
发布时间:2024-05-27 17:49:26 - 更新时间:2024年06月29日 15:22
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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
Ophthalmic implants. Ophthalmic viscosurgical devices. General safety requirements
Implantable drug-supplying device
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
Ophthalmic implants. Ophthalmic viscosurgical devices. General safety requirements
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
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)
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
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
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
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
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)
Implants for surgery - Active implantable medical devices - Part 4: Implantable infusion pumps
Single-use Huber needles used for implantable drug-supplying devices
Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants
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)
Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants
Non-active surgical implants — Joint replacement implants — Specific requirements for knee-joint replacement implants
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
Ophthalmic implants - Ophthalmic viscosurgical devices (ISO 15798:2013); German version EN ISO 15798:2013
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
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)
Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators
Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators
Non-active surgical implants - Joint replacement implants - Particular requirements.
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)
Implants for surgery - Active implantable medical devices - Part 7: Particular requirements for cochlear implant systems
Non-active surgical implants-Joint replacement implants-Particular requirements
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








