ISO/TR 12417-2:2017 PDF
Cardiovascular implants and extracorporeal systems — Vascular device-drug combination products — Part 2: Local regulatory information
Cardiovascular implants and extracorporeal systems — Vascular device-drug combination products — Part 2: Local regulatory information
- Статус документа:
- Отменён
- Формат:
- Электронный (PDF)
- Количество страниц:
- 29
- Дата публикации:
- 21 ноября 2017 г.
- Издание:
- ISO TR 12417 edition 1 version 1
- ICS:
- 11.040.40
ISO/TR 12417-2:2017 provides region-specific information for - local submissions and approvals for vascular device-drug combination products (VDDCPs) in countries and regions around the world; - changes related to the drug containing part and how they are evaluated by the different local regions. For implanted products, this document is considered as a supplement to ISO 14630, which specifies general requirements for the performance of non-active surgical implants. ISO/TR 12417-2:2017 is considered also as a supplement to ISO 12417‑1, and any relevant device-specific standards, such as the ISO 25539 series specifying requirements for endovascular devices. Requirements listed in this document also address VDDCPs that are not necessarily permanent implants.
Технические детали
- Технический комитет
- ISO/TC 150/SC 2 - Cardiovascular implants and extracorporeal systems
- SKU
- ISO/TR 12417-2:2017
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