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IEC 60601-2-33:2022
Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis- 발행일 : 2022-08-04
- 발행기관 : IEC
상세정보
| 분야 | TC 62/SC 62B : Medical imaging equipment, software, and systems |
|---|---|
| 적용범위 | IEC 60601-2-33:2022 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MAGNETIC RESONANCE (MR) EQUIPMENT and MAGNETIC RESONANCE (MR) SYSTEMS. This document does not cover the application of MR EQUIPMENT beyond the INTENDED USE. If a clause or subclause is specifically intended to be applicable to MR EQUIPMENT only, or to MR SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to MR EQUIPMENT and to MR SYSTEMS, as relevant. This document does not formulate additional specific requirements for MR EQUIPMENT or MR SYSTEMS used in INTERVENTIONAL MR EXAMINATIONS. IEC 60601-2-33:2022 cancels and replaces the third edition published in 2010, Amendment 1:2013 and Amendment 2:2015. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: a) aligned with IEC 60601-1:2005 and its two amendments IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020; b) addition of safety requirements for the EMERGENCY FIELD SHUT DOWN UNIT; c) clarification of acoustic protection measures for the PATIENT and MR WORKER; d) addition of noise emission declaration for exposure inside the MR EXAMINATION ROOM, to support occupational health assessment by the RESPONSIBLE ORGANIZATION; e) addition of compliance methods for thermal safety of RF coils; f) addition of RF transmit definitions to match MR CONDITIONAL labelling requirements for MEDICAL DEVICES; g) clarification of requirements for MR CONDITIONAL labelling of ACCESSORIES; h) alignment of static magnetic field limit for B0 HAZARD area to limits in other MEDICAL DEVICE standards (especially that for pacemakers, ISO 14117), the new limit value being 0,9 mT; i) improved description of the magnetic field related plots in the Compatibility Technical Specification Sheet (CTSS); j) provision of compatibility sequences (in the CTSS) to test auxiliary equipment by the MR manufacturer has become optional, and is expected to be eliminated in a future edition; k) a separate section with requirements for a site-planning document containing safety information; l) requirements for the alerting function (PATIENT to OPERATOR); m) introduction of MROC as mandatory functionality for 1,5 T and 3 T systems to facilitate scanning of PATIENTs with MEDICAL DEVICES labelled as MR CONDITIONAL, unless such scanning is explicitly contra-indicated by the MR MANUFACTURER; n) RF coil symbols in Table 201.A.102 have become mandatory, and the preferred and alternate signs have been swapped relative to the previous edition, with preferred now being the sign with color; o) determination of the B1 stray field in 201.12.4.105.3.3 based on calculations only The contents of the Interpretation Sheet 1 of May 2023 have been included in this copy. |
| 국제분류(ICS)코드 | 11.040.55 : 진단장비 |
| 페이지수 | 302 |
| Edition | 4.0 |
이력정보
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | IEC 60601-2-33:2022상세보기 | Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis | 2022-08-04 | 표준 |
| 2 | IEC 60601-2-33:2010/COR2:2016상세보기 | Corrigendum 2 - Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis | 2016-02-18 | 구판 |
| 3 | IEC 60601-2-33:2010/AMD2:2015상세보기 | Amendment 2 - Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis | 2015-06-18 | 구판 |
| 4 | IEC 60601-2-33:2010+AMD1:2013+AMD2:2015 CSV상세보기 | Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis | 2015-06-18 | 구판 |
| 5 | IEC 60601-2-33:2010/AMD1:2013상세보기 | Amendment 1 - Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis | 2013-04-23 | 구판 |
| 6 | IEC 60601-2-33:2010+AMD1:2013 CSV상세보기 | Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis | 2013-04-23 | 구판 |
| 7 | IEC 60601-2-33:2010/COR1:2012상세보기 | Corrigendum 1 - Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis | 2012-03-05 | 구판 |
| 8 | IEC 60601-2-33:2010상세보기 | Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis | 2010-03-10 | 구판 |
| 9 | IEC 60601-2-33:2002+AMD1:2005+AMD2:2007 CSV상세보기 | Medical electrical equipment - Part 2-33: Particular requirements for the safety of magnetic resonance equipment for medical diagnosis | 2008-04-14 | 구판 |
| 10 | IEC 60601-2-33:2002/AMD2:2007상세보기 | Amendment 2 - Medical electrical equipment - Part 2-33: Particular requirements for the safety of magnetic resonance equipment for medical diagnosis | 2007-11-07 | 구판 |
| 11 | IEC 60601-2-33:2002+AMD1:2005 CSV상세보기 | Medical electrical equipment - Part 2-33: Particular requirements for the safety of magnetic resonance equipment for medical diagnosis | 2006-02-21 | 구판 |
| 12 | IEC 60601-2-33:2002/AMD1:2005상세보기 | Amendment 1 - Medical electrical equipment - Part 2-33: Particular requirements for the safety of magnetic resonance equipment for medical diagnosis | 2005-08-30 | 구판 |
| 13 | IEC 60601-2-33:2002상세보기 | Medical electrical equipment - Part 2-33: Particular requirements for the safety of magnetic resonance equipment for medical diagnosis | 2002-05-22 | 구판 |
| 14 | IEC 60601-2-33:1995상세보기 | Medical electrical equipment - Part 2: Particular requirements for the safety of magnetic resonance equipment for medical diagnosis | 1995-07-08 | 구판 |
관련상품
- IEC/DIS 60601-2-26 - Medical electrical equipment — Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs
- IEC 60601-2-15:1988 - Medical electrical equipment. Part 2: Particular requirements for the safety of capacitor discharge X-ray generators
- IEC 60601-2-14:1989 - Medical electrical equipment. Part 2: Particular requirements for the safety of electroconvulsive therapy equipment
- IEC 60601-2-32:1994 - Medical electrical equipment - Part 2: Particular requirements for the safety of associated equipment of X-ray equipment
- IEC 60601-1-4:1996 - Medical electrical equipment - Part 1: General requirements for safety - 4. Collateral standard: Programmable electrical medical systems
다른 사람이 함께 구입한 상품
- ASME V V 10-2019 - Guide for Verification and Validation in Computational Solid Mechanics (V V 10 - 2019)
- ASME V V 40-2018 - Assessing Credibility of Computational Modeling through Verification and Validation: Application to Medical Devices
- NF EN IEC 62464-1:2019 - Magnetic resonance equipment for medical imaging - Part 1 : determination of essential image quality parameters
- IEC/IEEE 62704-3:2017 - Determining the peak spatial-average specific absorption rate (SAR) in the human body from wireless communications devices, 30 MHz to 6 GHz - Part 3: Specific requirements for using the finite difference time domain (FDTD) method for SAR calculations of mobile phones
- IEC/IEEE 62704-4:2020 - Determining the peak spatial-average specific absorption rate (SAR) in the human body from wireless communication devices, 30 MHz to 6 GHz - Part 4: General requirements for using the finite element method for SAR calculations
추천 상품
- IEC TS 63134:2020 - Active assisted living (AAL) use cases
- IEC 60034-5:2020 RLV - Rotating electrical machines - Part 5: Degrees of protection provided by the integral design of rotating electrical machines (IP code) - Classification
- KS B ISO TS 25740-1 - 에스컬레이터 및 무빙워크에 대한 안전요건 — 제1부: 세계공통 필수 안전요건(GESRs)
- KS B ISO TS 8100-21 - 승객 및 화물 운송용 엘리베이터 —제21부: 세계공통 필수안전요건(GESRs)을 충족하는 세계공통 안전 파라미터(GSPs)
- KS C IEC TS 62872 - 산업 시설과 스마트 그리드 사이의 산업 공정 측정, 제어 및 자동화 시스템 인터페이스
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