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YY/T 1774-2021: (Guidelines for the use of GB/T 7544 and YY/T 1777 in quality management of male condoms)
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(Guidelines for the use of GB/T 7544 and YY/T 1777 in quality management of male condoms)
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YY/T 1774-2021
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PDF similar to YY/T 1774-2021
Standard similar to YY/T 1774-2021 YY/T 1783 YY/T 1797 YY/T 1777 YY/T 1769 Basic data | Standard ID | YY/T 1774-2021 (YY/T1774-2021) | | Description (Translated English) | (Guidelines for the use of GB/T 7544 and YY/T 1777 in quality management of male condoms) | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C36 | | Word Count Estimation | 15,111 | | Issuing agency(ies) | State Drug Administration | YY/T 1774-2021: (Guidelines for the use of GB/T 7544 and YY/T 1777 in quality management of male condoms)
---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.
(Guidelines for the use of GB/T 7544 and YY/T 1777 in quality management of male condoms)
ICS 11.200
C36
People's Republic of China Pharmaceutical Industry Standard
Male condoms used in quality control of condoms
Guidelines for GB/T 7544 and YY/T 1777
(ISO 16038.2017, IDT)
Published on 2021-09-06
2022-09-01 Implementation
Released by the State Drug Administration
directory
Preface I
Introduction II
1 Scope 1
2 Normative references 1
3 Terms and Definitions 1
4 Design Quality 1
4.1 Overview 1
4.2 Clinical studies 2
4.3 Risk Management 2
4.3.1 Risk Analysis and Risk Management 2
4.3.2 Latex allergy 3
4.3.3 Microbial contamination (bioburden) 3
4.3.4 Nitrosamines 3
5 Production Quality 3
5.1 Quality Management 3
5.2 Batch-by-batch inspection (finished product inspection) 4
5.3 Round value 4
6 Purchasing Quality 4
7 Inspection quality 5
8 Important parameters to be considered when using GB/T 7544 and YY/T 17775
8.1 Application of GB/T 7544 and YY/T 1777 5
8.2 Size 5
8.3 Sealing of visible openings 6
8.4 Proof of Additional Claims 6
8.5 Compatibility of materials 6
8.6 Pinhole 6
8.7 Shelf life and aging resistance 6
8.8 Packaging and Labeling7
8.9 Type inspection 8
8.10 Lubricants 8
9 Sampling 8
Reference 9
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)
Please note that some content of this document may be patented. The issuing authority of this document assumes no responsibility for identifying these patents.
This standard is proposed by the State Drug Administration.
This standard is under the jurisdiction of the National Standardization Technical Committee for Family Planning Devices (SAC/TC169).
This standard was drafted by. Guangzhou Daming United Rubber Products Co., Ltd., Wuhan Jieshibang Sanitary Products Co., Ltd., Shanghai Medical Equipment Co., Ltd.
Mechanical Testing Institute.
The main drafters of this standard. Chen Weide, Ren Juan, Wang Zewei, Yao Tianping, Zhou Wei, Zhang Jing, Qian Xinyi, Jiang Xiaojun.
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.
Male condoms used in quality control of condoms
Guidelines for GB/T 7544 and YY/T 1777
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 article
pieces. 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
4.1 Overview
Condoms are single-use medical devices whose performance and safety depend on the design and production process. For verification purposes, the new design
of condoms may be appropriate for clinical trials, various other tests, and "limited data-based" analyses, such as determination of shelf life (type testing) and
risk assessment. These requirements are usually specified by a body with certification authority, and the resulting data will form part of the product master file
part. Guidelines are provided in the requirements of ISO 13485 and GMP. When developing a new product, the design of the new product should conform to
Design management requirements as specified in ISO 13485 and Good Manufacturing Practice Requirements for Medical Devices.
Design management principles should be applied to many of the following parameters.
--- the shape of the condom;
---Dimensions;
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