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IEC 80001-1:2010
Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities- 발행일 : 2010-10-27
- 발행기관 : IEC
- 대체표준 : IEC 80001-1:2021
상세정보
| 분야 | TC 62/SC 62A : Common aspects of medical equipment, software, and systems |
|---|---|
| 적용범위 | IEC 80001-1:2010 Recognizing that medical devices are incorporated into IT-networks to achieve desirable benefits (for example, interoperability), defines the roles, responsibilities and activities that are necessary for risk management of IT-networks incorporating medical devices to address safety, effectiveness and data and system security (the key properties). IEC 80001-1:2010 does not specify acceptable risk levels. IEC 80001-1:2010 applies after a medical device has been acquired by a responsible organization and is a candidate for incorporation into an IT-network. It applies throughout the life cycle of IT-networks incorporating medical devices. IEC 80001-1:2010 applies where there is no single medical device manufacturer assuming responsibility for addressing the key properties of the IT-network incorporating a medical device. IEC 80001-1:2010 applies to responsible organizations, medical device manufacturers and providers of other information technology for the purpose of risk management of an IT-network incorporating medical devices as specified by the responsible organization. It does not apply to personal use applications where the patient, operator and responsible organization are one and the same person. |
| 국제분류(ICS)코드 |
35.240.80 : 건강 관리 기술에서의 IT 응용
11.040.01 : 일반 의료장비 |
| 페이지수 | 86 |
| Edition | 1.0 |
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 80002-1:2009 - Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software
- ISO/TR 80001-2-6:2014 - Application of risk management for IT-networks incorporating medical devices — Part 2-6: Application guidance — Guidance for responsibility agreements
- 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 60601-1-8:2006+AMD1:2012+AMD2:2020 CSV - Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
- IEC TR 80001-2-5:2014 - Application of risk management for IT-networks incorporating medical devices - Part 2-5: Application guidance - Guidance on distributed alarm systems
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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