Some standard content:
GB8369--1998
This standard is equivalent to ISO1135-4:1998 "Medical blood transfusion equipment Part 4: - Disposable blood transfusion equipment". It is also a revised version of GB8369--93.
The main technical differences between this standard and IS1135-4:1998 are as follows: This standard adds technical indicators such as the filtration rate of air filters, hose wall thickness and outer diameter, flow regulator adjustment stroke, and ethylene oxide residue; the international standard for pH test in chemical requirements uses titration method, while this standard uses acidometer method; Appendix H inspection rules are added.
The main technical differences between this standard and GB8369-93 are as follows: In terms of physical requirements, the requirements for particulate contamination, sealing, bottle stopper piercer, air filter, hose size, drip bucket, flow regulator, injection piece, protective cover, external cone joint, etc. have changed; in terms of chemical requirements, the test method has been changed from reference to equivalent international standards, so the technical indicators have changed greatly accordingly, the test items have cancelled chloride, and added content determination and ultraviolet absorbance, etc.: In terms of packaging marking, some changes have been made. This revision of this standard incorporates the relevant contents of YY0029-90 "Blood Filter for Disposable Blood Transfusion Sets" and YY/T0142--9.1 "--Air Filter for Disposable Infusion and Blood Transfusion Sets" into this standard. This standard replaces GB8369~-93 from the date of implementation. YY0029-90 and YY/T0142--94 will be abolished at the same time. Appendix A, Appendix B, Appendix C, Appendix D, Appendix E, Appendix F, Appendix G and Appendix H of this standard are all appendices of the standard. Appendix J of this standard is a suggestive appendix.
This standard is proposed by the State Drug Administration. This standard is under the jurisdiction of the National Technical Committee for Standardization of Medical Infusion Equipment. The drafting unit of this standard: Quality Inspection Center for Medical Polymer Products of the State Drug Administration. The main drafters of this standard: Wu Ping, Luo Hongyu, Wang Yanwei, Qin Dongli, Song Jinzi. This standard was first issued in 1987.
GB 8369--1998
ISO Foreword
ISO (International Organization for Standardization) is a worldwide federation composed of national standardization bodies (ISO member bodies). The work of formulating international standards is usually completed by ISO's technical committees. If each member body is interested in the standard promotion project established by a technical committee, it has the right to participate in the work of the committee. International organizations (official or unofficial) that maintain contact with ISO may also participate in the relevant work. IS maintains a close cooperative relationship with the International Electrotechnical Commission (IEC) in the field of electrotechnical standardization. The draft international standard formally adopted by the technical committee is submitted to the member groups for voting. The international standard needs to obtain the consent of at least 75% of the member groups participating in the voting before it can be formally adopted. The international standard ISO1135-4 was developed by the ISO/TC76 International Organization for Standardization Technical Committee for Medical Blood Transfusion, Infusion and Injection Equipment.
This version is the second edition, which replaces the first edition (ISO1135-4:1987). The general title of ISO1135 is medical blood transfusion equipment, which consists of the following parts: Part 1: Glass blood transfusion bottles, stoppers and caps Part 3: Collection sets
Part 4:---Disposable blood transfusion sets
Appendix A, Appendix B, Appendix C, Appendix D, Appendix E and Appendix F are part of the standard, and Appendix G, Appendix H and Appendix J are for reference only.
1 Scope
National Standard of the People's Republic of China
Transfusion sets for single use
Transfusion sets for single useGB8369.. 1998
eqvIs01135-4:1998
Replaces GB 836993
This standard specifies the requirements for single-use transfusion sets to ensure compatibility with blood or blood product containers and intravenous equipment. This standard also specifies the requirements for air intake devices for rigid blood and blood component containers. This standard provides guidance on the performance and quality specifications of materials used in transfusion sets and gives the marking of transfusion set components. 2 Referenced standards
The provisions contained in the following standards constitute the provisions of this standard through reference in this standard. When this standard is published, the versions shown are valid. All standards will be revised. Parties using this standard should explore the possibility of using the latest versions of the following standards. GH1962-1995 Syringes, needles and other medical devices 6: 100 cone connector (cqvISO594-1: 1996) GB2828-87 Batch inspection counting sampling procedures and sampling tables (applicable to continuous batch inspection) (R8368-1998-Disposable infusion sets (eqvISO8536-4: 1998) G3/T14233.1-1998 Inspection methods for medical infusion, blood transfusion and injection equipment - Part - Chemical analysis methods GB/T14233.2-93 Inspection methods for medical infusion, blood transfusion and injection equipment - Part - Biological test methods GB/T14437-93 Product quality counting one-time supervision sampling inspection procedures (applicable to situations with a large total volume) GB 15811—1995
-Disposable sterile injection needles (neqIS) 7864: 1993) GB/T 16886.1-1997 Biological evaluation of medical devices Part 1: Guide to test selection (idtIS0) 10993-1: 1992) YY/T 0313—1998 Packaging, marking, transportation and storage of medical polymer products IS () 94-2: 1991 Syringes, injection needles and other medical devices 6% (Luer) cone connector Part 2: Locking cone head 3 General requirements
3.1 Name of blood transfusion set assembly
The name of the blood transfusion set assembly is shown in Figure 1, and the air inlet device for hard containers of blood and blood components is shown in Figure 2. Note: Figures 1 and 2 list the structures of the blood transfusion set and the separated air inlet device. As long as the same effect can be achieved, other structures may also be used. 3.2 Sterility maintenance
The blood transfusion set should have a protective cover to keep the inner cavity of the blood transfusion set sterile before use. The bottle stopper puncture device or puncture needle of the air inlet device should have a protective cover.
3.3 Marking
3.3.1 Blood transfusion set
The marking example of the blood transfusion set that meets the requirements of this standard is as follows: Blood transfusion set GB8369TS
3.3.2 Air inlet device
The marking example of the air inlet device that meets the requirements of this standard is as follows: Air inlet device GB8369AD
Approved by the State Administration for Quality and Technical Supervision on November 26, 1998 382
Implementation on February 1, 1999
GB 8369-1998
1--Bottle stopper piercer protective cover: 2 Bottle stopper piercer 3·Liquid channel: 1·Dropper, 5 Dropper; 6--Blood and blood component filter.*; 7-Hose: 8. Flow regulator; 9-Injection piece 10 External conical joint; 11·External conical joint protective cover 1) Other designs may also be used if safety can be guaranteed. 2) a) and b) illustrate the optional positions of the blood and blood component filters. 3) The injection device may not be installed.
Figure 1 Example of blood transfusion set
GB83691998
1 Protective cover; 2 Bottle stopper puncture or puncture needle; 3 Hose\; 4 Clamp\5 Air inlet with air filter 1) Other designs may also be used if safety can be guaranteed. Figure 2 Example of air inlet device
4 Materials
The materials for manufacturing the blood transfusion set and its components given in Chapter 3 shall meet the requirements specified in Chapter 5. The components of the blood transfusion set that come into contact with blood and blood components shall also meet the requirements specified in Chapters 6 and 7. Note: For the standard of polyethylene raw materials for blood transfusion sets, see GB15593. 5 Physical requirements
5.1 Particle contamination
Measured according to Appendix F or other equivalent methods, the number of particles of 15μm to 25μm in 200mL of eluent shall not exceed 1/ml; the number of particles larger than 25μm shall not exceed 0.5/mL. 5.2 Sealing
When tested according to Appendix A, there should be no gas leakage. 5.3 Connection strength
The connection between the components of the blood transfusion set, excluding the protective cover, should be able to withstand a static tensile force of not less than 15N for 15s. 5.4 Bottle stopper piercer
5.4.1 The dimensions of the bottle stopper piercer shall comply with those shown in Figure 3. Note: Metal piercers are not subject to the dimensions of Figure 3. 5.4.2 The bottle stopper piercer and the air inlet device (if used) shall be able to pierce the bottle stopper of the container for blood and blood components that has not been pierced before without causing debris to fall.
5.5 Air inlet device
GB 8369 - 1998
Figure 3 Size of bottle stopper piercer
5.5.1 The air inlet device shall comply with the requirements of 3.2 and 7.2. Dimensions: mm
5.5.2 The air inlet device should have an air filter to prevent microorganisms from entering the container into which it is inserted. When tested according to Appendix B, the air filter should have a filtration rate of not less than 90% for particles larger than 0.5um in the air. 5.5.3 The air inlet device should be separated from the bottle stopper puncture device of the blood transfusion set. 5.5.4 If one end of the air inlet device is connected to the air filter through a hose, the length of the tube should not be shorter than 250mm. 5.5.5 The air filter should be installed so that all air entering the rigid container passes through it. When tested according to Appendix B, the flow rate of the effluent relative to the free air inlet container should not be reduced by 20%. 5.6 Hose
5.6.1 Tubes made of soft materials should be plasticized and homogeneous, and transparent or sufficiently transparent. When bubbles pass through, the interface between water and air can be found with normal or corrected vision.
5.6.2 The length of the hose from the end to the drip bucket [including the injection seat (if any) and the outer conical joint 7] shall not be less than 1500mm5.6.3 The wall thickness of the hose shall be greater than 0.5mm and the outer diameter shall not be less than 4.0mm. 5.7 Blood and blood component filter
The blood transfusion set shall have a blood and blood component filter. The filter mesh shall be uniform and the total area shall not be less than 10cm. When tested according to Appendix C, the dry residue on the filter shall not be less than 80% (m/m) on the standard filter. 5.8 Drip bucket and dropper
5.8.1 The drip bucket shall be able to observe the droplets continuously. The liquid shall enter the drip bucket through a dropper inserted into the drip bucket. The distance from the end of the dropper to the drip bucket outlet shall not be less than 40mm, or the distance between the dropper and the blood and blood component filter shall not be less than 20mm. The distance between the drip bucket wall and the outer wall of the dropper terminal shall not be less than 5mm. At 23℃±2℃, flow rate of 50 drops/min±10 drops/min, 20 drops of distilled water dripped from the dropper should be 1 mL±0.1 mL (1 g±0.1 g). 5.8.2 The dropper should be able to introduce blood from the blood transfusion container into the blood transfusion set by virtue of its elasticity. 5.9 Flow regulator
The flow regulator should be able to adjust the flow of blood and blood components from zero to maximum, and its adjustment stroke should be not less than 30 mm. Note: The flow regulator should be able to be used continuously during a blood transfusion without damaging the hose. The flow regulator and the hose should not produce harmful reactions when stored together.
5.10 Flow rate of blood and blood components
The blood transfusion set should be able to output not less than 1000 ml of blood within 30 minutes at a static pressure head of 1 m and a temperature of 23℃±2℃. At a pressure 30 kPa higher than the atmospheric pressure, it should also be able to output not less than 500 ml of blood within 2 minutes. Instructions for use:
11, 2], 33ISO) 1135-4:1998 does not have this technical indicator. 365
GB8369--1998
Blood should be collected in a suitable anticoagulant, stored for not less than 2 weeks and without large blood clots. Note: 400g/1. glucose aqueous solution can be used instead of blood for the test. 45.11 Injection parts
If there are injection parts, the water leakage should not exceed one drop during the test according to Appendix 1). Note: The injection seat should be located near the external conical joint. 5.12 External conical joint
The end of the hose should have an external conical joint that complies with GB1962 or IS594-2. 5.13 Protective cover
The protective cover at the terminal of the blood transfusion set should keep the bottle stopper puncture, external conical joint and the inner surface of the blood transfusion set sterile. The protective cover should not fall off naturally and should be easy to remove. 6 Chemical requirements
6.1 Reducing substances (easy oxidation products)
When tested according to Appendix E, the difference in volume of potassium permanganate solution [c(KMnO2+) = 0.002 mol/L7 consumed by the test solution and the blank solution should not exceed 2.0 ml
6.2 Metal ions
When determined by atomic absorption spectrophotometry (AAS) or equivalent methods according to E3.1, the total content of chromium, copper, zinc and tin in the test solution should not exceed 1 μg/mL. The content of cadmium should not exceed 0.1 ug/mL. When tested according to E3.2, the color of the test solution should not exceed that of the standard control solution with a mass concentration of p(Pb2+) = 1 μg/ml. 6.3 pH 5
When tested according to Appendix E, the difference in pH between the test solution and the blank solution should not exceed 1.5. 6.4 Evaporation residue
When tested according to Appendix E, the total amount of evaporation residue should not exceed 2 mg. 6.5 UV absorbance
When tested according to Appendix E, the absorbance of the test solution should not be greater than 0.1. 6.6 Ethylene oxide residue)
When tested according to (GB/T14233.1, the ethylene oxide residue in each blood transfusion set should not be greater than 0.5 mg. 7 Biological requirements
7.1 General
Blood transfusion sets should not release any substances that have side effects on patients. Appropriate tests should be used to evaluate the toxicity of blood transfusion set materials, and the test results should indicate non-toxicity. GB/T16886.1 provides guidance on toxicity tests. 7.2 Sterility
Blood transfusion sets and/or air inlets in single packages The device should be sterilized by an effective sterilization process. Appendix (gives the sterility test method.
7.3 Pyrogen
Apply appropriate tests to evaluate the pyrogenicity of the transfusion device and/or the air inlet device, and the results should show that the transfusion device is free of pyrogens. Appendix (gives the pyrogen test method.
Instructions for use:
1IS0)1135-4:1998 has no such provision. 51IS)1135-4:1998 uses titration. 61IS)1135-4:1998 is 5mg
71150)1135-4:1998 yuan for this technical indicator. 386
GB 8369-1998
The transfusion device should be evaluated for the absence of hemolytic components, and the test results should show that the transfusion device has no lytic reaction. GB/T14233.2 gives the free blood test method.
7.5 Acute systemic toxicity
The acute systemic toxicity of the blood transfusion set should be evaluated, and the test results should show that the blood transfusion set has no acute systemic toxicity. GB/T14233.2 gives the test method for acute systemic toxicity.
8 Marking
8.1 Single package
The single package should be marked with at least the following information: a) Text description of the contents;
b) Use the graphic symbol given in YY/T0313 to indicate that the blood transfusion set is sterile; c) The blood transfusion set is pyrogen-free;
d) The blood transfusion set and/or the air inlet device are for single use only, or equivalent instructions; Note: A "single use" graphic symbol in accordance with YY/T0313 may be given in addition. e) Instructions for use, including warnings for checking the integrity of the package seal and the removal of the protective cover; Note: Instructions for use can also be in the form of a negative insert. {) Batch number, beginning with "\batch",
g) Expiration date (must be clearly identifiable); h) Name and address of manufacturer and/or distributor: i) Instructions that 20 drops of distilled water from a dropper are equivalent to 1mL±0.1mL (1g±0.1g); j) If an intravenous needle is provided, the specifications should be indicated.
8.2 Medium packaging
The medium packaging should have at least the following information:
a) Text description of the contents;
b) The number of blood transfusion sets;
c) Use the graphic symbols given in YY/T0313 to indicate that the blood transfusion set is sterile; d) Batch number, beginning with "\batch";
e) Expiration date;
1) Name and address of manufacturer and/or distributor: g) Recommended storage conditions (if any). 8.3 Outer packaging
The information on the outer packaging shall comply with YY/T0313.9 Packaging
9.1 Blood transfusion sets and/or air inlet devices shall be packaged individually to keep them sterile during the storage period. After opening the single package, there shall be signs of opening. 9.2 The packaging and sterilization of blood transfusion sets and/or air inlet devices shall ensure that they are not flat or folded when ready for use. 9.3 There shall be no visible foreign matter in the single package. 387
GB 8369—1998
Appendix A
(Appendix to the standard)
Sealing test
Blood transfusion set - sealed end, immersed in water at 20℃～30℃, and passed air pressure 50kPa higher than atmospheric pressure for 2min. Check for signs of leakage in the blood transfusion set.
Appendix B
(Appendix to the standard)
The test method for air filter removal rate and flow reduction rate is the same as that of Appendix B8368—1998 B
Appendix C
(Appendix of Standard Recommendation)
Blood and Blood Component Filter Efficiency Test C1 Principle
Make a fixed volume of filtered reserve blood flow through the test filter and the standard filter, and compare the quality of the filtered products of the two filters. C2 Standard Filter
The standard filter is woven from polyamide 6-6 monofilament, with a monofilament diameter of 100μm±10um, single warp and single weft, and a pore size of 200umt:20 μm.
C3 Step
Prepare anticoagulated human whole blood of the same type (AB30), stored for not less than 2 weeks, and pass it from its container through a coarse filter with a pore size of 2250μm [Net Note…41] to mix the blood thoroughly. Allow the blood in the container to flow through each 800mL of the filter material under the action of gravity to drain the excess blood from the filter. Dry the filter material to a substantially constant weight in an oven at 60±2°C and a pressure of about 0.65kPa (6.5mbar). C3.1 Method A (for filter material)
Cut two circular pieces of material with a diameter of 40mm from each of the standard filter material and the test filter material. During the test, fix the filter material to a test device that can cover the entire surface of the filter material with blood. C3.2 Method B (for filter assembly) The standard filter assembly should have a bottom seal 、Standard filter material with an area of 32cm2. The filter material should be placed in a plastic filter funnel with a hole at the bottom. The outlet of the funnel is a standard dropper with 1mL of distilled water for every 20 drops. The liquid inlet tube extends into the funnel. [Figure C1 shows the applicable standard filter assembly. The test steps are carried out according to C3. Note: Method A and Method B are optional.
C4 Result Expression
The percentage of salt removed by the test filter (material) relative to the standard filter (material) is given by formula (C1): 388
Where: mr.
GB8369
mti— mra
The mass of the test filter (material) before the liquid passes through; the mass of the test filter (material) after the blood passes through; the mass of the standard filter (material) before the liquid passes through: mk——The mass of the standard filter (material) after the blood passes through. 1998
1 Liquid inlet pipe 2 · Filter funnel, 3--Standard filter screen; 4-Filter screen fixing device; 5 20 drops/ml at the outlet of the filter funnel, dropper
Figure C1 Standard filter assembly
Appendix D
(Standard Appendix)
Injection self-sealing test
Same as Appendix D of GB8368-1998.
(C1)
F1 Preparation of test solution
GB 8369—1998
Appendix E
(Standard Appendix)
Chemical analysis of dissolved matter
Prepare the test solution as specified in GB/T14233.1-1998 (according to the method in Table 1~). Test for reducing substances (oxidizable substances)
Perform the test as specified in 5.2.2 of GB/T14233.1-1998. E3 Metal ion test
E3.1 Absorption: Perform the test as specified in 5.9.1 of GB/T14233.1-1998. E3.2 Colorimetry: Carry out according to the provisions of 5.6.1 method in GB/T14233.1-1998. E4 pH test
Carry out according to the provisions of 5.4.1 method in GB3/T11233.1-1998. F5 Evaporation residue test
Carry out according to the provisions of (GB3/T14233.1--1998. E6 Ultraviolet absorbance test
Carry out within the wavelength range of 250nm to 320nm as specified in (:13, T14233.1~1998). Appendix F
(Appendix to the standard)
Method for determination of particle content
Appendix F of Standard G8368--1998
Appendix G
(Appendix to the standard)
Sterility, pyrogen test and biological evaluation test G1 (G1BT14233.21 specifies the sterility and pyrogen test. Note: (B, T14233, 2 also specifies the bacterial endotoxin test method. G2 (The biological evaluation test method described in 13/T16886.1 should be used as a guide for the evaluation of material biocompatibility. Note: (Small 15593 specifies the biocompatibility test of polyvinyl fluoride materials. H1·Type inspection
H1.1 In the following cases Type inspection should be carried out in the following cases: GB8369-1998
Appendix H
(Appendix to the standard)
Inspection rules
a) When new products are put into production, the source of materials or the formula is changed; b) When there are major changes in the structure, key parts and components, or the process; c) No less than twice a year in continuous production; d) When production is stopped for rectification and then resumed;
e) Products made from each batch of raw materials
f) When required by the contract or the management department. H1.2 Type inspection is a full performance inspection. In case a), a comprehensive biological evaluation of the selected polyvinyl chloride materials should also be carried out. H1.3, During type inspection, the requirements specified in Chapter 5, Article 8.1 and Chapter 9 If there are no special provisions, 5 sets will be randomly sampled for inspection. If equipped with an intravenous needle, 5 sets will be randomly sampled for inspection for all physical requirements specified in the corresponding product standards. H1.4 If all type inspection items are qualified, the type inspection is passed. If the type inspection fails, mass production shall not be carried out. H2 Factory inspection
H2.1 Factory inspection shall be carried out batch by batch in accordance with the provisions of GB2828, and the products can only be shipped after passing the inspection. H2.2 The production batch is composed of the daily output of the same type of blood transfusion devices. H2.3 The physical requirements items (counting items), non-conforming classification, inspection level (IL) and acceptable quality level (AQL) of factory inspection shall be as specified in Table H1.
Inspection items
Particle contamination
Sealing||t t||Connection strength
Bottle piercer
Air inlet device
H2.4 Each production batch should also be tested for reducing substances (6.1), pH (6.3), ultraviolet absorbance (6.5) and pyrogens (7.3). H2.5 Products of the same sterilization process constitute a sterilization batch, and an effective method should be used to monitor the sterilization effect of each sterilization batch (7.2). Products sterilized with ethylene oxide can only be shipped after the residual ethylene oxide content after sterilization is controlled below the specified value (6.6). H3 National supervision and random inspection
Conducted in accordance with GB/T14437.
Adoption instructions:
8]IS) 1135-4: 1998 has no inspection rules. 3911 method. E4 pH test bzxZ.net
According to GB3/T11233.1-1998 5.4.1 method - provisions, F5 evaporation residue test
According to (GB3/T14233.1--1998 provisions. E6 UV absorbance test
According to (:13, T14233.1~1998 provisions within the wavelength range of 250nm ~ 320nm. Appendix F
(Standard Appendix)
Method for determination of particle content
Appendix F of GB8368--1998
Appendix G
(Standard Appendix)
Sterility, pyrogen test and biological evaluation test G1 (G1BT14233.2 1 specifies sterility , pyrogen test Note: (B, T14233, 2 also stipulates the test method for bacterial endotoxin. G2 (The biological evaluation test method described in 13/T16886.1 should be used as a guide for the evaluation of material biocompatibility. Note: (Small 15593 specification cage "biocompatibility test of polyvinyl fluoride materials. H1·Type inspection
H1.1 Type inspection should be carried out in the following cases: GB8369-1998
Appendix H
(Appendix to the standard)
Inspection rules
a) When new products are put into production, material sources or formulas are changed; b) When there are major changes in structure, key parts and components, and processes; c) No less than twice a year in continuous production; d) When production is resumed after suspension of production;
e) Every Products made from a batch of raw materials
f) as required by the contract or management department. H1.2 Type inspection is a full performance inspection. In case a), a comprehensive biological evaluation of the selected polyvinyl chloride material should also be carried out. H1.3, during type inspection, unless otherwise specified, 5 sets of each requirement specified in Chapter 5, Article 8.1 and Chapter 9 shall be randomly inspected. If equipped with an intravenous needle, 5 sets of all physical requirements specified in the corresponding product standards shall be randomly inspected. H1.4 If all type inspection items are qualified, the type inspection is passed. If the type inspection fails, mass production shall not be carried out. H2 Factory inspection
H2.1 Factory inspection shall be carried out batch by batch in accordance with the provisions of GB2828, and only after passing the inspection can it be shipped out of the factory. H2.2 Production is composed of the daily output of the same type of blood transfusion devices. Batch. H2.3 The physical requirements (counting items), non-conforming classification, inspection level (IL) and acceptable quality level (AQL) for factory inspection shall be as specified in Table H1.
Inspection items
Particle contamination
Sealing
Connection strength
Bottle stopper piercer
Air inlet device
H2.4 Each production batch shall also be inspected for reducing substances (6.1), pH (6.3), ultraviolet absorbance (6.5) and pyrogens (7.3). H2.5 Products of the same sterilization process constitute a sterilization batch, and each sterilization batch shall be monitored by an effective method for the sterilization effect (7.2). Products sterilized with ethylene oxide shall not be shipped until the residual ethylene oxide content after sterilization is controlled below the specified value (6.6). H3 National supervision and random inspection
Conducted in accordance with GB/T14437.
Adoption Note:
8]IS) 1135-4: 1998 No inspection rules. 3911 method. E4 pH test
According to GB3/T11233.1-1998 5.4.1 method - provisions, F5 evaporation residue test
According to (GB3/T14233.1--1998 provisions. E6 UV absorbance test
According to (:13, T14233.1~1998 provisions within the wavelength range of 250nm ~ 320nm. Appendix F
(Standard Appendix)
Method for determination of particle content
Appendix F of GB8368--1998
Appendix G
(Standard Appendix)
Sterility, pyrogen test and biological evaluation test G1 (G1BT14233.2 1 specifies sterility , pyrogen test Note: (B, T14233, 2 also stipulates the test method for bacterial endotoxin. G2 (The biological evaluation test method described in 13/T16886.1 should be used as a guide for the evaluation of material biocompatibility. Note: (Small 15593 specification cage "biocompatibility test of polyvinyl fluoride materials. H1·Type inspection
H1.1 Type inspection should be carried out in the following cases: GB8369-1998
Appendix H
(Appendix to the standard)
Inspection rules
a) When new products are put into production, material sources or formulas are changed; b) When there are major changes in structure, key parts and components, and processes; c) No less than twice a year in continuous production; d) When production is resumed after suspension of production;
e) Every Products made from a batch of raw materials
f) as required by the contract or management department. H1.2 Type inspection is a full performance inspection. In case a), a comprehensive biological evaluation of the selected polyvinyl chloride material should also be carried out. H1.3, during type inspection, unless otherwise specified, 5 sets of each requirement specified in Chapter 5, Article 8.1 and Chapter 9 shall be randomly inspected. If equipped with an intravenous needle, 5 sets of all physical requirements specified in the corresponding product standards shall be randomly inspected. H1.4 If all type inspection items are qualified, the type inspection is passed. If the type inspection fails, mass production shall not be carried out. H2 Factory inspection
H2.1 Factory inspection shall be carried out batch by batch in accordance with the provisions of GB2828, and only after passing the inspection can it be shipped out of the factory. H2.2 Production is composed of the daily output of the same type of blood transfusion devices. Batch. H2.3 The physical requirements (counting items), non-conforming classification, inspection level (IL) and acceptable quality level (AQL) for factory inspection shall be as specified in Table H1.
Inspection items
Particle contamination
Sealing
Connection strength
Bottle stopper piercer
Air inlet device
H2.4 Each production batch shall also be inspected for reducing substances (6.1), pH (6.3), ultraviolet absorbance (6.5) and pyrogens (7.3). H2.5 Products of the same sterilization process constitute a sterilization batch, and each sterilization batch shall be monitored by an effective method for the sterilization effect (7.2). Products sterilized with ethylene oxide shall not be shipped until the residual ethylene oxide content after sterilization is controlled below the specified value (6.6). H3 National supervision and random inspection
Conducted in accordance with GB/T14437.
Adoption Note:
8]IS) 1135-4: 1998 No inspection rules. 391
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