现行

KS P ISO 14971

의료기기 — 의료기기에 대한 위험관리의 적용
医疗器械 - 医疗器械风险管理的应用

2018-11-05

现行

KS P ISO 14971

의료기기 ─ 의료기기에 대한 위험 관리의 적용
医疗器械.医疗器械风险管理的应用

2021-06-28

现行

AS ISO 14971-2020

Medical devices - Application of risk management to medical devices
医疗器械.医疗器械风险管理的应用

2020-06-26

现行

AAMI/ISO 14971-2019

Medical devices - Application of risk management to medical devices
医疗器械.风险管理在医疗器械中的应用

2019-05-01

现行

GOST ISO 14971-2021

Изделия медицинские. Применение менеджмента риска к медицинским изделиям
医疗设备 风险管理应用于医疗器械

现行

GB/T 42062-2022

医疗器械 风险管理对医疗器械的应用
Medical devices—Application of risk management to medical devices

2022-10-12

现行

ISO 14971-2019

Medical devices — Application of risk management to medical devices
医疗器械 - 医疗器械风险管理的应用

2019-12-10

现行

YY/T 0316-2016

医疗器械　风险管理对医疗器械的应用
Medical devices—Application of risk management to medical devices

2016-01-26

现行

JIS T 14971-2012

Medical devices -- Application of risk management to medical devices (Foreign Standard)
医疗器械风险管理在医疗器械中的应用（国外标准）

2012-01-01

现行

BS EN IEC 80001-1-2021

Application of risk management for IT-networks incorporating medical devices-Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software
风险管理在医疗设备IT网络中的应用

2021-11-01

现行

UNE-EN ISO 14971-2001

Medical devices - Application of risk management to medical devices. (ISO 14971:2000)
医疗器械.风险管理在医疗器械上的应用 （ISO 14971-2000）

2001-10-31

现行

BS PD IEC/TR 80001-2-1-2012

Application of risk management for IT-networks incorporating medical devices-Step-by-step risk management of medical IT-networks. Practical applications and examples
风险管理在医疗设备IT网络中的应用

2012-07-10

现行

SEPT ISO 14971 Checklist

Checklist for ISO 14971:2019, Medical devices - Application of risk management to medical devices
ISO 14971:2019《医疗器械——风险管理在医疗器械中的应用》检查表

现行

KS X IEC 80001-1

의료기기 가 통합된 IT 네트워크에 대한 위 험 관리의 적용 ─ 제제1부부: 연결된 의료기 기 또는 연결된 헬스 소프트웨어의 구현 및 사용 시 안전안전, 유효성 및 보안
包含医疗设备的IT网络的风险管理应用.第1部分:连接医疗设备或连接健康软件实施和使用的安全性、有效性和安全性

2022-12-28

现行

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
联网医疗设备或联网健康软件实施和使用的安全性、有效性和安全性.第1部分:风险管理的应用

2021-09-22

现行

JIS Q 14971-1-2001

Medical devices -- Risk management -- Part 1: Application of risk analysis (FOREIGN STANDARD)
医疗器械风险管理第1部分:风险分析的应用（国外标准）

2001-01-01

现行

BS PD IEC/TR 80001-2-2-2012

Application of risk management for IT-networks incorporating medical devices-Guidance for the disclosure and communication of medical device security needs, risks and controls
风险管理在医疗设备IT网络中的应用

2012-07-10

现行

BS EN ISO 22442-1-2020

Medical devices utilizing animal tissues and their derivatives-Application of risk management
利用动物组织及其衍生物的医疗设备

2020-12-14

现行

KS X IEC TR 80001-2-1(2020 Confirm)

의료기기가 통합된 IT네트워크에 대한 위험 관리의 적용 — 제2-1부: 단계별 의료용 IT네트워크 위험관리 — 실제적용과 사례
医疗器械网络风险管理应用 - 第2-1部分:医疗网络风险管理 - 实践应用与实例

2015-08-05

现行

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
包含医疗设备的IT网络的风险管理应用第2-1部分:医疗IT网络的逐步风险管理；实际应用和实例

2012-07-13