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YY 0497-2005 English PDF (YY0497-2005)

YY 0497-2005 English PDF (YY0497-2005)

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YY 0497-2005: Sterile insulin syringe for single use
This Standard specifies classification, requirements, test methods, inspection rules, marks, operation instructions, packaging, transportation, storage, etc. for insulin syringe for single-use. It covers syringes for use with 40 units of insulin/ml (U-40) and 100 units of insulin/ml (U-100).
YY 0497-2005
YY
ICS 11.040.20
C 31
Pharmaceutical National Standard
of the People’s Republic of China
GB/T 8967-2007
Sterile Insulin Syringe for Single Use
(ISO 8537.1991 + A1.2000, Sterile single-use syringes,
with or without needle, for insulin, NEQ)
ISSUED ON. DECEMBER 7, 2005
IMPLEMENTED ON. DECEMBER 1, 2006
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 Types of syringe ... 6
5 Requirements ... 7
6 Test methods ... 13
7 Packaging ... 16
8 Marks, operation instructions, and product certificate ... 17
9 Storage ... 20
Annex A ... 21
Annex B ... 23
Annex C ... 24
Annex D ... 26
Annex E ... 27
Annex F ... 29
Annex G ... 30
Annex H ... 32
Foreword
This Standard non-equivalently adopts International Standard ISO 8537.1991 “Sterile Single-use Syringes, with or without Needle, for Insulin” and its Amendment 1.2000. Main technical differences between this Standard and ISO 8537.1991 as well as its Amendment 1 are as follows.
— This Standard adds easily oxidized substance, hemolysis, acute systemic toxicity, cytotoxicity, subcutaneous stimulation or sensitization response performance indexes; adopts the test methods in GB/T 14233.1-1998 “Test Methods for Infusion, Transfusion, Injection Equipment for Medical Use - Part 1. Chemical Analysis Methods” for chemical properties; and adopts the test methods in GB/T 14233.2-1993 “Test Methods for Infusion, Transfusion,
Injection Equipment for Medical Use - Part 2. Biological Test Methods” and GB/T 16886.1-2001 “Biological Evaluation of Medical Devices - Part 1. Evaluation and Test” for biological properties.
— This Standard adds performance indexes of plungers, which shall comply with YY/T 0243-2003 “Plunger of Sterile Syringes for Single Use”.
— This Standard cites GB 15810-2001 “Sterile hypodermic syringes for single use” and specifies push-and-pull acting forces during whole process of test activities after fitting of syringe coat and plunger.
— This Standard adopts GB/T 2828.1-2003 “Sampling Procedures and Tables for Batch Inspection Apply to Inspection of Continuous Batches)” and GB/T
2829-2002 “Sampling Procedures and Tables for Periodic Inspection by
Attributes (Apply to Inspection of Process Stability)”.
Annex A, Annex B, Annex C, and Annex D to this Standard are normative, while Annex E, Annex F, Annex G, and Annex H are informative.
This Standard was proposed by National Technical Committee on Standardization of Injectors (Needles) for Medical Purposes.
This Standard is responsibly drafted by Shanghai Misawa Medical Industry Co., Ltd. This Standard shall be under the jurisdiction of National Technical Committee on Standardization of Injectors (Needles) for Medical Purposes.
Drafters of this Standard. Wang Hongbin, Sang Weidong, and He Bin.
Sterile Insulin Syringe for Single Use
1 Scope
This Standard specifies classification, requirements, test methods, inspection rules, marks, operation instructions, packaging, transportation, storage, etc. for insulin syringe for single-use. It covers syringes for use with 40 units of insulin/ml (U-40) and 100 units of insulin/ml (U-100).
This Standard applies to the insulin syringe for single-use that injects into human body soon after extracting insulin liquid (hereinafter refereed to as syringe). This Standard does not apply to sterile syringe for single-use, glass syringe for single-use, and prefilled syringe.
2 Normative references
The provisions in following documents become the provisions of this Standard through reference in this Standard. For dated references, the subsequent amendments (excluding corrigendum) or revisions do not apply to this Standard, however, parties who reach an agreement based on this Standard are encouraged to study if the latest versions of these documents are applicable. For undated references, the latest edition of the referenced document applies.
GB/T 1962.1-2001 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment (idt ISO 594-1.1996)
GB/T 2828-1987 Sampling procedures and tables for lot-by-lot inspection by attributes (Apply to inspection of successive lots or batches)
GB/T 2829-1987 Sampling procedures and tables for periodic inspection by attributes (Apply to inspection of stability for productive process)
GB 6682-1992 Water for laboratory use; Specifications
GB/T 14233.1-1998 Infusion, transfusion, injection equipment for medical use - Part 1. Chemical analysis methods
GB/T 14233.2-2005 Test methods for infusion, transfusion, injection equipment for medical use - Part 2. Biological test methods
GB 15810-2001 Sterile hypodermic syringes for single-use (eqv ISO 7886-1.1993) 13 - Nominal capacity lines;
14 - Graduated capacity lines;
15 - Conical head.
NOTE. This figure is intended to be illustrative of components of a syringe only. It does not show a detachable needle or a permanently attached needle tube, and does not form part of the specification. The piston/plunger assembly may or may not be of integral construction and may incorporate more than one seal.
Figure 1 Schematic diagram of insulin syringe
4.2 The types of syringe shall be designated as follows.
Type 1. Syringe having a 6.100 (Luer) male conical fitting, supplied without a needle, and packaged in a unit container.
Type 2. Syringe having a 6.100 (Luer) male conical fitting, supplied without a needle, and fitted with protective end caps.
Type 3. Syringe having a 6.100 (Luer) male conical fitting, supplied with a detached or detachable needle, and packaged in a unit container.
Type 4. Syringe having a 6.100 (Luer) male conical fitting, supplied with a detachable needle, and fitted with protective end caps.
Type 5. Syringe having a fitting other than a 6.100 (Luer) taper, supplied with a needle not intended to be detached, and packaged in a unit container.
Type 6. Syringe having a fitting other than a 6.100 (Luer) taper, supplied with a needle not intended to be detached, and fitted with protective end caps. Type 7. Syringe with fixed needle tube and packaged in a unit container. Type 8. Syringe with fixed needle tube and fitted with protective end caps. 4.3 See Annex D for requirements of syringe material.
5 Requirements
5.1 Syringe coat
5.1.1 Requirements for syringe appearance
5.1.1.1 Syringe coat shall be free of rough edges, burrs, plastic flow, defects, and other molding defects.
5.1.1.2 Syringe coat shall have sufficient transparency and fiducialine can be clearly solution of the same batch; pH difference must not exceed 1.0.
5.10.3 Easily oxidized substance
Syringe leach solution (see Annex B) is contrasted with blank contrast solution of the same batch with an equal volume; consumption difference of potassium
permanganate solution at 0.002 mol/L shall not exceed 0.5 mL.
5.10.4 Residue of ethylene oxide
Residue of ethylene oxide shall not be greater than 10 μg/g.
5.11 Biological performance requirements
5.11.1 Syringe shall be sterile.
5.11.2 Syringe endotoxin shall be less than 0.5 EU/mL.
5.11.3 Syringe shall have no hemolytic reaction; hemolysis rate shall not exceed 5%. 5.11.4 Syringe shall have no acute systemic toxicity.
6 Test methods
6.1 Appearance
OBSERVE it by vision, which shall conform to the provisions of 5.1.1, 5.1.3.2, 5.1.4.2, 5.3, 5.4.1.2, 5.4.2, 5.4.3, 5.5, 5.6, and 5.7.
6.2 Dimensions
MEASURE with general or special measuring tools, which shall conform to the provisions of 5.1.2, 5.2, 5.4.1.1, and 5.4.1.3.
6.3 Dimensions of conical head
CONDUCT the test according to the method specified in GB 1962-2001, which shall conform to the provisions of 5.1.4.1.
6.4 Edge curl
USE a bevel plate with a 10° angle to the level; place syringe on ramp in parallel, which shall conform to the provisions of 5.1.3.1.
6.5 Physical performance test of syringe
6.5.1 Fitting of plunger and coat (slip resistance test)
6.6 Chemical performance test
6.6.1 Extractable metal content test
Test solution prepared based on ...
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