CENELEC
Project
| Reference | EN 60601-2-34:201X |
|---|---|
| Title | Medical electrical equipment - Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment |
| Project Number | 22292 |
| Abstract/Scope | IEC 60601-2-34:2011 concerns the basic safety and essential performance of invasive blood pressure monitoring equipment. It amends and supplements IEC 60601-1 (third edition, 2005): Medical electrical equipment - Part 1: General requirements for basic safety and essential performance. The third edition of IEC 60601-2-34 cancels and replaces the second edition published in 2001 and constitutes a technical revision in order to align structurally with the 2005 edition of IEC 60601-1. IEC 60601-2-34 applies to basic safety and essential performance of invasive blood pressure monitoring equipment. It does not apply to catheter tubing, catheter needles, Luer locks, taps and tap tables connected. It does not apply to non-invasive blood pressure monitoring equipment. |
| Status |
Approval stage
|
Status
| Current Stage code | 5091 |
|---|---|
| Current Stage code date | 2013-05-30 |
| Current Stage code deadline | |
| Deadline date for vote |
Legal
| Directive(s) | MDD (93/42/EEC) |
|---|---|
| Mandate(s) | M/295 |
| Order Voucher |
Details
| IEC Technical Body | IEC/SC 62D |
|---|---|
| Reference Document | IEC 60601-2-34:2011 (EQV) |
| ICS | |
| Keywords | Medical; Invasive; Blood; Pressure; Monitoring |
| Note | Publication editing allocated to svandriessche@cencenelec.eu * Will supersede EN 60601-2-34:2000 * To be used in conjunction with EN 60601-1:2006 |
| A-Deviation(s) | |
| Special National Condition(s) |
Environment
|
Clause
|
Categories - Aspects
|
Product Life Cycle
|
Information
|
|---|
History
Implementation Dates
| date of Ratification (DOR) (1) | 2011-10-09 |
|---|---|
| date of Availability (DAV) (2) | |
| date of Announcement (DOA) (3) | 2012-01-09 |
| date of Publication (DOP) (4) | 2012-07-09 |
| date of Withdrawal (DOW) (5) | 2014-10-09 |
Relations
| Supersedes | EN 60601-2-34:2000 |
|---|---|
| Superseded by | |
| Normative reference (6) | ISO 15223-1:2007 EN 60601-1-2:2007 corr. March 2010 EN 60601-1-8:2007 corr. March 2010 EN 60601-2-2:2009 A11:2011 IEC 60601-2-27 IEC 60601-2-49 |
(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.
