YY/T 0497-2018_English: PDF (YY/T0497-2018)
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Sterile insulin syringe for single use
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| Standard ID | YY/T 0497-2018 (YY/T0497-2018) | | Description (Translated English) | Sterile insulin syringe for single use | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Word Count Estimation | 25,268 | | Date of Issue | 2018-04-11 | | Date of Implementation | 2019-05-01 | | Older Standard (superseded by this standard) | YY 0497-2005 | | Drafting Organization | Shandong Xinhua Ande Medical Products Co., Ltd., Suzhou Bidi Medical Devices Co., Ltd., Shanghai Medical Device Testing Institute | | Administrative Organization | National Medical Syringe (Needle) Standardization Technical Committee (SAC/TC 95) | | Regulation (derived from) | China Drug Administration Announcement No. 4 of 2018 | | Proposing organization | State Drug Administration | | Issuing agency(ies) | State Drug Administration | | Standard ID | YY 0497-2005 (YY0497-2005) | | Description (Translated English) | Sterile insulin syringe for single use | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C31 | | Classification of International Standard | 11.040.20 | | Word Count Estimation | 23,226 | | Date of Issue | 2005-12-07 | | Date of Implementation | 2006-12-01 | | Adopted Standard | ISO 8537-1991, NEQ | | Drafting Organization | Medical Industry Co., Ltd. Shanghai meters Shawa | | Administrative Organization | National Standardization Technical Committee of medical syringes (needles) | | Regulation (derived from) | Industry Standard Notice 2006 No. 2 (No. 74 overall) | | Proposing organization | National Medical Syringe (needle) Standardization Technical Committee | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard specifies the classification of disposable insulin syringes, requirements, test methods, inspection rules, marking, manual, packaging, transportation and storage requirements. It consists of 40 units of insulin syringe (U-40) and 100 units of insulin syringe (U-100). This standard applies to pumping insulin human injection immediately after liquid disposable insulin syringes (hereinafter referred to as the syringe). Does not apply to one-time use of sterile syringes, disposable glass syringe, pre-injection of liquid syringes. |
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 (ISO 10993-1:2009, IDT)
GB 18278.1-2015 Sterilization of health care products - Moist heat - Part 1:
Requirements for the development, validation and routine control of a
sterilization process for medical devices (ISO 17665-1:2006, IDT)
GB 18279.1-2015 Sterilization of health care products - Ethylene oxide - Part
1: Requirements for development, validation and routine control of a
sterilization process for medical devices (ISO 11135-1:2007, IDT)
GB 18280.1-2015 Sterilization of health care products - Radiation - Part 1:
Requirements for development, validation and routine control of a
sterilization process for medical devices (ISO 11137-1:2006, IDT)
GB/T 18457 Stainless steel needle tubing for the manufacture of medical
devices (ISO 9626:1991:2001, MOD)
GB/T 19633.1 Packaging for terminally sterilized medical devices - Part 1:
Requirements for materials, sterile barrier systems and packaging systems
(ISO 11607-1:2006, IDT)
ISO 7000:2014 Graphical symbols for use on equipment - Registered
symbols
ISO 81714-1:2010 Design of graphical symbols for use in the technical
documentation of products - Part 1: Basic rules
YY/T 0466.1 Medical devices - Symbols to be used with medical device
labels, labelling and information to be supplied - Part 1: General
requirements (ISO 15233-1:2012, IDT)
3 Terms and definitions
The following terms and definitions apply to this document.
3.1
Graduated capacity
Volume of water at 20 °C±3 °C or 27 °C±3 °C expelled from the syringe when
the fiducial line on the piston traverses a given scale interval or intervals.
3.2
Needle cap
Protective end cap intended to maintain the sterility of the needle tube and to
protect physically the needle tube and needle hub, if present.
3.3
......
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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