CENELEC
Project
| Reference | EN 60601-2-5 |
|---|---|
| Title | Medical electrical equipment - Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment |
| Project Number | 21936 |
| Abstract/Scope | IEC 60601-2-5:2009 applies to the basic safety and essential performance of ultrasonic physiotherapy equipment employing a single plane unfocused circular transducer per treatment head, producing static beams perpendicular to the face of the treatment head. This standard can also be applied to ultrasonic physiotherapy equipment used for compensation or alleviation of disease, injury or disability. This third edition cancels and replaces the second edition published in 2000. This edition constitutes a technical revision. The numbering was revised to agree with IEC 60601-1:2005 (third edition). Beyond this, essential performance characteristics are defined in 201.4.3.101, guidance on maintenance is added in 201.7.9.2.1, a new requirement regarding dielectric withstand was added in 201.8.8.3. The clause on transducer surface temperature rise, 201.11, has been modified to allow for simulated use conditions. Measurements of ultrasound-related parameters are now referenced to IEC 61689:2007 (second edition). The most important change in the ultrasound-related parameters is the definition of effective radiating area, 201.3.207. This change will also affect the value of the effective intensity and its uncertainty. |
| Status |
Approval stage
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Status
| Current Stage code | 5098 |
|---|---|
| Current Stage code date | 2012-05-30 |
| 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 60601-2-5:2009 (EQV) |
| ICS | 11.040.60 - Therapy equipment |
| Keywords | Medical; Ultrasonic; Physiotherapy; Safety |
| Note | Will supersede EN 60601-2-5:2000 * 62D/766/RVC established on 2009-03-06: To be published without FDIS stage * TC advice: A proposal for a corrigendum has been issued as 62D/841/DC closing on 18th June 2010. Corrigendum delayed. See 62D/916/inf await corrigendum. Published document to be sent by CCMC to MDD consultant for assessment. Results to be passed to 62D MT 17 for meeting Sept 2011 to be drafted into corrigendum to allow listing under MDD * D141/066: VR dropped - D141/067: CLC/TC 62 & consultants to solve the negative assessment |
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Environment
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Product Life Cycle
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Information
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History
Implementation Dates
| date of Ratification (DOR) (1) | |
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| 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 60601-2-5:2000 |
|---|---|
| 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.
