CENELEC
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
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Status
| Current Stage code | 6060 |
|---|---|
| Current Stage code date | 2011-03-18 |
| Current Stage code deadline | 2011-11-01 |
| Deadline date for vote |
Legal
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| 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
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Clause
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Categories - Aspects
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Product Life Cycle
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Information
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History
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Stage
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Date
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Deadline Date
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Documents
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| 6060 | 2011-03-18 | 2011-11-01 |  EN FR DE |
| 5099 | 2011-02-01 | 2011-04-01 | |
| 5061 | 2010-11-29 | 2011-02-01 | |
| 5060 | 2010-09-27 | 2010-10-11 | 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 | 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
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| 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.
