Codeofchina.com is in charge of this English translation. In case of any doubt about the English translation, the Chinese original shall be considered authoritative.
The technical content of this standard mainly refers to ISO 1135-4: 1998 Transfusion equipment for medical use - Part 4: Transfusion sets for single use and international standards for related products.
This standard is formulated on the basis of YY 0311-1998 General specification for single-use blood flow product. This standard replaces YY 0311-1998.
Annexes A, B, C, D, E and F of this standard are all normative.
This standard was proposed by the China Food and Drug Administration.
This standard is under the jurisdiction of the National Technical Committee on Medical Syringes of Standardization Administration of China.
Blood flow products for single use - General specification
1 Scope
This standard specifies the general specification of blood flow products for single use.
This standard is applicable to blood flow products which are made from PVC as the main material as well as the auxiliary tubing connected with them, including products composed of fluid lines and pressure monitoring tubing (hereinafter referred to as tube for blood flow).
The relevant provisions in the product standards shall take precedence over this standard.
2 Normative references
The following normative documents contain provisions which, through reference in this text, constitute provisions of this standard. For dated references, subsequent amendments (excluding corrections) to, or revisions, of any of these publications do not apply. However, parties to agreements based on this standard are encouraged to investigate the possibility of applying the most recent editions of the normative documents indicated below. For undated references, the latest edition applies.
GB/T 1962 (All parts) Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment
GB/T 14233.1-1998 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 15593 Plasticized polyvinyl chloride (PVC) compounds for transfusion (infusion) equipment
GB 15811 Sterile hypodermic needles for single use
GB/T 16886.1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
YY/T 0313 Package, label, transport and storage for medical polymer products
3 Requirements
3.1 Materials
The PVC materials from which the tubing that directly or indirectly comes into contact with blood is manufactured shall comply with the requirements specified in GB 15593.
3.2 Physical properties
3.2.1 Tightness
Immerse the tube for blood flow, with both ends blocked, in water at 20℃~30℃ and apply an internal air pressure of 50kPa above atmospheric pressure or 1.5 times the maximum working pressure claimed by the manufacturer for 2min, and it shall be free from any leakage.
Note: As for the tubes for blood flow with special requirements (for example, those that are required to withstand negative pressure), the tightness shall be determined on a case-by-case basis.
3.2.2 Connection fastness
Any connections between the tubes for blood flow, excluding protective caps, shall withstand a static axial tensile force of 15N for 15s without breaking or detaching.
3.2.3 Protective caps
The protective caps at the inlet and outlet of the blood flow product shall be firm and maintained sterile inside and shall be easily removable.
3.2.4 Particulate content
The tube for blood flow shall be manufactured under conditions that minimize particulate contamination. When tested as specified in Annex A or using other equivalent methods, the number of particles with a size of 15μm~25μm shall not exceed 1.00 per square centimeter of internal surface area, and the number of particles with a size greater than 25μm shall not exceed 0.50.
3.2.5 Injection site
When the injection site, if provided, of the tube for blood flow is tested in accordance with Annex B, there shall be no leakage of more than one falling drop of water.
3.2.6 Color mark
If the tubes for blood flow are divided into two types, i.e., tubes for arteries and tubes for veins, there shall be an obvious color mark within 100mm of the end of the tube, with red for tubes for arteries and blue for tubes for veins.
3.2.7 6% (Luer) taper
The 6% (Luer) tapers between the tubes for blood flow shall meet the requirements of GB/T 1962.
3.2.8 Filter for blood
The filter for blood and blood components on the tubes for flood flow shall have uniform pores and shall have an effective filtering area of not less than 10cm2. When tested in accordance with Annex C, the filtration rate shall not be less than 80%.
3.2.9 Stopcock
3.2.9.1 Non-contact tubing clips or flow regulators shall be preferred to be used as the stopcocks of tubes for blood flow, and they shall have a reliable service performance
3.2.9.2 The switches (such as single-valve three-way switch, two-valve four-way switch and three-valve five-way switch) of tubes for blood flow shall be provided with clear indications of the switch status, and they shall have a reliable service performance
3.2.10 Air filter
If the tube for blood flow is provided with an air-inlet tubing, it shall be equipped with an air filter to prevent the ingress of external microorganisms and dust. When tested in accordance with Annex D, the air filter shall be able to filter out at least 90% of the particles with a size of above 0.5μm in the air.
3.2.11 Appearance
The flexible tube on the tube for blood flow shall be plasticized uniformly, without kinks, and it shall have a sufficient transparency so that the bubbles in the tube for blood flow can be observed with normal or corrected-to-normal vision.
3.3 Chemical properties
The test solution prepared in accordance with Annex E shall meet the requirements of 3.3.1 to 3.3.6.
3.3.1 Color
The test solution shall be colorless and transparent when observed with normal or corrected-to-normal vision.
3.3.2 Reducing matter
When tested in accordance with 5.2.2 of GB/T 14233.1-1998, the difference in volumes of potassium permanganate solution [c(KMnO4)=0.002 mol/L] consumed by the test solution and the blank solution shall not exceed 2.0mL.
3.3.3 Metal ions
The test solution shall not contain in total more than 1μg/mL of barium, chromium, copper, lead and tin, and not more than 0.1μg/mL of cadmium, when determined by atomic absorption spectrophotometric method (AAS) according to 5.9.1 of GB/T 14233.1-1998.
When tested in accordance with 5.6 of GB/T 14233.1-1998, the color produced in the test solution shall not exceed that of the standard control solution with the mass concentration ρ(Pb2+)=1μg/mL.
3.3.4 Acidity or alkalinity
When teste in accordance with 5.4.1 of GB/T 14233.1-1998, the difference of pH values between the test solution and the same batch of blank solution shall not exceed 1.5.
3.3.5 Residue on evaporation
When tested in accordance with 5.5 of GB/T 14233.1-1998, the total weight of nonvolatile matter in 50mL of test solution shall not exceed 2mg.
3.3.6 UV absorption
When tested in accordance with 5.7 of GB/T 14233.1-1998, the test solution shall not show absorption greater than 0.1 in the range of 250nm~320nm.
Foreword i
1 Scope
2 Normative references
3 Requirements
4 Packaging and marking
Annex A (Normative) Test method for particulate content
Annex B (Normative) Test method for self-sealing of injection site
Annex C (Normative) Tests method for efficiency of filter for blood and blood components
Annex D (Normative) Test methods for filtration rate of air filter
Annex E (Normative) Preparation of chemical performance test solution
Annex F (Normative) Method for analysis of ethylene oxide residue
Bibliography
Codeofchina.com is in charge of this English translation. In case of any doubt about the English translation, the Chinese original shall be considered authoritative.
The technical content of this standard mainly refers to ISO 1135-4: 1998 Transfusion equipment for medical use - Part 4: Transfusion sets for single use and international standards for related products.
This standard is formulated on the basis of YY 0311-1998 General specification for single-use blood flow product. This standard replaces YY 0311-1998.
Annexes A, B, C, D, E and F of this standard are all normative.
This standard was proposed by the China Food and Drug Administration.
This standard is under the jurisdiction of the National Technical Committee on Medical Syringes of Standardization Administration of China.
Blood flow products for single use - General specification
1 Scope
This standard specifies the general specification of blood flow products for single use.
This standard is applicable to blood flow products which are made from PVC as the main material as well as the auxiliary tubing connected with them, including products composed of fluid lines and pressure monitoring tubing (hereinafter referred to as tube for blood flow).
The relevant provisions in the product standards shall take precedence over this standard.
2 Normative references
The following normative documents contain provisions which, through reference in this text, constitute provisions of this standard. For dated references, subsequent amendments (excluding corrections) to, or revisions, of any of these publications do not apply. However, parties to agreements based on this standard are encouraged to investigate the possibility of applying the most recent editions of the normative documents indicated below. For undated references, the latest edition applies.
GB/T 1962 (All parts) Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment
GB/T 14233.1-1998 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 15593 Plasticized polyvinyl chloride (PVC) compounds for transfusion (infusion) equipment
GB 15811 Sterile hypodermic needles for single use
GB/T 16886.1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
YY/T 0313 Package, label, transport and storage for medical polymer products
3 Requirements
3.1 Materials
The PVC materials from which the tubing that directly or indirectly comes into contact with blood is manufactured shall comply with the requirements specified in GB 15593.
3.2 Physical properties
3.2.1 Tightness
Immerse the tube for blood flow, with both ends blocked, in water at 20℃~30℃ and apply an internal air pressure of 50kPa above atmospheric pressure or 1.5 times the maximum working pressure claimed by the manufacturer for 2min, and it shall be free from any leakage.
Note: As for the tubes for blood flow with special requirements (for example, those that are required to withstand negative pressure), the tightness shall be determined on a case-by-case basis.
3.2.2 Connection fastness
Any connections between the tubes for blood flow, excluding protective caps, shall withstand a static axial tensile force of 15N for 15s without breaking or detaching.
3.2.3 Protective caps
The protective caps at the inlet and outlet of the blood flow product shall be firm and maintained sterile inside and shall be easily removable.
3.2.4 Particulate content
The tube for blood flow shall be manufactured under conditions that minimize particulate contamination. When tested as specified in Annex A or using other equivalent methods, the number of particles with a size of 15μm~25μm shall not exceed 1.00 per square centimeter of internal surface area, and the number of particles with a size greater than 25μm shall not exceed 0.50.
3.2.5 Injection site
When the injection site, if provided, of the tube for blood flow is tested in accordance with Annex B, there shall be no leakage of more than one falling drop of water.
3.2.6 Color mark
If the tubes for blood flow are divided into two types, i.e., tubes for arteries and tubes for veins, there shall be an obvious color mark within 100mm of the end of the tube, with red for tubes for arteries and blue for tubes for veins.
3.2.7 6% (Luer) taper
The 6% (Luer) tapers between the tubes for blood flow shall meet the requirements of GB/T 1962.
3.2.8 Filter for blood
The filter for blood and blood components on the tubes for flood flow shall have uniform pores and shall have an effective filtering area of not less than 10cm2. When tested in accordance with Annex C, the filtration rate shall not be less than 80%.
3.2.9 Stopcock
3.2.9.1 Non-contact tubing clips or flow regulators shall be preferred to be used as the stopcocks of tubes for blood flow, and they shall have a reliable service performance
3.2.9.2 The switches (such as single-valve three-way switch, two-valve four-way switch and three-valve five-way switch) of tubes for blood flow shall be provided with clear indications of the switch status, and they shall have a reliable service performance
3.2.10 Air filter
If the tube for blood flow is provided with an air-inlet tubing, it shall be equipped with an air filter to prevent the ingress of external microorganisms and dust. When tested in accordance with Annex D, the air filter shall be able to filter out at least 90% of the particles with a size of above 0.5μm in the air.
3.2.11 Appearance
The flexible tube on the tube for blood flow shall be plasticized uniformly, without kinks, and it shall have a sufficient transparency so that the bubbles in the tube for blood flow can be observed with normal or corrected-to-normal vision.
3.3 Chemical properties
The test solution prepared in accordance with Annex E shall meet the requirements of 3.3.1 to 3.3.6.
3.3.1 Color
The test solution shall be colorless and transparent when observed with normal or corrected-to-normal vision.
3.3.2 Reducing matter
When tested in accordance with 5.2.2 of GB/T 14233.1-1998, the difference in volumes of potassium permanganate solution [c(KMnO4)=0.002 mol/L] consumed by the test solution and the blank solution shall not exceed 2.0mL.
3.3.3 Metal ions
The test solution shall not contain in total more than 1μg/mL of barium, chromium, copper, lead and tin, and not more than 0.1μg/mL of cadmium, when determined by atomic absorption spectrophotometric method (AAS) according to 5.9.1 of GB/T 14233.1-1998.
When tested in accordance with 5.6 of GB/T 14233.1-1998, the color produced in the test solution shall not exceed that of the standard control solution with the mass concentration ρ(Pb2+)=1μg/mL.
3.3.4 Acidity or alkalinity
When teste in accordance with 5.4.1 of GB/T 14233.1-1998, the difference of pH values between the test solution and the same batch of blank solution shall not exceed 1.5.
3.3.5 Residue on evaporation
When tested in accordance with 5.5 of GB/T 14233.1-1998, the total weight of nonvolatile matter in 50mL of test solution shall not exceed 2mg.
3.3.6 UV absorption
When tested in accordance with 5.7 of GB/T 14233.1-1998, the test solution shall not show absorption greater than 0.1 in the range of 250nm~320nm.
Contents of GB 19335-2003
Foreword i
1 Scope
2 Normative references
3 Requirements
4 Packaging and marking
Annex A (Normative) Test method for particulate content
Annex B (Normative) Test method for self-sealing of injection site
Annex C (Normative) Tests method for efficiency of filter for blood and blood components
Annex D (Normative) Test methods for filtration rate of air filter
Annex E (Normative) Preparation of chemical performance test solution
Annex F (Normative) Method for analysis of ethylene oxide residue
Bibliography
