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YY 0336-2020: Sterile vaginal dilator for single use
Status: Valid YY 0336: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY 0336-2020 | English | 249 |
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Sterile vaginal dilator for single use
| Valid |
YY 0336-2020
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| YY 0336-2013 | English | 519 |
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Sterile vaginal dilator for single use
| Obsolete |
YY 0336-2013
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| YY 0336-2002 | English | 359 |
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Sterile vagina dilator for single use
| Obsolete |
YY 0336-2002
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PDF similar to YY 0336-2020
Basic data | Standard ID | YY 0336-2020 (YY0336-2020) | | Description (Translated English) | Sterile vaginal dilator for single use | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C36 | | Classification of International Standard | 11.040.30 | | Word Count Estimation | 13,110 | | Date of Issue | 2020 | | Date of Implementation | 2021-04-01 | | Issuing agency(ies) | State Drug Administration | | Summary | This standard specifies the structure type and basic dimensions, requirements, test methods, inspection rules, signs, packaging and instructions for use, transportation, storage, and sterilization expiration date of disposable sterile vaginal dilator products. This standard applies to disposable sterile vaginal dilators used in obstetrics and gynecology examinations and vaginal cleaning. This standard does not apply to surgical vaginal dilators. | YY 0336-2020: Sterile vaginal dilator for single use---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Sterile vaginal dilator for single use
ICS 11.040.30C36
People's Republic of China Pharmaceutical Industry Standards
Released on 2020-03-31
Implementation of 2021-04-01
Issued by the National Medical Products Administration
Foreword
All technical content of this standard is mandatory.
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard replaces YY 0336-2013 "Sterile Vaginal Dilator for Single Use". Compared with YY 0336-2013, this standard mainly
The technical changes are as follows.
---Modified the scope of application (see Chapter 1, Chapter 1 of the.2013 edition);
---The year of the reference standard is revised (see Chapter 2, Chapter 2 of the.2013 edition);
---Modified the requirements of appearance (see 4.1, 4.1 of the.2013 edition);
---The size requirements are revised (see 4.2, 4.2 of the.2013 edition);
---Modified the performance requirements (see 4.3.1 and 4.3.2, the.2013 version of 4.3.1 and 4.3.2);
---The requirements for structural strength have been revised (see 4.4.2, 4.4.2 of the.2013 edition);
---Modified the requirements for cytotoxicity (see 4.7.1, 4.7.1 of the.2013 edition);
---The requirements for re-carrying out biological evaluations have been revised (see 6.4.4, 6.4.4 of the.2013 edition);
---Modified the test method of anti-deformation ability (see Appendix A, A.2 and A.3,.2013 edition of Appendix A, A.2 and A.3);
---The calculation formula for the amount of deformation has been added (see A.4).
Please note that some of the contents of this document may involve patents. The issuing agency of this document is not responsible for identifying these patents.
This standard was proposed by the State Drug Administration.
This standard is under the jurisdiction of the National Standardization Technical Committee for Family Planning Devices (SAC/TC169).
Drafting organizations of this standard. Shanghai Medical Device Testing Institute, Shanghai Heng Instrument Factory Co., Ltd., Henan Medical Device Testing Institute.
The main drafters of this standard. Yao Tianping, Wang Huyu, Wang Haitao, Weng Binghao, Zhang Junzi, Zou Bing, Qian Xinyi.
The previous editions of the standard replaced by this standard are as follows.
1 Scope
This standard specifies the structural type, basic dimensions, requirements, and tests of disposable sterile vaginal dilators (hereinafter referred to as dilators).
Requirements for inspection methods, inspection rules, signs, packaging and instructions for use, transportation, storage, and sterilization expiry date.
This standard applies to single-use sterile vaginal dilators used in obstetrics and gynecology examinations and vaginal cleaning.
This standard does not apply to vaginal dilators for surgery.
2 Normative references
The following documents are indispensable for the application of this document. For dated reference documents, only the dated version applies to this article
Pieces. For undated reference documents, the latest version (including all amendments) is applicable to this document.
GB/T 191 Graphical signs for packaging, storage and transportation
GB/T 2828.1 Sampling inspection procedures by attributes Part 1.Sampling plan for batch-by-batch inspection searched by acceptance quality limit (AQL)
GB/T 2829 Count sampling procedures and tables for periodic inspection (applicable to the inspection of process stability)
GB/T 9969 General Rules for Use of Industrial Products
GB/T 14233.1-2008 Medical transfusion, blood transfusion, injection equipment inspection methods Part 1.Chemical analysis methods
GB/T 16886.1 Biological Evaluation of Medical Devices Part 1.Evaluation and Testing in the Process of Risk Management
GB/T 16886.5 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 Test
YY/T 04666.1 Medical devices used for medical device labeling, marking and information symbols. Part 1.General requirements
The Fourth Pharmacopoeia of the People's Republic of China (2015 Edition)
3 Structure type and basic size
3.1 The structure of the expander
The expander is mainly composed of upper and lower lobes (including handles). According to the way it is opened, its main structural types include pivot type and push-pull type, such as
As shown in Figure 1 and Figure 2, if it can meet the requirements of this standard, other structural types can also be used.
4 requirements
4.1 Appearance
The surface of the expander should be smooth and free of impurities. The upper and lower lobes of the expander should have smooth arcs, no sharp edges, and no burrs, and the handle should have no sharp edges,
No glitches. When the upper and lower lobes of the dilator are closed, the contact surface to the outer edge should be smooth.
4.2 Dimensions
4.2.1 When the expander is in the natural closed state, the upper and lower lobes should be basically anastomosed, and the upper and lower lobes' head and left and right deviations should be no more than 2mm.
4.3 Performance
4.3.1 The adjustment of each gear of the expander should be flexible, and there should be no jamming.
4.3.2 The gears of the expander should be stable and should not slip, fall off or break.
4.3.3 In any working state, no part of the expander should block the view port.
4.4 Physical properties
4.4.1 Anti-deformation ability
When the expander is expanded to the maximum stop, a force of 20N is applied, and the allowable amount of deformation should not exceed 30mm.
4.4.2 Structural strength
When the expander expands to the maximum stop, apply a force of 30N, and any part should not slip off, crack or break.
4.5 Sterile
The dilator should be sterilized by a confirmed sterilization process, and the dilator after sterilization should be sterile.
4.6 Residual amount of ethylene oxide
If the expander is sterilized with ethylene oxide, the residual amount of ethylene oxide should not exceed 10μg/g.
4.7 Biological evaluation
4.7.1 Cytotoxicity
The cytotoxicity reaction should not be greater than level 1.
4.7.2 Delayed type hypersensitivity
There should be no delayed hypersensitivity.
4.7.3 Irritation test of vaginal mucosa
The average score of the stimulus index should not be greater than 4.
5 Test method
5.1 Appearance
Check with visual observation and hand touching, and it should meet the requirements of 4.1.
5.2 Dimensions
5.2.1 Keep the expander in a natural closed state and measure it with a general or special measuring tool, which should meet the requirements of 4.2.1.
5.2.2 Use general-purpose or special-purpose measuring tools to measure, which should meet the requirements of 4.2.2.
5.2.3 Expand the expander to the maximum stop, set the rear end of the field of view to be vertical, and measure with a general or special measuring tool. The central axis of the outer surface of the upper lobe
The vertical distance between the lowest point of the lower leaf and the intersection of the central axis of the outer surface of the lower leaf and the arc on the handle shall meet the requirements of 4.2.3.
5.3 Performance
5.3.1 Apply a force of 20N at a distance of 20mm from the front end of the upper lobe, and the expander should be in compliance with the requirements of 4.3.1 and 4.3.2 from closing and opening to all gears.
Regulations.
5.3.2 Place the expander at any working position, the bottom of the field of view in the line of sight coincides with the bottom of the lower lobe, and observe visually, the result should be consistent with
4.3.3 Regulations
5.4 Physical properties
5.4.1 Anti-deformation ability
According to the test method in Appendix A, apply a force to 20N for (5 ± 1) s, which should meet the requirements of 4.4.1.
5.4.2 Structural strength
According to the test method in Appendix A, apply the force to 30N for 1min, which should meet the requirements of 4.4.2.
5.5 Sterile
The test is carried out in accordance with the sterility inspection method stipulated in the Pharmacopoeia of the People's Republic of China, and shall meet the requirements of 4.5.
Note. Each sterilization batch is sterilized by a confirmed effective sterilization process, so that the product can achieve aseptic effect.
5.6 Residual amount of ethylene oxide
According to GB/T 14233.1-2008 specified in Chapter 9 or Chapter 10, the test should meet the requirements of 4.6.
Note. Gas chromatography is used in arbitration.
5.7 Biological evaluation
5.7.1 The test is carried out in accordance with the extract test method in GB/T 16886.5, which shall meet the requirements of 4.7.1.
5.7.2 Test according to the method in GB/T 16886.10, which should meet the requirements of 4.7.2.
5.7.3 Test according to the method in GB/T 16886.10, which should meet the requirements of 4.7.3.
6 Inspection rules
6.1 Acceptance
The expander should be inspected by the quality inspection department of the manufacturer, and only after it is qualified can it be submitted for acceptance.
6.2 Inspection method
Expanders should be submitted for inspection in batches, which are divided into batch-by-batch inspection (factory inspection) and periodic inspection (type inspection).
6.3 Batch inspection
6.3.1 The batch-by-batch inspection shall be carried out in accordance with the regulations in GB/T 2828.
6.3.2 The sampling plan adopts one-time sampling. The strictness of the sampling plan starts from the normal inspection sampling plan. The unqualified classification group and inspection items
The items, inspection level and acceptance quality limit (AQL) shall be in accordance with the provisions of Table 3 (calculated based on the number of unqualified products per hundred units).
6.4 Periodic inspection
6.4.1 Periodic inspection should be carried out in the following cases.
a) Before the new product is put into production (including the transfer of the old product to factory production);
b) When it is put into production after more than one year interval;
c) When there are major changes in product design, technology or materials;
d) Continuously produced products once a year;
e) When requested by the National Quality Supervision and Inspection Department.
6.4.2 Periodic inspection should be carried out in accordance with the provisions of GB/T 2829.
6.4.3 The periodic inspection adopts a one-time sampling plan, and its unqualified classification, test group, inspection item, discrimination level, and unqualified quality level
(RQL) and sampling plan according to Table 4 (calculated based on the number of non-conforming products per hundred units).
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