YY 0881-2013Single-use Huber needles used for implantable drug-supplying devices (English PDF)

Foreword

This Standard is drafted in accordance with the rules given in GB/T 1.1.

Introduction

After the implantable drug-supplying device as specified in YY 0332 implants subcutaneously, it needs to use a Huber needle to puncture and inject into its injection seat, through which the drug will be infused into the body's fluid circulation system or specific parts. Experiments show that using traditional intravenous infusion needle or hypodermic needle to puncture the injection seat of the drug-supplying device will easily produce debris, which will bring not only harm to the human body when falling into the human body, but also bad effects on the device life and performance. The configuration of the Huber needle specified in this Standard can significantly reduce the amount of debris produced during the puncture process.

The implantable drug-supplying device is divided into two types, i.e. hypodermic needle and infusion needle, according to the use. At present, the structural feature of all Huber needles for subcutaneous puncture is that there is a bending angle between the needle tip and the needle tubing axis, so that the first bevel of the needle tip is parallel to the needle tubing axis, and the edge becomes a "side hole", to reduce debris produced during the puncture process.

There is a kind of Huber needle on the market, its composition is as same as the composition of the hypodermic needle; this kind of needle not only has a bending angle on the needle tip, but also the needle tubing is bent into 90° to make it became the infusion needle. Considering that the needle is clinically difficult to puncture, the committee does not advocate such a design, so that this type of Huber needle is not included in the schematic diagram given in this Standard. In addition to the examples given by the standard, there are many types of Huber infusion needles seen on the market, such as that with anti-acupuncture protection device, injection seat and other components. The product with these components may refer to the relevant infusion, injection device standards. This Standard does not repeat the requirements for these components.

Not easy to produce falling debris during the puncture process is a widely-concerned requirement. However, due to the absence of reference material for puncture debris test, it is not possible to develop a test method for evaluating the puncture debris performance of the needle tip. Nonetheless, C.2 of this Standard recommends a reference method for evaluating puncture debris. The standardized test method in the future, if any, will be added to this Standard. Single-use Huber needles used for implantable drug-supplying devices

1 Scope

This Standard specifies the requirements for single-use Huber needles used for implantable drug-supplying devices (including infusion needles and hypodermic needles) to ensure the compatibility of implantable drug-supplying devices and infusion and injection devices.

This Standard provides guidance on the performance and quality specifications of materials used for Huber needles.

This Standard does not involve the anti-acupuncture safety requirements for Huber needles.

2 Normative references

The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this document. For undated references, the latest edition (including all amendments) applies to this document.

GB/T 1962.1 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment - Part 1. General requirement

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

GB 8368 Infusion sets for single use - gravity feed

GB 15811 Sterile hypodermic needles for single use

GB 18457 Stainless steel needle tubing for the manufacture of medical devices

GB 18671 Intravenous needles for single use

YY 0286.4-2006 Special infusion sets - Part 4. Single-use infusion equipment for use with pressure infusion apparatus

YY/T 0296 Hypodermic needles for single use - Color coding for identification

6 Physical requirements

9 Marking