This Standard specifies the requirements for the subcutaneous infusion set for use with insulin pump that consists of interface, piping, piercing assembly (hereinafter referred to as "the subcutaneous infusion set"). This product is a single use sterile product. This Standard does not include the requirements for insulin-filled devices (e.g., drug reservoirs, pre-filled cassette bottles) in insulin pumps. This Standard does not address the accuracy requirements for flow control when the subcutaneous infusion set are fitted with an insulin pump.
Basic Data
Standard ID
YY/T 1291-2016 (YY/T1291-2016)
Description (Translated English)
Single use subcutaneous infusion sets for use with insulin pump
Sector / Industry
Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard
C31
Classification of International Standard
11.040.20
Word Count Estimation
19,149
Date of Issue
2016-03-23
Date of Implementation
2017-01-01
Regulation (derived from)
Notice of the General Administration of Food and Drug Administration (No. 74 of 2016)
