YY/T 1704.1-2020Cervical dilator for single use - Part 1: Progressive dilators (English PDF)
一次性使用宫颈扩张器 第1部分：渐进式
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
February 21, 2020
Implementation date
January 1, 2021
Scope
YY/T 1704.1-2020 is the English-translated version of 一次性使用宫颈扩张器 第1部分：渐进式.
YY/T 1704.1-2020 is the Chinese pharmaceutical industry standard for the single-use gradual cervical dilator, the set of tapered dilators used one after another to open the cervix.
It is the first part of the YY/T 1704 series and sets the classification, the requirements, the test methods, the marks, packaging and instruction manual, and the rules for transport, storage and the sterile shelf life, covering the dimensions and the taper of each size, the surface finish, the strength and stiffness of the dilator, the materials and their biological evaluation, and sterility. It was issued on 21 February 2020 and has applied since 1 January 2021.
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Document preview — YY/T 1704.1-2020
National Standard of the People's Republic of China
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword3
- 1 Scope4
- 2 Normative references4
- 3 Classification4
- 4 Requirements6
- 5 Test methods7
- 6 Marks, packaging and instruction manual9
- 7 Transport, storage9
1 Scope
This Part of YY/T 1704 specifies the classification, requirements, test methods, marks, packaging and instruction manual, transport, storage and sterilization period for gradual cervical dilator for single use (hereinafter referred to as the dilator).
This Part is applicable to cervical dilator for single use. This product is used for dilatation of the cervix in obstetrics and gynecology and family planning departments.
This Part is not applicable to the cervical dilator made of metal.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
GB/T 14233.1-2008, Test methods for infusion transfusion injection equipment for medical use - Part 1: Chemical analysis methods
GB/T 16886.1, Biological evaluation of medical devices - Part 1: Evaluation and testing
YY/T 0171, Surgical instruments - Packaging, Marking and Instructions Pharmacopoeia of the People's Republic of China (2015 Edition) Part IV
3 Classification
3.1 Type
3.1.1 The dilator is the expansion section within 60mm of the ring line from the head end. It is usually composed of 3 gradual units. Each unit is about 20mm long.
4 Requirements
4.1 Appearance
4.1.1 The head of the dilator shall be round and smooth, and no fibers shall be pulled out.
4.1.2 The marks of the dilator shall be clear and obvious.
4.1.3 The overall dilator shall be smooth and uniform in color, and there shall be no cracks, burrs, plastic flow, or defects.
4.2 Dimensions
The gradual diameter range d1 and d2 of the dilator, the tilt angle theta of the tip shall meet the requirements of Table 1.
4.3 Physical properties
4.3.1 The dilator shall be able to withstand 50N axial tension without breaking.
4.3.2 Apply a force of 15N to the head of the dilator, and there shall be no obvious deformation or fracture.
NOTE: Obvious deformation can be understood as the tip tilt angle theta<=0° after applying force.
4.4 Chemical properties
4.4.1 Heavy metals
The total content of heavy metals in the dilator test solution shall not exceed 1µg/mL.
4.4.2 PH
Compare the dilator test solution with the blank solution. The difference in pH shall not exceed 1.5.
4.4.3 UV absorbance
The absorbance of the dilator test solution in the wavelength range of 250nm~320nm shall not exceed 0.1.
4.5 Sterilization
The dilator shall be sterilized by a confirmed sterilization process, and the sterilized dilator shall be sterile.
NOTE: N is the loading force.
Figure 2 -- Schematic diagram of bending performance test of the dilator
5 Test methods
5.4 Chemical properties
5.4.1 Test solution preparation
Take sample. Add water at a ratio: 0.2g of sample to 1mL of water. Keep constant temperature at (37±1)°C for 8h. Separate the sample from water. Cool to room temperature as the test solution. Take the same volume of water and place it in a glass container. Prepare blank control solution in the same way.
5.4.2 Heavy metals
Test according to the method specified in 5.6.1 of GB/T 14233.1-2008, in accordance with the requirements of 4.4.1.
5.4.3 PH
Test according to the method specified in 5.4.1 of GB/T 14233.1-2008, in accordance with the requirements of 4.4.2.
5.4.4 UV absorbance
Test according to the method specified in 5.7 of GB/T 14233.1-2008, in accordance with the requirements of 4.4.3.
5.5 Sterilization
The inspection is carried out in accordance with the method stipulated in the fourth part 1101 sterile inspection method of the "Pharmacopoeia of the People's Republic of China" (Edition 2015), in accordance with the requirements of 4.5.
NOTE: Each sterilization batch undergoes an effective monitoring process to make the product sterile.
5.6 Residual ethylene oxide
Test according to the method in Clause 9 of GB/T 14233.1-2008, in accordance with the requirements of 4.6.
5.7 Biological evaluation
Evaluate according to the corresponding method of biological evaluation, in accordance with the requirements of 4.7.
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 21 pages — is available in the English PDF.
Referenced standards
Normative references
- GB/T 14233.1-2008Test methods for infusion, transfusion, injection equipments for medical use - Part 1: Chemical analysis methods
- GB/T 16886.1Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
- YY/T 0171Surgical instruments - Packaging, Marking and Instructions
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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 16886.1-2022 — Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
YY/T 0171-1994 — General specifications for the packaging of surgical instruments
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