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판매
IEC 80001-1:2021
Application of risk management for IT-networks incorporating medical devices - Part 1: Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software- 발행일 : 2021-09-21
- 발행기관 : IEC
상세정보
| 분야 | TC 62/SC 62A : Common aspects of medical equipment, software, and systems |
|---|---|
| 적용범위 | IEC 80001-1:2021 specifies general requirements for ORGANIZATIONS in the application of RISK MANAGEMENT before, during and after the connection of a HEALTH IT SYSTEM within a HEALTH IT INFRASTRUCTURE, by addressing the KEY PROPERTIES of SAFETY, EFFECTIVENESS and SECURITY whilst engaging appropriate stakeholders. IEC 80001-1:2021 cancels and replaces the first edition published in 2010. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: a) structure changed to better align with ISO 31000; b) establishment of requirements for an ORGANIZATION in the application of RISK MANAGEMENT; c) communication of the value, intention and purpose of RISK MANAGEMENT through principles that support preservation of the KEY PROPERTIES during the implementation and use of connected HEALTH SOFTWARE and/or HEALTH IT SYSTEMS. |
| 국제분류(ICS)코드 |
35.240.80 : 건강 관리 기술에서의 IT 응용
11.040.01 : 일반 의료장비 |
| 페이지수 | 75 |
| Edition | 2.0 |
이력정보
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | IEC 80001-1:2021상세보기 | Application of risk management for IT-networks incorporating medical devices - Part 1: Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software | 2021-09-21 | 표준 |
| 2 | IEC 80001-1:2010상세보기 | Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities | 2010-10-27 | 구판 |
관련상품
- IEC TR 80001-2-3:2012 - Application of risk management for IT-networks incorporating medical devices - Part 2-3: Guidance for wireless networks
- IEC TR 80001-2-2:2012 - Application of risk management for IT-networks incorporating medical devices - Part 2-2: Guidance for the disclosure and communication of medical device security needs, risks and controls
- IEC TR 80001-2-1:2012 - Application of risk management for IT-networks incorporating medical devices - Part 2-1: Step by step risk management of medical IT-networks - Practical applications and examples
- IEC/TR 80001-2-1:2012 - Application of risk management for IT-networks incorporating medical devices — Part 2-1: Step by Step Risk Management of Medical IT-Networks; Practical Applications and Examples
- IEC/TR 80001-2-2:2012 - Application of risk management for IT-networks incorporating medical devices — Part 2-2: Guidance for the communication of medical device security needs, risks and controls
다른 사람이 함께 구입한 상품
- IEC TR 80001-2-2:2012 - Application of risk management for IT-networks incorporating medical devices - Part 2-2: Guidance for the disclosure and communication of medical device security needs, risks and controls
- IEC TR 80001-2-1:2012 - Application of risk management for IT-networks incorporating medical devices - Part 2-1: Step by step risk management of medical IT-networks - Practical applications and examples
- IEC 60068-2-52:2017 - Environmental testing - Part 2-52: Tests - Test Kb: Salt mist, cyclic (sodium chloride solution)
- IEC 62366-1:2015+AMD1:2020 CSV - Medical devices - Part 1: Application of usability engineering to medical devices
- IEC 60068-2-11:2021 - Environmental testing - Part 2-11: Tests - Test Ka: Salt mist
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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