CENELEC
CLC/TC 62 |
Electrical equipment in medical practice |
Project
| Reference | EN 60601-1-2:2007 |
|---|---|
| Title | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests |
| Project Number | 20576 |
| Abstract/Scope | This collateral standard applies to electromagnetic compatibility of medical electrical equipment and medical electrical systems. The object of this collateral standard is to specify general requirements and tests for electromagnetic compatibility of medical electrical equipment and medical electrical systems. They are in addition to the requirements of the general standard and serve as the basis for particular standards. This edition of IEC 60601-1-2 was revised to structurally align it with the 2005 edition of IEC 60601-1 and to implement the decision of IEC subcommittee 62A that the clause numbering structure of collateral standards written to IEC 60601-1:2005 would adhere to the form specified in ISO/IEC Directives, Part 2:2004. The principle technical changes are in Clause 4, which now recognizes that there is a general requirement for a risk management process in IEC 60601-1:2005. |
| Status |
Published
|
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) | EMC related (2004/108/EC), MDD (93/42/EEC) |
|---|---|
| Mandate(s) | M/432 |
| Order Voucher |
Details
| IEC Technical Body | IEC/SC 62A |
|---|---|
| Reference Document | IEC 60601-1-2:2007 (MOD) |
| ICS | 11.040.01 - Medical equipment in general 33.100.10 - Emission 33.100.20 - Immunity |
| Keywords | Medical equipment; Electromagnetic compatibility; EMC; Test; Safety |
| Note | |
| A-Deviation(s) | |
| Special National Condition(s) |
Environment
|
Clause
|
Categories - Aspects
|
Product Life Cycle
|
Information
|
|---|
History
|
Stage
|
Date
|
Deadline Date
|
Documents
|
|---|---|---|---|
| 6060 | 2007-07-31 | 2008-02-01 |  EN FR DE |
| 5099 | 2007-04-11 | 2007-08-01 | |
| 5062 | 2007-04-02 | 2007-04-11 | |
| 5060 | 2007-02-15 | 2007-03-01 | EN |
| 5020 | 2006-12-08 | 2007-02-09 | |
| 5020 | 2006-12-05 | 2007-02-09 | |
| 4099 | 2006-09-08 | 2006-12-31 | |
| 5060 | 2006-07-10 | 2006-07-24 | EN |
| 5020 | 2006-02-03 | 2006-07-07 | |
| 1090 | 2006-01-31 | 2006-02-03 |
Implementation Dates
| date of Ratification (DOR) (1) | 2007-04-11 |
|---|---|
| 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 60601-1-2:2001 EN 60601-1-2:2001/A1:2006 |
|---|---|
| Superseded by | FprEN 60601-1-2:2012 |
| Normative reference (6) |
EN 55011:2007
EN 55014-1:2006 EN 55015:2006 EN 55016-1-2:2004 CISPR 22:2005 EN 60601-1:2006 corr. March 2010 A11:2011 EN 60601-1-8:2007 corr. March 2010 EN 61000-3-2:2006 EN 61000-3-3:1995 corr. July 1997 EN 61000-4-2:1995 EN 61000-4-3:2006 EN 61000-4-4:2004 EN 61000-4-5:2006 EN 61000-4-6:2007 corr. August 2007 : : EN 61000-4-8:1993 EN 61000-4-11:2004 IEC 60417-DB |
(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.
