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분야 | TC 62/SC 62D : Particular medical equipment, software, and systems |
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적용범위 | IEC 80601-2-77:2019+AMD1.2023 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ROBOTICALLY ASSISTED SURGICAL EQUIPMENT (RASE) and ROBOTICALLY ASSISTED SURGICAL SYSTEMS (RASS), referred to as ME EQUIPMENT and ME SYSTEMS together with their INTERACTION CONDITIONS and INTERFACE CONDITIONS. |
국제분류(ICS)코드 |
11.040.30 : 외과장비
11.040.01 : 일반 의료장비 |
페이지수 | 230 |
Edition | 1.1 |
No. | 표준번호 | 표준명 | 발행일 | 상태 |
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1 | IEC 80601-2-77:2019/AMD1:2023 | Amendment 1 - Medical electrical equipment - Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment | 2023-11-15 | 표준 |
2 | IEC 80601-2-77:2019+AMD1:2023 CSV | Medical electrical equipment - Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment | 2023-11-15 | 표준 |
3 | IEC 80601-2-77:2019 | Medical electrical equipment - Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment | 2019-07-09 | 표준 |
IEC/DIS 80601-2-23 - Medical electrical equipment — Part 2-23: Particular requirements for the basic safety and essential performance of transcutaneous partial pressure monitoring equipment 상세보기
IEC/DIS 80601-2-52 - Medical electrical equipment — Part 2-52: Particular requirements for the basic safety and essential performance of medical beds 상세보기
IEC/DIS 80601-2-89 - Medical electrical equipment — Part 2-89: Particular requirements for the basic safety and essential performance of medical beds for children 상세보기
IEC/FDIS 80601-2-71 - Medical electrical equipment — Part 2-71: Particular requirements for the basic safety and essential performance of functional near-infrared spectroscopy (functional NIRS) equipment 상세보기
IEC/DIS 80601-2-31 - Medical electrical equipment — Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source 상세보기
ASTM F2554-22 - Standard Practice for Measurement of Positional Accuracy of Computer-Assisted Surgical Systems 상세보기
ISO 10993-17:2023 - Biological evaluation of medical devices — Part 17: Toxicological risk assessment of medical device constituents 상세보기
ISO 10993-7:2008/Amd 1:2019 - Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals — Amendment 1: Applicability of allowable limits for neonates and infants 상세보기
ISO 10993-7:2008 - Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals 상세보기
IEC 80601-2-78:2019+AMD1:2024 CSV - Medical electrical equipment - Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation 상세보기
IEC TS 63134:2020 - Active assisted living (AAL) use cases 상세보기
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 상세보기
KS B ISO TS 25740-1 - 에스컬레이터 및 무빙워크에 대한 안전요건 — 제1부: 세계공통 필수 안전요건(GESRs) 상세보기
KS B ISO TS 8100-21 - 승객 및 화물 운송용 엘리베이터 —제21부: 세계공통 필수안전요건(GESRs)을 충족하는 세계공통 안전 파라미터(GSPs) 상세보기
KS C IEC TS 62872 - 산업 시설과 스마트 그리드 사이의 산업 공정 측정, 제어 및 자동화 시스템 인터페이스 상세보기