YY/T 0285.6-2020 Active Industry standards-Medicine

YY/T 0285.6-2020 Intravascular catheters—Sterile and single-use catheters—Part 6:Subcutaneous implanted ports

Publish Date: 2020-09-27 Implement Date: 2021-09-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 0285.6-2020

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Generally, it refers to microsurgical instruments

ICS Name: Medical equipment

Publish Date: 2020-09-27

Implement Date: 2021-09-01

Pages: 24 pages

Scope

This part of YY/T 0285 specifies the relevant performance and safety requirements for subcutaneous implantable drug delivery devices supplied in a sterile state and intended for single use. This part applies to subcutaneous implantable drug delivery devices consisting of subcutaneous implantable infusion ports and catheters, which are intended for long-term or permanent use within blood vessels.
Note 1: It is known that subcutaneous implantable drug delivery devices are also used for non-vascular indications, such as intraperitoneal, intrathecal, and epidural administration. Based on risk assessment, only implantable drug delivery devices intended for non-vascular applications can refer to this part. It is encouraged that all subcutaneous implantable drug delivery devices for non-vascular applications comply with the requirements of this part.
This part does not specify the relevant performance and safety requirements for implantable drug delivery device-specific needles (hereinafter referred to as dedicated needles).
Note 2: The requirements for implantable drug delivery device-specific needles are specified in YY 0881.