CENELEC
Project
| Reference | EN 60601-1-11:2010 |
|---|---|
| Title | Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment |
| Project Number | 22366 |
| Abstract/Scope | IEC 60601-1-11:2010 applies to the basic safety and essential performance of medical electrical equipment and medical electrical systems which are intended by their manufacturer for use in the home healthcare environment, regardless of whether the medical electrical equipment or medical electrical system is intended for use by a lay operator or by trained healthcare personnel. The object of IEC 60601-1-11:2010 is to specify general requirements that are in addition to those of the general standard IEC 60601-1:2005 and to serve as the basis for particular standards. It is the recommendation of the committee that the content of this publication be adopted for implementation nationally not earlier than 3 years from the date of publication. |
| Status |
Published
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Status
| Current Stage code | 6060 |
|---|---|
| Current Stage code date | 2010-06-04 |
| Current Stage code deadline | 2011-03-01 |
| Deadline date for vote |
Legal
| Directive(s) | MDD (93/42/EEC) |
|---|---|
| Mandate(s) | M/295 |
| Order Voucher |
Details
| IEC Technical Body | IEC/SC 62A |
|---|---|
| Reference Document | IEC 60601-1-11:2010 (EQV) |
| ICS | 11.040 - Medical equipment |
| Keywords | Medical equipment; Collateral standard; Healthcare; Home |
| Note | IEC 60601-1-11 developed by ISO/TC 121/SC 3 - IEC/SC 62A WG6 and also circulated in ISO/TC 121/SC 3 |
| 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) | 2010-06-01 |
|---|---|
| date of Availability (DAV) (2) | 2010-06-04 |
| date of Announcement (DOA) (3) | 2010-09-01 |
| date of Publication (DOP) (4) | 2011-03-01 |
| date of Withdrawal (DOW) (5) | 2013-06-01 |
Relations
| Supersedes | |
|---|---|
| Superseded by | |
| Normative reference (6) |
EN 55011
EN 60068-2-27 EN 60068-2-31 EN 60068-2-64 EN 60529 EN 60601-1 EN 60601-1-2 EN 60601-1-6 EN 60601-1-8 |
(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.
