YY 0332-2011 植入式给药装置
本标准规定了体内植入式给药装置(以下简称:给药装置,见3.1)的要求、本标准未规定与给药装置配套供应的辅助器械的要求
Implantable drug-supplying device
GOST 31579-2012 眼科植入物.黏弹性眼科植入装置.通用安全性要求
Ophthalmic implants. Ophthalmic viscosurgical devices. General safety requirements
YY/T 0332-2011 植入式给药装置
Implantable drug-supplying device
YY 0332-2002 植入式给药装置
本标准规定了体内植入式给药装置的要求。 本标准未规定与给药装置配套供应的辅助器械的要求
Implantable drug-supplying device
GOST R 53078-2008 眼科植入物.粘弹性眼科植入物装置.一般安全要求
Ophthalmic implants. Ophthalmic viscosurgical devices. General safety requirements
DB37/T 2903.29-2017 赛鼾鼻
YY 0881-2013 一次性使用植入式给药装置专用针
本标准规定了一次性使用植入式给药装置专用针(包括输液针和注射针)的要求,以保证与植入式给药装置和输注装置相适应。本标准为专用针所用材料的性能及其质量规范提供了指南。本标准不涉及专用针防针刺安全要求
Single-use Huber needles used for implantable drug-supplying devices
EN ISO 14708-5:2022 外科植入物.有源可植入医疗装置.第5部分:循环支撑装置
This document specifies requirements for safety and performance of active implantable circulatory support devices, including type tests, animal
Implants for surgery - Active implantable medical devices - Part 5: Circulatory support devices (ISO 14708-5:2020)
ISO 14708-5:2010 外科植入物.有源可植入医疗装置.第5部分:循环支撑装置
This part of ISO 14708 specifies requirements for safety and performance of active implantable circulatory support devices. It is not applicable
Implants for surgery - Active implantable medical devices - Part 5: Circulatory support devices
ANSI/AAMI/ISO 14708-5:2010 外科植入物.有源可植入医疗装置.第5部分:循环支撑装置
Specifies requirements for safety and performance of active implantable circulatory support devices. Excluded from this scope are intra-aortic balloon
Implants for surgery - Active implantable medical devices - Part 5: Circulatory support devices
KS P ISO 14708-5:2012 外科植入物.有源可植入医疗装置.第5部分:循环支撑装置
이 표준은 능동 이식형 순환 보조 장치의 안전성과 성능에 대한 요건을 규정한다. 이는 체외
Implants for surgery－Active implantable medical devices－Part 5：Circulatory support devices
KS P ISO 14708-4:2010 外科植入物.有源可植入医疗装置.第4部分:可植入输注管
이 표준은 인체 내 정해진 곳으로 약물을 공급하는 기능성 이식형 의료기기에 적용할 수 있다
Implants for surgery-N implantable medical devices-Part 4:Implantable infusion pumps
EN ISO 14708-4:2022 外科植入物.有源可植入医疗装置.第4部分:可植入输注管
This document specifies particular requirements for active implantable medical devices intended to deliver a medicinal substance to site-specific
Implants for surgery - Active implantable medical devices - Part 4: Implantable infusion pump systems (ISO 14708-4:2022)
ISO 14708-4:2008 外科植入物.有源可植入医疗装置.第4部分:可植入输注管
Implants for surgery - Active implantable medical devices - Part 4: Implantable infusion pumps
YY/T 0881-2013 一次性使用植入式给药装置专用针
Single-use Huber needles used for implantable drug-supplying devices
NF S94-165*NF EN ISO 21535:2009 非活性外科植入物 关节置换植入物 髋关节置换植入物的具体要求
Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants
BS EN ISO 21535:2007 非活性外科植入物.关节置换植入物.髋关节置换植入物的特殊要求
This International Standard provides specific requirements for hip joint replacement implants. With regard to safety, this International Standard
Non-active surgical implants — Joint replacement implants — Specific requirements for hipjoint replacement implants (ISO 21535:2007)
BS EN ISO 21535:2009 非活性外科植入物.关节置换植入物.髋关节置换植入物的专门要求
Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants
KS P ISO 21536:2020 非活性外科植入物 - 关节置换植入物 - 膝关节置换植入物的具体要求
Non-active surgical implants — Joint replacement implants — Specific requirements for knee-joint replacement implants
DIN EN ISO 15798:2010 眼科植入物.黏弹性眼科植入装置(ISO 15798-2010).德文版本EN ISO 15798-2010
This International Standard is applicable to ophthalmic viscosurgical devices (OVDs), a class of non-active surgical implants with viscous
Ophthalmic implants - Ophthalmic viscosurgical devices (ISO 15798:2010); German version EN ISO 15798:2010
DIN EN ISO 15798:2014 眼科植入物.黏弹性眼科植入装置(ISO 15798-2013).德文版本EN ISO 15798-2013
Ophthalmic implants - Ophthalmic viscosurgical devices (ISO 15798:2013); German version EN ISO 15798:2013
KS P ISO 14708-3:2010 外科植入物.有源可植入意料装置.第3部分:可植入神经刺激器
이 표준은 중추 신경 또는 말초 신경 계통에 전기 자극을 주는 기능성 이식형 의료기기에 적
Implants for surgery-N implantable medical devices-Part 3:Implantable neurostimulators
EN ISO 14708-3:2022 外科植入物.有源可植入意料装置.第3部分:可植入神经刺激器
ISO 14708-3:2017 is applicable to active implantable medical devices intended for electrical stimulation of the central or peripheral nervous system
Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators (ISO 14708-3:2017)
ISO 14708-3:2008 外科植入物.有源可植入意料装置.第3部分:可植入神经刺激器
Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators
ISO 14708-3:2017 外科植入物.有源可植入意料装置.第3部分:可植入神经刺激器
Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators
NF S94-164*NF EN ISO 21534:2009 非活性外科植入物.关节置换植入物.特殊要求
Non-active surgical implants - Joint replacement implants - Particular requirements.
EN ISO 14708-7:2022 外科植入物.有源可植入医疗装置.第7部分:耳蜗植入系统的详细要求
This document specifies requirements that are applicable to those active implantable medical devices that are intended to treat hearing impairment via
Implants for surgery - Active implantable medical devices - Part 7: Particular requirements for cochlear and auditory brainstem implant systems (ISO 14708-7:2019)
ISO 14708-7:2013 外科植入物.有源可植入医疗装置.第7部分:耳蜗植入系统的详细要求
Implants for surgery - Active implantable medical devices - Part 7: Particular requirements for cochlear implant systems
KS P ISO 21534-2009(2019 非活性外科植入物关节置换植入物的特殊要求
Non－active surgical implants－Joint replacement implants－Particular requirements
DIN EN 45502-2-2:2008 有源可植入的医疗装置.第2-2部分:用于治疗缓慢性心率失常的有源可植入医疗装置(包括可植入心脏起搏器)的特殊要求
Active implantable medical devices - Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators); German version EN 45502-2-2:2008
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