BS EN ISO 7439:2023 PDF

Scope: 1 Scope This document specifies requirements and tests for single-use, copper-bearing contraceptive intrauterine devices ( IUDs ) and their insertion instruments . It is not applicable to IUDs consisting only of a plastics body or whose primary purpose is to release progestogens or other medicinal products. NOTE Some aspects of this document can be applicable to medicated intrauterine devices and IUDs not containing copper.

BS EN ISO 7439:2023 Referenced Document

ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
ISO 14155 Clinical investigation of medical devices for human subjects - Good clinical practice
ISO 14630:2012 Non-active surgical implants - General requirements
ISO 14971 Medical devices - Application of risk management to medical devices
ISO 15223-1 Medical devices-Symbols to be used with information to be supplied by the manufacturer-Part 1: General requirements

2023 BS EN ISO 7439:2023 Copper-bearing contraceptive intrauterine devices. Requirements and tests
2015 BS EN ISO 7439:2015 Copper-bearing contraceptive intrauterine devices. Requirements and tests
2011 BS EN ISO 7439:2011 Copper-bearing contraceptive intrauterine devices. Requirements and tests
2010 BS EN ISO 7439:2010 Copper-bearing intra-uterine contraceptive devices. Requirements, tests
0000 BS EN ISO 7439:2009
2008 BS EN 15377-2:2008 Heating systems in buildings - Design of embedded water based surface heating and cooling systems - Design, dimensioning and installation
0000 BS EN ISO 7439:2002
2001 BS EN 1264-4:2001 Floor heating - Systems and components - Installation