CENELEC
Project
| Reference | EN 62366:2008 |
|---|---|
| Title | Medical devices - Application of usability engineering to medical devices |
| Project Number | 20763 |
| Abstract/Scope | Specifies a process for a manufacturer to analyse, specify, design, verify and validate usability, as it relates to safety of a medical device. This usability engineering process assesses and mitigates risks caused by usability problems associated with correct use and use errors, i.e. normal use. It can be used to identify but does not assess or mitigate risks associated with abnormal use. If the usability engineering process detailed in this International Standard has been complied with and the acceptance criteria documented in the usability validation plan have been met, then the residual risks, as defined in ISO 14971, associated with usability of a medical device are presumed to be acceptable, unless there is objective evidence to the contrary. This International Standard does not apply to clinical decision-making relating to the use of a medical device. |
| Status |
Published
|
Status
| Current Stage code | 6060 |
|---|---|
| Current Stage code date | 2008-01-25 |
| Current Stage code deadline | 2008-09-01 |
| Deadline date for vote |
Legal
| Directive(s) | MDD (93/42/EEC), IVD (98/79/EC) |
|---|---|
| Mandate(s) | M/432 |
| Order Voucher |
Details
| IEC Technical Body | IEC/SC 62A |
|---|---|
| Reference Document | IEC 62366:2007 (EQV) |
| ICS | 11.040 - Medical equipment |
| Keywords | Medical; Usability engineering |
| 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
Implementation Dates
| date of Ratification (DOR) (1) | 2007-12-01 |
|---|---|
| date of Availability (DAV) (2) | 2008-01-25 |
| date of Announcement (DOA) (3) | 2008-03-01 |
| date of Publication (DOP) (4) | 2008-09-01 |
| date of Withdrawal (DOW) (5) | 2010-12-01 |
Relations
| Supersedes | |
|---|---|
| Superseded by | |
| Normative reference (6) |
EN ISO 14971:2012
|
(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.
