Foreword
This document is drafted in accordance with the provisions of GB/T 1.1-2020 "Guidelines for standardization work Part 1: Structure and drafting rules of standardization documents".
Please note that some of the contents of this document may involve patents. The issuing agency of this document does not assume the responsibility of identifying patents. This document is presented by the State Drug Administration.
This document is categorized by the National Technical Committee for Standardization of Family Planning Devices (SAC/TC169).
Introduction
Polyurethane condoms can be made from pure polyurethane latex or from a mixture of polyurethane latex and natural rubber latex. An intact polyurethane film serves as a barrier to human immunodeficiency virus (HIV), sexually transmitted infections (STIs) and sperm. Numerous comparative studies have demonstrated that the proper use of polyurethane condoms can provide effective contraception and reduce the risk of transmission of STIs, including HIV.
For condoms to be effective and prevent the transmission of STIs, they should be of appropriate size, free of pinholes, and strong enough to ensure no rupture during use, appropriate packaging to protect the product during its shelf life, and proper labeling to facilitate consumer use. All these issues are covered in this document.
Condoms are medical devices and should be produced under a good quality management system in order to ensure high quality products. Quality management requirements see GB/T 19000 family standards and YY/T 0287, risk management requirements see YY/T 0316 standards.
To ensure the safety of condoms, the condom itself and any lubricants, additives, labeling materials, excipients, individual packaging materials or powdered substances used should not have or release toxicity, cause allergies and local irritation or other hazards. Manufacturers should pay attention to research on the chemical characterization of condoms.
Condoms are non-sterile medical devices, but manufacturers are advised to take appropriate measures to minimize microbial contamination of the product during production and packaging. This document recommends that manufacturers reduce microbial contamination in advance during the production process, and the test methods used to determine the level of microbial contamination are described in Appendix G.
For manufacturers claim that the thickness is less than or equal to 0.022 mm condoms, it is appropriate for the manufacturer to develop the corresponding burst volume and burst pressure indicators, and submit supporting data to the regulatory authority or certification body to prove the safety and effectiveness of the product.
This document recommends that manufacturers conduct stability tests on new types of condoms before they are placed on the market to determine storage periods and to begin real-time stability test studies, which are specified in Chapter 10. Real-time stability testing can be used as part of the manufacturer's regulatory requirements for its marketed products. These requirements are used to ensure that manufacturers have sufficient data to support their claims of storage life prior to market launch, and that regulatory, third-party laboratories, and purchasers have access to these data for review. These requirements are also used to guide the needs of third parties conducting long-term stability studies.
1 Scope
This document establishes the minimum technical requirements and test methods for male condoms manufactured from polyurethane latex and offered to consumers for use in contraception and to help protect against sexually transmitted diseases.
This document applies to 100% polyurethane condoms and other composite male condoms made of polyurethane latex as the main material.
2 Normative reference documents
The following documents constitute the essential provisions of this document through the normative references in the text. Among them, note the date of the cited documents, only the date of the corresponding version applies to this document; do not note the date of the cited documents, the latest version (including all the revision of the list) applies to this document.
GB/T 2828.1-2012 Counting sampling inspection procedures Part 1: Lot-by-lot inspection sampling plan according to the acceptance quality limit (AQL) retrieval
GB/T 7544 Natural rubber latex male condom technical requirements and test methods
GB/T 16886.1 Medical device biological evaluation Part 1: Evaluation and testing in the risk management process
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
GB/T 19000 Quality management system foundation and terminology
YY/T 0316 Medical device risk management for medical devices
YY/T 0466.1 Medical devices, medical device labeling, marking and information symbols Part 1: General requirements
YY/T 1777 Male condom synthetic material condom technical requirements and test methods
ISO/TR 8550 (all parts) The selection and use of acceptance sampling systems for inspection of discrete items in lots (Guidance on the selection and usage of acceptance sampling systems for inspection of discrete items in lots) lots)
Pharmacopoeia of the People's Republic of China (2020 Edition)
3 terms and definitions
YY/T 1777 and GB/T 2828.1-2012 defined as well as the following terms and definitions apply to this document.
4 Quality assurance
Condoms are mass-produced products and differences between individual products are unavoidable, and a few condoms may not meet the requirements of this document during each production process. In addition, the main test methods in this document are destructive. Therefore, the only feasible way to evaluate whether the product meets the requirements of this document is to test a representative sample of a batch or consecutive batches. The basic sampling scheme is given in GB/T 2828.1-2012. At the same time, the corresponding sampling system, sampling table or sampling plan can be selected in accordance with ISO/TR 8550 (all parts) for the testing of discontinuous batches of products. For testing purposes, the sampling should be performed using lots rather than identification numbers.
If the quality of condoms is to be verified, it is recommended that the authorities should not only focus on the quality of the finished product, but also on the quality system of the manufacturer. Therefore, for the production of medical devices, attention should be paid to the GB/T19000 family of standards and YY/T 0287 covering the terms of their entire quality system.
5 Batch
The maximum number of each batch in the production process does not exceed 500,000.
Note: This document does not specify the lot size, but in the purchase contract, the purchaser may have to specify the lot size. The lot size specified by the purchaser shall be coordinated with the manufacturer's quality control system.
The lot size specified by the purchaser should be coordinated with the manufacturer's quality management system.
6 Biocompatibility
7 Microbial contamination (environmental control)
8 Product Declaration
9 Design 10 Stability and storage period
11 Pinhole
12 Visible defects
13 Package Integrity
14 Product Bioburden
15 Packaging and labeling
16 test report
Appendix A (normative) applies to the number of sufficient and transfer rules for continuous production batches to determine the conformity of the sampling party
Appendix B (prescriptive) applicable to isolated production batch quality consistency inspection sampling program
Appendix C (normative) the determination of the total amount of lubricant in a single package condom
Appendix D (normative) the determination of length
Appendix E (normative) Determination of width
Appendix F (normative) determination of thickness
Appendix G (normative) Microbial contamination (environmental control)
Appendix H (normative) burst volume and pressure test
Appendix I (normative) condom hot air aging
Appendix J (normative) condom test piece tearing force and tearing elongation determination
Appendix K (normative) Determination of storage period Real-time stability study
Appendix L (normative) Analytical guidelines for accelerated aging studies
Appendix M (normative) Pinhole test
Appendix N (normative) Package integrity test
Appendix О (informative) determination of burst volume and pressure inflation equipment calibration
Appendix Р (normative) determination of water resistance
Appendix Q (informative) virus isolation performance test method
Bibliography
Foreword
Introduction
1 Scope
2 Normative reference documents
3 terms and definitions
4 Quality assurance
5 Batch
6 Biocompatibility
7 Microbial contamination (environmental control)
8 Product Declaration
9 Design 10 Stability and storage period
11 Pinhole
12 Visible defects
13 Package Integrity
14 Product Bioburden
15 Packaging and labeling
16 test report
Appendix A (normative) applies to the number of sufficient and transfer rules for continuous production batches to determine the conformity of the sampling party
Appendix B (prescriptive) applicable to isolated production batch quality consistency inspection sampling program
Appendix C (normative) the determination of the total amount of lubricant in a single package condom
Appendix D (normative) the determination of length
Appendix E (normative) Determination of width
Appendix F (normative) determination of thickness
Appendix G (normative) Microbial contamination (environmental control)
Appendix H (normative) burst volume and pressure test
Appendix I (normative) condom hot air aging
Appendix J (normative) condom test piece tearing force and tearing elongation determination
Appendix K (normative) Determination of storage period Real-time stability study
Appendix L (normative) Analytical guidelines for accelerated aging studies
Appendix M (normative) Pinhole test
Appendix N (normative) Package integrity test
Appendix О (informative) determination of burst volume and pressure inflation equipment calibration
Appendix Р (normative) determination of water resistance
Appendix Q (informative) virus isolation performance test method
Bibliography
