GB/T 7544-2019Natural rubber latex male condoms - Requirements and test methods (English PDF)

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009.

This standard replaces GB/T 7544-2009 "Technical requirements and test methods for natural latex rubber condoms", and GB/T 7544-

Compared with.2009, the main technical changes except editorial changes are as follows.

--- Change the standard name to "Technical Requirements and Test Methods for Natural Rubber Latex Male Condoms";

--- In the scope of "this standard specifies the manufacture of natural latex, providing consumers with contraception and helping to prevent sexually transmitted diseases

The minimum technical requirements and test methods for condoms. "Modified to" This standard specifies the technical requirements for natural rubber latex male condoms

Seek test methods. (see Chapter 1, Chapter 1 of the.2009 edition);

--- Normative references added "ISO 10993-1 Medical Device Biology Evaluation Part 1. Risk Management Process

Evaluation and testing, ISO 10993-5 Biological evaluation of medical devices - Part 5. In vitro cytotoxicity test, ISO 10993-

10 Medical Device Biology Evaluation Part 10. Stimulation and Delayed Hypersensitivity Test, ISO 15223-2 Medical Device

Symbols for the labeling, marking and provision of information for medical devices - Part 2. Formulation, selection and confirmation of symbols,

ISO /IEC 17025 Test and Calibration Laboratory Capability Approval Guidelines, removes "EN980 for medical device labels

Graphical symbols" (see Chapter 2, Chapter 2 of the.2009 edition);

--- Removed the note for the 3.8 batch (see 3.8 of the.2009 edition);

--- Removed the 3.10 batch inspection (see 3.10 of the.2009 edition);

--- Added the terms and definitions of "3.14 production date" and "3.15 visible defects (not holes and tears)" (see 3.14,

3.15);

--- Removed the content of c) in the quality assurance (see Chapter 4 of the.2009 edition);

--- Added "Chapter 5 Batch" (see Chapter 5);

--- Added "Chapter 6 Biocompatibility" (see Chapter 6);

--- Added "Chapter 7 Microbial Contamination" (see Chapter 7);

--- Added "Chapter 8 Product Declaration" (see Chapter 8);

--- Revised the width of the provisions (see 9.3.2,.2009 version 5.3.2);

--- Revised the thickness requirements (see 9.3.3, 5.3.3 of the.2009 edition);

--- Revised the blast volume and pressure regulations (see Chapter 10, Chapter 6 of the.2009 edition);

---Modified the contents of the "General Provisions" (see 11.1, 7.1 of the.2009 edition);

--- Modified the "minimum stability requirements" (see 11.2, 7.2 of the.2009 edition);

--- Added "The pinhole test can also be performed using the method specified in ASTM D3492 [8]. For the middle width less than 45.0 mm

And/or condoms that do not include the seminal vesicle portion less than 160 mm in length cannot be considered to meet this standard. These condoms

See Appendix P for the pinhole test method. The sale of these products should be determined by the regulatory authorities or certification bodies. " (see section 12)

Chapter, Chapter 8 of the.2009 edition);

---Modified package integrity (see Chapter 14, Chapter 10 of the.2009 edition);

---Modified the contents of the package (see 15.1, 11.1 of the.2009 edition);

--- Added "General Provisions" (see 15.2.1);

---Modified the contents of the symbol (see 15.2.2, 11.2.1 of the.2009 edition);

---Modified the contents of a single package (see 15.2.3, 11.2.2 of the.2009 version);

---Modified the contents of "General Provisions a), d), f), j)" in "Consumer Packaging", adding "k), l), m), n)" (see 15.2.4.1,.2009) Year edition

11.2.3.1);

--- Removed the "sign of the super condom" (see 11.2.3.2 of the.2009 edition);

---Modified the "Additional Description of Consumer Packaging" (see 15.2.4.2, 11.2.4 of the.2009 edition);

---Added the "condoms sold in non-consumer packaging" (see 15.2.5);

---Modified the contents of the "Test Report" (see Chapter 16, Chapter 12 of the.2009 edition);

--- Revised the contents of Appendix A (see Appendix A.1, A.2, Table A.1, Appendix A.1, A.2, Table A.1 of the.2009 edition);

--- Added in Table B.1 "Inspection level and receiving quality of individual packages, lubricant content, thickness with visible seal openings

Limit" (see Appendix B);

--- Revised the contents of Appendix C and added the "Surfactant Aqueous Solution Method" (see Appendix C.3, Appendix C of the.2009 edition);

--- Revised the contents of Appendix F, adding the "thickness method to determine the thickness of condoms" (see Appendix F.3, Appendix F of the.2009 edition);

--- Added the informational appendix G, and added the corresponding strains of the Chinese Pharmacopoeia to the G.4.3 strains (see Appendix G);

--- Revised the contents of Appendix H, [see Appendix H.2.1c), H.2.1d), H.2.2, H.3.5, Appendix G.2.1c of the.2009 edition,

G.2.1d), G.2.2, G.3.5];

--- Revised the contents of Appendix I (see Appendix I.2.1, I.4.3, I.5, Appendix H.2, H.4.3 of the.2009 edition);

--- Added "the calculation formula and result representation of the tensile strength of condom test piece" in Appendix J (see Appendix J.5.2, J.6);

---Modified the contents of Appendix K (see Appendix K, Appendix J of the.2009 edition);

---Modified the contents of Appendix L (see Appendix L, Appendix K of the.2009 edition);

--- Added "Check individual packaging and record any visible sealing openings" in the test procedure for the Appendix M pinhole test (see attached)

Record M.2.3.1, M.3.3.1);

--- Amend Appendix M to "record visible defects in condoms. broken, missing or severely deformed crimps and film severely bonded" to

"Record condoms with visible defects (see 3.15) except for pinholes and tears" (see appendix M.2.3.4, M.3.3.5,.2009 edition)

L.2.3.3, L.3.3.4);

--- Modify the contents of M.2.3.6 and M.3.3.7 in Appendix M (see Appendix M.2.3.6, M.3.3.7,.2009 edition of L.2.3.5,

L.3.3.7);

--- Revised the contents of Appendix N (see Appendix N.1, N.2.5, N.2.7,.2009 edition of M.1, M.2.3, M.2.6, M.2.8);

--- Appendix P deleted the informative appendix "Description" and added "Proposals for condom testing beyond the size specified in this standard" (see attached

Record P, Appendix P of the.2009 edition.

This standard uses the translation method equivalent to ISO 4074.2015 "Technical requirements and test methods for natural rubber latex male condoms".

The documents of our country that have a consistent correspondence with the international documents referenced in this standard are as follows.

--- GB/T 2828.1-2012 Procedures for the enumeration of samplings - Part 1. Sweeping batch-by-batch inspections by the acceptance quality limit (AQL)

Sample plan (ISO 2859-1.1999, IDT)

--- GB/T 16886.1-2011 Biological evaluation of medical devices - Part 1. Evaluation and testing in the process of risk management

(ISO 10993-1.2009, IDT)

--- GB/T 16886.5-2017 Biological evaluation of medical devices - Part 5. In vitro cytotoxicity test (ISO 10993-5.

2009, IDT)

--- GB/T 16886.10-2017 Medical Device Biology Evaluation Part 10. Stimulation and Skin Sensitization Test (ISO 10993-

10.2010, IDT)

---GB/T 27025-2008 General requirements for testing and calibration laboratory capabilities (ISO /IEC 17025.2005, IDT)

---YY/T 0466.1-2016 Symbols for medical devices used for labeling, marking and providing information on medical devices - Part 1.

Requirements (ISO 15223-1.2012, IDT)

---YY/T 0466.2-2015 Symbols for medical devices for labeling, marking and providing information on medical devices - Part 2

Development, selection and validation (ISO 15223-2.2010, IDT)

This standard was proposed by the China Petroleum and Chemical Industry Federation.

This standard is under the jurisdiction of the National Rubber and Rubber Products Standardization Technical Committee (SAC/TC35).

This standard was drafted. National Latex Products Quality Supervision and Inspection Center, National Institute of Health and Family Planning Science and Technology, Shenzhen Pharmaceuticals

Inspection Institute (Shenzhen Medical Device Testing Center), Tianjin Family Planning Drug Management Center, Sichuan Food and Drug Inspection and Testing Institute,

Qingdao London Durex Co., Ltd., Wuhan Jieshibang Hygiene Products Co., Ltd., Shanghai Fama Personality Network Technology Co., Ltd., Qingdao Double

Butterfly Group Co., Ltd., Guangzhou Shuangyi Latex Products Co., Ltd., Guilin Zizhu Latex Products Co., Ltd., Dalian Latex Co., Ltd.

Division, Shanghai Mingbang Rubber Products Co., Ltd., Tianjin Zhongsheng Latex Co., Ltd., Zhejiang Xiangjiao Latex Products Co., Ltd., Zhanjiang Huitong Pharmaceutical Co., Ltd.

Company, Guangzhou Wanfangjian Pharmaceutical Co., Ltd., Haishi Hainuo Latex (Qingdao) Co., Ltd., Shanghai Jinxiang Latex Products Co., Ltd., Hebei Excellent

Kesi Rubber Technology Co., Ltd., Beijing Yupai Technology Co., Ltd., Xinjiang Uygur Autonomous Region Food and Drug Inspection Institute, Hunan Medical Equipment

Inspection and Testing Institute, Dongguan Jingan New Material Co., Ltd., Guangdong Shunde Chuangke Testing Technology Co., Ltd., China Chemical Zhuzhou Rubber Research Institute

Research Institute Co., Ltd.

Introduction

Condoms with intact adhesive film have been proven to be isolated from human immunodeficiency virus (HIV) and sexually transmitted diseases (STIs).

The role of quality and sperm. A large number of clinical studies have confirmed that condoms are effective for contraception and reduce many sexually transmitted diseases (STIs) including human immunodeficiency diseases.

The risk of transmission of HIV.

In order to ensure effective contraception and prevent the spread of STIs, the most basic requirement is that the condom should have a suitable penis size, no

Pinholes, with sufficient physical strength to prevent cracking during use, use appropriate packaging to protect products during storage, with appropriate marking

Convenient for consumers. All of these issues are covered in this standard.

Condoms are medical devices. In order to ensure high quality products, production should be carried out under the operation of a good quality management system. Quality Control

See YY/T 0287 [4] for requirements and YY/T 0316 [5] for risk management requirements.

Condoms are non-sterile medical devices, but manufacturers are advised to take appropriate measures to microbial contamination of products during production and packaging.

Minimized. This standard recommends that manufacturers pre-reducing microbial contamination in the production process and testing the test for microbial contamination levels.

See Appendix G for the method.

This standard requires manufacturers to conduct stability tests on new or improved condoms before they are placed on the market to determine the shelf life and

Seek to begin the actual time stability test study, Chapter 11 specifies these requirements. Actual time stability test can be used as manufacturing

Part of the regulatory requirements for the listing of products. Use these requirements to ensure that manufacturers have enough before the product is placed on the market

The data supports its claimed shelf life, which is available to the management, third-party laboratories, and purchasers for review. These requirements are also used

The need to limit third-party stability studies.

In addition to meeting the requirements of this standard, condoms should also comply with the requirements of local national laws.

HG/T 5056 [6] provides guidelines for the use of this standard, including additional test methods and technical requirements specified in this standard.

information.

Natural rubber latex male condom

Technical requirements and test methods

1 Scope

This standard specifies the technical requirements and test methods for natural rubber latex male condoms.

2 Normative references

The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article.

Pieces. For undated references, the latest edition (including all amendments) applies to this document.

ISO 2859-1 - Sampling procedures for sampling - Part 1. Procedures for batch-to-batch inspections by the quality of reception (AQL) [Sam-

plingproceduresforinspectionbyattributes-Part 1.samplingschemesindexedbyacceptancequality

Limit(AQL)forlot-by-lotinspection]

ISO 10993-1 Biological evaluation of medical devices - Part 1. Evaluation and testing in the process of risk management (Biologicalevalua-

tionofmedicaldevices-Part 1.Evaluationandtestingwithinariskmanagementprocess)

ISO 10993-5 Biological evaluation of medical devices - Part 5. In vitro cytotoxicity test (Biologicalevaluationof

medicaldevices-Part 5.Testsforinvitrocytotoxicity)

ISO 10993-10 Biological evaluation of medical devices - Part 10. Stimulation and skin sensitization test (Biologicalevaluationof

medicaldevices-Part 10.Testsforirritationandskinsensitization)

ISO 15223-1 Medical devices - Symbols for labeling, marking and providing information on medical devices - Part 1. General requirements

(Medicaldevices-Symbolstobeusedwithmedicaldevicelabels,labelingandinformationtobesup-

plied-Part 1.Generalrequirements)

ISO 15223-2 Medical devices - Symbols for labeling, marking and providing information on medical devices - Part 2. Development and selection of symbols

Selection and confirmation (Medicaldevices-Symbolstobeusedwithmedicaldevicelabels,labeling,andinformation

tobesupplied-Part 2.Symboldevelopment, selectionandvalidation)

General requirements for ISO /IEC 17025 testing and calibration laboratory capabilities (Generalrequirementsforthecompetenceof

Testingandcalibrationlaboratories)

3 Terms and definitions

The following terms and definitions defined by ISO 2859-1 apply to this document.

3.1

Receive quality limit acceptablequalitylimit; AQL

The worst-case average quality level that can be allowed when a continuous series of batches is submitted for acceptance sampling.

[ISO 2859-1.1999, definition 3.1.26]

3.2

Male condom malecondom

A medical device worn on the penis for contraception and prevention of sexually transmitted diseases during sexual intercourse.