CENELEC
Project
| Reference | EN 60601-1-6:2007 |
|---|---|
| Title | Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral Standard: Usability |
| Project Number | 20485 |
| Abstract/Scope | Specifies requirements for a process to analyse, design, verify and validate the usability, as it relates to basic safety and essential performance of medical electrical equipment. This collateral standard addresses normal use and use errors but excludes abnormal use. The object of this collateral standard is to specify general requirements that are in addition to those of the general standard IEC 60601-1 and to serve as the basis for particular standards. |
| Status |
Withdrawn
|
Status
| Current Stage code | 6060 |
|---|---|
| Current Stage code date | 2007-07-31 |
| Current Stage code deadline | 2008-02-01 |
| Deadline date for vote |
Legal
| Directive(s) | MDD (93/42/EEC) |
|---|---|
| Mandate(s) | M/432 |
| Order Voucher |
Details
| IEC Technical Body | IEC/SC 62A |
|---|---|
| Reference Document | IEC 60601-1-6:2006 (EQV) |
| ICS | 11.040 - Medical equipment |
| Keywords | Medical equipment; Collateral standard; Usability |
| Note | Superseded by EN 60601-1-6:2010 |
| A-Deviation(s) | |
| Special National Condition(s) |
Environment
|
Clause
|
Categories - Aspects
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Product Life Cycle
|
Information
|
|---|
History
Implementation Dates
| date of Ratification (DOR) (1) | 2007-05-01 |
|---|---|
| date of Availability (DAV) (2) | 2007-07-31 |
| date of Announcement (DOA) (3) | 2007-08-01 |
| date of Publication (DOP) (4) | 2008-02-01 |
| date of Withdrawal (DOW) (5) | 2012-06-01 |
Relations
| Supersedes | EN 60601-1-6:2004 |
|---|---|
| Superseded by | EN 60601-1-6:2010 |
| Normative reference (6) |
EN ISO 14971:2000
corr. February 2002 EN 60601-1:2006 corr. March 2010 A11:2011 EN 60601-1-8:2007 corr. March 2010 |
(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.
