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ISO 8009

Mechanical contraceptives - Reusable natural and silicone rubber contraceptive diaphragms - Requirements and tests

active, Most Current
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Organization: ISO
Publication Date: 15 November 2014
Status: active
Page Count: 34
ICS Code (Birth control. Mechanical contraceptives): 11.200
scope:

This International standards specifies the minimum requirements and test methods to be used for reusable diaphragms made from natural and silicone rubber. These diaphragms are intended for contraceptive use.

This International Standard is not applicable to other vaginal contraceptive barriers, such as those known as cervical caps, vaginal sponges, and vaginal sheaths.

Document History

ISO 8009
November 15, 2014
Mechanical contraceptives - Reusable natural and silicone rubber contraceptive diaphragms - Requirements and tests
This International standards specifies the minimum requirements and test methods to be used for reusable diaphragms made from natural and silicone rubber. These diaphragms are intended for...
ISO 8009
February 15, 2012
Mechanical contraceptives — Reusable natural and silicone rubber contraceptive diaphragms — Requirements and tests AMENDMENT 1
A description is not available for this item.
ISO 8009
October 1, 2004
Mechanical contraceptives Reusable natural and silicone rubber contraceptive diaphragms Requirements and tests
A description is not available for this item.

References

This document references:
ISO 10993-1 - Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
Published by ISO on August 1, 2018
This document specifies: — the general principles governing the biological evaluation of medical devices within a risk management process; — the general categorization of medical devices based on the...
This document references:
10993-10 - Biological evaluation of medical devices — Part 10: Tests for skin sensitization
Published by ISO on November 1, 2021
This document specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to induce skin sensitization. This document includes: —...
This document references:
ISO 10993-5 - Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
Published by ISO on June 1, 2009
This part of ISO 10993 describes test methods to assess the in vitro cytotoxicity of medical devices. These methods specify the incubation of cultured cells in contact with a device and/or extracts...
This document references:
ISO 13485 - Medical devices - Quality management systems - Requirements for regulatory purposes
Published by ISO on March 1, 2016
This International Standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that...
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