CENELEC
Project
| Reference | EN 60601-2-18 |
|---|---|
| Title | Medical electrical equipment - Part 2-18: Particular requirements for basic safety and essential performance of endoscopic equipment |
| Project Number | 21838 |
| Abstract/Scope | IEC 60601-2-18:2009 establishes particular basic safety and essential performance requirements for endoscopic equipment. The minimum safety requirements specified in this particular standard are considered to provide for a practical degree of safety in the operation of endoscopic equipment. IEC 60601-2-18:2009 amends and supplements IEC 60601-1:2005. This third edition cancels and replaces the second edition, published in 1996, and its Amendment 1 (2000). This edition constitutes a technical revision and has been aligned or harmonized with IEC 60601-1:2005. The main changes with respect to the previous edition include: - alignment of requirements with IEC 60601-1:2005; - inclusion of essential performance requirements; - the inclusion of energized endoscopes and energized endotherapy devices used through second and subsequent punctures within the scope of the standard; - reference to IEC 60601-2-2 for the dielectric strength testing of HF energized endotherapy devices, rather than defining different tests. |
| 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 60601-2-18:2009 (EQV) |
| ICS | 11.040.50 - Radiographic equipment |
| Keywords | Medical; Safety; Endoscopic |
| Note | Will supersede EN 60601-2-18:1996 + A1:2000 * 2011-07 TC advice: Amendment still under consideration * Negative assessment from MDD consultant * D141/066: VR dropped - D141/067: CLC/TC 62 & consultants to solve the negative assessment |
| 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) | |
|---|---|
| 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 60601-2-18:1996
EN 60601-2-18:1996/A1:2000 |
|---|---|
| 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.
