-15 2010-02-24  
5060 2010-01-11 2010-01-25 export to doc file  EN
5020 2009-07-31 2010-01-08  
1090 2009-07-28 2009-07-31  

Implementation Dates

date of Ratification (DOR) (1) 2011-02-01
date of Availability (DAV) (2) 2011-03-18
date of Announcement (DOA) (3) 2011-05-01
date of Publication (DOP) (4) 2011-11-01
date of Withdrawal (DOW) (5) 2014-02-01

Relations

Supersedes  
Superseded by  
Normative reference (6)  

(1) Date of ratification (dor) date when the Technical Board notes the approval of an EN (and HD for CENELEC), from which time the standard may be said to be approved


(2) Date of availability (dav) date when the definitive text in the official language versions of an approved CEN/CENELEC publication is distributed by the Central Secretariat


(3) Date of announcement (doa) latest date by which the existence of an EN (and HD for CENELEC), a TS or a CWA has to be announced at national level


(4) Date of publication (dop) latest date by which an EN has to be implemented at national level by publication of an identical national standard or by endorsement


(5) Date of withdrawal (dow) latest date by which national standards conflicting with an EN (and HD for CENELEC) have to be withdrawn


(6) This list of normative references is purely indicative. The only official list of normative reference is the list of the published standard.