YY 0451-2010 PDF in English
YY 0451-2010 (YY0451-2010) PDF English
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Portable infusion devices for single use - Non electrically driven
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YY 0451-2010: PDF in English YY 0451-2010
YY
NATIONAL PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE'S REPUBLIC OF CHINA
ICS 11.120.30
C 46
Replacing YY 0451-2003
Portable infusion devices for single use –
Non electrically driven
ISSUED ON. DECEMBER 27, 2010
IMPLEMENTED ON. JUNE 1, 2012
Issued by. China Food and Drug Administration
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Normative references ... 4
3 Terms and definitions ... 5
4 General requirements ... 6
5 Operation requirements ... 10
6 Test methods ... 10
7 Information that shall be contained in the package and(or) on the product
... 15
8 Accompanied documents ... 16
Appendix A ... 17
References ... 20
Foreword
This Standard was drafted according to rules of GB/T 1.1-2009.
This Standard replaces YY 0451-2003 "Single-use injectors for continuous
ambulatory administration of medicinal products by parenteral route".
Technical contents of this Standard references to ISO/DIS 28620.2009
"Portable infusion devices for single use - Non electrically driven".
The main technical differences between this Standard and YY 0451-2003 are.
- Modify nominal capacity and the definition of nominal capacity; add the
definition of residue; delete the definition of effective infusion;
- Modify the requirements and test methods for flow rate; modify the
requirements and test methods for bolus;
- Modify the requirements and tests for design and characteristics;
- Modify the requirements and test methods for chemical performance.
This Standard was proposed by and shall be under the jurisdiction of National
Standardization Technical Committee of Infusion Appliances (SAC/TC 106).
Drafting organizations of this Standard. Shandong Provincial Quality Inspection
Center for Medical Devices and Shanghai Yixin Medical Treatment Equipment
Co., Ltd.
Drafters of this Standard. Wu Ping, Yao Xiujun, Shen Yong, Jia Yufei and Li
Kefang.
Portable infusion devices for single use –
Non electrically driven
1 Scope
This Standard specifies the basic requirements and appropriate test methods
for non electrically driven portable infusion devices (hereinafter referred to as
"infusion device"). It is applicable to sustainable infusion device (fixed or
adjustable) and (or) automatic bolus infusion device.
This Standard is not applicable to.
- Electrically driven or electrically controlled infusion devices included by
IEC 60601-2-24;
- Implantable devices;
- Enteral supply pump;
- Transdermal infusion device;
- Device of which the infusion power is not provided by the device but by
the active intervention of patient (e.g. the device which only takes gravity
as power).
2 Normative references
The following referenced documents are indispensable for the application of
this Standard. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any
amendments) applies.
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 1962.1-
2001, ISO 594-1.1986, IDT);
GB/T 1962.2 Conical fittings with a 6% (Luer) taper for syringes, needles and
certain other medical equipment - Part 2. Lock fittings (GB/T 1962.2-2001,
ISO 594-2.1998, IDT);
GB 8368 Infusion sets for single use, gravity feed (GB 8368-2005, ISO 8536-
4.2004, MOD);
GB/T 14233.1 Test methods for infusion transfusion injection equipment for
medical use - Part 1. Chemical analysis methods;
GB/T 14233.2 Test methods for infusion, transfusion, injection equipment for
medical use - Part 2. Biological test methods;
GB/T 16886 (All parts) Biological evaluation of medical devices;
GB/T 6682 Water for analytical laboratory use - Specification and test
methods (GB/T 6682-2008,ISO 3696.1987, MOD);
YY/T 0466.1 Medical devices - Symbols to be used with medical device
labels labelling and information to be supplied (YY/T 0466.1-2009, ISO
15223-1.2007, IDT).
3 Terms and definitions
The following terms and definitions are applicable to this Standard.
3.1 Bolus
A certain volume of medicinal liquid infused by the patient in a short time.
3.2 Bolus refill time
The required time of refilling empty bolus device to bolus capacity.
3.3 Nominal bolus refill time
The bolus refill time marked on the infusion device or its package.
3.4 Filling volume
The nominal capacity plus the residual capacity.
3.5 Residual volume
The volume of residual liquid in infusion device as well as in its components.
3.6 Instantaneous flow rate
The ratio between the volume of some infusion and the time required by filling
this volume, represented by mL/h.
3.7 Mean flow rate
The ratio between the nominal capacity and the actual time required by infusing
this solution, represented by mL/h.
3.8 Nominal time
The ratio between the nominal capacity and the nominal flow rate.
3.9 Nominal flow rate
The flow rate marked on the infusion device, represented by mL/h.
3.10 Nominal volume
The expected maximum output capacity marked on the infusion device.
3.11 Nominal bolus volume
The bolus volume marked on the infusion device or its package.
3.12 Portable infusion device
The device that a patience is expected to be infused with medical liquid in
controlled way, and it is expected to be carried by the patient.
3.13 Protective packing
The material structure that is designed to prevent sterile barrier system and its
contents from damage, from assembly to end-use. [ISO 11607-1.2006]
3.14 Sterile barrier system
The minimum package which can prevent the microorganism and make the
product be used aseptically in the end-use place. [ISO 11607-1.2006]
4 General requirements
4.1 Composition
The infusion device shall contain the following components.
- Components of supplying power (non battery driven);
- Flow rate-limiting device;
- Reservoir bag for containing the infusion of liquid;
- Liquid medicine filter on the infusion passage of the liquid medicine.
5 Operation requirements
5.1 Accuracy of infusion device
5.1 Flow rate
The nominal flow rate of infusion device shall be calibrated by control solution
under given temperature. The nominal flow rate, control solution as well as the
temperature shall be specially specified in the instructions for use that is
accompanied with the infusion device [see 8c and g)].
When doing the test according to 6.2, the mean flow rate shall be within ±15%
deviation range of the nominal flow rate. The adjustable flow rate shall be within
±20% deviation range of the nominal flow rate. The instantaneous flow rate of
at least 80% of nominal flow rate shall be infused within ±50% deviation range
of the nominal flow rate.
5.1.2 Bolus, if applicable
When doing the test according to 6.7, the amount of bolus shall not exceed
115% of nominal bolus.
When doing Test 1 according to 6.8, activate the bolus device while refilling the
nominal bolus. The bolus shall be within 50%~115% of nominal bolus.
When doing Test 2 according to 6.8, activate the bolus device while refilling the
nominal bolus till 50%. The bolus shall be less than 75% of nominal bolus.
6 Test methods
6.1 General test conditions
Note. Unless otherwise specified, the following provisions are applicable to all the tests.
6.1.1 Instruments and material
6.1.1.1 Control solution
It shall use the control solution recommended by the manufacturer and listed in
the attached documents [see 8.c)].
6.1.1.2 Needle
The specification of needle is specified by the manufacturer. When there is no
specification by the manufacturer, it shall use the needle of which the minimum
inner diameter is 1.2 mm.
After the pressure resistance test of 6.3 and the tensile strength test of 6.6 are
completed, carry out the flow rate determination test under 0 back pressure or
back pressure conditions provided by the manufacturer.
When time t = 0, activate the flow rate.
Note. Reactivate the flow rate after the required stable time recommended by the
manufacturer.
Measure according to the time interval specified in 6.1.3.2 till all the solution in
the infusion device is outputted2).
6.3 Pressure resistance test
Respectively fill the solution of nominal capacity and the dyeing solution of
nominal capacity into the infusion device. Apply 150 N of pressure for 5 s in the
direction perpendicular to the major axis of the infusion device via two suitable
parallel hard-boards which can cover the whole reservoir bag. After removing
the pressure, respectively carry out the flow rate test of 6.2 and the anti-leak
test of 6.5.
6.4 Dropping test
Fill the dyeing solution of nominal capacity into the infusion device. After the
pressure resistance test of 6.3 and the tensile strength test of 6.6 are completed,
drop it twice f...
......
Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.
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