YY/T 1748-2021: Neurovascular implants - Intracranial embolization coils

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Scope

This Standard specifies general requirements, design properties and laboratory design
evaluations for coils, pushers and coil systems. This Standard is applicable to coil products for
the treatment of intracranial aneurysms, arteriovenous fistulas, arteriovenous malformations
and other intracranial vascular diseases, as well as the pushers and introducer sheaths that are
matched with them.
This Standard does not apply to coil products for the treatment of other vascular aneurysms.
NOTE 1: Coil products used for other vascular aneurysms may refer to this Standard for implementation.
This Standard does not apply to devices that assist in the release of coils (referred to as releasers,
such as separation control boxes, etc.).
NOTE 2: For the releaser, the relevant standards or technical requirements shall be met. It is possible to
use a releaser as an auxiliary device in the design evaluation of the coil.
This Standard does not deal with drug-related content.
NOTE 3: For the pharmaceutical ingredients included in the product design, it shall be implemented in
accordance with the corresponding laws, regulations and other documents.
NOTE 4: YY/T 0640 specifies general requirements for the performance of passive surgical implants,
this Standard can be used as a supplement to YY/T 0640.

Basic Data

Standard ID	YY/T 1748-2021 (YY/T1748-2021)
Description (Translated English)	Neurovascular implants - Intracranial embolization coils
Sector / Industry	Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard	C35
Word Count Estimation	28,235
Issuing agency(ies)	State Drug Administration