YY/T 0573.3-2019 PDF English
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Sterile hypodermic syringes for single use - Part 3: Auto-disable syringes for fixed dose immunization
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Sterile hypodermic syringes for single use. Part 3: Auto-disable syringes for fixed dose immunization
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YY/T 0573.3-2019: Sterile hypodermic syringes for single use - Part 3: Auto-disable syringes for fixed dose immunization
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Sterile hypodermic syringes for single use - Part 3. Auto-disable syringes for fixed dose immunization
ICS 11.040.25
C31
People's Republic of China Pharmaceutical Industry Standard
Replacing YY 0573.3-2005
Disposable sterile syringe
Part 3. Self-destructive fixed-dose vaccine syringes
Sterilehypodermicsyringesforsingleuse-
Part 3. Auto-disablesyringesforfixeddoseimmunization
(ISO 7886-3.2005, MOD)
Published on.2019-05-31
2020-06-01 implementation
State Drug Administration issued
Foreword
YY/T 0573 "Single Use Sterile Syringes" consists of the following.
--- Part 2. Syringes for power-driven syringe pumps;
--- Part 3. Self-destructive fixed-dose vaccine syringes;
--- Part 4. Prevent reuse of the syringe.
This part is part 3 of YY/T 0573, "Single Use Sterile Syringes".
GB 15810 "Single-use sterile syringe" modified using ISO 7886-1 "Single-use sterile hypodermic syringe Part 1
Minute. Manual Syringe, so the standard series of YY/T 0573 "Disposable Sterile Syringes" has no part 1.
This part is drafted in accordance with the rules given in GB/T 1.1-2009.
This section replaces YY 0573.3-2005 "Single-use sterile syringes Part 3. Self-destructive fixed-dose vaccine syringes".
Compared with YY 0573.3-2005, the main technical changes in this section are as follows.
--- Introduce the contents of 14.4 "post-shipment performance" into 8.3 "big package";
--- Increased the requirements for easy oxides and ethylene oxide residues in chemical requirements;
--- Increased the requirements for sterility and bacterial endotoxin in biological requirements;
---Modified the requirements of "primary packaging or self-sealing packaging";
--- Added Appendix A "Test Methods for Capacity Tolerance and Residual Capacity";
--- Added Appendix B "Test Method for Leakage of Piston or Seal Ring and Separation of Piston and Mandrel When Syringe Is Pumped Negative Pressure";
--- Added Appendix C "Test Methods for Coordination of Jackets and Piston Components";
--- Added Appendix D "Squeeze at the piston or seal at the positive pressure of the syringe, the leak at the joint between the fixed needle and the needle seat
method";
--- Added Appendix F.2 "Test Method for Ethylene Oxide Residues";
--- Added Appendix G "Guidelines for Design and Materials";
--- Removed the requirements and test methods for sliding performance.
This section uses the redrafting method to modify the use of ISO 7886-3.2005 "Single-use sterile syringes Part 3. Self-destructive solids
Dosage Vaccine Syringes.
The technical differences between this part and ISO 7886-3.2005 and their reasons are as follows.
---About the normative reference documents, this part has made technical adjustments to adapt to China's technical conditions, adjustments
The situation is reflected in Chapter 2, “Regulatory References”, and the specific adjustments are as follows.
● Removed ISO 8537.1991;
● Removed ASTMD999-01;
● Removed ASTM D5276-98;
● Replaced ISO 3696.1987 with GB/T 6682-2008 modified to adopt international standards;
● Replace ISO 7864 with GB 15811, which is not equivalent to the international standard (see 5.6.1 and 5.6.2);
● Replace ISO 9626 with GB/T 18457 modified to international standards (see 5.6.1);
● Added reference to GB/T 191 (see 9.3);
● Added reference to GB/T 14233.1 (see 6.3);
● Added reference to GB/T 14233.2 (see 7.3);
● Added reference to YY/T 0466.1 (see 9.1 and 9.2).
--- Introduce the contents of "post-shipment performance" into 8.3 "big package";
--- Increased the requirements for easy oxides and ethylene oxide residues in chemical requirements;
--- Increased the requirements for sterility and bacterial endotoxin in biological requirements;
---Modified the requirements of "primary packaging or self-sealing packaging";
--- Added Appendix A "Test Methods for Capacity Tolerance and Residual Capacity";
--- Added Appendix B "Test Method for Leakage of Piston or Seal Ring and Separation of Piston and Mandrel When Syringe Is Pumped Negative Pressure";
--- Added Appendix C "Test Methods for Coordination of Jackets and Piston Components";
--- Added Appendix D "Squeeze at the piston or seal at the positive pressure of the syringe, the leak at the joint between the fixed needle and the needle seat
method";
--- Added F.2 "Test Method for Ethylene Oxide Residues" in Appendix F;
--- Added Appendix G "Guidelines for Design and Materials";
--- Removed the requirements and test methods for sliding performance.
Please note that some of the contents of this document may involve patents. The issuing organization of this document is not responsible for identifying these patents.
This part is proposed by the State Drug Administration.
This part is under the jurisdiction of the National Medical Syringe (Needle) Standardization Technical Committee (SAC/TC95).
This section drafted by. Shanghai Medical Device Testing Institute, Zhejiang Lingyang Medical Devices Co., Ltd., Suzhou BD Medical Devices Limited
the company.
The main drafters of this section. Hua Songhe, Luo Jianbing, Liu Peihua, and Jia Na.
The previous versions of the standards replaced by this standard are. YY 0573.3-2005.
introduction
This section is intended to provide for self-destructing fixed-dose vaccine syringes that are no longer used after a predetermined dose has been injected.
Designed self-destructive fixed-dose vaccine syringes should reduce the damage caused by the tip, and its self-destructive performance should meet the requirements of this section. but
This section does not address provisions for preventing injury from the tip of a self-destructive fixed-dose vaccine syringe.
This section does not specify the design requirements for self-destructive features.
The compatibility of self-destructive fixed-dose vaccine syringes with injectable solutions/vaccines is not covered in this section.
Disposable sterile syringe
Part 3. Self-destructive fixed-dose vaccine syringes
1 Scope
This section of YY/T 0573 specifies a single-use sterile syringe that will automatically fail when delivered to a preset vaccine dose.
(hereinafter referred to as the syringe) terms and definitions, naming, physical requirements, chemical requirements, biological requirements, packaging and signs.
This section applies to needles or non-staples made of plastic materials and stainless steel for injection or immediately after injection.
A disposable sterile syringe for the needle.
This section does not apply to insulin syringes, glass syringes, syringes with powered syringe pumps, self-destructive injections with unfixed doses.
The injector and the syringe with the pre-filled liquid.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article.
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
GB/T 191-2008 Packaging and transportation pictorial signs (ISO 780.1997, MOD)
GB/T 6682-2008 Analytical laboratory water specifications and test methods (ISO 3696.1987, MOD)
GB/T 14233.1-2008 Methods of test for infusions, blood trans
GB/T 14233.2 Medical infusion, blood transfusion, and injecting machines - Test methods - Part 2
GB 15810 single use sterile syringe
GB 15811-2016 Disposable sterile injection needle (ISO 7864.1993, NEQ)
GB/T 18457-2015 Stainless steel needles for the manufacture of medical devices (ISO 9626.1991/Amd.1.2001, MOD)
YY/T 0466.1 Medical devices for the labeling, marking and information of medical devices - Part 1. General requirements
(YY/T 0466.1-2016, ISO 15223-1.2012, IDT)
3 Terms and definitions
The following terms and definitions defined in GB 15810 apply to this document.
3.1
Self-destructive syringe feature auto-disablesyringefeature
The self-destructive performance automatically works when the preset fixed-dose injection is completed to prevent the syringe and needle from being reused.
4 naming
The names of the various components of the syringe are shown in Figure 1.
YY/T 0573.3-2019
Sterile hypodermic syringes for single use - Part 3. Auto-disable syringes for fixed dose immunization
ICS 11.040.25
C31
People's Republic of China Pharmaceutical Industry Standard
Replacing YY 0573.3-2005
Disposable sterile syringe
Part 3. Self-destructive fixed-dose vaccine syringes
Sterilehypodermicsyringesforsingleuse-
Part 3. Auto-disablesyringesforfixeddoseimmunization
(ISO 7886-3.2005, MOD)
Published on.2019-05-31
2020-06-01 implementation
State Drug Administration issued
Foreword
YY/T 0573 "Single Use Sterile Syringes" consists of the following.
--- Part 2. Syringes for power-driven syringe pumps;
--- Part 3. Self-destructive fixed-dose vaccine syringes;
--- Part 4. Prevent reuse of the syringe.
This part is part 3 of YY/T 0573, "Single Use Sterile Syringes".
GB 15810 "Single-use sterile syringe" modified using ISO 7886-1 "Single-use sterile hypodermic syringe Part 1
Minute. Manual Syringe, so the standard series of YY/T 0573 "Disposable Sterile Syringes" has no part 1.
This part is drafted in accordance with the rules given in GB/T 1.1-2009.
This section replaces YY 0573.3-2005 "Single-use sterile syringes Part 3. Self-destructive fixed-dose vaccine syringes".
Compared with YY 0573.3-2005, the main technical changes in this section are as follows.
--- Introduce the contents of 14.4 "post-shipment performance" into 8.3 "big package";
--- Increased the requirements for easy oxides and ethylene oxide residues in chemical requirements;
--- Increased the requirements for sterility and bacterial endotoxin in biological requirements;
---Modified the requirements of "primary packaging or self-sealing packaging";
--- Added Appendix A "Test Methods for Capacity Tolerance and Residual Capacity";
--- Added Appendix B "Test Method for Leakage of Piston or Seal Ring and Separation of Piston and Mandrel When Syringe Is Pumped Negative Pressure";
--- Added Appendix C "Test Methods for Coordination of Jackets and Piston Components";
--- Added Appendix D "Squeeze at the piston or seal at the positive pressure of the syringe, the leak at the joint between the fixed needle and the needle seat
method";
--- Added Appendix F.2 "Test Method for Ethylene Oxide Residues";
--- Added Appendix G "Guidelines for Design and Materials";
--- Removed the requirements and test methods for sliding performance.
This section uses the redrafting method to modify the use of ISO 7886-3.2005 "Single-use sterile syringes Part 3. Self-destructive solids
Dosage Vaccine Syringes.
The technical differences between this part and ISO 7886-3.2005 and their reasons are as follows.
---About the normative reference documents, this part has made technical adjustments to adapt to China's technical conditions, adjustments
The situation is reflected in Chapter 2, “Regulatory References”, and the specific adjustments are as follows.
● Removed ISO 8537.1991;
● Removed ASTMD999-01;
● Removed ASTM D5276-98;
● Replaced ISO 3696.1987 with GB/T 6682-2008 modified to adopt international standards;
● Replace ISO 7864 with GB 15811, which is not equivalent to the international standard (see 5.6.1 and 5.6.2);
● Replace ISO 9626 with GB/T 18457 modified to international standards (see 5.6.1);
● Added reference to GB/T 191 (see 9.3);
● Added reference to GB/T 14233.1 (see 6.3);
● Added reference to GB/T 14233.2 (see 7.3);
● Added reference to YY/T 0466.1 (see 9.1 and 9.2).
--- Introduce the contents of "post-shipment performance" into 8.3 "big package";
--- Increased the requirements for easy oxides and ethylene oxide residues in chemical requirements;
--- Increased the requirements for sterility and bacterial endotoxin in biological requirements;
---Modified the requirements of "primary packaging or self-sealing packaging";
--- Added Appendix A "Test Methods for Capacity Tolerance and Residual Capacity";
--- Added Appendix B "Test Method for Leakage of Piston or Seal Ring and Separation of Piston and Mandrel When Syringe Is Pumped Negative Pressure";
--- Added Appendix C "Test Methods for Coordination of Jackets and Piston Components";
--- Added Appendix D "Squeeze at the piston or seal at the positive pressure of the syringe, the leak at the joint between the fixed needle and the needle seat
method";
--- Added F.2 "Test Method for Ethylene Oxide Residues" in Appendix F;
--- Added Appendix G "Guidelines for Design and Materials";
--- Removed the requirements and test methods for sliding performance.
Please note that some of the contents of this document may involve patents. The issuing organization of this document is not responsible for identifying these patents.
This part is proposed by the State Drug Administration.
This part is under the jurisdiction of the National Medical Syringe (Needle) Standardization Technical Committee (SAC/TC95).
This section drafted by. Shanghai Medical Device Testing Institute, Zhejiang Lingyang Medical Devices Co., Ltd., Suzhou BD Medical Devices Limited
the company.
The main drafters of this section. Hua Songhe, Luo Jianbing, Liu Peihua, and Jia Na.
The previous versions of the standards replaced by this standard are. YY 0573.3-2005.
introduction
This section is intended to provide for self-destructing fixed-dose vaccine syringes that are no longer used after a predetermined dose has been injected.
Designed self-destructive fixed-dose vaccine syringes should reduce the damage caused by the tip, and its self-destructive performance should meet the requirements of this section. but
This section does not address provisions for preventing injury from the tip of a self-destructive fixed-dose vaccine syringe.
This section does not specify the design requirements for self-destructive features.
The compatibility of self-destructive fixed-dose vaccine syringes with injectable solutions/vaccines is not covered in this section.
Disposable sterile syringe
Part 3. Self-destructive fixed-dose vaccine syringes
1 Scope
This section of YY/T 0573 specifies a single-use sterile syringe that will automatically fail when delivered to a preset vaccine dose.
(hereinafter referred to as the syringe) terms and definitions, naming, physical requirements, chemical requirements, biological requirements, packaging and signs.
This section applies to needles or non-staples made of plastic materials and stainless steel for injection or immediately after injection.
A disposable sterile syringe for the needle.
This section does not apply to insulin syringes, glass syringes, syringes with powered syringe pumps, self-destructive injections with unfixed doses.
The injector and the syringe with the pre-filled liquid.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article.
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
GB/T 191-2008 Packaging and transportation pictorial signs (ISO 780.1997, MOD)
GB/T 6682-2008 Analytical laboratory water specifications and test methods (ISO 3696.1987, MOD)
GB/T 14233.1-2008 Methods of test for infusions, blood trans
GB/T 14233.2 Medical infusion, blood transfusion, and injecting machines - Test methods - Part 2
GB 15810 single use sterile syringe
GB 15811-2016 Disposable sterile injection needle (ISO 7864.1993, NEQ)
GB/T 18457-2015 Stainless steel needles for the manufacture of medical devices (ISO 9626.1991/Amd.1.2001, MOD)
YY/T 0466.1 Medical devices for the labeling, marking and information of medical devices - Part 1. General requirements
(YY/T 0466.1-2016, ISO 15223-1.2012, IDT)
3 Terms and definitions
The following terms and definitions defined in GB 15810 apply to this document.
3.1
Self-destructive syringe feature auto-disablesyringefeature
The self-destructive performance automatically works when the preset fixed-dose injection is completed to prevent the syringe and needle from being reused.
4 naming
The names of the various components of the syringe are shown in Figure 1.
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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