YY/T 1567: Evolution and historical versions
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Basic data | Standard ID | YY/T 1567-2025 (YY/T1567-2025) | | Description (Translated English) | (Female condoms - Technical requirements and test methods) | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C36 | | Classification of International Standard | 11.200 | | Date of Issue | 2025-06-18 | | Date of Implementation | 2026-07-01 | | Older Standard (superseded by this standard) | YY/T 1567-2017 | | Issuing agency(ies) | National Medical Products Administration | YY/T 1567-2017: Female condoms - Requirements and test methods---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.
Female condoms-Requirements and test methods
ICS 11.200
C36
People's Republic of China Pharmaceutical Industry Standard
Female condom technical requirements and test methods
(ISO 25841.2014, IDT)
Published on.2017-09-25
2018-10-01 implementation
State Food and Drug Administration issued
Content
Foreword III
Introduction IV
1 Scope 1
2 Normative references 1
3 Terms and Definitions 1
4 Quality Verification 3
5 Design 4
6 barrier performance 6
7 Biocompatibility 6
8 clinical (for human body) test 6
9 Blasting volume and pressure 7
10 Stability and shelf life test 7
11 pinhole free 8
12 visible defects 8
13 packaging and signs 8
14 Inspection report 10
Appendix A (Normative Appendix) Applicable to a qualified production sampling plan for a continuous production lot with sufficient quantity and transfer rules 12
Appendix B (informative appendix) Sampling plan 13 for the approval of isolated production batches
Appendix C (Normative) Determination of total amount of lubricant for individual packaging female condoms 14
Appendix D (Normative) Female condom length determination 15
Appendix E (Normative) Determination of the width of female condoms 16
Appendix F (Normative) Determination of the thickness of female condoms 17
Appendix G (Normative) Test for barrier properties using the phage method 18
Appendix H (Normative) Determination of blasting volume and pressure 22
Appendix I (Normative) Determination of storage period - real-time stability study 24
Appendix J (Normative) Accelerated Aging Research Analysis and Operation Guide 26
Appendix K (Normative Appendix) Pinhole Test 28
Appendix L (Normative) Female condom package integrity test 34
Reference 36
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard uses the translation method equivalent to ISO 25841.2014 "Technical Requirements and Test Methods for Female Condoms" (English version).
This standard is compared with ISO 25841.2014 "Technical requirements and test methods for female condoms" (English version).
modify.
--- Modified some formatting formats according to Chinese habits;
--- The order of the appendix has been rearranged;
--- Amend some statements applicable to international standards to those applicable to Chinese standards.
The documents of our country that have a consistent correspondence with the international documents referenced in this standard are as follows.
--- GB 7544 natural latex rubber condom technical requirements and test methods (GB/T 7544-2009, ISO 4074.2002,
IDT)
--- GB/T 16886.1 Biological evaluation of medical devices - Part 1. Evaluation and testing of risk management procedures (GB/T 16886.1-
2011, ISO 10993-1..2009, IDT)
--- GB/T 16886.5 Biological evaluation of medical devices - Part 5. In vitro cytotoxicity test (GB/T 16886.5-2003,
ISO 10993-5.1999, IDT)
--- GB/T 16886.10 Medical device biological evaluation Part 10. Stimulation and delayed type hypersensitivity test
(GB/T 16886.10-2005, ISO 10993-10.2002, IDT)
--- GB/T 16886.11 Biological evaluation of medical devices - Part 11. Systemic toxicity test (GB/T 16886.11-2011,
ISO 10993-11.2006, IDT)
---YY/T 0287 Medical device quality management system for regulatory requirements (YY/T 0287-2003, ISO 13485.
2003, IDT)
---YY/T 0316 (all parts) Medical device risk management for medical devices [ISO 14971 (all parts)]
---YY 0466 (all parts) Medical devices for medical device labels, markings and symbols for providing information [ISO 15223
(all parts)]
Please note that some of the contents of this document may involve patents. The issuing organization of this document is not responsible for identifying these patents.
This standard is proposed and managed by the National Family Planning Equipment Standardization Technical Committee (SAC/TC169).
This standard was drafted. Tianjin Family Planning Medicine Management Center, Tianjin Medical Instrument Factory Co., Ltd., Shanghai Dahua Medical Equipment
Co., Ltd., Shanghai Medical Device Testing Institute.
The main drafters of this standard. Yan Juxian, Yao Tianping, Ren Biao, Chen Hua, Zhang Suying, Wang Zezhen, Gu Jia, Wang Xiaodong, and Zhong Shangde.
Introduction
A female condom is a sheath that completely covers the vaginal canal and remains in the vagina during sexual intercourse and after the penis is withdrawn to prevent accidents.
Pregnancy and sexually transmitted diseases (STIs).
A female condom is different from a male condom, which remains in the vagina after the penis is withdrawn. Its external fixed parts can partially cover
Female external genitalia. A pinhole-free, intact polymer film that effectively blocks human immunodeficiency virus (HIV), other sexually transmitted diseases
The role of infectious media and sperm. Female condoms made from polymer films are effective for contraception and prevent sexually transmitted infections.
To ensure its effectiveness, the female condom should be able to be fully inserted into the vaginal canal, free of pinholes, flawless, and have appropriate physical properties to enable it.
It will not break during use, use the correct packaging to protect the products during the storage period, and use the appropriate logo to facilitate consumer use.
To ensure safety, the female condom and any lubricants, additives, dressings, and individual used during normal storage or use
The packaging material or powder should contain neither substances nor substances sufficient to cause toxicity, allergies, local irritation or other hazards.
Female condoms are non-sterile medical devices. Manufacturers should take appropriate precautions to produce products during production and packaging.
Microbial contamination is minimized. In order to ensure high quality, female condoms should be designed and produced under a good quality management system.
Refer to GB/T 19000, GB/T 19001, GB/T 19004, ISO 13485 and ISO 14971. The manufacturer should place the product before it is placed on the market.
Stability testing of new or improved female condoms to estimate their shelf life to ensure that manufacturers have sufficient data to support them
Management, third-party laboratories, and purchasers are able to obtain and review these data during the claimed storage period. Also for the purpose of reducing
Less third parties need to conduct long-term stability testing. The product should also be tested for real-time storage period before the product is placed on the market. But the test
The test does not need to be completed before the product is placed on the market.
Because female condoms are a relatively new type of device, the design of different products is quite different. Therefore, it is necessary to carry out clinical trials.
To continue to find evidence of its safety and effectiveness. These studies can provide an overall view of the overall performance of the female condom's internal and external fixed parts,
Failure mode, safety and effectiveness are evaluated. The contents listed in this standard are the minimum technical requirements and test methods. New design may require
More stringent fixtures and other features, or manufacturers are required to re-define specifications and test methods.
All of these issues are covered in this standard.
Female condom technical requirements and test methods
1 Scope
This standard specifies the minimum technical requirements and tests for female condoms that are provided to consumers for contraception and help prevent sexually transmitted diseases.
Test method.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article.
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
GB/T 2828.1-2012.Sampling procedures for sampling by sampling - Part 1 . Batch-by-batch inspections by Retrieving Quality of Acceptance (AQL)
Plan (ISO 2859-1.1999, IDT)
Technical requirements and test methods for ISO 4074 natural latex rubber condoms (Naturalrubberlatexmalecondoms-
Requirementsandtestmethods)
ISO 10993-1 Biological evaluation of medical devices - Part 1. Evaluation and testing of risk management processes (Biologicalevalution
ofmedicaldevices-Part 1.Evalutionandtestingwithinariskmanagementprocess)
ISO 10993-5 Biological evaluation of medical devices - Part 5. In vitro cytotoxicity test (Biologicalevalutionof
medicaldevices-Part 5.Testsforinvitrocytotoxicity)
ISO 10993-10 Biological evaluation of medical devices - Part 10. Stimulation and delayed hypersensitivity test (Biological
evalutionofmedicaldevices-Part 10.Testsforirritationandskinsensitization)
ISO 10993-11 Biological evaluation of medical devices - Part 11. Systemic toxicity test (Biologicalevalution ofmedical
devices-Part 11.Testsforsystemictoxicity)
ISO 13485 Medical Device Quality Management System for regulatory requirements (Medicaldevices-Qualitymanagement
systems-Requirementforregulatorypurposes)
ISO 14155 Clinical investigation of human medical devices (Clinicalinvestigationofmedivicesforhumansubjects)
ISO 14971 Medical Device Risk Management for Medical Devices (Medicaldevices-Applicationofriskman-
Agementtomedicaldevices)
ISO 15223 (all parts) Medical devices used for labeling, marking and providing information for medical devices
3 Terms and definitions
The following terms and definitions as defined in GB/T 2828.1-2012 apply to this document.
3.1
Receive quality limit (AQL) acceptablequalitylimit
The worst-case average quality level that can be allowed when a continuous series of batches is submitted for acceptance sampling.
See [GB/T 2828.1-2012, definition 3.1.26]
3.2
Consumer package consumerpackage
One or more individually packaged female condom packages distributed (sold) to the consumer.
3.3
Date of manufacture dateofmanufacture
Female condom bag production or female condoms are placed on separate packaging dates. If the date of product packaging is the date of manufacture, then
The storage period of the female condom in bulk is clarified, and the storage period of the product is measured using the sample stored for the longest bulk storage period.
3.4
Expiration date expirydate
The final date of shelf life.
3.5
Female condom femalecondom
A sheath that completely covers the vaginal canal and remains in the vagina during sexual intercourse. It can be used for contraception and can prevent sexually transmitted diseases
infection.
3.6
Identification number identification number
A number printed by a manufacturer on a consumer packaging material or an identification number consisting of a combination of numbers, symbols, and letters. Identification code can be used to identify the package
The batch number of a single female condom. The identification code traces the entire process from production to packaging to distribution (sales).
Note. When there is only one type of female condom in the consumer package, the identification code and batch number can be the same. If the consumer package contains different types
Female condoms, such as female condoms of different shapes or colors, have an identification code different from the lot number.
3.7
Single package individualcontainer
Direct packaging of a single female condom.
3.8
Check level inspectionlevel
The relationship between batch size and sample size.
See [GB/T 2828.1-2012, definition 10.1]
3.9
Batch lot
A collection of female condoms produced under the same elements. The element refers to the design, color, shape, specification and formula of the female condom.
Same, using the same specification of raw materials, using the same process and general equipment for production in the same time, and using
The lubricant is the same as any other additive or dressing, and the individual package types are the same.
Note. This standard does not specify batches, but the buyer can give batches in the procurement contract. Note that too large a batch will increase the product's distribution and control.
Difficulty. A maximum of 500,000 female condoms are recommended for a single production batch.
3.10
Lot number lotnumber
The identification code used by the manufacturer to identify a batch of individual packaged female condom batches consisting of a combination of numbers or numbers, symbols and letters.
From the identification code, the entire process from manufacturing to packaging can be traced.
3.11
Batch test lottest
Conduct a conformity assessment of a batch of products.
Note. Batch inspections can be limited to parameters that vary between batch and batch.
3.12
Invisible pinhole non-visiblehole
Visually visible or normalized visual acuity, invisible small holes in female condoms, but can be found by appropriate water leak tests
Small hole.
Note 1. For example, water can be injected into a female condom and rolled on absorbent paper to detect the presence of water leakage.
Note 2. This standard specifies the appropriate test method.
3.13
Sampling plan samplingplan
The combination of sample size used and the relevant batch acceptance criteria.
3.14
Storage period shelf-life
The time from the date of manufacture to the date of claim of expiration. During this time, the condom should meet the requirements of the various regulations.
3.15
Total clinical failure totalclinicalfailure
In the risk assessment, clinical rupture, shedding, and dislocation of the protective function of the female condom, invagination or any other failure
The sum of the number of forms.
Note. The total clinical failure rate is the number of female condoms for all clinical failures divided by the number of female condoms used in sexual intercourse.
3.16
Visible pinhole visiblehole
Visually visible or corrected visual acuity, visible small holes or tears on the female condom.
3.17
Visible defect visibledefect
In addition to visible pinholes, any rupture, defect, severe deformation, permanent wrinkles, adhesions, attachments and impurities on the female condom.
4 quality verification
Female condoms are products that are produced in large quantities. There is inevitably a difference between each product. And every time in the production process
There may be a small number of female condoms that do not meet the requirements of this standard. In addition, the main test method in this standard is the destructive test. therefore,
The use of this standard to extract representative samples from batch or batch batches for product consistency testing is the only viable option.
The basic sampling plan is given in GB/T 2828.1-2012. Please refer to ISO /T R8550, select the appropriate sampling system, sampling table or pumping
The sample program tests the discontinuous batch products. For testing purposes, samples should be based on the lot number rather than the identification code. Operation and prior to sampling
Storage conditions are recorded.
Appropriate sampling plans that tend to protect consumers should be selected, and Appendix A and Appendix B are appropriate sampling plans.
The sampling plan based on GB/T 2828.1-2012 in Appendix A is most suitable for the consistency of continuous batch products by manufacturers or purchasers.
test. In order to ensure the maximum protection for consumers, when the quality is found to be degraded, more stringent inspection measures should be taken. For the initial inspection
The two batches of products tested cannot be guaranteed to be safe by tightening rules, but as the number of continuous batches increases, the quality of inspections gradually becomes more
Plus effective. When the number of batches tested is 5 or more, the sampling plan in Appendix A is recommended.
The sampling plan based on GB/T 2828.1-2012 in Appendix B is recommended for the inspection of isolated batch products. When the number of inspection batches is less than 5
In the case of batches, it is recommended to use this sampling plan for product inspection, such as disputes, for comparison, type inspection, quality assessment or short production time.
Continuous batch.
The number of samples for inspection should be found in GB/T 2828.1-2012 given the batch size of the product. Different manufacturing
The batch size specified by the quotient is not the same. Manufacturers use batch size as one of the parameters of process and quality control.
The quality evaluation of female condoms should not be limited to the final product. The design and production should also meet the requirements of ISO 13485, including.
a) control the working environment to ensure product safety;
b) focus on risk management and design transfer during product development;
c) specific requirements for inspection and traceability of implantable devices;
d) specific requirements for process documentation and verification of sterile medical devices;
e) Specific requirements for verification of the effectiveness of corrective and preventive actions.
5 design
5.1 General
Female condoms should prevent pregnancy and sexually transmitted infections during vaginal intercourse. Female condoms are different from male condoms, it
Retained in the vagina after placement. Female condoms can be made from natural latex rubber (NRL) or synthetic materials.
The design of a new female condom should consider the following.
a) the product is inserted into the vagina;
b) the product remains in the vagina during sexual intercourse or when the penis is withdrawn;
c) prevent penile dislocation in sexual intercourse;
d) The product is safely removed after sexual intercourse.
5.2 Product placement device
The design of a female condom should include a device or tool to help insert and place it in the vagina, or without these additional means
The method of inserting it into the vagina.
The design, materials, and/or methods of the placement device should be evaluated as part of the design verification and functional evaluation of the final product clinical evaluation.
See Chapter 8 for the method.
Materials for placement of the device should be evaluated for biocompatibility (irritant, sensitizing, cytotoxic, and acute systemic toxicity). According to the first
Chapter 7, the project should be evaluated along with the female condom finished product.
The manufacturer shall specify the appropriate specifications and test methods to verify the design and ensure the quality of the materials and components used in each placement device and
consistency. Specifications considered by the manufacturer should include critical dimensions, hardness, stiffness and density.
5.3 fixed parts
The design of the female condom should include a fixed intravaginal component that keeps the female condom in the vagina during sexual intercourse and is in use.
It can be safely removed afterwards. The internal fixation components of the vagina can be attached to a female condom or placed in a female condom. Vaginal internal fixation components include
However, it is not limited to elastic rings and open or closed cell sponge assemblies.
The design of the female condom should include external fixation components so that the open end of the female condom remains open during sexual intercourse, avoiding the penis
Misplaced to prevent female condoms from sinking. External fixation components include, but are not limited to, a ring, triangle or other attached to the open end of a female condom
Shaped components.
The design, materials, and/or methods of the fixed components should be evaluated as part of the design verification and functional evaluation of the final product clinical evaluation.
See Chapter 8 for the method. This should be used to ensure that the fixed parts are always attached to the female condom or placed in the female condom to make it during sexual intercourse.
Keep it intact when taking out a female condom. When the female condom is removed from the vagina, the fixation components are then completely removed from the vagina.
The material of the fixed part should be evaluated for biocompatibility (irritant, sensitizing, cytotoxic and acute systemic toxicity). According to the first
Chapter 7, the project should be evaluated along with the female condom finished product.
The manufacturer shall specify the appropriate specifications and test methods to verify the design and ensure the quality of the materials and components used in each fixed component and
consistency. Specifications considered by the manufacturer should include critical dimensions, hardness, stiffness and density.
5.4 Lubrication
The design of a female condom can include any of the following lubrication methods.
a) pre-coating the lubricant on the packaged female condom;
b) The lubricant is packaged separately and the user applies it to the female condom when using it;
c) Apply lubricant to the female condom beforehand, and provide a separate packaging lubricant.
Different types of female condoms are designed to use different types and amounts of lubricants. The manufacturer shall follow the clinical trial described in Chapter 8.
The amount of lubricant used in the stage to specify the actual amount range. When the method in Appendix C is used, 13 female condoms are taken from each batch.
The amount of lubricant used should be within the range specified by the manufacturer during the test.
The manufacturer shall specify the appropriate specifications and test methods to verify the design and ensure the quality and consistency of the lubricant. Manufacturer's consideration
Grid should include viscosity.
5.5 size
5.5.1 Length
The length of a female condom varies from design to design. The manufacturer shall give a nominal value or length range, which is a range or length
It should be consistent with the length of the female condom used in the clinical trials described in Chapter 8. When testing according to the method in Appendix D, each
A total of 13 female condoms were drawn in batches, and the length of all female condoms should be within the range specified by the manufacturer.
5.5.2 Width
The width of a female condom varies from design to design. The manufacturer shall give a nominal width range, which shall be as described in Chapter 8.
The female condom used in the clinical trials was of the same width. When testing according to the method in Appendix E, 13 women were selected per batch.
Condoms, the width of all female condoms should be within the range specified by the manufacturer.
5.5.3 Thickness
The thickness of a female condom varies from design to design. The manufacturer shall give a nominal thickness range, which shall be as described in Chapter 8.
The female condom used in clinical trials was of uniform thickness. When testing according to the method in Appendix F, 13 women were selected per batch.
Condoms, the thickness of all female condoms should be within the manufacturer's specifications (thickness from clinical trials).
5.6 Risk assessment
5.6.1 The product should be evaluated for risk in accordance with ISO 14971. The assessment should identify potential failure modes of the product and any other
For safety and effectiveness issues, the failure modes identified in the risk analysis should be compared to those listed in 5.6.2. except this
In addition to known failure modes, any new failure modes in the design and operation of pre-clinical or clinical trials of female condoms should be reviewed.
estimate. Manufacturers should provide risk assessment results when required by regulatory agencies.
5.6.2 The following are definitions of known female condom failure modes.
a) Clinical rupture refers to rupture during sexual intercourse or when a female condom is removed from the vagina. Clinical rupture has potential adverse clinical
Bed consequences. The clinical rupture rate is calculated as the number of female condom ruptures reported during sexual activity or when taking out a female condom.
The number of female condoms used to divide sex.
Note. Total rupture refers to the total amount of female condoms that rupture before, during, or after sexual activity. It includes clinical rupture and non-clinical rupture.
The total rupture rate is calculated as the total number of ruptured female condoms divided by the number of female condoms that are unpacked.
b) Shedding refers to the situation in which a female condom slides completely out of the vagina during sexual intercourse. The shedding rate is calculated as. a female condom that has fallen off
The number divided by the number of female condoms used in sexual activity.
c) Misplacement means that when inserted into the vagina, the penis is located between the female condom and the vaginal wall. The misalignment rate is calculated as. the reported error...
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