首页 馆藏资源 舆情信息 标准服务 科研活动 关于我们
现行 KS P ISO 17664-1-2021
到馆提醒
收藏跟踪
购买正版
의료제품 공정 — 의료기기 제조자가 제공하는 정보 — 제1부: 위험 및 준위험 의료기기 医疗保健产品的加工.医疗器械制造商为医疗器械加工提供的信息.第1部分:关键和半关键医疗器械
发布日期: 2021-12-28
该标准明确了医疗器械制造者对危险或准危险医疗器械(如通常插入人体灭菌部位的医疗器械或与黏膜或未受损皮肤接触的医疗器械)的公正或应灭菌的医疗器械所应提供的信息的要求。
이 표준은 위험 또는 준위험 의료기기(예: 일반적으로 인체의 멸균 부위에 삽입되는 의료기기 또는 점막 또는 손상되지 않은 피부와 접촉하는 의료기기)의 공정 또는 멸균되어야 하는 의료기기에 대해 의료기기 제조자가 제공해야 하는 정보에 대한 요구 사항을 명시한다.
分类信息
关联关系
研制信息
相似标准/计划/法规
现行
DIN EN ISO 17664
Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices (ISO 17664:2017)
医疗保健产品的加工.医疗器械制造商为医疗器械加工提供的信息(ISO 17664-2017)
2018-04-01
现行
BS ISO 17664-2-2021
Processing of health care products. Information to be provided by the medical device manufacturer for the processing of medical devices-Non-critical medical devices
医疗保健产品的加工 医疗器械制造商为医疗器械加工提供的信息
2021-02-26
现行
BS EN ISO 17664-1-2021
Processing of health care products. Information to be provided by the medical device manufacturer for the processing of medical devices-Critical and semi-critical medical devices
医疗保健产品的加工 医疗器械制造商为医疗器械加工提供的信息
2021-09-01
现行
AAMI ST90-2017
Processing of health care products - Quality management systems for processing in health care facilities
医疗保健产品的加工.医疗保健设施加工的质量管理体系
2017-07-18
现行
KS P ISO 17664-2
의료 제품 공정 의료기기 제조자가 제공하는 정보 제제2부부: 비위험 의료기기
医疗保健产品加工.医疗器械制造商为医疗器械加工提供的信息.第2部分:非关键医疗器械
2022-12-28
现行
ISO 17664-2-2021
Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 2: Non-critical medical devices
医疗保健品加工医疗器械生产企业提供的医疗器械加工信息第2部分:非关键医疗器械
2021-02-25
现行
ISO 17664-1-2021
Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 1: Critical and semi-critical medical devices
医疗保健产品的加工医疗器械制造商为医疗器械加工提供的信息第1部分:关键和半关键医疗器械
2021-07-06
现行
BS EN ISO 13408-1-2015
Aseptic processing of health care products-General requirements
保健品的无菌加工
2015-08-31
现行
BS EN ISO 13408-6-2021
Aseptic processing of health care products-Isolator systems
保健品的无菌加工
2021-05-24
现行
BS EN ISO 13408-7-2015
Aseptic processing of health care products-Alternative processes for medical devices and combination products
保健品的无菌加工
2015-08-31
现行
BS ISO 13408-7-2012
Aseptic processing of health care products. Alternative processes for medical devices and combination products
医疗保健产品的无菌处理 医疗器械和组合产品的替代工艺
2013-02-28
现行
KS P ISO 13408-2(2016 Confirm)
헬스케어 제품의 무균 처리-제2부:여과
保健品无菌加工第2部分:过滤
2010-12-30
现行
KS P ISO 13408-3(2016 Confirm)
헬스케어 제품의 무균 처리-제3부:동결 건조
保健品无菌加工第3部分:冻干
2010-12-30
现行
ISO 13408-3-2006
Aseptic processing of health care products — Part 3: Lyophilization
保健品的无菌处理第3部分:冷冻干燥
2006-09-01
现行
KS P ISO 13408-3
의료제품의 무균 공정 —제3부: 동결 건조
保健品的无菌处理.第3部分:冷冻干燥
2021-12-28
现行
YY/T 0567.3-2011
医疗保健产品的无菌加工 第3部分:冻干法
Aseptic processing of health care products—Part 3:Lyophilization
2011-12-31
现行
GOST R ISO 13408-2-2007
Асептическое производство медицинской продукции. Часть 2. Фильтрация
无菌加工保健品 过滤
现行
AAMI/ISO 13408-3-2006/(R)2015
Aseptic processing of health care products - Part 3: Lyophilization
保健品的无菌处理.第3部分:冷冻干燥
2008-09-23
现行
GOST R ISO 13408-3-2011
Асептическое производство медицинской продукции. Часть 3. Лиофилизация
无菌加工保健品 第3部分冻干
现行
BS EN ISO 4073-2009
Dentistry. Information system on the location of dental equipment in the working area of the oral health care provider
牙科 口腔保健提供者工作区牙科设备位置信息系统
2009-08-31