YY/T 1405-2016Mechanical contraceptives-Reusable natural and silicone rubber contraceptive diaphragms-Requirements and tests (English PDF)

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".

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.

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 document. 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 Terms and definitions