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YY 0881-2013 English PDF (YY0881-2013)

YY 0881-2013 English PDF (YY0881-2013)

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YY 0881-2013: Single-use Huber neeldes used for implantable drug-supplying devices

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.
YY 0881-2013
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE REPUBLIC OF CHINA
ICS 11.040.20
C 31
Single-use Huber needles used for
implantable drug-supplying devices
ISSUED ON. DECEMBER 21, 2013
IMPLEMENTED ON. DECEMBER 1, 2014
Issued by. China Food and Drug Administration
Table of Contents
Foreword ... 3
Introduction ... 4
1 Scope ... 5
2 Normative references ... 5
3 Structure type and naming ... 6
4 Marking ... 6
5 Materials ... 6
6 Physical requirements ... 7
7 Chemical requirements ... 10
8 Biological requirements ... 10
9 Marking ... 10
10 Packaging... 12
Annex A (normative) Physical test methods ... 13
Annex B (informative) Type inspection ... 15
Annex C (informative) Relevant information on further evaluation of the quality of needle tips ... 16
Bibliography ... 20
Foreword
This Standard is drafted in accordance with the rules given in GB/T 1.1. This Standard is proposed by State Food and Drug Administration.
This Standard is under the jurisdiction of National Technical Committee on Infusion Equipment for Medical Use of Standardization Administration of China (SAC/TC 106). Drafting of organizations this Standard. State Food and Drug Administration Jinan Medical Device Quality Supervision and Inspection Center, Zhejiang Kindly Medical Devices Co., Ltd.
Main drafters of this Standard. Wan Min, Yu Xin, Mou Pengtao, Zhang Honghui. 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 6.7 Needle tip
6.7.1 The needle tip of the Huber needle shall have a bending angle facing the direction of the cutting edge (which is approximately equal to the first bevel angle ?? of the needle tip), so that the first bevel is parallel to the needle tubing axis.
NOTE. This configuration allows the needle tip to become a ?€?side hole?€? needle, to effectively reduce puncture debris. C.2 gives the information on the evaluation of puncture debris. See also the introduction.
6.7.2 The needle tip of the Huber needle shall be sharp; in the 2.5 times magnification condition, with normal or corrected visual acuity, the needle tip shall be no burrs, hooks and other defects.
NOTE 1. In order to reduce the bending angle of the needle tubing, the first bevel angle of the needle tip is usually a ?€?long bevel angle?€? of (12 ?? 2) ??. C.1 gives the geometry and naming illustrations of the needle tip. When describing the configuration of the needle tip, it is not necessary to use all the illustrations shown.
NOTE 2. C.3 gives a method for evaluating the puncture performance of the needle tip. 6.7.3 The first bevel angle of the needle tip shall be facing the direction of the needle handle (as shown in Figure 1).
6.8 Lubricant
If the needle tubing is coated with lubricants, observe with normal or corrected visual acuity, the outer surface of the needle tubing shall not have visible lubricant buildup. NOTE 1. The suitable lubricant is polydimethylsiloxane.
NOTE 2. The amount of lubricant per square centimeter on the needle tubing shall not exceed 0.25 mg.
6.9 Connecting seat
The conical joint of the connecting seat shall meet the requirements of GB/T 1962.1 or GB/T 1962.2.
The connecting seat of the Huber needle used in conjunction with the infusion set for pressure infusion apparatus shall use lock fittings.
6.10 Needle handle
The needle handle of the Huber infusion needle shall be complete, and the mark shall be clear.
NOTE. The graphic symbols given in YY/T 0466 can be used to meet the above requirements. 9.2 Mediate packaging
There shall be at least the following information in the mediate packaging. a) product name and the specification mark in accordance with Clause 4; b) quantity;
c) words of ?€?sterile?€?, ?€?pyrogen free?€? or ?€?no bacterial endotoxin?€?;
d) batch number, started with the word ?€?Batch?€?;
e) failure date;
f) words of ?€?single-use?€? or equivalent words;
g) letter ?€?P?€? that represents the pressure, its height shall be higher than the surrounding words, if applicable;
h) requirements for handling, storage and transportation (if required); i) name and address of manufacturer and/or distributor;
j) recommended storage conditions (if any).
NOTE. The graphic symbols given in YY/T 0466 can be used to meet the above requirements. 9.3 Transportation packaging
There shall be at least the following marks on the transportation packaging. a) product name and the specification mark in accordance...

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