YY 0881-2013_English: PDF (YY0881-2013)
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Single-use Huber neeldes used for implantable drug-supplying devices
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YY 0881-2013
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Standards related to: YY 0881-2013
| Standard ID | YY 0881-2013 (YY0881-2013) | | Description (Translated English) | Single-use Huber neeldes used for implantable drug-supplying devices | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C31 | | Classification of International Standard | 11.040.20 | | Word Count Estimation | 16,166 | | Quoted Standard | GB/T 1962.1; GB/T 1962.2; GB 8368; GB 15811; GB 18457; GB 18671; YY 0286.4-2006; YY/T 0296 | | Drafting Organization | Jinan, the State Food and Drug Administration Medical Device Quality Supervision and Inspection Center | | Administrative Organization | National Standardization Technical Committee medical infusion | | Regulation (derived from) | State Food and Drug Administration announcement 2013 No. 36; industry standard for filing Notice 2013 No. 12 (No. 168 overall) | | Proposing organization | State Food and Drug Administration | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard specifies: Disposable Needle implantable drug delivery devices (including infusion needle and needle) Requirements, to ensure the implantable drug delivery devices and infusion devices to adapt. The standard material used for the exclusive u | YY 0881-2013
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S 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 α 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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