CENELEC
Project
| Reference | EN 60601-1:2006 |
|---|---|
| Title | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
| Project Number | 15126 |
| Abstract/Scope | |
| Status |
Published
|
Status
| Current Stage code | 6060 |
|---|---|
| Current Stage code date | 2006-10-20 |
| Current Stage code deadline | 2007-07-01 |
| Deadline date for vote |
Legal
| Directive(s) | MDD (93/42/EEC), AIMD (90/385/EEC) |
|---|---|
| Mandate(s) | M/432 |
| Order Voucher |
Details
| IEC Technical Body | IEC/SC 62A |
|---|---|
| Reference Document | IEC 60601-1:2005 (EQV) |
| ICS | 11.040 - Medical equipment |
| Keywords | Medical equipment; Essential performance; Safety |
| Note | |
| A-Deviation(s) | |
| Special National Condition(s) |
Environment
|
Clause
|
Categories - Aspects
|
Product Life Cycle
|
Information
|
|---|---|---|---|
| Annex B.7 | Energy use - Energy consumption | Use | B2B, B2C |
| 7.9.2.15 | Waste - Hazardous waste | Disposal | B2B, B2C |
History
|
Stage
|
Date
|
Deadline Date
|
Documents
|
|---|---|---|---|
| 6060 | 2006-10-20 | 2007-07-01 |  EN FR |
| 5099 | 2006-09-12 | 2006-11-12 | |
| 5062 | 2006-07-01 | 2006-09-12 | |
| 5061 | 2006-04-01 | 2006-07-01 | |
| 5061 | 2006-02-28 | 2006-04-01 | |
| 5060 | 2005-11-24 | 2005-11-28 | |
| 5020 | 2005-10-07 | 2005-11-11 | |
| 4099 | 2005-04-08 | 2005-09-30 | |
| 4020 | 2004-03-12 | 2004-08-13 | |
| 4093 | 2004-03-09 | 2004-03-12 | |
| 4060 | 2003-06-20 | 2003-09-29 | |
| 4020 | 2002-03-15 | 2002-08-16 | |
| 3099 | 2002-03-12 | 2002-03-15 |
Implementation Dates
| date of Ratification (DOR) (1) | 2006-09-12 |
|---|---|
| date of Availability (DAV) (2) | 2006-10-20 |
| date of Announcement (DOA) (3) | 2007-01-01 |
| date of Publication (DOP) (4) | 2007-07-01 |
| date of Withdrawal (DOW) (5) | 2012-06-01 |
Relations
| Supersedes | EN 60601-1:1990 EN 60601-1:1990/A1:1993 EN 60601-1:1990/A2:1995 EN 60601-1:1990/A13:1996 EN 60601-1:1990/A1:1993/corrigendum Jul. 1994 EN 60601-1-1:2001 EN 60601-1-4:1996 EN 60601-1-4:1996/A1:1999 |
|---|---|
| Superseded by | |
| Normative reference (6) | ISO 31-1:1978 ISO 780:1997 ISO 1000:1992 ISO 1853:1998 ISO 2878:1987 ISO 2882:1979 ISO 3746:1995 ISO 3864-1:2002 EN 60065:2002 corr. March 2006 corr. August 2007 A12:2011 A11:2008 EN 60068-2-2:1993 A1:1993 A2:1994 EN 60079-0:2006 EN 60079-2:2004 corr. April 2006 IEC 60079-5:1997 IEC 60079-6:1995 IEC 60083:1997 EN 60085:2004 EN 60086-4:2000 EN 60112:2003 EN 60127-1:2006 IEC 60227-1:1993 IEC 60245-1:2003 EN 60252-1:2001 EN 60320-1:2001 EN 60335-1:2002 corr. July 2009 corr. May 2010 A12:2006 A11:2004 A15:2011 A14:2010 A13:2008 HD 60364-4-41:2007 corr. July 2007 EN 60384-14:2005 EN 60445:2000 EN 60447:2004 EN 60529:1991 corr. May 1993 A1:2000 EN 60601-1-2:2001 EN 60601-1-3:1994 EN 60601-1-6:2004 EN 60601-1-8:2004 EN 60664-1:2003 : : EN 60695-11-10:1999 EN 60730-1:2000 corr. August 2007 A1:2004 A14:2005 A11:2002 A13:2004 A15:2007 A12:2003 A16:2007 EN 60825-1:1994 corr. February 1995 A1:2002 A2:2001 A11:1996 EN 60851-3:1996 A1:1997 A2:2003 EN 60851-5:1996 A1:1997 A2:2004 EN 60851-6:1996 A1:1997 IEC/TR 60878:2003 IEC 60884-1:2002 EN 60950-1:2001 corr. April 2004 corr. December 2007 A11:2004 EN 61058-1:2002 : A1: EN 61558-1:1997 corr. April 2003 A1:1998 A11:2003 EN 61558-2-1:1997 EN 61672-1:2003 EN 61672-2:2003 EN 61965:2003 IEC 60417-DB:2002 |
(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.
