现行

厚生省条例(第723号)

의료기기산업 육성 및 혁신의료기기 지원법 시행규칙
医疗器械产业培育和革新医疗器械支援法实施规则

2020-05-04

现行

首相令(第1819号)

의료기기법 시행규칙
医疗器械法实施规则

2022-07-20

现行

首相令(第1786号)

의료기기법 시행규칙
医疗器械法实施规则

2022-01-21

现行

EN ISO 14971-2019

Medical devices - Application of risk management to medical devices (ISO 14971:2019)
医疗器械 - 医疗器械应用风险管理

2019-12-18

现行

法律(第16433号)

체외진단의료기기법
体外诊断医疗器械法

2019-04-30

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

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

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

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

BS PD IEC/TR 62366-2-2016

Medical devices-Guidance on the application of usability engineering to medical devices
医疗器械

2016-04-27

现行

BS EN 62366-1-2015+A1-2020

Medical devices-Application of usability engineering to medical devices
医疗器械

2020-08-19

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

BS EN 556-2-2015

Sterilization of medical devices. Requirements for medical devices to be designated "STERILE"-Requirements for aseptically processed medical devices
医疗器械的消毒 指定为“无菌”医疗器械的要求

2015-09-30

现行

UNE-EN 13824-2005

Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements
医疗器械的灭菌.液体医疗器械的无菌处理.要求

2005-05-25

现行

GB/Z 42217-2022

医疗器械 用于医疗器械质量体系软件的确认
Medical device —Validation of software for medical device quality system

2022-12-30

现行

YY/T 1474-2016

医疗器械　可用性工程对医疗器械的应用
Medical devices—Application of usability engineering to medical devices

2016-01-26

现行

BS PD ISO/TR 80002-2-2017

Medical device software-Validation of software for medical device quality systems
医疗器械软件

2017-10-31

现行

BS PD IEC/TR 80002-3-2014

Medical device software-Process reference model of medical device software life cycle processes (IEC 62304)
医疗器械软件

2014-06-04