YY/T 0497-2018 English PDF (YYT0497-2018)

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YY/T 0497-2018: Sterile insulin syringe for single use
YY/T 0497-2018
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.20
C 31
Replacing YY 0497-2005
Sterile insulin syringe for single use
(ISO 8537:2007, MOD)
ISSUED ON: APRIL 11, 2018
IMPLEMENTED ON: MAY 01, 2019
Issued by: National Medical Products Administration
Table of Contents
Foreword ... 3 
1 Scope ... 7 
2 Normative references ... 7 
3 Terms and definitions ... 8 
4 Product classification ... 9 
5 Materials ... 11 
6 Physical properties ... 11 
7 Chemical properties ... 15 
8 Biological properties ... 15 
9 Packaging ... 16 
10 Marking ... 18 
11 Storage... 20 
Annex A (Normative) Test method for force required to operate plunger ... 21 
Annex B (Normative) Properties of needles and needle tubing ... 22 
Annex C (Normative) Test method for determination of dead space ... 24 
Annex D (Normative) Test method for leakage at syringe piston and syringe
nozzle/hub or needle/barrel unions during compression ... 26 
Annex E (Normative) Test method for air leakage past syringe nozzle/hub or
needle/barrel unions during aspiration ... 29 
Annex F (Normative) Test method for air leakage past syringe piston during
aspiration ... 30 
Annex G (Normative) Preparation of test fluid for acidity/alkalinity, extractable
metals, and readily-oxidizable substances ... 32 
Annex H (Normative) Test method for residue of ethylene oxide ... 33 
Annex I (Informative) Biological evaluation ... 34 
Annex J (Informative) Symbol for “do not re-use” ... 35 
Foreword
This Standard is drafted in accordance with the rules given in GB/T 1.1-2009.
This Standard replaces YY 0497-2005 "Sterile insulin syringe for single use".
Compared with YY 0497-2005, the main technical changes of this Standard are
as follows:
- Modify Clause 2 Normative references;
- Modify Clause 3 Terms and definitions;
- Delete 4.3 Materials of the previous standard and move to Clause 5 of this
Standard;
- Delete 5.2 Distance from the finger grips to the push-button from the
previous standard;
- Delete 5.3 Piston from the previous standard;
- Delete Figure 3 "Examples of numerical indication of quantities" from the
previous standard;
- Delete 5.11.3 from the previous standard, there shall be no hemolytic
reaction;
- Delete 5.11.4 from the previous standard, there shall be no acute systemic
toxicity;
- Modify 6.4 Graduated scale;
- ADD the specification in Table 1 with a nominal capacity of 0.3 mL and a
scale interval of 0.5;
- ADD 6.6.1 General for piston/plunger assembly;
- ADD 6.8.2 needle leakage;
- Delete the test method in Clause 6 of the previous standard;
- Modify 8.2 Sterility;
- Modify 8.3 Bacterial endotoxin;
- Delete the instruction manual and product certificate in Clause 8 of the
previous standard;
- ADD the requirement in 9.1 that “Syringes of types 1, 3, 5 and 7 use the
packaging material of one side of the dialysis paper and the other side of
the plastic material”;
- Delete "License number according to regulations", "Sterilization method,
sterilization validity period, sterilization certificate" in Clause 8 of the
previous standard;
- Adjust Annex A in the previous standard into Annex B and modify it;
- ADD Annex A "Test method for force required to operate plunger";
- Adjust Annex B in the previous standard into Annex G and modify the
preparation method of readily-oxidizable substances;
- Adjust Annex C in the previous standard into Annex D and modify it;
- Delete Annex D of the previous standard;
- Delete Annex E of the previous standard;
- ADD Annex E "Test method for air leakage past syringe nozzle/hub or
needle/barrel unions during aspiration";
- Adjust Annex F in the previous standard into Annex I and modify it;
- ADD Annex F "Test method for air leakage past syringe piston during
aspiration";
- Adjust Annex G in the previous standard into Annex J and modify it;
- Delete Annex H of the previous standard;
- ADD Annex H "Test method for residue of ethylene oxide".
This Standard uses the redraft law to modify and adopt ISO 8537:2007 "Sterile
single-use syringes, with or without needle, for insulin".
The technical differences between this Standard and ISO 8537:2007 and their
reasons are as follows:
- As for the normative references, this Standard has made adjustments with
technical differences, to adapt to the technical conditions of China. The
adjustments are specifically reflected in Clause 2 “Normative references”.
The specific adjustments are as follows:
 Replace ISO 9626 with GB/T 18457 which modifies and adopts the
international standard (see 6.8.2);
- Move Annex E of ISO 8537:2007 to Annex C of this Standard;
- Move Annex F of ISO 8537:2007 to Annex D of this Standard;
- Move Annex G of ISO 8537:2007 to Annex E of this Standard;
- Delete Annex H in ISO 8537:2007;
- Move Annex I of ISO 8537:2007 to Annex J of this Standard;
- ADD Annex H "Test method for residue of ethylene oxide";
- ADD Annex I "Biological evaluation".
Attention is drawn to the possibility that some of the elements of this document
may be the subject of patent rights. The issuing authority of this document shall
not be held responsible for identifying any or all such patent rights.
This Standard was proposed by National Medical Products Administration.
This Standard shall be under the jurisdiction of National Technical Committee
95 on Injector for Medical Purpose of Standardization Administration of China
(SAC/TC 95).
Drafting organizations of this Standard: Shinva Ande Healthcare Apparatus Co.,
Ltd., Suzhou BD Medical Devices Co., Ltd., Shanghai Testing and Inspection
Institute for Medical Devices.
Main drafters of this Standard: Nie Yucai, Tian Xiaolei, Du Qin, Li Meng, Hua
Songhe.
This Standard was first issued in 2005.
Sterile insulin syringe for single use
1 Scope
This Standard specifies the requirements and test methods for sterile insulin
syringe for single use (hereinafter referred to as syringe). The syringe is used
only once and is used for human injection immediately after aspiration of insulin.
This Standard applies to syringes for use with 40 units of insulin/ml (U-40) and
100 units of insulin/ml (U-100).
This Standard does not apply to syringes for long-term storage of insulin.
2 Normative references
The following documents are indispensable for the application of this document.
For the dated references, only the editions with the dates indicated are
applicable to this document. For the undated references, the latest edition
(including all the amendments) are applicable 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 (ISO 594-
1:1986, IDT)
GB/T 6682-2008 Water for analytical laboratory use - Specification and test
methods (ISO 3696:1987, MOD)
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 15810-2001 Sterile hypodermic syringes for single use (ISO 7886-
1:1993, EQV)
GB 15811 Sterile hypodermic needles for single use (ISO 7864:1993, MOD)
GB/T 16886.1 Biological evaluation of medical devices - Part 1: Evaluation
and testing within a risk management process ...