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.
Basic Data
Standard ID
YY/T 1704.1-2020 (YY/T1704.1-2020)
Description (Translated English)
Cervical dilator for single use - Part 1: Gradual dilator
Sector / Industry
Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard
C36
Classification of International Standard
11.040.30
Word Count Estimation
7,755
Date of Issue
2020
Date of Implementation
2021-01-01
Issuing agency(ies)
State Drug Administration
Summary
This standard specifies the classification, requirements, test methods, marking, packaging and instructions for use, transportation, storage and sterilization validity of progressive single-use cervical dilators. This standard applies to disposable cervical dilators, which are used for oral dilation of the cervix in obstetrics and gynecology and family planning departments. This standard does not apply to cervical dilators made of metal.
