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IEC 60601-2-31:2020
Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source- 발행일 : 2020-01-17
- 발행기관 : IEC
상세정보
| 분야 | TC 62/SC 62D : Particular medical equipment, software, and systems |
|---|---|
| 적용범위 | IEC 60601-2-31:2020 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of EXTERNAL PACEMAKERS powered by an INTERNAL ELECTRICAL POWER SOURCE, hereafter referred to as ME EQUIPMENT. This document applies to PATIENT CABLES as defined in 201.3.209, but does not apply to LEADS as defined in 201.3.206. HAZARDS inherent in the intended physiological function of ME EQUIPMENT within the scope of this document are not covered by specific requirements in this document except in 7.2.13 and 8.4.1 of the general standard. This document does not apply to the implantable parts of ACTIVE IMPLANTABLE MEDICAL DEVICES covered by ISO 14708-1. This document does not apply to EXTERNAL PACEMAKERS which can be connected directly or indirectly to a SUPPLY MAINS. This document does not apply to transthoracic and oesophageal pacing ME EQUIPMENT and antitachycardia ME EQUIPMENT. IEC 60601-2-31:2020 cancels and replaces the second edition published in 2008 and Amendment 1:2011. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: a) The requirement for testing for energy reduction has been removed; b) The test for exposure to external defibrillation has been completely revised; c) The exclusion for testing ESD immunity only with respect to air discharges has been removed; d) Alignment with the latest edition of ISO 14708-2 for pacemakers, as well as the associated EMC standard ISO 14117; e) Additional rationale for all changes. |
| 국제분류(ICS)코드 | 11.040.01 : 일반 의료장비 |
| 페이지수 | 110 |
| Edition | 3.0 |
이력정보
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | IEC 60601-2-31:2020 RLV상세보기 | Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source | 2020-01-17 | 표준 |
| 2 | IEC 60601-2-31:2020상세보기 | Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source | 2020-01-17 | 표준 |
| 3 | IEC 60601-2-31:2008+AMD1:2011 CSV상세보기 | Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source | 2011-09-29 | 구판 |
| 4 | IEC 60601-2-31:2008/AMD1:2011상세보기 | Amendment 1 - Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source | 2011-06-29 | 구판 |
| 5 | IEC 60601-2-31:2008상세보기 | Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source | 2008-03-26 | 구판 |
| 6 | IEC 60601-2-31:1994/AMD1:1998상세보기 | Amendment 1 - Medical electrical equipment - Part 2-31: Particular requirements for the safety of external cardiac pacemakers with internal power source | 1998-01-01 | 구판 |
| 7 | IEC 60601-2-31:1994상세보기 | Medical electrical equipment - Part 2: Particular requirements for the safety of external cardiac pacemakers with internal power source | 1994-10-12 | 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
- ASTM F2624-12(2020) - Standard Test Method for Static, Dynamic, and Wear Assessment of Extra-Discal Single Level Spinal Constructs
- ISO 8537:2016 - Sterile single-use syringes, with or without needle, for insulin
- ISO 80601-2-55:2018 - Medical electrical equipment — Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors
- KS P ISO 12865 - 안과용 기구 — 검영기
- ASTM F2502-17 - Standard Specification and Test Methods for Absorbable Plates and Screws for Internal Fixation Implants
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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