CENELEC
Project
| Reference | EN 60601-2-8:201X |
|---|---|
| Title | Medical electrical equipment - Part 2-8: Particular requirements for the basic safety and essential performance of therapeutic X-ray equipment operating in the range 10 kV to 1 MV |
| Project Number | 22435 |
| Abstract/Scope | IEC 60601-2-8:2010 establishes particular basic safety and essential performance requirements for therapeutic X-ray equipment with nominal X-ray tube voltages in the range 10 kV to 1 MV when connected to alternating current supply mains. It includes the requirements for accuracy and reproducibility of performance to the extent that these are related to radiation quality and the quantity of ionizing radiation produced and thus must be considered as aspects of safety. This second edition cancels and replaces the first edition of IEC 60601-2-8. This edition constitutes a technical revision which brings this standard in line with the third edition of IEC 60601-1 and its collateral standards. |
| Status |
Approval stage
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Status
| Current Stage code | 5091 |
|---|---|
| Current Stage code date | 2011-08-25 |
| 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 62C |
|---|---|
| Reference Document | IEC 60601-2-8:2010 (EQV) |
| ICS | 11.040.50 - Radiographic equipment |
| Keywords | Medical; Therapeutic; X-ray; Safety |
| Note | Will supersede EN 60601-2-8:1997 + A1:1997 |
| 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) | 2011-02-01 |
|---|---|
| date of Availability (DAV) (2) | |
| date of Announcement (DOA) (3) | 2011-05-01 |
| date of Publication (DOP) (4) | 2011-11-01 |
| date of Withdrawal (DOW) (5) | 2014-02-01 |
Relations
| Supersedes |
EN 60601-2-8:1997
EN 60601-2-8:1997/A1:1997 |
|---|---|
| Superseded by | |
| Normative reference (6) | IEC 60601-2-1 IEC/TR 60788 EN 61217:2012 |
(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.
