CENELEC
Project
| Reference | EN 60601-2-12:2006 |
|---|---|
| Title | Medical electrical equipment - Part 2-12: Particular requirements for the safety of lung ventilators - Critical care ventilators |
| Project Number | 17023 |
| Abstract/Scope | Specifies the safety requirements for ventilators, as defined below, intended for use in critical care settings. Ventilator: automatic equipment that is intended to augment or provide ventilation of the lungs of the patient when connected to the airway of the patient. |
| Status |
Published
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Status
| Current Stage code | 6060 |
|---|---|
| Current Stage code date | 2006-06-28 |
| Current Stage code deadline | 2007-05-01 |
| Deadline date for vote |
Legal
| Directive(s) | MDD (93/42/EEC) |
|---|---|
| Mandate(s) | M/432 |
| Order Voucher |
Details
| IEC Technical Body | IEC/SC 62D |
|---|---|
| Reference Document | IEC 60601-2-12:2001 (EQV) |
| ICS | 11.040.10 - Anaesthetic, respiratory and reanimation equipment |
| Keywords | Medical equipment; Ventilator; Lung; Critical care |
| Note | TC advice: CEN BT Resolution C009/2005 applies * Will be superseded by EN ISO 80601-2-12 (circulated by CEN in // with ISO) |
| 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) | 2006-05-01 |
|---|---|
| date of Availability (DAV) (2) | 2006-06-28 |
| date of Announcement (DOA) (3) | 2006-11-01 |
| date of Publication (DOP) (4) | 2007-05-01 |
| date of Withdrawal (DOW) (5) | 2009-05-01 |
Relations
| Supersedes | |
|---|---|
| Superseded by | |
| Normative reference (6) | ISO 4135:1995 ISO 5356-1:1996 ISO 5356-2:1987 ISO 5359:2000 ISO 5362:2000 ISO 5367:2000 ISO 7000:1989 ISO 7396:1987 ISO 7767:1997 ISO 8185:1997 ISO 8835-3:1997 ISO 9360-1:2000 ISO 9360-2:2001 ISO 9703-1:1992 ISO 9703-2:1994 ISO 9703-3:1998 ISO 9918:1993 ISO 9919:1992 ISO 11134:1994 ISO 11135:1994 ISO 11137:1995 ISO 11138-1:1994 ISO 11138-2:1994 ISO 11138-3:1995 EN ISO 14971:2012 ISO 15223:2000 IEC 60079-4:1975 IEC 60079-4A:1970 IEC 60417-1:2000 EN 60417-2:1999 A1: EN 60601-1:1990 corr. July 1994 A1:1993 A2:1995 A11:1993 A12:1993 A13:1996 EN 60601-1-1:2001 EN 60601-1-2:2001 EN 60601-1-4:1996 A1:1999 |
(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.
