CENELEC
Project
| Reference | EN 60601-2-11:1997 |
|---|---|
| Title | Medical electrical equipment - Part 2-11: Particular requirements for the safety of gamma beam therapy equipment |
| Project Number | 7099 |
| Abstract/Scope | This standard specifies requirements for the safety of gamma beam therapy equipment intended for radiotherapy in human medical practice and includes equipment in which the selection and display of operating parameters can be controlled by a programmable electronic system. Applies to equipment which is intended to deliver a gamma radiation beam(s) at normal treatment distances greater than 5 cm using a sealed radioactive source(s). Establishes requirements to ensure the radiation safety and enhance the electrical and mechanical safety of gamma beam therapy equipment used in human medical practice and specifies tests for demonstrating compliance with those requirements. |
| Status |
Published
|
Status
| Current Stage code | 6060 |
|---|---|
| Current Stage code date | 1997-09-30 |
| Current Stage code deadline | 1998-05-01 |
| Deadline date for vote |
Legal
| Directive(s) | MDD (93/42/EEC) |
|---|---|
| Mandate(s) | M/023; M/432 |
| Order Voucher | BC/CLC/93-01 |
Details
| IEC Technical Body | IEC/SC 62C |
|---|---|
| Reference Document | IEC 60601-2-11:1997 (EQV) |
| ICS | 11.040.50 - Radiographic equipment |
| Keywords | Medical equipment; Gamma beam therapy; Safety |
| Note | EN following parallel vote * Supersedes HD 395.2.11 S2 |
| 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) | 1997-07-01 |
|---|---|
| date of Availability (DAV) (2) | 1997-09-30 |
| date of Announcement (DOA) (3) | 1997-11-01 |
| date of Publication (DOP) (4) | 1998-05-01 |
| date of Withdrawal (DOW) (5) | 1998-05-01 |
Relations
| Supersedes | HD 395.2.11 S2:1990 |
|---|---|
| Superseded by | FprEN 60601-2-11:2012 |
| Normative reference (6) |
HD 501 S1:1988
EN 61217:1996 |
(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.
