YY/T 0981-2016 (YY/T0981-2016, YYT 0981-2016, YYT0981-2016)
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Facial features rinse syringes for single use
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YY/T 0981-2016
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Standards related to: YY/T 0981-2016
| Standard ID | YY/T 0981-2016 (YY/T0981-2016) | | Description (Translated English) | Facial features rinse syringes for single use | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C31 | | Classification of International Standard | 11.040.20 | | Word Count Estimation | 12,199 | | Date of Issue | 2016-03-23 | | Date of Implementation | 2017-01-01 | | Drafting Organization | Jiangsu Suyun Medical Equipment Co., Ltd., Shandong Xinhua Andy Medical Supplies Co., Ltd., Shanghai Medical Devices Testing Institute | | Administrative Organization | National Medical Syringe (Needle) Standardization Technical Committee (SAC/TC 95) | | Regulation (derived from) | Notice of the General Administration of Food and Drug Administration (No. 74 of 2016) | | Proposing organization | State Administration of Food and Drug Administration | | Issuing agency(ies) | State Administration of Food and Drug Administration | YY/T 0981-2016
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.20
C 31
Facial features rinse syringes for single use
ISSUED ON. MARCH 23, 2016
IMPLEMENTED ON. JANUARY 01, 2017
Issued by. China Food and Drug Administration
Table of Contents
Foreword . 3
Introduction .. 4
1 Scope .. 5
2 Normative references . 5
3 Terms and definitions . 6
4 Structure and marking . 7
5 Material .. 9
6 Requirements . 9
7 Test methods . 12
8 Packaging .. 14
9 Marking . 15
10 Storage . 17
Appendix A (Informative) Type inspection .. 18
Facial features rinse syringes for single use
1 Scope
This standard specifies the terms and definitions, structure and marking,
materials, requirements, test methods, packaging, marking and storage for
single use of facial features rinse syringes (hereinafter referred to as syringe).
This standard is applicable to the syringes used in clinical facial features
department.
2 Normative references
The following referenced documents are indispensable for the application of
this document. 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 1962.2 Conical fittings with a 6% (Luer) taper for syringes, needles and
certain other medical equipment - Part 2. Lock fittings
GB/T 6682 Water for analytical laboratory use - Specification and test methods
GB/T 14233.1-2008 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 15810 Sterile hypodermic syringes for single use
GB 15811-2016 Sterile hypodermic needles for single use
GB/T 16886.1 Biological evaluation of medical devices. Part 16. Toxicokinetic
study design for degradation products and leachables
GB 18279.1 Sterilization of health care products. Ethylene oxide - Part 1.
Requirements for development, validation and routine control of a sterilization
process
GB 18279.2 Sterilization of health care products - Part 2. Guidance on the
application of GB 18279.1
GB 18280.1 Sterilization of health care products. Radiation - Part 1. Requirements
for development, validation and routine control of a sterilization process for m
GB/T 18457 Stainless steel needle tubing for the manufacture of medical devices
GB/T 19633.1 Packaging for terminally sterilized medical devices - Part 1.
Requirements for materials, sterile barrier systems and packaging systems
YY/T 0242 Polypropylene material for manufacture of infusion, transfusion and
injection equipment for medical use
YY/T 0296 Hypodermic needles for single use - Colour coding for identification
YY/T 0466.1 Medical devices. Symbols to be used with medical device labels,
labelling and information to be supplied - Part 1. General requirements
3 Terms and definitions
The following terms and definitions apply to this standard.
3.1
Nominal capacity
The capacity of the injector indicated by the manufacturer.
Note. the injector structure is shown in figure 1.
3.2
Graduated capacity
When the piston fiducial line moves in axial direction one or several given
calibration intervals, the volume of water of temperature 20°C±5°C discharged
from the injector.
3.3
Total graduated capacity
The injector capacity between the zero-scale line and the furthest scale line.
3.4
Maximum usable capacity
The connection between the needle seat and the needle shall be firm. Tension
test shall be performed according to GB 15811-2016, the two parts shall not be
loosened or separated.
6.1.2.8 Protective sheathing
The needle seat and the sheathing shall be well matched. The sheathing shall
not fall off naturally. The separation force of the two shall not be greater than
15N.
6.1.2.9 Smoothness
The rinsing needle shall be unimpeded. The stylet specified in GB 15811-2016
can freely pass through, or, with water pressure of no more than 100 KPa, the
flow shall not be less than 80% of the flow of the needle of the same external
diameter and length and the minimum inner diameter specified in GB/T 18457
under the same condition.
6.2. Chemical requirements
6.2.1 Extractable metal content
In comparison of the leaching solution of the syringe and the same batch of
blank control solution, the total content of heavy shall be ≤5 μg/mL.
6.2.2 pH value
The difference of pH value of the leaching solution of the syringe and the same
batch of blank control solution shall be no more than.
6.2.3 Readily oxidizable substance
In comparison of the leaching solution of the syringe and the same batch of
blank control solution, the difference of consumption of 0.002mol/L potassium
manganate solution shall be ≤0.5 mL.
6.2.4 Ethylene oxide residue
The residual amount of ethylene oxide shall be ≤10 μg/g.
6.3 Biological requirements
6.3.1 Bio-compatibility
Conduct biological evaluation of the syringe in accordance with GB/T 16886.1.
The evaluation result shall be no biological hazard.
6.3.2 Sterility
i) Warning to check the integrity of each package before use.
9.2 Medium packaging
The medium packaging shall include the following markings.
a) Description of the contents, including nominal capacity and quantity;
b) The word "aseptic" or equivalent symbol;
c) The word "single use" or equivalent symbol;
d) Production date and/ or batch number;
e) Name and address of the manufacturer or supplier;
f) Year of invalidation;
g) The specification of the attached rinsing needle shall be indicated.
9.3 Large packaging
The large packaging shall include the following markings.
a) Description of the contents, including nominal capacity and quantity;
b) The word "aseptic" or equivalent symbol;
c) The word "single use" or equivalent symbol;
d) date and / or lot number of production;
e) Name and address of the manufacturer or supplier;
f) Year of invalidation;
g) The specification of the attached rinsing needle shall be indicated;
h) Requirements for handling, storage and transportation.
9.4. Material for transportation packaging
If the large package is not used and the medium packages are packed for
transportation, the markings specified in 9.3 shall be marked on the transport
packaging material; or the markings specified in 9.3 shall be visible through the
packaging material.
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