CENELEC
Project
| Reference | EN 60601-2-39:2008/A11:2011 |
|---|---|
| Title | Medical electrical equipment - Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment |
| Project Number | 23809 |
| Abstract/Scope | Applies to the basic safety and essential performance of peritoneal dialysis medical electrical equipment. It applies to peritoneal dialysis equipment intended for use either by medical staff or under the supervision of medical experts, including peritoneal dialysis equipment operated by the patient, regardless of whether the peritoneal dialysis equipment is used in a hospital or domestic environment. This second edition cancels and replaces the first edition of IEC 60601-2-39. It constitutes a technical revision. Major changes since the last edition include a summary of additional essential performance requirements. |
| Status |
Published
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Status
| Current Stage code | 6060 |
|---|---|
| Current Stage code date | 2011-10-14 |
| Current Stage code deadline | 2012-10-01 |
| Deadline date for vote |
Legal
| Directive(s) | MDD (93/42/EEC) |
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| Mandate(s) | |
| Order Voucher |
Details
| IEC Technical Body | |
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| Reference Document | |
| ICS | 11.040.99 - Other medical equipment |
| Keywords | Medical equipment; Peritoneal dialysis; Dialysis; Safety |
| Note | D139/C149: BT approved the modified Annex ZZ for EN 60601-2-39:2008 |
| 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) | 2011-10-01 |
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| date of Availability (DAV) (2) | 2011-10-14 |
| date of Announcement (DOA) (3) | - |
| date of Publication (DOP) (4) | - |
| date of Withdrawal (DOW) (5) | - |
Relations
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| Superseded by | |
| Normative reference (6) |
(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.
