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YY 1271-2016 English PDF (YY1271-2016)

YY 1271-2016 English PDF (YY1271-2016)

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YY 1271-2016: Cardiopulmonary bypass systems. Suction catheter for single use
This standard specifies the classification and structure, requirements, test methods, markings, labels, instructions for use, packaging, transportation, and storage of sterile suction catheter for single use (hereinafter referred to as suction catheter). This standard applies to suction catheters, for supporting cardiopulmonary bypass system, suction catheter for cardiovascular ventilation in the left heart, suction decompression or reduction of left heart load, to attract the intracardiac blood and other fluids.
YY 1271-2016
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.40
C 45
Cardiopulmonary bypass systems –
Suction catheter for single use
ISSUED ON. MARCH 23, 2016
IMPLEMENTED ON. JANUARY 01, 2018
Issued by. China Food and Drug Administration
Table of Contents
Foreword . 3
1 Scope .. 4
2 Normative references . 4
3 Classification and structure . 5
4 Requirements . 6
5 Test methods .. 8
6 Marking, instruction manual . 11
7 Packaging, transport, storage . 12
Cardiopulmonary bypass systems –
Suction catheter for single use
1 Scope
This standard specifies the classification and structure, requirements, test methods, markings, labels, instructions for use, packaging, transportation, and storage of sterile suction catheter for single use (hereinafter referred to as suction catheter).
This standard applies to suction catheters, for supporting cardiopulmonary bypass system, suction catheter for cardiovascular ventilation in the left heart, suction decompression or reduction of left heart load, to attract the intracardiac blood and other fluids.
2 Normative references
The following documents are essential to the application of this document. For the dated documents, only the versions with the dates indicated are applicable to this document; for the undated documents, only the latest version (including all the amendments) are applicable to this standard.
GB/T 191-2008 Packaging - Pictorial marking for handling of goods
GB/T 9969-2008 General principles for preparation of instructions for use of industrial products
GB/T 14233.1-2008 Test methods for 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/T 16886.1 Biological evaluation of medical devices - Part 1. Evaluation and testing within a risk management process
GB 18279 Medical devices - Validation and routine control of ethylene oxide sterilization
4.2.1 Leakage-free
Suction catheter shall be no leakage free.
4.2.2 Connection strength
Suction catheter shall be firmly connected.
4.2.3 Temperature adaptability
The suction catheter shall be free from deformation and rupture in the
temperature range of 0 °C ~ 50 °C.
4.2.4 Negative pressure tolerance
Under room temperature conditions, when a negative pressure of 20 kPa (150 mmHg) is applied for 15 seconds, the suction catheter body shall not be flattened.
4.3 Biological properties
4.3.1 Biological evaluation
Suction catheters shall be free of biological hazards.
4.3.2 Sterility
The suction catheter shall be sterilized by the sterilization process that has been confirmed.
4.3.3 Pyrogen-free
The suction catheter shall be pyrogen free.
4.4 Chemical properties
4.4.1 Reducing substances (easily oxides)
The difference between the 20 mL of test solution and the volume of potassium permanganate solution [c(KMnO4) = 0.002 mol/L] consumed by the same batch of blank control solution shall not exceed 2.0 mL.
4.4.2 Heavy metals
When measured by atomic absorption spectrophotometry (AAS) or equivalent method, the total content of bismuth, chromium, copper, lead, and tin in the test solution shall not exceed 1 μg/mL. The content of cadmium shall not exceed 0.1 μg/mL.
When it is subject to visual observation, the suction catheter shall meet the requirements of 4.1.
5.2 Physical properties
5.2.1 Leakage-free
CONNECT the suction catheter passage, LEAD in air or nitrogen gas at a
pressure of 50 kPa above atmospheric pressure, PLACE it in water, MAINTAIN it for 10 min, there shall be free from air bubble escape under careful observation. It shall comply with the requirements of 4.2.1.
5.2.2 Connection strength
APPLY the axial static tensile force of 15 N at each joint of the suction catheter for 15 s. It shall be free from separation. It shall comply with the requirements of 4.2.2.
5.2.3 Temperature adaptability
PLACE the suction catheter in a 0°C environment for 3 minutes, then PLACE it in a 50°C environment for 3 hours. After removal, RESTORE it to room
temperature for observation, MAKE it subject to the leakage free test of 5.2.1, it shall comply with the requirements of 4.2.3.
5.2.4 Negative pressure tolerance
CONNECT the suction end of the suction catheter to a vacuum source, BLOCK the suction hole, APPLY a negative pressure of 20 kPa for 15 seconds at room temperature. The suction catheter body shall not be flattened, it shall comply with the provisions of 4.2.4.
5.3 Biological properties
5.3.1 Biological evaluation
The biological properties shall be evaluated in accordance with the provisions of GB/T 16886.1.
5.3.2 Sterility test
The sterilization process shall be confirmed in accordance with relevant standards such as GB 18279 or GB 18280.
Sterility test is performed in accordance with the provisions of GB/T 14233.2- 2005, the method should not be used for exit-factory inspection.
5.5 Corrosion resistance
Take out the metal parts, make it subject test in accordance with the sodium chloride solution test method in YY/T 0149-2006, the results shall comply with the provisions of 4.5.
5.6 Particle contamination
The test shall be conducted in accordance with the provisions in Appendix A of GB 19335-2003, it shall comply with the provisions of 4.6.
5.7 Validity period test
Take the products that have expired not exceeding one month (arbitration method, which is preferred), or perform aging in accordance with the provisions of YY/T 0681.1-2009, to test the items of 4.2, 4.3.2, 4.3.3, the results shall comply with the requirements of 4.7.
6 Marking, instruction manual
6.1 Marking
6.1.1 The product packaging shall have the following markings.
a) The name of the manufacturer;
b) The product name, model specifications;
c) The production lot number, validity period;
d) Words or illustrations such as “for single-use”, “sterility”, “do not use if package broken”, “please read manual before use”, etc.
6.1.2 Product packaging shall have the following markings.
a) Manufacturer's name, address;
b) Product name, model specifications;
c) Implemented standard number;
d) Product registration number;
e) Production license number;
f) Production lot number;
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