This Part of YY/T 0285 specifies the relevant performance and safety requirements for sterile and single-use subcutaneous implanted ports. This Part applies to the subcutaneous implanted ports intended for long-term or persistent intravascular use, consisting of a subcutaneously implanted infusion port and catheter. NOTE 1: The known subcutaneous implanted ports are also used for non-endovascular indications such as intraperitoneal, intrathecal and epidural access. The implanted ports based on risk assessment and for non-endovascular applications only may refer to this Part. All subcutaneous implanted ports for non-endovascular applications are encouraged to implement the requirements of this Part. This Part does not specify the performance and safety requirements related to the non- coring needle for the implanted ports (hereinafter referred to as the non-coring needle). NOTE 2: See YY 0881 for the requirements for the non-coring needle.
Basic Data
Standard ID
YY/T 0285.6-2020 (YY/T0285.6-2020)
Description (Translated English)
Intravascular catheters - Sterile and single-use catheters - Part 6: Subcutaneous implanted ports
Sector / Industry
Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard
C31
Classification of International Standard
11.040.25
Word Count Estimation
19,179
Date of Issue
2020-09-27
Date of Implementation
2021-09-01
Regulation (derived from)
Announcement No. 108 (2020) of the National Medical Products Administration
