YY/T 1704.3-2021Cervical dilator for single use - Part 3: Ripening balloon (English PDF)
一次性使用宫颈扩张器 第3部分：球囊式
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
September 6, 2021
Implementation date
September 1, 2022
Scope
YY/T 1704.3-2021 is the English-translated version of 一次性使用宫颈扩张器 第3部分：球囊式.
YY/T 1704.3-2021 is the Chinese pharmaceutical industry standard for the single-use balloon cervical dilator used to ripen an unfavourable cervix before induction of labour at term.
It is the third part of the YY/T 1704 series and sets the classification and the requirements, the test methods, the marks, packaging and instructions for use, and the rules for transport, storage and the sterile shelf life, covering the balloon and its inflation volume and burst pressure, the catheter and its connections, the freedom from leakage, the materials and their biological evaluation, and sterility. Issued on 6 September 2021, it has applied since 1 September 2022.
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Document preview — YY/T 1704.3-2021
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
- Foreword
- 1 Scope
- 2 Normative references
- 3 Categories
Foreword
YY/T 1704 "Disposable Cervical Dilator" is divided into the following three parts.
--- Part 1: Progressive;
--- Part 2: Expansion;
--- Part 3: Balloon. This part is part 3 of YY/T 1704.
This section is drafted in accordance with the rules given in GB/T 1.1-2009.
1 Scope
This part of YY/T 1704 specifies the classification and requirements of single-use cervical dilator balloon type (hereinafter referred to as balloon cervical dilator). requirements, test methods, signs, packaging and instructions for use, transportation, storage and sterilization validity.
This section applies to balloon dilators used to dilate a poorly mature cervix before induction of labor at term.
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 191 Graphical signs of packaging, storage and transportation
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 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
YY 0285.1-2017 Intravascular catheters for single-use sterile catheters Part 1: General requirements
YY 0285.4-2017 Intravascular catheters - One-time use sterile catheters - Part 4: Balloon dilatation catheters
YY/T 0466.1 Medical Devices Symbols for Medical Device Labeling, Marking and Providing Information Part 1: General Requirements
YY/T 0586 Test method for X-ray opacity of medical polymer products Pharmacopoeia of the People's Republic of China (2020 Edition)
3 Categories
3.1 Composition and structure
3.1.1 Balloon cervical dilator can be divided into single balloon and double balloon, as shown in Figure 1, Figure 2 and Figure 3.
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 23 pages — is available in the English PDF.
Referenced standards
Normative references
- GB/T 191Graphical symbols marking for handling and storage of packages
- 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 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 15812.1-2005 — Catheters other than intravascular catheters -- Part 1: Test methods for common for properties
GB/T 16886.1-2022 — Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
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YY/T 1704.3-2021
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