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Medical devices for human assisted reproductive technology - Artificial insemination catheter
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YY/T 1769-2022
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PDF similar to YY/T 1769-2022
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Basic data | Standard ID | YY/T 1769-2022 (YY/T1769-2022) | | Description (Translated English) | Medical devices for human assisted reproductive technology - Artificial insemination catheter | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C36 | | Word Count Estimation | 10,142 | | Issuing agency(ies) | State Drug Administration |
YY/T 1769-2022: Medical devices for human assisted reproductive technology - Artificial insemination catheter ---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.
Medical devices for human assisted reproductive technology - Artificial insemination catheter
ICS 11.040.30
C36
People's Republic of China Pharmaceutical Industry Standard
Medical Devices for Human Assisted Reproductive Technology
artificial insemination catheter
Published on 2022-05-18
2023-06-01 Implementation
Released by the State Drug Administration
directory
Preface I
1 Scope 1
2 Normative references 1
3 Terms and Definitions 1
4 Product structure and composition 2
5 Design Properties 2
6 Requirements and test methods 2
7 pack 5
8 Signs and Instructions5
Reference 7
foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that some content of this document may be patented. The issuing authority of this document assumes no responsibility for identifying these patents.
This standard is proposed by the State Drug Administration.
This standard is under the jurisdiction of China National Institute for Food and Drug Control.
This standard was drafted by. China National Institute for Food and Drug Control, Guangzhou Hehong Biotechnology Co., Ltd., Shandong Medical Device Manufacturer
Product Quality Inspection Center, Sichuan University (Sichuan Medical Device Biomaterials and Products Inspection Center), Ruibai Biological (China) Co., Ltd.
The main drafters of this standard. Wang Ying, Han Qianqian, Wang Chunren, Li Qiu, Liang Jie, Zhang Qing, Liu Dong, Feng Yu, Feng Huailiang, Li Chongchong, Fu Bufang,
Chen Dandan, Fu Haiyang, Liu Li, Ke Linnan, Gu Yan'e, Liang Hongbin.
Medical Devices for Human Assisted Reproductive Technology
artificial insemination catheter
1 Scope
This standard specifies the terms and definitions of artificial insemination catheters, product structure and composition, design attributes, requirements and test methods, packaging, labeling
records and manuals.
This standard applies to transvaginal insertion into the uterine cavity to inject in vitro treated sperm, or in vitro treatment of semen into the cervix, for human
Artificial insemination catheters for assisted reproductive technology of artificial insemination.
2 Normative references
The following documents are essential for the application of this document. For dated references, only the dated version applies to this article
pieces. For undated references, the latest edition (including all amendments) applies to this document.
GB/T 1962.1 Syringes, injection needles and other medical devices - 6% (Luer) conical joints - Part 1.General requirements
GB/T 1962.2 Syringes, needles and other medical devices - 6% (Luer) conical connectors - Part 2.Locking connectors
GB/T 9969 General Principles of Instruction Manual for Industrial Products
GB/T 14233.1-2008 Test methods for medical infusion, blood transfusion and injection equipment - Part 1.Chemical analysis methods
GB/T 14233.2-2005 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 Risk Management Process
GB/T 16886.4 Biological Evaluation of Medical Devices Part 4.Selection of Tests for Interaction with Blood
GB/T 16886.5-2017 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 Tests
GB/T 19633.1 Terminally sterilized medical device packaging - Part 1.Requirements for materials, sterile barrier systems and packaging systems
YY 0285.1-2017 Intravascular catheters for single-use sterile catheters Part 1.General requirements
YY/T 0995 Terms and Definitions of Medical Devices for Human Assisted Reproductive Technology
YY 1282-2016 Disposable intravenous indwelling needle
YY/T 1434 In vitro mouse embryo test of medical devices for human in vitro assisted reproductive technology
YY/T 1535 Biological Evaluation of Human Sperm Survival Test of Medical Devices for Human In Vitro Assisted Reproductive Technology
Pharmacopoeia of the People's Republic of China (2015 Edition Part 4)
3 Terms and Definitions
YY/T 0995 and the following terms and definitions apply to this document.
3.1
Insertion of spermatozoa after in vitro treatment into the uterine cavity through the vagina, or injection of spermatozoa after treatment in vitro into the cervix to assist in artificial insemination
Catheters for reproductive technology.
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