YY/T 1567-2025Female condoms - Requirements and test methods (English PDF)

Foreword

This document complies with the provisions of GB/T 1.1-2020 "Standardization Work Guidelines Part 1: Structure and Drafting Rules of Standardization Documents".

Drafting.

This document replaces YY/T 1567-2017 "Technical Requirements and Test Methods for Female Condoms" and is consistent with YY/T 1567-2017.

Compared to previous versions, aside from structural adjustments and editorial changes, the main technical changes are as follows.

---Terminology and definitions have been revised and added (see Chapter 3, Chapter 3 of the 2017 edition);

---The description of the default number of items in an unknown batch for quality verification has been removed (see Chapter 4 in the 2017 edition);

---Added "Relevant descriptions of design and production in the quality evaluation of female condoms during quality verification" (see Chapter 4);

---The requirements for "Quality Verification" have been changed (see Chapter 4, Chapter 4 in the 2017 edition);

---Added clauses "d), f), g), h) of "The design of new female condoms should consider the following points," and revised the original clause arrangement.

Preface (see 6.1, 5.1 in the 2017 edition);

---Changes have been made to "Fixed Components" (see 6.3, 5.3 in the 2017 version), "Lubrication" (see 6.4, 5.4 in the 2017 version), "Length", and "Width".

The content of "thickness" (see 6.5, 5.5 in the 2017 edition) and "risk assessment" (see 6.6, 5.6 in the 2017 edition);

---The content regarding "barrier performance" has been changed (see Chapter 7, Chapter 6 in the 2017 edition);

---The content on "Biocompatibility" has been revised (see Chapter 8, Chapter 7 in the 2017 edition);

---The content of "Clinical (for human) trials" has been revised (see Chapter 9, Chapter 8 in the 2017 edition);

---Added "Microbial Contamination" (see Chapter 10);

---The regulations regarding "explosive volume and pressure" have been amended (see Chapter 11, Chapter 9 of the 2017 edition);

---Added "Definition of Production Date and Factors Affecting Shelf Life" and "Humidity Requirements During Accelerated Aging" (see 12.1 and 12.2).

12.3);

---The rules regarding "logo" have been changed (see 15.3, 13.3 in the 2017 edition);

---Added "g in the test report" (see Chapter 16);

---Added "A.1 Quality Verification", Table A.1 now includes specifications for the inspection level and acceptance quality limits for fixed component dimensions (see appendix).

Record A);

---The content of "Sampling Plan Applicable to Acceptance of Isolated Production Lots" has been revised (see Appendix B, Appendix B of the 2017 edition);

---The content of "C.2.3 Solvent", "C.3.7", "C.3.8" and "C.4 Result Representation" has been revised (see Appendix C, Appendix C of the 2017 edition);

---Changes have been made to "Measurement of Female Condom Length", "Measurement of Female Condom Width", "Measurement of Female Condom Thickness", and "Female Condom".

The contents of "Integrity Test of Individual Packages" and "Barrier Performance Test Using Phage Method" (see Appendix D, Appendix E, Appendix F, Appendix) Appendix G, Appendix H, Appendix D, Appendix E, Appendix F, Appendix L, and Appendix G of the 2017 edition);

---Added "Determination of Microbial Contamination" (see Appendix I);

---The minimum and maximum times for temperature and humidity control have been revised (see Appendix J, Appendix H of the 2017 edition);

---Added "Calculating the maximum fill power of female condoms" (see Appendix K);

---Added humidity control and situations where humidity control is not applicable (see Appendix L and Appendix M).

This document is modified to adopt ISO 25841:2017 "Technical requirements and test methods for female condoms".

The technical differences between this document and ISO 25841:2017, and the reasons therefor, are as follows.

---The relevant EU requirements have been removed to accommodate my country's technological conditions;

---Added a note regarding the organotin content of polyurethane materials to adapt to my country's technical conditions (see note 2 in Chapter 8);

---Some content in C.3.7 and C.3.8 has been modified;

---Some content in F.3.8 has been changed;

---Some content in H.5 has been modified.

The following editorial changes have been made to this document.

---Add normative references ISO 10993-3 and ISO 10993-11.

Please note that some content in this document may involve patents. The issuing organization of this document assumes no responsibility for identifying patents.

This document was proposed by the National Medical Products Administration.

This document is under the jurisdiction of the National Technical Committee on Standardization of Contraceptive and Obstetric Devices (SAC/TC169).

Introduction

A female condom is a sheath that completely covers the vaginal cavity and remains inside the vagina during intercourse and after the penis is withdrawn to prevent accidental penetration.

Ectopic pregnancy and sexually transmitted diseases (STIs).

Female condoms differ from male condoms in that they remain inside the vagina after the penis is withdrawn. Their external fastening components partially cover the vagina.

Female external genitalia. A pinhole-free, intact polymer film effectively blocks HIV and other sexually transmitted diseases.

The role of the infectious medium and sperm. Female condoms are made of polymer film, without holes or defects, and have sufficient strength during use.

It will not be damaged. Use proper packaging to protect the product within its shelf life. Appropriate labeling should be used for consumer convenience. It can be used for contraception and...

Prevention of sexually transmitted diseases.

To ensure safety, during normal storage or use, female condoms and any lubricants, additives, adjuvants, or individual condoms should be kept away from the air.

Packaging materials or powders should not contain or release substances that are toxic, cause allergies, local irritation or other harm.

Female condoms are non-sterile medical devices. Manufacturers should take appropriate precautions to prevent the generation of contaminated products during manufacturing and packaging.

To minimize microbial contamination. To ensure high quality, female condoms should be designed and manufactured under a sound quality management system.

Refer to ISO 9000, ISO 9001, ISO 9004, ISO 13485, and ISO 14971.Manufacturers should address new or...

Improved female condoms undergo stability testing to estimate their shelf life, ensuring that manufacturers have sufficient data to support their claimed storage capacity.

During the storage period, regulatory agencies, third-party laboratories, and purchasers can access and review this data, which also serves to reduce the risk of third-party interference.

Long-term stability testing is necessary. Real-time storage testing should also be conducted before the product is launched to the market, but this testing is not required.

Completed before the product is launched on the market.

Because female condoms are a relatively new type of medical device, different products vary greatly in design. Therefore, clinical trials are necessary.

To continue searching for evidence of its safety and effectiveness. These studies can assess the overall performance of the internal and external fixation components of female condoms, Failure modes, safety, and effectiveness are assessed. This document lists the minimum technical requirements and test methods. New designs may require More stringent requirements for fixed components and other characteristics, or the need for manufacturers to redefine specifications and testing methods.

All of these issues are addressed in this document.

Technical requirements and test methods for female condoms

1 Scope

This document specifies the minimum technical requirements for female condoms and describes the corresponding testing methods.

This document applies to female condoms provided to consumers for contraception and to help prevent sexually transmitted diseases.

2 Normative references

The contents of the following documents, through normative references within the text, constitute essential provisions of this document. Dated citations are not included.

For references to documents, only the version corresponding to that date applies to this document; for undated references, the latest version (including all amendments) applies.

This document.

GB/T 2828.1-2012 Sampling Procedures for Inspection by Attributes – Part 1: Lot-by-lot Inspection Sampling Indexed by Acceptable Quality Limit (AQL) Plan (ISO 2859-1:1999, IDT) ISO 2859-1 Sampling Procedures for Inspection by Attributes – Part 1: Sampling Schemes Indexed by Acceptable Quality Limit (AQL) for Lot-by-Lot Inspection ISO 4074 Technical requirements and test methods for male condoms made from natural rubber latex.

Note. GB/T 7544-2019 Technical Requirements and Test Methods for Male Condoms Made of Natural Rubber Latex (ISO 4074:2015, IDT) ISO 10993-1 Biological evaluation of medical devices – Part 1: Evaluation and testing in a risk management process Note. GB/T 16886.1-2022 Biological evaluation of medical devices – Part 1: Evaluation and testing in risk management processes (ISO 10993-1.

2018, IDT)

ISO 10993-3 Biological evaluation of medical devices – Part 3: Genotoxicity, carcinogenicity and reproductive toxicity testing Note. GB/T 16886.3-2019 Biological evaluation of medical devices – Part 3: Genotoxicity, carcinogenicity and reproductive toxicity tests (ISO 10993-3.

2014, IDT)

Note. GB/T 16886.5-2017 Biological evaluation of medical devices - Part 5: In vitro cytotoxicity tests (ISO 10993-5:2009, IDT) Note. GB/T 16886.10-2017 Biological evaluation of medical devices - Part 10: Irritation and skin sensitization tests (ISO 10993-10:2010, IDT) Note. GB/T 16886.11-2021 Biological evaluation of medical devices - Part 11: Systemic toxicity testing (ISO 10993-11:2017, IDT) Note. YY/T 0297-1997 Clinical Investigation of Medical Devices (ISO 14155:1996, IDT)