CENELEC
Project
| Reference | EN 60601-2-2:2009/A11:2011 |
|---|---|
| Title | Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories |
| Project Number | 23801 |
| Abstract/Scope | IEC 60601-2-2:2009 specifies particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories. This particular standard amends and supplements IEC 60601-1 (third edition, 2005): Medical electrical equipment - Part 1: General requirements for basic safety and essential performance. This fifth edition cancels and replaces the fourth edition published in 2006. This edition constitutes a technical revision. Revisions in this edition include new language for preconditioning accessories prior to insulation testing, refining the requirements for electromagnetic compatibility testing and correcting some of the equations used in deriving the thermal test for neutral electrodes. |
| Status |
Published
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Status
| Current Stage code | 6060 |
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| 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 | 11.040.30 - Surgical instruments and materials |
| Keywords | Medical; Safety; High frequency; Surgical |
| Note | D139/C149: BT approved the modified Annex ZZ for EN 60601-2-2:2009 |
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| 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.
