BS EN ISO 10993-1:2020
Biological evaluation of medical devices. Evaluation and testing within a risk management process
| Fecha edición: |
2020-12-16
En Vigor
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|---|---|
| Idiomas disponibles: | Inglés |
| Resumen: | 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 nature and duration of their contact with the body; — the
evaluation of existing relevant data from all sources; — the
identification of gaps in the available data set on the basis of a
risk analysis; — the identification of additional data sets
necessary to analyse the biological safety of the medical device; —
the assessment of the biological safety of the medical device. This
document applies to evaluation of materials and medical devices
that are expected to have direct or indirect contact with: — the
patient's body during intended use; — the user's body, if the
medical device is intended for protection (e.g., surgical gloves,
masks and others). This document is applicable to biological
evaluation of all types of medical devices including active,
non-active, implantable and non-implantable medical devices. This
document also gives guidelines for the assessment of biological
hazards arising from: — risks, such as changes to the medical
device over time, as a part of the overall biological safety
assessment; — breakage of a medical device or medical device
component which exposes body tissue to new or novel materials.
Other parts of ISO 10993 cover specific aspects of biological
assessments and related tests. Device-specific or product standards
address mechanical testing. This document excludes hazards related
to bacteria, moulds, yeasts, viruses, transmissible spongiform
encephalopathy (TSE) agents and other pathogens.
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| ICS: | |
| CTN: | CH/194 - CH/194 |
|
Equivalencia Internacional |
Idéntica FprEN ISO 10993-1 Idéntica ISO 10993-1:2018 |
|
Reemplazo Normas |
Reemplaza a BS EN ISO 10993-1:October 2009 |
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