CENELEC
Project
| Reference | EN 60601-2-17:2004 |
|---|---|
| Title | Medical electrical equipment - Part 2-17: Particular requirements for the safety of automatically-controlled brachytherapy afterloading equipment |
| Project Number | 15469 |
| Abstract/Scope | The use of afterloading equipment for brachytherapy purposes may expose patients to danger if the equipment fails to deliver the required dose to the patient, or if the equipment design does not satisfy standards of electrical and mechanical safety. The equipment may also cause danger to persons in the vicinity if the equipment itself fails to contain the radioactive source(s) adequately within the storage container(s) and/or if there are inadequacies in the design of the treatment room. This Particular Standard establishes requirements to be complied with by manufacturers in the design and construction of afterloading equipment for use in temporary brachytherapy procedures. Its purpose is to identify those features of design that are regarded, at the present time, as essential for the safe operation of such equipment. It places limits on the degradation of equipment performance beyond which it can be presumed that a fault condition exists and where an interlock then operates to return the radioactive source(s) to the storage container(s) and afterwards to prevent continued operation of the equipment. |
| Status |
Published
|
Status
| Current Stage code | 6060 |
|---|---|
| Current Stage code date | 2004-04-06 |
| Current Stage code deadline | 2004-12-01 |
| Deadline date for vote |
Legal
| Directive(s) | MDD (93/42/EEC) |
|---|---|
| Mandate(s) | M/432 |
| Order Voucher |
Details
| IEC Technical Body | IEC/SC 62C |
|---|---|
| Reference Document | IEC 60601-2-17:2004 (EQV) |
| ICS | 11.040.60 - Therapy equipment 19.100 - Non-destructive testing |
| Keywords | Medical equipment; Brachytherapy; Afterloading; Automatically-controlled; Safety |
| Note | |
| A-Deviation(s) | |
| Special National Condition(s) |
Environment
|
Clause
|
Categories - Aspects
|
Product Life Cycle
|
Information
|
|---|
History
Implementation Dates
| date of Ratification (DOR) (1) | 2004-03-01 |
|---|---|
| date of Availability (DAV) (2) | 2004-04-06 |
| date of Announcement (DOA) (3) | 2004-06-01 |
| date of Publication (DOP) (4) | 2004-12-01 |
| date of Withdrawal (DOW) (5) | 2007-03-01 |
Relations
| Supersedes | EN 60601-2-17:1996 EN 60601-2-17:1996/A1:1996 |
|---|---|
| Superseded by | FprEN 60601-2-17:201X |
| Normative reference (6) |
EN 60601-1:1990
corr. July 1994 A1:1993 A2:1995 A11:1993 A12:1993 A13:1996 EN 60601-1-1:2001 EN 60601-1-2:2001 EN 60601-1-4:1996 A1:1999 HD 501 S1:1988 EN 61217:1996 A1:2001 EN 62083:2001 |
(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.
