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YY/T 0497-2018 PDF English

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YY/T 0497-2018: Sterile insulin syringe for single use
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YY/T 0497: Historical versions

Standard IDUSDBUY PDFDeliveryStandard Title (Description)Status
YY/T 0497-2018390 Add to Cart Auto, 9 seconds. Sterile insulin syringe for single use Valid
YY 0497-2005160 Add to Cart Auto, 9 seconds. Sterile insulin syringe for single use Obsolete

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YY/T 0497-2018: Sterile insulin syringe for single use

---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/YYT0497-2018
YY PHARMACEUTICAL INDUSTRY STANDARD 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);  Replace ISO 594-1 with GB/T 1962.1 identical to the international standard (see 6.7.1);  Replace ISO 7864 with GB 15811 not equivalent to the international standard (see 6.8.1 and 6.8.2);  ADD reference to GB 15810 (see 6.4.1.2);  ADD reference to GB/T 6682 (see 7.4);  ADD reference to GB/T 14233.2 (see 8.2);  ADD reference to GB 18278.1 (see 8.2);  ADD reference to GB 18279.1 (see 8.2);  ADD reference to GB 18280.1 (see 8.2);  ADD reference to YY/T 0466.1 (10.3.4). - ADD "Clause 5 Materials", to regulate the requirements of materials; - ADD the requirement in 6.4.2 that for the 1.0 mL and 2.0 mL syringes, numbers can be marked at every 5 units of graduated capacity lines; - Modify the requirement of "content of extractable metals"; - ADD "7.3 Readily-oxidizable substances"; - ADD "7.4 Residue of ethylene oxide"; - ADD "Clause 8 Biological properties", to regulate the biological requirements of products; - 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”; - Modify the packaging requirements; - Modify the marking requirements; - Modify Annex A of ISO 8537.2007 and move to Annex G of this Standard; - Move Annex B of ISO 8537.2007 to Annex F of this Standard; - Move Annex C of ISO 8537.2007 to Annex A of this Standard; - Modify Annex D of ISO 8537.2007 and move to Annex B of this Standard; - 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)

3 Terms and definitions

The following terms and definitions apply to this document. Cover intended to provide physical protection to the needle tube. Covers intended to enclose the projecting portion of the plunger and push- button and the nozzle and/or the needle tube.

4 Product classification

The types of syringe shall be designated as follows in relation to their packaging and combinations with needles.

5 Materials

The materials used to manufacture syringe and its components shall meet the requirements of Clause 6.Components, which come into contact with the liquid medicine, shall also meet the requirements of Clauses 7 and 8.

6 Physical properties

If the interior surface of the syringe, including the piston, and the exterior surface of the needle tube are lubricated, use normal or corrected vision to observe without magnification; the lubricant shall not form pools of fluid on the interior surface of the syringe nor drops on the exterior surface of the needle tube or in the bore.

7 Chemical properties

A test fluid prepared as described in G.1 shall not contain more than a combined total of 5 μg/mL of lead, tin, zinc and iron when tested by a recognized micro- analytical method, for example by an atomic absorption method. The cadmium content shall be less than 0.1 μg/mL. If ethylene oxide is used for sterilization, control of the residue of ethylene oxide shall be confirmed. Carry out the test according to Annex H. The residue of ethylene oxide shall be ≤10 μg/g.

8 Biological properties

For syringes in unit containers and self-contained syringe units, according to GB 18278.1, GB 18279.1, or GB 18280.1, the sterilization process should be confirmed and routinely controlled, to ensure that the probability of bacterial survival on the product is less than 10-6. Carry out the test according to the method stipulated in GB/T 14233.2.The limit of bacterial endotoxin in syringe does not exceed 20EU each.

9 Packaging

The syringe, together with the needle if supplied, shall be sealed individually in a unit container. The syringe unit shall be fitted with protective end cap. ......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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