YY 0948-2015 English PDF (YY0948-2015)

This standard specifies the classification and structure, requirements, testing methods, marks, labels, instructions for use, packaging, transportation and storage of aseptic disposable arteriovenous cannula (hereinafter referred to as Arteriovenous cannula). This standard is suitable for arteriovenous cannula supporting cardiopulmonary bypass system. It is used for drainage or perfusion of blood during direct vision cardiac operation of cardiopulmonary bypass (CPB).

YY 0948-2015
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.40
C 45
Cardiopulmonary bypass systems -
Arteriovenous cannula for single use
ISSUED ON. MARCH 02, 2015
IMPLEMENTED ON. JANUARY 01, 2017
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 . 5
5 Testing method .. 8
6 Marks, labels, instructions for use . 11
7 Packaging, transportation, storage . 12
Cardiopulmonary bypass systems -
Arteriovenous cannula for single use
1 Scope
This standard specifies the classification and structure, requirements, testing methods, marks, labels, instructions for use, packaging, transportation and storage of aseptic disposable arteriovenous cannula (hereinafter referred to as Arteriovenous cannula).
This standard is suitable for arteriovenous cannula supporting cardiopulmonary bypass system. It is used for drainage or perfusion of blood during direct vision cardiac operation of cardiopulmonary bypass (CPB).
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
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
GB 18280 Sterilization of health care products - Requirement for validation and routine control. Radiation sterilization
cannula plug shall have certain arc transition. The tube shall have no kink phenomenon. The surface of the arteriovenous cannula shall be marked with specifications and easy to identify.
4.2 Physical performance
4.2.1 No leakage
There shall be no leakage in the connection of arteriovenous cannula.
4.2.2 Connection strength
The connections of arteriovenous cannula shall be firm.
4.2.3 Temperature adaptability
The arteriovenous cannula shall not be deformed or broken in the temperature range of 0°C ~ 50°C.
4.2.4 Bending resistance
When the venous cannula is bent, the inner wall shall not be adhered.
Note. This test is not required for arterial cannula.
4.3 Biological performance
4.3.1 Biological evaluation
The arteriovenous cannula shall have no biological hazards.
4.3.2 Sterile
The arteriovenous cannula shall go through confirmed sterilization process to ensure product sterility.
4.3.3 No pyrogen
The arteriovenous cannula shall be no pyrogen.
4.4. Chemical performance
4.4.1 Reducing substance
The difference between the volumes of the potassium permanganate solution [c(KMnO4) = 0.002mol/L] consumed by the 20mL test solution and the same batch of blank control solution shall not exceed 2.0mL.
4.4.2 Heavy metals
5 Testing method
5.1 Appearance
Use visual inspection. Requirements of 4.1 shall be met.
5.2 Physical performance
5.2.1 Leakage test
Connect artery cannula channel, seal all outlets, inject air or nitrogen gas which is 50kPa higher than atmospheric pressure, put it into water, keep for 10 min, observe carefully whether there are bubbles escaping from each junction. It shall meet the specifications in 4.2.1.
Fill water in venous cannula, seal all outlets, connect to vacuum pump, keep the pressure 20 kPa below the atmospheric pressure, maintain for 10 min, observe carefully whether there are bubbles entering the venous cannula at each junction. It shall meet the specifications in 4.2.1.
Note. In order to prevent water from entering the vacuum pump, a pipeline without injected water can be used to connect the sample with the machine.
5.2.2 Connection strength test
Apply 15 N axial static tension to each of the junctions of arteriovenous cannula and keep for 15 s. They shall not be separated and shall conform to the specifications in 4.2.2.
5.2.3 Temperature adaptability test
Place the arteriovenous cannula in the environment of 0°C for 3 min, then put in the environment of 50°C for 3 h, and then take back to room temperature for observation. Perform the leakage test of 5.2.1 and the requirements in 4.2.3 shall be met.
5.2.4 Bending resistance test
The length of the test shall be 200 mm. If the length of venous cannula is less than 200 mm, the test length shall be the whole length of the product. Bend the venous cannula as shown in figure 2 and remain for 10 s, visually check it in the bent state. The requirements in 4.2.4 shall be met.
Take products with expiration of no more than 1 month (arbitration, preferred), or age according to YY/T 0681.1-2009. Test 4.2, 4.3.2, 4.3.3, and the results shall conform to 4.7.
6 Marks, labels, instructions for use
6.1 Mark
6.1.1 Product individual package
The individual packaging of each product shall be provided with the following marks.
a) The name of the manufacturer;
b) Product name, model specification;
c) Production batch number, validity period;
d) Words or marks such as "One-time use", "Aseptic", " Prohibit of use in case of packaging breakage", "Please read the instructions before use". 6.1.2 Product external package
The product external packaging shall be provided with the following marks. a) The name and address of the manufacturer;
b) Product name, model specification;
c) Implementation of the standard number;
d) Product registration number;
e) Production license number;
f) Production batch number;
g) The words or marks of "one-time use" etc.;
h) Sterilization methods;
I) The period of validity;
j) Packaging quantity, volume (length×width×height);
k) The words or marks such as "careful and light", "do not press heavily", "fear of moisture", etc., shall conform to the relevant provisions in GB/T