This document specifies terminology, principles and a process for risk management of medical devices, including software as a medical device and in vitro diagnostic medical devices. The process described in this document intends to assist manufacturers of medical devices to identify the hazards associated with the medical device, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.
The requirements of this document are applicab...
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2021-04-26_JO: BT N 12459 and BT168/DG12120/DV to decouple from  Directives 90/385/EEC, 93/42/EEC, 98/79/EC and Regulations 2017/745

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This document specifies a test method and the minimum requirements for the microbicidal activity of a defined disinfection process for the treatment of contaminated textile. This procedure is carried out by using a washing machine as defined in 5.3.2.18 and refers to the disinfection step without prewash. This procedure is not limited to certain types of textile. The suppliers instructions shall be sufficient to allow the method in the standard to be carried out fully (e.g. dosing disinfectant i...view more

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This document specifies a test method and the minimum requirements for the microbicidal activity of a defined disinfection process for the treatment of contaminated textile. This procedure is carried out by using a washing machine as defined in 5.3.2.18 and refers to the disinfection step without prewash. This procedure is not limited to certain types of textile. The suppliers' instructions are expected to be sufficient to allow the method in this document to be carried out fully (e.g. dosing di...view more

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This document provides general principles for the systematic evaluation of the potential and observed degradation of medical devices through the design and performance of in vitro degradation studies. Information obtained from these studies can be used in the biological evaluation described in the ISO 10993 series.
This document is applicable to both materials designed to degrade in the body as well as materials that are not intended to degrade.
This document is not applicable to:
a) the eval...
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CEN/BT C082/2011:  DOW = DAV + 36 months
2018-10-08 - ISO 80601-2-13 is linked to the MDR however, no mandate yet as no Sreq is available

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This document specifies requirements for the characterization of a liquid chemical sterilizing agent and for the development, validation, process control and monitoring of sterilization by liquid chemical sterilizing agents of single-use medical devices comprising, in whole or in part, materials of animal origin.
This document covers the control of risks arising from contamination with bacteria and fungi by application of a liquid chemical sterilization process. Risks associated with other micr...
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This document specifies a test method and the minimum requirements for fungicidal or yeasticidal activity of chemical disinfectant and antiseptic products that form a homogeneous, physically stable preparation when diluted with hard water, or - in the case of ready-to-use products - with water. Products can only be tested at a concentration of 80 % or less (97 % with a modified method for special cases) as some dilution is always produced by adding the test organisms and interfering substance.
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This European Standard specifies requirements and the relevant tests for large steam sterilizers primarily used in health care for the sterilization of medical devices and their accessories contained in one or more sterilization modules. The test loads described in this European Standard are selected to represent the majority of loads (i.e. wrapped goods consisting of metal, rubber and porous materials) for the evaluation of general purpose steam sterilizers for medical devices. However, specifi...view more

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ISO 14708-4:2008 is applicable to active implantable medical devices intended to deliver medicinal substances to site-specific locations within the human body.
ISO 14708-4:2008 is also applicable to some non-implantable parts and accessories of the devices.
The tests that are specified in ISO 14708-4:2008 are type tests intended to be carried out on a sample of a device to show compliance, and are not intended to be used for the routine testing of manufactured products.

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