现行

GOST R ISO 17664-2012

Стерилизация медицинских изделий. Информация, предоставляемая изготовителем для проведения повторной стерилизации медицинских изделий
医疗器械灭菌由制造商提供的用于处理可再次消毒的医疗设备的信息

现行

UNE-EN ISO 17664-2004

Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices (ISO 17664:2004)
医疗器械的灭菌.制造商为可再灭菌医疗器械的处理提供的信息（ISO 17664-2004）

2004-09-30

现行

FDA 97-4179

Medical Device Quality Systems Manual: A Small Entity Compliance Guide - First Edition (Supersedes the Medical Device Good Manufacturing Practices Manual - FDA 97-4179)
医疗器械质量体系手册:小型实体合规指南——第一版（取代《医疗器械良好制造规范手册》——FDA 97-4179）

1996-12-01

现行

KS P ISO 14155

의료기기의 임상시험 — 임상시험 관리기준
医学设备对人类临床调查 - 良好的临床实践

2019-11-25

现行

KS P ISO 14155

사람을 대상으로 하는 의료기기 임상시험 임상시험 관리기준
人体医疗器械的临床研究——良好临床实践

2022-12-28

现行

ISO 14155-2020

Clinical investigation of medical devices for human subjects — Good clinical practice
医学设备对人类临床调查 - 良好的临床实践

2020-07-28

现行

BS EN ISO 14155-2020

Clinical investigation of medical devices for human subjects. Good clinical practice
人体医疗器械的临床研究 良好临床实践

2020-11-26

现行

AAMI/ISO 14155-2020

Clinical investigation of medical devices for human subjects - Good clinical practice
人体医疗器械的临床研究.良好临床实践

2020-12-07

现行

UNE-EN ISO 14155-2012

Clinical investigation of medical devices for human subjects - Good clinical practice
人体医疗器械的临床研究.良好临床实践

2012-02-01

现行

ASTM E3418-23e1

Standard Practice for Calculating Scientifically Justifiable Limits of Residues for Cleaning of Pharmaceutical and Medical Device Manufacturing Equipment and for Medical Devices
制药和医疗器械制造设备及医疗器械清洁用残留物科学合理限值计算的标准实施规程

2023-11-01

现行

YY/T 0698.6-2009

最终灭菌医疗器械包装材料　第6部分：用于低温灭菌过程或辐射灭菌的无菌屏障系统生产用纸要求和试验方法
Packaging materials for terminal sterilized medical devices—Part 6:Paper for manufacture of sterile barrier systems intended for sterilization by low temperature sterilization processes or irradiation—Requirements and test methods

2009-06-16

现行

YY/T 0698.7-2009

最终灭菌医疗器械包装材料　第7部分：环氧乙烷或辐射灭菌　无菌屏障系统生产用可密封涂胶纸要求和试验方法
Packaging materials for terminal sterilized medical devices—Part 7:Adhesive coated paper for the manufacture of sealable packs for medical use for sterilization by ethylene oxide or irradiation—Requirements and test methods

2009-06-16

现行

ASTM E3263-22e1

Standard Practice for Qualification of Visual Inspection of Pharmaceutical Manufacturing Equipment and Medical Devices for Residues
药品制造设备和医疗器械残留物目视检查的评定标准实施规程

2022-05-01

现行

DIN EN ISO 14155

Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)
人体医疗器械的临床研究.良好临床实践（ISO 14155-2020）；德文版EN ISO 14155:2020

2020-12-01

现行

CSA PLUS 9001MD(R2003)

The ISO 9000 and 13485 Essentials: A Practical Handbook for Implementing the ISO 9000 and 13485 Standards for Medical Device Manufacturers
ISO 9000和13485要点:医疗器械制造商实施ISO 9000和13485标准的实用手册

2000-02-25

现行

CSA 9001MD

The ISO 9000 and 13485 Essentials - A Practical Handbook for Implementing the ISO 9000 and 13485 Standards for Medical Device Manufacturers
ISO 9000和13485基本要求-医疗器械制造商实施ISO 9000和13485标准的实用手册

1998-01-01

现行

KS P ISO 20916

체외 진단 의료기기 연구 피험자의 검체를 사용한 임상적 성능 시험 임상적 성능 시험 관리 기준
体外诊断医疗器械.使用人体标本的临床性能研究.良好研究规范

2022-12-28

现行

ISO 20916-2019

In vitro diagnostic medical devices — Clinical performance studies using specimens from human subjects — Good study practice
使用人类标本的体外诊断设备（IVD）的临床表现研究 - 良好的学习实践

2019-06-04

现行

BS ISO 20916-2019

In vitro diagnostic medical devices. Clinical performance studies using specimens from human subjects. Good study practice
体外诊断医疗设备 使用人体样本进行临床表现研究 良好的学习习惯

2019-06-06

现行

BS EN 868-3-2017

Packaging for terminally sterilized medical devices-Paper for use in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5). Requirements and test methods
最终灭菌医疗器械的包装

2017-02-28