YY/T 1769-2022Medical devices for human assisted reproductive technology—Artificial insemination catheter (English PDF)
人类辅助生殖技术用医疗器械 人工授精导管
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
May 18, 2022
Implementation date
June 1, 2023
Scope
YY/T 1769-2022 is the English-translated version of 人类辅助生殖技术用医疗器械 人工授精导管.
YY/T 1769-2022 is the Chinese pharmaceutical industry standard for artificial insemination catheters, the catheters passed through the vagina to place treated sperm in the uterine cavity or semen at the cervix in assisted reproduction.
It gives the terms and definitions, the structure and composition of the product and its design attributes, then the requirements and the test methods, covering the materials and their effect on gametes, the dimensions and the flexibility of the catheter, the tip and the connection to the syringe, freedom from leakage, sterility and non-pyrogenicity, and it sets out the packaging, labelling and the manual. Issued on 18 May 2022, it has applied since 1 June 2023.
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Document preview — YY/T 1769-2022
National Standard of the People's Republic of China
- Classification
- C 36
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Preface
- 1 Scope
- 2 Normative references
- 3 Terms and Definitions
- 4 Product structure and composition
- 5 Design Properties
- 6 Requirements and test methods
- 7 pack
- 8 Signs and Instructions5 Reference
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
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 document. 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 Artificial insemination catheter
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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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 25 pages — is available in the English PDF.
Referenced standards
Normative references
- GB/T 1962.1Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirement
- GB/T 1962.2Conical fittings with a 6 %(Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings
- GB/T 9969General principles for preparation of instructions for use of industrial products
- GB/T 14233.1-2008Test methods for infusion, transfusion, injection equipments for medical use - Part 1: Chemical analysis methods
- GB/T 14233.2-2005Test methods for infusion, transfusion, injection equipment for medical use - Part 2: Biological test methods
- GB/T 15812.1-2005Catheters other than intravascular catheters -- Part 1: Test methods for common for properties
Similar standards
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Related Standards
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 15812.1-2005 — Catheters other than intravascular catheters -- Part 1: Test methods for common for properties
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