About CEN
The European Committee for Standardization is one of three European Standardization Organizations (together with CENELEC and ETSI) that have been officially recognized by the European Union and by the European Free Trade Association (EFTA) as being responsible for developing and defining voluntary standards at European level.
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Project
| Reference | EN ISO/IEEE 11073-40101:2022 |
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| Title | Health informatics - Device interoperability - Part 40101: Foundational - Cybersecurity - Processes for vulnerability assessment (ISO/IEEE 11073-40101:2022) |
| Work Item Number | 00251374 |
| Abstract/Scope | Within the context of secure plug-and-play interoperability, cybersecurity is the process and capability of preventing unauthorized access or modification, misuse, denial of use, or the unauthorized use of information that is stored on, accessed from, or transferred to and from a PHD/PoCD. The process part of cybersecurity is risk analysis of use cases specific to a PHD/PoCD. For PHDs/PoCDs, this standard defines an iterative, systematic, scalable, and auditable approach to identification of cybersecurity vulnerabilities and estimation of risk. This iterative vulnerability assessment uses the Spoofing, Tampering, Repudiation, Information Disclosure, Denial of Service, and Elevation of Privilege (STRIDE) classification scheme and the embedded Common Vulnerability Scoring System (eCVSS). The assessment includes system context, system decomposition, pre-mitigation scoring, mitigation, and post-mitigation scoring and iterates until the remaining vulnerabilities are reduced to an acceptable level of risk. |
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Published
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| Reference Document |
ISO/IEEE 11073-40101:2022 (EQV)
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| date of Availability (DAV) | 2022-03-30 |
| ICS | 35.240.80 - IT applications in health care technology |
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Implementation Dates
| date of Ratification (DOR) (1) | 2022-03-13 |
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| date of Availability (DAV) (2) | 2022-03-30 |
| date of Announcement (DOA) (3) | 2022-06-30 |
| date of Publication (DOP) (4) | 2022-09-30 |
| date of Withdrawal (DOW) (5) | 2022-09-30 |
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(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.
In the case of undated standard, a link to the last dated version is provided.
In the case of series, a link to each standard identified in the series is provided.
We also invite you to check (via the website) whether corrigenda and/or amendments shall be read in conjunction with the main standard.