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YY/T 1704.2-2020Cervical dilator for single use - Part 2: Expandable dilators (English PDF)

一次性使用宫颈扩张器第2部分：膨胀式

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

February 21, 2020

Implementation date

January 1, 2021

Scope

YY/T 1704.2-2020 is the English-translated version of 一次性使用宫颈扩张器第2部分：膨胀式.

YY/T 1704.2-2020 is the Chinese pharmaceutical industry standard for the single-use swelling cervical dilator, the hygroscopic dilator that opens the cervix by absorbing moisture and expanding.

It is the second 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 before and after swelling, the rate and extent of expansion, the strength of the dilator and of its retrieval cord, 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 1704.2-2020

National Standard of the People's Republic of China

Issued by: National Medical Products Administration of the People's Republic of China

Foreword3
1 Scope4
2 Normative references4
3 Classification4
4 Requirements5
5 Test methods7
6 Marks, packaging and instruction manual8
7 Transport, storage8

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 swollen cervical dilator for single use (hereinafter referred to as the dilator).

This Part is applicable to the single-use swollen cervical dilator used for dilation of the uterus in the 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 Composition and structure

3.1.1 The dilator consists of a rod body and a placer (if any), as shown in Figure 1.

4 Requirements

4.1.1 The rod of the dilator shall be smooth and uniform in color, and there shall be no defects such as cracks and burrs, and the head of the rod shall be smooth.

4.1.2 The dilator placer (if any) shall be smooth and free of sharp edges and burrs.

4.2 Dimensions

The length and diameter of the dilator rod shall meet the requirements of Table 1.

4.3 Physical properties

4.3.1 The manufacturer shall specify the use time of the dilator and provide information on the diameter change with time after the rod has absorbed water (during use).

4.3.2 The dilator rod body shall have no cracks in the initial state and the state after water absorption (use time).

4.3.3 The dilator rod body and the placer (if any) shall be firmly connected in the initial state and the state after water absorption (use time).

4.3.4 There shall be no visible falling off after the dilator rod absorbs water.

4.4 Chemical properties

4.4.1 Heavy metals

The total content of heavy metals in the dilator extract shall not exceed 1µg/mL.

4.4.2 PH

Compare the dilator extract with the blank solution. The difference in pH shall not exceed 1.5.

4.5 Sterilization

The dilator shall be sterilized by a confirmed sterilization process, and the sterilized dilator shall be sterile.

4.6 Residual ethylene oxide

If the dilator is sterilized by ethylene oxide, the residual amount of ethylene oxide shall not exceed 10µg/g.

4.7 Biological evaluation

The final product of the dilator shall be evaluated according to GB/T 16886.1.

Take sample. Add water at a ratio: 0.1g of dilator (including placer, if any) to 5mL of water. Keep constant temperature at (37±1)°C for 1h. Separate the sample from water. Cool to room temperature as the extract. Take the same volume of water and place it in a glass container. Prepare blank control solution in the same way.

5 Test methods

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.

5.5 Sterilization

It shall be carried out in accordance with the general principles "sterile test method" of part IV 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 specified in GB/T 14233.1-2008. Use gas chromatography in arbitration, 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.

6 Marks, packaging and instruction manual

The marks, packaging and instruction manual of the dilator shall comply with the provisions of YY/T 0171.

7 Transport, storage

7.1 Transport

Packaging and transportation requirements are in accordance with the

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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 18 pages — is available in the English PDF.

Referenced standards

Normative references

Similar standards

YY/T 1704.1-2020|YY/T 1704.3-2021|YY 0336-2020

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