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YY/T 1718-2020 English PDF

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YY/T 1718-2020: Medical devices for human assisted reproductive technology in vitro--Embryo transfer catheters
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YY/T 1718-2020English169 Add to Cart 3 days [Need to translate] Medical devices for human assisted reproductive technology in vitro--Embryo transfer catheters Valid YY/T 1718-2020

PDF similar to YY/T 1718-2020


Standard similar to YY/T 1718-2020

YY/T 1686   YY/T 1752   YY/T 1746   YY/T 1723   YY 1727   

Basic data

Standard ID YY/T 1718-2020 (YY/T1718-2020)
Description (Translated English) Medical devices for human assisted reproductive technology in vitro--Embryo transfer catheters
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C30
Classification of International Standard 11.040.30
Word Count Estimation 9,944
Date of Issue 2020
Date of Implementation 2021-04-01
Issuing agency(ies) State Drug Administration
Summary This standard specifies the composition, requirements, test methods, marking, packaging and transportation of embryo transfer catheters for medical devices for human in vitro assisted reproductive technology. This standard applies to embryo transfer catheters for transferring gametes, zygotes, cleavage-stage embryos or blastocysts into the uterine cavity or fallopian tubes.

YY/T 1718-2020: Medical devices for human assisted reproductive technology in vitro--Embryo transfer catheters


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Medical devices for human assisted reproductive technology in vitro--Embryo transfer catheters ICS 11.040.30 C30 People's Republic of China Pharmaceutical Industry Standard Medical devices for human in vitro assisted reproductive technology Embryo transfer catheter 2020-03-31 released Implementation on 2021-04-01 Issued by the State Drug Administration

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009. Please note that certain contents of this document may involve patents. The issuing agency of this document is not responsible for identifying these patents. This standard was proposed by the State Drug Administration. This standard is under the jurisdiction of the China Food and Drug Control Institute. This standard was drafted. Shandong Weigao Xinsheng Medical Devices Co., Ltd., China Food and Drug Control Research Institute. The main drafters of this standard. Han Qianqian, Lu Ruju, Lu Hongmin, Yu Lingyun, Peng Fengli, Wang Chunren, Wang Ying. Medical devices for human in vitro assisted reproductive technology Embryo transfer catheter

1 Scope

This standard specifies the composition, requirements, test methods, markings, packages of medical device embryo transfer catheters for human in vitro assisted reproductive technology. Loading and transportation. This standard applies to embryo transfer catheters used to transfer gametes, zygotes, cleavage stage embryos or blastocysts into the uterine cavity or fallopian tube.

2 Normative references

The following documents are indispensable for the application of this document. For dated reference documents, only the dated version applies to this article Pieces. For undated references, the latest version (including all amendments) applies to this document. GB/T 191 Packaging, Storage and Transportation Graphic Mark GB/T 1962.1 Syringes, injection needles and other medical devices 6% (Luer) tapered joints Part 1.General requirements GB/T 1962.2 Syringes, injection needles and other medical devices 6% (Luer) tapered joints Part 2.Locking joints GB/T 14233.1-2008 Medical infusion, blood transfusion, and injection equipment inspection methods Part 1.Chemical analysis methods GB/T 14233.2 Test methods for medical infusion, blood transfusion and injection equipment-Part 2.Biological test methods GB/T 15812.1-2005 Non-intravascular catheters Part 1.General performance test methods GB/T 16886.1 Biological Evaluation of Medical Devices Part 1.Evaluation and Testing in the Process of Risk Management GB/T 16886.4 Biological Evaluation of Medical Devices Part 4.Test Selection for Interaction with Blood GB/T 16886.5 Biological Evaluation of Medical Devices Part 5.In Vitro Cytotoxicity Test GB/T 16886.10 Biological Evaluation of Medical Devices Part 10.Irritation and Skin Sensitization Test GB/T 16886.11 Biological Evaluation of Medical Devices Part 11.Systemic Toxicity Test GB 18278.1 Sterilization Damp Heat of Medical and Healthcare Products Part 1.Development, Validation and Routine Control of the Sterilization Process of Medical Devices Claim GB 18279.1 Sterilization of medical and health care products ethylene oxide Part 1.Development, validation and routine control of the sterilization process of medical devices System requirements GB/T 18279.2 Sterilization of Medical and Health Care Products Ethylene Oxide Part 2.GB 18279.1 Application Guide GB 18280.1 Sterilization radiation of medical and health care products Part 1.Development, validation and routine control of the sterilization process of medical devices Claim GB 18280.2 Medical and health products sterilization radiation Part 2.Establishing sterilization dose GB/T 18280.3 Sterilization Radiation of Medical and Health Care Products Part 3.Dose Measurement Guidelines GB/T.19974 The characteristics of sterilization factors for medical and health care products and the setting, confirmation and routine control of sterilization processes for medical devices General requirements YY/T 0149-2006 Stainless steel medical equipment corrosion resistance test method YY/T 0313 Medical polymer product packaging and information requirements provided by manufacturers YY/T 0466.1 Medical devices are used for medical device labeling, marking and providing information symbols. Part 1.General requirements YY/T 0995 Terms and definitions of medical devices used in human assisted reproductive technology YY/T 1434 In vitro mouse embryo test of medical devices for human in vitro assisted reproductive technology

3 Terms and definitions

The following terms and definitions defined in YY/T 0995 apply to this document. 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 Product structure, composition and materials 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.

5 Design attributes

In order to achieve the expected performance, the design attributes should take into account the possible damage during the embryo transfer process when the product is used.

6 Requirements and test methods

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%.

7 Sterile products

The product sterilization process should be confirmed and routinely controlled, and the sterility assurance level (SAL) of 10-6 should be reached. a) If the product is sterilized by ethylene oxide, it should meet the requirements of GB 18279.1 and GB/T 18279.2; b) If the product is sterilized by moist heat, it should meet the requirements of GB 18278.1; c) If the product is sterilized by radiation, it should meet the requirements of GB 18280.1, GB 18280.2 and GB/T 18280.3; d) If the product uses other sterilization processes, it should meet the requirements of GB/T.19974.

8 packaging

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 Signs and instructions

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.

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