YY/T 1774-2021Male condoms—Guidance on the use of GB/T 7544 and YY/T 1777 in the quality management of condoms (English PDF)

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 16038:2017 "The use of ISO 4074 and ISO 4074 in the quality management of male condoms and condoms".

Guidelines for ISO 23409.

The Chinese documents that have a consistent correspondence with the international documents normatively cited in this standard are as follows.

---GB/T 19000-2016 Quality Management System Fundamentals and Terminology (ISO 9000:2015, IDT)

---YY/T 0287-2017 Medical device quality management system for regulatory requirements (ISO 13485:2016, IDT)

---YY/T 0316-2016 Application of Medical Device Risk Management to Medical Devices (ISO 14971:2007 Corrected Edition, IDT)

Introduction

A condom is a medical device used for contraception and prevention of sexually transmitted diseases.

GB/T 7544 is the quality standard for natural rubber latex condoms, and YY/T 1777 is the quality standard for synthetic condoms. they A reference document that is a standardized final product quality inspection scheme and provides benchmark specifications for key characteristics that will Affects the safety and effectiveness of condoms. Parties using the standard include manufacturers, purchasing agencies, regulatory agencies and testing laboratories.

The use of GB/T 7544 and YY/T 1777 itself cannot ensure the consistency of quality; only through a standardized quality management system can To achieve the purpose of low cost and high quality, only through this way can the quality of the product be ensured, and the quality of the product can be ensured in design, planning, production and procurement.

This goal is guaranteed in many links such as purchasing. This standard is intended to continuously improve manufacturing, purchasing and testing procedures. application When GB/T 7544 and YY/T 1777 are used, the special requirements of buyers and consumers should be fully considered, because GB/T 7544 and YY/T 1777 The formulation of YY/T 1777 focuses on general principles and cannot completely cover all situations.

This standard is a guidance document that provides guidance to manufacturers, purchasers and third-party testing laboratories for use in the condom production process

GB/T 7544 and YY/T 1777 are implemented and applied in Indicators, used to check whether the condoms arrived meet the technical indicators.

Condoms can be considered acceptable if they meet or exceed the minimum requirements specified in GB/T 7544 and YY/T 1777.

It is not possible, nor necessary, to conduct user trials on every batch of condoms. It is for this reason that some Estimation is only performed during pre-market validation; for example, in the event of a new design being introduced or a significant change in design.

Under normal circumstances, the requirements for design verification include all Good Manufacturing Practices (GMP for short), such as medical device production quality management practices) verification requirements and the verification requirements of ISO 9001 and ISO 13485; these are not included in GB/T 7544 and

YY/T 1777, but regulatory agencies usually regard these contents as a necessary condition for the registration of new designs of medical devices. but,

GB/T 7544 and YY/T 1777 involve issues that should be considered in design, such as stability testing, and YY/T 1777 also involves clinical And the evaluation of barrier performance by blasting test, etc.

GB/T 7544 and YY/T 1777 mainly focus on the testing of finished products, and the purpose of implementing these tests is to monitor or verify the production of condoms.

Appropriate stable quality levels are achieved at the time of production. To this end, the experiments were designed with speed and economy of implementation in mind. based on Current knowledge, the requirements in GB/T 7544 and YY/T 1777 are based on those considered to be closely related to the performance of condoms in normal use characteristics.

However, due to the lack of controlled studies, lack of operational trials, high trial costs, and different user requirements for Due to different technical indicators, some important properties of condoms are difficult to define quantitatively. Therefore, GB/T 7544 and

YY/T 1777 mainly focuses on the most necessary properties, the limits of which can be clearly quantified. Other properties have been outlined The description is intended to be enriched by suitable production records, manufacturer's certification or purchaser's specifications.

This standard also deals with other important matters not covered by GB/T 7544 and YY/T 1777.Meaning is to help Users of GB/T 7544 and YY/T 1777 understand all risks associated with condom use. At the same time, when weighing the interests of users help it to judge whether the risk is acceptable. GB/T 7544 and YY/T 1777 also help to assess whether a product is theoretically safe, and Provide health insurance. In order to avoid unnecessary inspections or inappropriate technical indicators and reduce the corresponding inspection costs, the relationship between the purchaser and the manufacturer There should be sufficient communication between them, so that a satisfactory and safe product can be finally produced.

1 Scope

This standard specifies the guidelines for the use of GB/T 7544 and YY/T 1777, as well as the resolution of quality problems, which may exist in the development, manufacture, quality verification and procurement of condoms. It covers quality in condom design, manufacture and distribution All aspects of the management system, with particular emphasis on condom performance, safety and reliability.

This standard applies to male condoms made of natural rubber latex conforming to GB/T 7544, and can also be Male condoms are made of synthetic materials or a mixture of synthetic materials and natural rubber latex.

2 Normative references

The following documents are essential for the application of this document. For dated references, only the dated version applies to this document. For undated references, the latest edition (including all amendments) applies to this document.

GB/T 7544-2019 Technical requirements and test methods of natural rubber latex male condoms (ISO 4074:2015, IDT)

YY/T 1777-2021 Technical requirements and test methods of synthetic condoms for male condoms (ISO 23409:2011, IDT) ulary)

ISO 13485 Medical device quality management system for regulatory requirements (Medicaldevices-Qualitymanagement

3 Terms and Definitions

Terms and definitions defined in GB/T 7544, YY/T 1777, ISO 9000, ISO 13485 and ISO 14971 apply to this document.

4 Design quality