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

天然橡胶胶乳男用避孕套技术要求与试验方法

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Issued by

State Administration for Market Regulation, China National Standardization Administration

Level / Type

National · Recommended

Issue date

October 18, 2019

Implementation date

September 1, 2020

Scope

GB/T 7544-2019 is the English-translated version of 天然橡胶胶乳男用避孕套技术要求与试验方法.

GB/T 7544-2019 is the Chinese standard "Natural rubber latex male condoms - Requirements and test methods". Its scope clause reads: This standard specifies the technical requirements and test methods for natural rubber latex male condoms. Its clauses include terms and definitions.

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Document preview — GB/T 7544-2019

National Standard of the People's Republic of China

ICS: 11.200
Classification: C 63

Issued by: State Administration for Market Regulation, China National Standardization Administration

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and Definitions
4 Quality Assurance
5 batch
6 Biocompatibility
7 Microbial contamination
8 Product Declaration
9 design
10 Blasting volume and pressure
11 Stability and shelf life
12 pinholes
13 visible defects
14 Package integrity of individual packages
15 Packaging and identification
16 Test report
Appendix B (informative appendix) Applicable to isolated production batch quality consistency inspection sampling plan
Appendix C (Normative) Determination of the total amount of lubricant in a single package of condoms
Appendix D (Normative) Determination of length
Appendix E (Normative Appendix) Determination of Width
Appendix F (Normative) Determination of thickness
Appendix G (informative) Determination of microbial contamination
Appendix H (Normative) Blasting Volume and Pressure Test
Appendix I (normative appendix) Condom hot air aging
Appendix J (informative) Determination of the breaking force and elongation of the condom test piece
Appendix K (Normative Appendix) Determination of storage period by real time study
Appendix L (Informative Appendix) Accelerated Aging Research Analysis Guide
Appendix M (Normative Appendix) Pinhole Test
Appendix N (Normative) Packaging Integrity Test
Appendix O (informative) Determination of blasting volume and pressure inflator calibration
Appendix P (informative) Recommendations for condom testing outside of this standard

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

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

TB/T 2344.2 | AQ 4273 | GB 12367 | GB/T 30917 | […]

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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 91 pages — is available in the English PDF.

Referenced standards

Normative references

ISO 2859 · ISO 10993 · ISO 15223 · IEC 17025

Cited by

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