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YY/T 1850-2023 English PDF

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YY/T 1850-2023: Male condoms - Requirements and test methods for condoms made from polyurethane
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PDF similar to YY/T 1850-2023


Standard similar to YY/T 1850-2023

YY/T 1783   YY/T 1777   YY/T 1797   YY/T 1866   YY/T 1921   

Basic data

Standard ID YY/T 1850-2023 (YY/T1850-2023)
Description (Translated English) Male condoms - Requirements and test methods for condoms made from polyurethane
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C36
Classification of International Standard 11.200
Word Count Estimation 44,426
Date of Issue 2023-01-13
Date of Implementation 2024-01-15
Issuing agency(ies) State Drug Administration
Summary This standard specifies the minimum technical requirements and test methods for male condoms made of polyurethane latex and provided to consumers for contraception and to help prevent sexually transmitted diseases. This standard applies to 100% polyurethane male condoms and other composite male condoms with polyurethane latex as the main material.

YY/T 1850-2023: Male condoms - Requirements and test methods for condoms made from polyurethane

---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.
ICS 11.200 CCSC36 Pharmaceutical Industry Standard of the People's Republic of China Male Condoms Polyurethane Condoms Technical requirements and test methods Released on 2023-01-13 2024-01-15 Implementation Released by the State Drug Administration

table of contents

Preface III Introduction IV 1 Scope 1 2 Normative references 1 3 Terms and Definitions 1 4 Quality Assurance 3 5 batches of 4 6 Biocompatibility4 7 Microbial contamination (environmental control) 4 8 Product Statement 4 9 design 5 10 Stability and shelf life6 11 pinhole 7 12 Visible defects 7 13 Package integrity 7 14 Product Bioburden 7 15 Packaging and Labeling 7 16 Test report 9 Appendix A (Normative) Qualification determination sampling plan applicable to continuous production batches with sufficient quantity and transfer rules 11 Appendix B (Normative) Sampling Plan for Quality Consistency Inspection of Isolated Production Batches 12 Appendix C (Normative) Determination of the total amount of lubricant in a single packaged condom 13 Appendix D (Normative) Determination of Length 16 Appendix E (Normative) Determination of Width 17 Appendix F (Normative) Determination of Thickness 18 Appendix G (Normative) Microbial Contamination (Environmental Control) 19 Appendix H (Normative) Burst volume and pressure test 23 Appendix I (Normative) Hot air aging of condoms 25 Appendix J (Normative) Determination of tearing force and elongation at break of condom test pieces 26 Appendix K (Normative) Determination of storage period --- real-time stability study 28 Appendix L (Normative) Guidelines for Accelerated Aging Research Analysis 30 Appendix M (Normative) Pinhole Test 32 Appendix N (Normative) Package Integrity Test 35 Appendix O (Informative) Determination of Burst Volume and Pressure Calibration of Inflatable Equipment 37 Appendix P (Normative) Determination of Water Resistance 40 Appendix Q (informative) Virus isolation performance test method 41 Reference 44

foreword

This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for Standardization Work Part 1.Structure and Drafting Rules for Standardization Documents" drafting. Please note that some contents of this document may refer to patents. The issuing agency of this document assumes no responsibility for identifying patents. This document is proposed by the State Drug Administration. This document is under the jurisdiction of the National Standardization Technical Committee of Family Planning Devices (SAC/TC169). This document is drafted by. Lanzhou Ketian Health Technology Co., Ltd., Shanghai Medical Device Testing Institute, Henan Provincial Medical Device Inspection Institute, Qingdao London Durex Co., Ltd. (Reckitt Benckiser (China) Investment Co., Ltd.), Wuhan Jieshibang Sanitary Products Co., Ltd., Gansu Provincial Medical Therapeutic Device Inspection Institute, Hefei Ketian Water-based Technology Co., Ltd. The main drafters of this document. Chen Liang, Yao Tianping, Wang Haitao, Wang Zhiyuan, Qian Xinyi, Jia Yunkun, Ren Hansheng, Feng Linlin, Zhang Junzi, Sun Kaifeng, Ren Juan, Chen Dalei, Wang Zewei, Xu Huiping, Li Weihu, Zhu Youkui.

Introduction

Polyurethane condoms can be made of pure polyurethane latex, or a mixture of polyurethane latex and natural rubber latex. Intact polyurethane films can isolate infectious agents of human immunodeficiency virus (HIV), sexually transmitted diseases (STIs) and sperm effect. A large number of comparative studies have proved that the correct use of polyurethane condoms can effectively prevent pregnancy and reduce the transmission of STIs, including HIV. broadcast risk. For condoms to be effective in preventing pregnancy and preventing the transmission of STIs, condoms should be the proper size, free from pinholes, and strong enough to ensure Ensure that there is no breakage during use, suitable packaging protects the product during the storage period, and appropriate labels are convenient for consumers to use. all of these Issues are addressed in this document. Condoms are medical devices, in order to ensure high-quality products, they should be produced under a good quality management system. quality management See GB/T 19000 family of standards and YY/T 0287, and see YY/T 0316 standard for risk management requirements. In order to ensure the safety of the condom, the condom itself and any lubricants, additives, marking materials, accessories, individual packaging Neither the material nor the powdered substance should have or release toxicity, cause allergies and local irritation or other hazards. Manufacturers should focus on contraception Set of studies related to chemical characterization. Condoms are non-sterile medical devices, but manufacturers are advised to take appropriate measures to minimize microbial contamination of products during production and packaging minimized. This document recommends that manufacturers preemptively reduce microbial contamination during production. The test method used to determine the level of microbial contamination See appendix G for details. For condoms with a thickness less than or equal to 0.022mm claimed by the manufacturer, the corresponding bursting volume and bursting pressure should be formulated by the manufacturer indicators, and submit supporting data to regulatory authorities or certification bodies 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 the shelf life and begin Real-time stability test studies, Chapter 10 specifies these requirements. Real-time stability testing can be performed by manufacturers on their marketed products part of regulatory requirements. Use these requirements to ensure that the manufacturer has sufficient data to support its claimed storage before the product is placed on the market. These data are available to regulators, third-party laboratories and purchasers for review. These requirements are also used to guide third parties in conducting long-term The need for long-term stability studies. Male Condoms Polyurethane Condoms Technical requirements and test methods

1 Scope

This document specifies the male condoms made of polyurethane latex, which are intended for use by consumers as contraception and to help prevent sexually transmitted diseases The minimum technical requirements and test methods. This document is applicable to 100% polyurethane condoms and other composite male condoms with polyurethane latex as the main material.

2 Normative references

The contents of the following documents constitute the essential provisions of this document through normative references in the text. Among them, dated references For documents, only the version corresponding to the date is applicable to this document; for undated reference documents, the latest version (including all amendments) is applicable to this document. GB/T 2828.1-2012 Counting sampling inspection procedure Part 1.Batch-by-batch inspection sampling retrieved by acceptance quality limit (AQL) plan GB/T 7544 Technical requirements and test methods for natural rubber latex male condoms GB/T 16886.1 Biological evaluation of medical devices Part 1.Evaluation and testing in the risk management process GB/T 16886.5 Biological evaluation of medical devices - Part 5.Cytotoxicity test in vitro GB/T 16886.10 Biological evaluation of medical devices - Part 10.Irritation and skin sensitization tests GB/T 19000 Quality Management System Fundamentals and Terminology YY/T 0316 Application of Medical Device Risk Management to Medical Devices YY/T 0466.1 Symbols for Medical Device Labeling, Marking and Information Provision for Medical Devices Part 1.General Requirements YY/T 1777 Male Condoms Technical Requirements and Test Methods for Synthetic Condoms ISO /T R8550 (all parts) Guidelines for the selection and use of sampling systems for batch inspection and acceptance of discontinuous items (Guidanceon Pharmacopoeia of the People's Republic of China (2020 Edition)

3 Terms and Definitions

YY/T 1777 and GB/T 2828.1-2012 and the following terms and definitions apply to this document. 3.1 The worst process average quality level that can be tolerated when a continuous series of lots is submitted for acceptance sampling. [Source. GB/T 2828.1-2012, 3.1.26] 3.2 male condom male condom Medical devices that enable consumers to achieve the purpose of contraception and prevention of STIs by covering or wrapping the penis during sexual intercourse. [Source. YY/T 1777-2021, 3.2]

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