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YY/T 1698-2020: (Medical devices for assisted reproductive technology in vitro for humans)
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| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 1698-2020 | English | 209 |
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(Medical devices for assisted reproductive technology in vitro for humans)
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YY/T 1698-2020
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PDF similar to YY/T 1698-2020
Basic data | Standard ID | YY/T 1698-2020 (YY/T1698-2020) | | Description (Translated English) | (Medical devices for assisted reproductive technology in vitro for humans) | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C30 | | Word Count Estimation | 11,176 | | Date of Issue | 2020-06-30 | | Date of Implementation | 2021-06-01 | | Regulation (derived from) | Announcement No. 76 (2020) of the National Medical Products Administration | | Issuing agency(ies) | State Drug Administration | YY/T 1698-2020: (Medical devices for assisted reproductive technology in vitro for humans)---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
People's Republic of China Pharmaceutical Industry Standards
Released on 2020-06-30
Implementation of 2021-06-01
Issued by the National Medical Products Administration
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that some of the contents of this document may involve patents. Publication of this document
The agency is not responsible for identifying these patents.
This standard was proposed by the State Drug Administration.
This standard is under the jurisdiction of China Food and Drug Control Research Institute.
Drafting organizations of this standard. Shandong Weigao Xinsheng Medical Devices Co., Ltd., China Institute for Food and Drug Control.
The main drafters of this standard. Lu Ruju, Han Qianqian, Lu Hongmin, Yu Lingyun, Peng Fengli, Wang Chunren, Wang Ying.
Medical devices for human in vitro assisted reproductive technology
Assisted reproduction needle
1 Scope
This standard specifies the specifications, models, composition, materials, and design of the needles for assisted reproductive puncture and egg retrieval for medical devices used in human in vitro assisted reproductive technology.
Design attributes, requirements and test methods, sterilization requirements for sterile products, packaging, markings and instructions.
This standard is applicable to the medical device assisted reproductive puncture and egg retrieval needle for human in vitro assisted reproductive technology (hereinafter referred to as the puncture egg retrieval needle).
Under the guidance of ultrasound, the ovaries are punctured and the follicular fluid is sucked to obtain oocytes.
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 reference documents, the latest version (including all amendments) is applicable to this document.
GB/T 191 Graphical signs for packaging, storage and transportation
GB/T 1962.1 Syringes, injection needles and other medical devices 6% (Ruhr) 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 transfusion, blood transfusion, 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 of Medical and Health Products Moisture Heat Part 1.Development, Validation and Routine Control of the Sterilization Process of Medical Devices
Claim
GB 18279.1 Sterilization of Medical and Healthcare 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 Sterilization Radiation of Medical and Health Care Products Part 2.Establishing the Sterilization Dosage
GB/T 18280.3 Medical and health care products sterilization radiation Part 3.Dose measurement guide
GB/T 18457-2015 Stainless steel needle tube for manufacturing medical equipment
GB/T 1974 The characteristics of sterilization factors for medical and health care products and the development, validation and routine control of the sterilization process of medical devices
General requirements
YY/T 0313 Medical polymer product packaging and information provided by the manufacturer
YY/T 04666.1 Medical devices used for medical device labeling, marking and information symbols. Part 1.General requirements
YY/T 0995 Terms and Definitions of Medical Devices for Human Assisted Reproductive Technology
YY/T 1698-2020
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
In the process of in vitro fertilization-embryo transfer and its derivative technology, it is used to puncture follicles in the ovary to obtain oocytes.
instrument.
4 Specifications, models, composition and materials
4.1 Specifications
The manufacturer shall describe in detail the specifications and models of each product in the same registration unit, generally divided into single-chamber, double-chamber and two-section tube types. Single cavity take
The egg needle is composed of a puncture needle, a puncture needle protective cover, a handle, a suction catheter, a catheter sleeve, a silicone plug, a vacuum catheter and an inner conical connector. Of which double cavity
The egg retrieval needle also includes a flushing catheter. The two-section tube type egg retrieval needle is different in the main puncture needle, which is divided into the front section and the back section.
4.2 Product composition
The specific names of the various components of the puncture needle product are shown in Figure 1 to Figure 3, and the names and functions of the accessories are shown in Table 1.
Description.
4.3 Materials
4.3.1 Raw materials
The manufacturer shall evaluate the raw materials that make up the parts of the product.
4.3.2 Containers and packaging
The safety of packaging materials should be guaranteed.
5 Design attributes
In order to achieve the expected performance requirements, the design attributes should take into account the damage to the patient during the puncture process when the product is used, and the negative pressure suction
Potential damage to oocytes may be.
6 Requirements and test methods
6.1 Physical properties
6.1.1 Overall
6.1.1.1 Dimensions
The manufacturer should consider what is applicable in the following dimensions.
a) Effective length of puncture needle;
b) The inner and outer diameter of the puncture needle;
c) The length of the suction catheter;
d) The length of the vacuum duct;
e) Length of irrigation catheter;
f) The thickness of the catheter wall.
The manufacturer shall give the nominal size and tolerance.
6.1.1.2 Vacuum leakage
Remove the protective cover of the puncture and egg retrieval needle, connect it to the hydraulic system, and fill the system with de-bubble distilled water or deionized water at (23±2)°C.
Exhaust air, occlude the test sample, apply the negative pressure specified by the company, and keep the system stable for 120s. Keep the system under negative pressure
120s. During this period, there should be no leakage of the entire assembly (that is, the formation of one or more bubbles) and no droplets should occur.
6.1.1.3 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.
6.1.1.4 Connection strength
The connection between the pipe and the handle, and the connection between the pipe and the conical joint should be able to withstand a 3N axial static tension without separation for 5 seconds.
6.1.2 Puncture needle
6.1.2.1 Appearance
Observed with normal or corrected vision, the outer surface of the needle tube should be smooth and free of defects.
6.1.2.2 Cleanliness
Observe with normal or corrected vision, the outer surface of the needle tube should be free of impurities produced during metal processing.
6.1.2.3 Rigidity
When testing according to GB/T 18457-2015, the deflection value of the needle tube should meet the requirements.
6.1.2.4 Toughness
When testing according to GB/T 18457-2015, the needle tube shall not be broken.
6.1.2.5 Corrosion resistance
When testing in accordance with GB/T 18457-2015 Appendix F, there should be no traces of corrosion on the part where the needle tube is immersed.
6.1.2.6 Ultrasonic detectable
The puncture needle is tested by the applicable model, and the marked position under the B-ultrasound is clearly marked.
6.1.2.7 Protective sleeve for puncture needle
Observe with normal or corrected vision. The surface should be smooth, free of black spots and impurities, and the protective cover should not fall off naturally and be easy to remove.
6.1.3 Handle
6.1.3.1 Appearance
Observe with normal or corrected vision, the surface should be smooth, free of impurities, and there should be no obvious deformation.
6.1.3.2 Positioning
The handle must have an obvious mark corresponding to the direction of the needle tip blade surface, and the mark should be clear and intuitive.
YY/T 1698-2020
6.1.4 Piping system
Observe with normal or corrected vision. The surface should be smooth, free of black spots and impurities, and the entire pipeline should be free of creases.
6.1.5 Silicone plug
6.1.5.1 Appearance
Observed with normal or corrected vision, the surface should be smooth, free of black spots, and free of impurities, and there should be no obvious deformation.
6.1.5.2 Egg protection measures
When the oocytes enter the constant temperature test tube through the suction catheter, in order to prevent oocyte damage at the end of the suction catheter, the suction catheter should be
The end or the silicone plug is equipped with egg protection measures, such as the flaring of the end of the suction catheter or the silicone plug into the test tube.
6.1.6 Within...
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