CENELEC
Project
| Reference | EN 60601-2-37:2008/FprA1:2012 |
|---|---|
| Title | Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment |
| Project Number | 24465 |
| Abstract/Scope | Applies to the basic safety and essential performance of ultrasonic diagnostic equipment. The approach and philosophy used in drafting this particular standard for safety of ultrasonic diagnostic equipment are consistent with those in standards of the IEC 60601 2 xx series that apply to other diagnostic modalities, such as X-ray equipment and magnetic resonance systems. In each case, the safety standard is intended to require increasing sophistication of output display indicators and/or controls with increasing energy levels in the interrogating field of diagnosis. Thus, for all such diagnostic modalities, it is the responsibility of the operator to understand the risk of the output of the ultrasonic diagnostic equipment, and to act appropriately in order to obtain the needed diagnostic information with the minimum risk to the patient. This second edition cancels and replaces the first edition published in 2001 and its Amendment 1 (2004) and Amendment 2 (2005). This edition combines the previous edition and its amendments into a form compatible with the parent IEC 60601-1:2005. |
| Status |
Approval stage
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Status
| Current Stage code | 5060 |
|---|---|
| Current Stage code date | 2013-01-14 |
| Current Stage code deadline | 2013-02-04 |
| Deadline date for vote |
Legal
| Directive(s) | MDD (93/42/EEC) |
|---|---|
| Mandate(s) | M/432 |
| Order Voucher |
Details
| IEC Technical Body | IEC/SC 62B |
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| Reference Document | IEC 60601-2-37:2007/A1:201X (62B/896/CDV) (EQV) |
| ICS | |
| Keywords | Medical equipment; Ultrasonic; Diagnostic; Monitoring; Safety |
| Note | |
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| Special National Condition(s) |
Environment
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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 | |
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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.
