YY 0581.1-2011Infusion access adapters - Part 1: Needle access adapters(Heparin plugs) (English PDF)

Foreword

YY 0581 "infusion connector" is divided into two parts.

--- Part 1. piercing connector (heparin cap);

--- Part 2. needle-free connectors. This is Part 1 YY 0581 of. This section drafted in accordance with GB/T 1.1-2009 given rules.

YY 0581 This part of Amendment YY 0581-2005. The main difference between this part and the YY 0581-2005 YY 0581 are.

--- Modify the standard name;

--- Modify the chemical test methods;

Increase the volume of the cavity --- labeling requirements on a single package.

Introduction

Common market infusion into piercing connectors (also known as pin connectors have) and non-penetrating formula (also known as needle-free connection) of two types. foreign On the market there is a blunt plastic pin connector type connections. Interface and after use to maintain its sealing its total requirement. Piercing Connector interface for patients with puncture risk off the crumbs into the infusion system, as well as medical staff have needle prick accident risk; non-punch Barbed connector member such risks piercing connection does not exist, but there is the risk of multiple uses microbial invasion infusion system.

Infusion connector YY 0581 relates generally intravascular long-term use of indwelling catheters (eg intravenous catheter, central venous catheters)

With the use, through which the liquid to the intravascular infusion and extraction of blood or liquid. Whether the use of needles or needle-free connection is connected, at the output At the end of the infusion liquid or liquid between different, it must be made in physiological saline via infusion catheter flushing pipe fittings, flush left in the catheter Drugs to prevent complications such as phlebitis. At the end of the infusion with saline or heparin saline through Pin connector, or needleless connectors on the catheter forward sealed tube to prevent backflow of blood transfusion due to pull out when the appliance caused.

Prolonged use in connection with intravascular indwelling catheter if improper connections between, there is the risk of accidental loss, which may cause Patients with massive bleeding into the patient and endanger their lives. Therefore, the lock connector and require clinical use is to maintain a reliable connection Necessary, recommendations on joint injection or related product packaging or instructions for use on the reliability of the connection holding given the necessary warnings.

1 Scope

YY 0581 This section provides puncture infusion connectors (also known as heparin cap, hereinafter referred to as. connections) requirements and test methods.

Connection with indwelling intravascular devices (such as intravenous catheter) into one integrated product supply, can refer to the implementation of this section.

2 Normative references

The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein Member. For undated references, the latest edition (including any amendments) applies to this document.

GB/T 1962.2 syringes, needles and other medical equipment - 6% (Luer) taper fittings - Part 2. Lock fittings

GB 8368 disposable infusion set gravity transfusion formula

GB 15810 single-use sterile syringes

GB 15811-time use of sterile needles Symbols - Part 1 YY/T 0466.1 medical equipment used with medical device labels, labeling and information. General requirements

3 Mark

Infusion connector marked by the text and description of the part number, numbered. Connection YY 0581.1

4 Materials

Material connecting member shall meet the requirements specified in Chapter 5, 6 and 7.

5 Physical Requirements