What is BS EN 13532 - Requirements for in vitro diagnostic medical devices for self-testing about?

BS EN 13532 is a European standard that discusses in vitro diagnostic medical devices for self-testing. BS EN 13532 outlines the general requirements for in vitro diagnostic medical devices (IVD MDs) for self-testing to ensure that IVD MDs are safe to use and are suitable for the purposes specified by the manufacturer.

Note: BS EN 13532 does not address the medical aspects of IVD MDs for self-testing.

Who is BS EN 13532 - Requirements for in vitro diagnostic medical devices for self-testing for?

BS EN 13532 on the general requirements for in vitro diagnostic medical devices for self-testing is useful for:

In vitro diagnostic medical devices manufacturers
In vitro diagnostic centres and medical laboratories
Regulatory authorities

Why should you use BS EN 13532 - Requirements for in vitro diagnostic medical devices for self-testing?

An in-vitro diagnostic medical device is any medical device that is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, solely or principally to provide information concerning a physiological or pathological state or concerning a congenital abnormality, or determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.

BS EN 13532 guideline assists you with requirements on design criteria on ergonomic and human factor aspects, electromagnetic compatibility, protection against electric shock, protection against mechanical hazards, mechanical resistance to shock, mechanical resistance to vibration, mechanical resistance to impact, equipment temperature exposure limits, resistance to heat, moisture resistance, resistance to liquids, risk analysis, design change, protection against liberated gases, explosion, and implosion for in vitro diagnostic medical devices for self-testing.

BS EN 13532 also guides you on the performance evaluation, user verification, markings, and information supplied by the manufacturer like information for use of IVD MDs for in vitro diagnostic medical devices for self-testing.

With obedience and compliance to requirements under BS EN 13532, you can enhance the performance and efficacy of in vitro diagnostic medical devices for self-testing. In addition, ensure their safe use.

BS EN 13532:2002

General requirements for in vitro diagnostic medical devices for self-testing

Current, Under Review

Published:

8 May 2002