CENELEC
Project
| Reference | FprEN 60601-2-16:2008 |
|---|---|
| Title | Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment |
| Project Number | 20652 |
| Abstract/Scope | |
| Status |
Approval stage
|
Status
| Current Stage code | 5091 |
|---|---|
| Current Stage code date | 2008-09-01 |
| Current Stage code deadline | 2009-03-01 |
| Deadline date for vote |
Legal
| Directive(s) | MDD (93/42/EEC) |
|---|---|
| Mandate(s) | M/295 |
| Order Voucher |
Details
| IEC Technical Body | IEC/SC 62D |
|---|---|
| Reference Document | IEC 60601-2-16:2008 (EQV) + corrigendum Oct. 2008 (EQV) |
| ICS | 11.040.20 - Transfusion, infusion and injection equipment |
| Keywords | Medical equipment; Haemodialysis; Haemodiafiltration; Haemofiltration; Safety |
| Note | Will supersede EN 60601-2-16:1998 * D133/C090: Ratification deferred until IEC has published a corrigendum to correct editorial errors and address the concerns raised by the MDD consultant (to allow EN to be listed in the OJEC under the MDD) * An amendment has been developed in IEC/SC 62D/MT 20 it is expected that it will be established as a project and submitted for vote as CDV.*2012-02-07: Publication editing allocated to cpalagi@cencenelec.eu |
| A-Deviation(s) | |
| Special National Condition(s) |
Environment
|
Clause
|
Categories - Aspects
|
Product Life Cycle
|
Information
|
|---|
History
Implementation Dates
| date of Ratification (DOR) (1) | |
|---|---|
| date of Availability (DAV) (2) | |
| date of Announcement (DOA) (3) | dor + 3 months |
| date of Publication (DOP) (4) | dor + 9 months |
| date of Withdrawal (DOW) (5) | dor + 36 months |
Relations
| Supersedes |
EN 60601-2-16:1998
EN 60601-2-16:1998/corrigendum Dec. 1999 |
|---|---|
| Superseded by | FprEN 60601-2-16:2011 |
| Normative reference (6) | ISO 594-2 ISO 3744 ISO 8638 EN 60601-1-9:2008 EN 60601-1-10:2008 EN 61672-1 |
(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.
