CENELEC
CLC/TC 62 |
Electrical equipment in medical practice |
Project
| Reference | EN 80601-2-35:2009 |
|---|---|
| Title | Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads and mattresses and intended for heating in medical use |
| Project Number | 21913 |
| Abstract/Scope | IEC 80601-2-35:2009 establishes particular basic safety and essential performance requirements, which minimize hazards to patients, and operators for heating devices using blankets, pads or mattresses and intended for heating in medical use and specifies tests for demonstrating compliance with these requirements. This second edition cancels and replaces the first edition published in 1996. This edition constitutes a technical revision. This new edition provides consistency with the third edition of IEC 60601-1, as well as with the four other particular standards related to paediatric equipment for which the committee is responsible. |
| Status |
Published
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Status
| Current Stage code | 6060 |
|---|---|
| Current Stage code date | 2009-12-11 |
| Current Stage code deadline | 2010-08-01 |
| 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 80601-2-35:2009 (EQV) + corrigendum Mar. 2012 (EQV) |
| ICS | 11.140 - Hospital equipment |
| Keywords | Medical;Blanket;Pad;Mattresses;Heating |
| Note | Future IEC 80601-2-35 prepared by a JWG IEC/ISO with IEC lead * Supersedes EN 60601-2-35:1996 |
| 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) | 2009-11-01 |
|---|---|
| date of Availability (DAV) (2) | 2009-12-11 |
| date of Announcement (DOA) (3) | 2010-02-01 |
| date of Publication (DOP) (4) | 2010-08-01 |
| date of Withdrawal (DOW) (5) | 2012-11-01 |
Relations
| Supersedes | EN 60601-2-35:1996 |
|---|---|
| Superseded by | |
| Normative reference (6) | ISO 2439:2008 ISO 3743-1:1994 EN ISO 14971:2012 EN 60601-1-2:2007 corr. March 2010 EN 60601-1-8:2007 corr. March 2010 EN 60601-1-10:2008 |
(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.
