IEC 60601-2-1 Ed. 4.0:2020 (b)
医用電気機器－第2-1部：1 MeV～50 MeVの範囲の電子加速装置の基礎安全及び基本性能の特定要求事項
Medical electrical equipment - Part 2-1: Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV
発行年月日：
2020-10-28
状態：
有効
邦訳版：
無
英語 232ページ
80,465 円（税込） 本体価格：73,150円
- 規格概要
-
IEC 60601-2-1:2020 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ELECTRON ACCELERATORS, hereafter referred to as ME EQUIPMENT, in the range 1 MeV to 50 MeV, used for TREATMENT of PATIENTS.全文を表示する
NOTE 1 While ELECTRON ACCELERATORS used for TREATMENT of PATIENTS are always ME EQUIPMENT, there are times in this document where they are referred to as EXTERNAL BEAM EQUIPMENT (EBE). Usage of EBE does not remove the requirements placed on the ME EQUIPMENT but is meant to clarify that the ME EQUIPMENT being discussed is the EBE and not some other ME EQUIPMENT that may be part of the system configuration.
This particular standard, with the inclusion of TYPE TESTS and SITE TESTS, applies to the manufacture and some installation aspects of ELECTRON ACCELERATORS and their included equipment used to increase the precision, accuracy and volumetric targeting of the TREATMENT delivery
intended for RADIOTHERAPY in medical practice, including those in which the selection and DISPLAY of TREATMENT PARAMETERS can be controlled automatically by PROGRAMMABLE ELECTRONIC SUBSYSTEMS (PESS),
that, under NORMAL CONDITIONS and in NORMAL USE, deliver a RADIATION BEAM of X-RADIATION or ELECTRON RADIATION having
NOMINAL ENERGY in the range 1 MeV to 50 MeV,
maximum ABSORBED DOSE RATES between 0,001 Gy x s 1 and 1 Gy x s 1 at the ERP from the RADIATION SOURCE, and
REFERENCE TREATMENT DISTANCES (RTDs) between 0,5 m and 2 m from the RADIATION SOURCE;
and
intended to be
for NORMAL USE, operated under the authority of the RESPONSIBLE ORGANIZATION by QUALIFIED PERSONS appropriately licensed or having the required skills for a particular medical application, for particular SPECIFIED clinical purposes,
maintained in accordance with the recommendations given in the INSTRUCTIONS FOR USE, and
subject to regular QUALITY ASSURANCE performance and calibration checks by a QUALIFIED PERSON.
| TC |
TC 62/SC 62C |
|---|---|
| ICS |
11.040.60 |
| 備考 |
