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YY/T 1405-2016 English PDF

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YY/T 1405-2016: Mechanical contraceptives--Reusable natural and silicone rubber contraceptive diaphragms--Requirements and tests
Status: Valid
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YY/T 1405-2016English499 Add to Cart 4 days [Need to translate] Mechanical contraceptives--Reusable natural and silicone rubber contraceptive diaphragms--Requirements and tests Valid YY/T 1405-2016

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Basic data

Standard ID YY/T 1405-2016 (YY/T1405-2016)
Description (Translated English) Mechanical contraceptives--Reusable natural and silicone rubber contraceptive diaphragms--Requirements and tests
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C36
Classification of International Standard 11.200
Word Count Estimation 25,252
Date of Issue 2016-03-23
Date of Implementation 2017-01-01
Regulation (derived from) Notice of the General Administration of Food and Drug Administration (No. 74 of 2016)
Issuing agency(ies) State Food and Drug Administration

YY/T 1405-2016: Mechanical contraceptives--Reusable natural and silicone rubber contraceptive diaphragms--Requirements and tests


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Mechanical contraceptives - Reusable natural and silicone rubber contraceptive diaphragms - Requirements and tests ICS 11.200 C36 People's Republic of China Pharmaceutical Industry Standard Mechanical contraceptive devices can be reused naturally and Silicone rubber vaginal membrane requirements and testing (ISO 8009..2004, MOD) 2016-03-23 release 2017-01-01 Implementation State Food and Drug Administration issued Directory Preface III Introduction IV 1 Scope 1 2 normative reference document 1 3 Terms and definitions 1 4 Sampling 2 Category 5 Material 2 Design 2 8 Dimensions 3 Tensile properties of dome for 3 10 ring and spring mechanical properties --- type 1 and type 2 diaphragm 3 11 visible defects 4 12 Test Report 4 Packaging, marking and storage Appendix A (normative appendix) Measurement of dimensions 6 Appendix B (normative) Determination of the thickness of the fornix Appendix C (normative) Determination of tensile properties Appendix D (normative) Accelerated aging after aging treatment Appendix E (Normative Appendix) Determination of compression and anti - fatigue of coil springs and leaf springs Appendix F (normative) Torsional measurement of coil spring and leaf spring diaphragm compression 13 Appendix G (normative) Appearance Defect determination 16 Appendix H (Normative Appendix) Test Report 19 Appendix I (Normative Appendix) Reusable Rubber Vaginal Diaphragm Maintenance and Use Instructions 20 Reference 21

Foreword

This standard is drafted in accordance with the rules given in GB/T 1.1-2009. This standard uses the re-drafting method to modify the use of ISO 8009..2004 "mechanical contraceptive devices reusable natural and silicone rubber Diaphragm requirements and tests "(English version) and" Mechanical contraceptive devices Reusable natural and silicone rubber vaginal membrane requirements and tests Revision Order "ISO 8009..2004/FDAM1..2012 (E). This standard and ISO 8009..2004 "mechanical contraceptive devices can be reused natural and silicone rubber vaginal diaphragm requirements and testing" (English) and ISO 8009..2004/FDAM1..2012 (E) "Mechanical contraceptive devices Reusable natural and silicone rubber vaginal septum Requirements and trial revisions "compared to the editorial changes in the main technical changes are as follows. --- modified 13.1.2 The second paragraph in the outer package is the second paragraph in 13.1.1 single package; --- modified "l" in the formula E5.2 "l"; - modified "l" in the last paragraph of Appendix E5.2 to "l1000"; --- Modification of Appendix E Figure E.1 Compression test device Note 1 "Metal rod with a mass of 290g" is "metal rod with a mass of 280g". Please note that some of the contents of this document may involve patents. The issuer of this document does not assume responsibility for the identification of these patents. This standard is proposed and centralized by the National Standardization Technical Committee for Family Planning Instruments (SAC/TC169). The drafting of this standard. Shanghai Medical Devices Testing Institute. The main drafters of this standard. Yao Tianping, Lin Feng.

Introduction

Vaginal diaphragm is a medical device. Therefore, it should be manufactured under a good quality management system. As the case may be, should be combined YY/T 0287 refer to other standards, such as reference GB/T 19000 series of standards. The sampling scheme and the reception quality limit (AQL) given in this standard are for detection reference only. AQL indicates the maximum allowable product defect Error level. Vaginal septum can be reused, manufacturers should strive to produce products without any defects. For the use of the product and the management at the factory, the manufacturer can develop and implement additional and alternative quality control methods. different The method used by the manufacturer can vary. Mechanical contraceptive devices can be reused naturally and Silicone rubber vaginal membrane requirements and testing

1 Scope

This standard specifies the minimum requirements and testing methods for reusable natural and silicone rubber vaginal membranes. The intended use of these membranes Is contraception. This standard applies to the use of natural rubber and silicone rubber made of reusable vaginal diaphragm. This standard does not apply to other vaginal contraceptive barriers, such as cervical cap, vaginal sponge and vaginal sheath.

2 normative reference documents

The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this article Pieces. For undated references, the latest edition (including all modifications) applies to this document. GB/T 2828.1 Sampling inspection procedures Part 1. Batch inspection sampling plan for retrieval by quality limit (AQL) (GB/T 2828.1-2012, ISO 2859-1..1999, IDT) GB/T 3512 vulcanized rubber or thermoplastic rubber hot air accelerated aging and heat resistance test (GB/T 3512-2014/ISO 188. 2001, IDT) GB/T 16886.1 Biological evaluation of medical devices - Part 1. Evaluation and testing in risk management (GB/T 16886.1- 2011, ISO 10993-1..2009, IDT) GB/T 16886.5 Biological evaluation of medical devices - Part 5. In vitro cytotoxicity test (GB/T 16886.5-2003, ISO 10993-5..1999, IDT) GB/T 16886.10 Biological evaluation of medical devices - Part 10. Stimulation and delayed hypersensitivity test (GB/T 16886.10- 2005, ISO 10993-10..2002, IDT) ISO 463 Geometrical Product Specifications (GPS) - Size measuring equipment - Design and metrological characteristics of mechanical micrometer [GeometricalProductSpecifications (GPS) -Dimensionalmeasuringequipment-Designandmetro- logicalcharactensticsofmechanicaldialgauges] Terminology and Definitions GB/T 2828.1 Definitions and the following terms and definitions apply to this document. 3.1 batch The collection of septa has the same design, color, shape, size and recipe, essentially at the same time manufacturing, using the same process, raw material The same batch of equipment, equipment and personnel the same. Note. In this standard, the size of the batch is not specified, but the purchaser can specify a batch size in the purchase contract. According to the manufacturing method The approved batches may be produced in multiple batches. In this case, it should be done by means of batch and batch methods in order to maintain traceability Traceability.

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