YY/T 1718-2020Medical devices for human assisted reproductive technology in vitro—Embryo transfer catheters (English PDF)

3.1 Embryo transfer catheter

Transfer the gametes, zygotes, cleavage stage embryos or blastocysts produced by in vitro fertilization (IVF) and transfer of gametes into the uterine cavity or fallopian tubes Special equipment for intra-tube transplantation.

4.1 Product composition

The manufacturer shall describe in detail the specifications and models of each product in the same registration unit. The basic structure of the embryo transfer catheter is shown in Figure 1. Products may vary.

4.2 Materials

4.2.1 Raw materials

The manufacturer shall evaluate the raw materials of the main components of the product.

4.2.2 Containers and packaging

The safety of packaging materials should be guaranteed.

6.1 Physical properties

6.1.1 Dimensions

The manufacturer should consider what is applicable in the following dimensions.

a) Length of inner and outer pipes;

b) The diameter of the inner and outer pipes;

c) Length of stainless steel pipe;

d) Stainless steel pipe diameter; e) Ferrule diameter. The manufacturer shall give the nominal size and tolerance.

6.1.2 Distance indicator

The inner tube, outer tube or stainless steel tube of the embryo transfer catheter should have a distance indicating mark, the width of the mark, the length of the mark and the nominal size of the interval, The tolerance does not exceed ±10%.

6.1.3 Appearance

The surface of all fittings should be smooth, no black spots, no impurities, the inner tube and outer tube should be clearly marked on the scale, and the inner tube, outer tube, and guide core should have a pointed circle at the front end Passivation.

6.1.4 Corrosion resistance

According to the boiling water test method in Chapter 5 of YY/T 0149-2006, there should be no traces of corrosion on the surface of the stainless steel pipe.

6.1.5 Ultrasonic detectable

The outer tube of the embryo transfer catheter can be clearly displayed under B-mode ultrasound.

6.1.6 Cone joint

The tapered joint is tested according to the GB/T 1962.1 or GB/T 1962.2 method, and should meet the requirements of GB/T 1962.1 or GB/T 1962.2 Regulations.

6.1.7 Flow

According to GB/T 15812.1-2005 Appendix E method for testing, the amount of liquid passed in 60s is not less than 2mL.

6.1.8 Tightness

There is no liquid leakage in the inner tube with 100kPa pressure.

6.1.9 Connection strength

The inner tube and the joint should be able to withstand 3N axial static tension, and it will not separate for 5s, and the outer tube and the joint should be able to withstand a 3N shaft Pull to the static state for 5 seconds without separation.

6.2 Chemical properties

6.2.1 Preparation of test solution

Prepare the test solution according to the method specified in GB/T 14233.1-2008.

6.2.2 Reducing substances

Test according to the method specified in GB/T 14233.1-2008, the test solution and blank solution consume potassium permanganate solution [c(KMnO4)= The volume difference of 0.002mol/L] should not exceed 1.5mL.

6.2.3 Metal ions

Test according to the method specified in GB/T 14233.1-2008, the total extractable metal content in the test solution shall not exceed 1 µg/mL, and the content of cadmium The amount should not exceed 0.1µg/mL.

6.2.4 pH

According to the method specified in GB/T 14233.1-2008, the pH difference between the test solution and the control solution of the same batch shall not be greater than 1.0.

6.2.5 Evaporation residue

According to the method specified in 5.5 of GB/T 14233.1-2008, the total amount of evaporation residue should not exceed 2mg.

6.2.6 UV absorbance

Test according to the method specified in 5.7 of GB/T 14233.1-2008, within the wavelength range of 250nm~320nm, the absorbance of the test solution should not Greater than 0.1.

6.2.7 Residual ethylene oxide

Test according to the method specified in 9.4 of GB/T 14233.1-2008, the residual amount of ethylene oxide in each embryo transfer catheter should not exceed 0.5mg.

6.3 Biological performance

6.3.1 Sterility

According to GB/T 14233.2, the embryo transfer catheter should be sterile.

6.3.2 Bacterial endotoxin

Test according to the provisions of GB/T 14233.2, bacterial endotoxin should not be greater than 5EU/set.

6.4 Biological evaluation

6.4.1 General

The embryo transfer catheter should be biologically evaluated in accordance with the provisions of GB/T 16886.1, and should be For material manufacturing, the following items should be evaluated.

6.4.2 Pyrogen

According to GB/T 14233.2, the product should be pyrogen-free.

6.4.3 Cytotoxicity

According to the method specified in GB/T 16886.5, the cytotoxicity reaction is not greater than Grade I.

6.4.4 Intradermal stimulation

According to the method specified in GB/T 16886.10, there should be no intradermal irritation.

6.4.5 Skin sensitization

According to the maximum dose method in GB/T 16886.10, there should be no sensitization.

6.4.6 Hemolysis

According to the method specified in GB/T 16886.4, the hemolysis rate should be less than 5.0%.

6.4.7 Acute systemic toxicity

According to the method specified in GB/T 16886.11, there should be no acute systemic toxicity.

6.4.8 Mouse embryo test

The extract was prepared and tested according to the regulations in YY/T 1434, and the blastocyst formation rate was >=80%.

8.1 General

The packaging of the product should comply with the relevant regulations of YY/T 0466.1, GB/T 191, and YY/T 0313.

8.2 Single package

Each embryo transfer catheter should be enclosed in a single package.

When using ethylene oxide sterilization, the embryo transfer catheter should be made of dialysis paper on one side and plastic material or full dialysis paper packaging material.

Encourage the use of packaging materials with better dialysis effects, and packaging materials must not have harmful effects on the contents. The material and design of this packaging should make sure.

a) Under dry, clean and fully ventilated storage conditions, the contents can be guaranteed to be sterile;

b) When taken out of the package, the risk of contamination of the contents is minimal;

c) During normal handling, transportation and storage, the single package should fully protect the contents;

d) Once opened, the package cannot be easily resealed, and there should be obvious signs of tearing.

8.3 Medium packaging

One or more single packages should be packed in one middle package.

During normal handling, transportation and storage, the intermediate packaging should adequately protect the contents.

The inspection certificate and product instruction manual should be placed in the middle package.

8.4 Large packaging

One or more medium packages should be packed in one large package.

During normal handling, transportation and storage, the bulk packaging should be able to adequately protect the contents.

9.1 General

Symbols should comply with the requirements of YY/T 0466.1.

9.2 Single package

The single package should have at least the following signs.

a) Product name and marking according to Chapter 4 product structure, composition and material;

b) The words or equivalent signs of "sterile" and the method of sterilization;

c) Production batch number or production date;

d) Expiration year and month or expiration date;

e) "One-time use" or equivalent mark;

f) The name and address of the manufacturer and/or supplier.

9.3 Medium packaging

At least the following signs should be on the middle package.

a) Product name and marking according to Chapter 4 product structure, composition and material;

b) The words or equivalent signs of "sterile" and the method of sterilization;

c) Production batch number or production date;

d) Expiration year and month or expiration date;

e) "One-time use" or equivalent mark;

f) The name and address of the manufacturer and/or supplier.

9.4 Large packaging

If the medium package is packed in a large package, the large package should have at least the following signs.

a) Product name and marking according to Chapter 4 product structure, composition and material;

b) The words or equivalent signs of "sterile" and the method of sterilization;

c) Production batch number or production date;

d) Expiration year and month or expiration date;

e) "One-time use" or equivalent mark;

f) The name and address of the manufacturer and/or supplier;

g) Requirements for handling, storage and transportation.

9.5 Instructions

The instructions should specify the precautions, warning information and contraindications of the operation, and prompt the related risks and safety precautions to be taken.