ARSA O01-P02-S02-DDM-G-001O01-P02-S02-DDM-G-001
Currentness under review. Whether this instrument remains applicable is under review. Consult the later instruments and source context below before relying on it.
O01-P02-S02-DDM-G-001 is the official ARSA identifier for “Guía de Clasificación por Riesgo de Dispositivos Médicos”. O01-P02-S02-DDM-G-001 is the official identifier ARSA uses for this instrument.
- Instrument
- O01-P02-S02-DDM-G-001
- Full name
- O01-P02-S02-DDM-G-001
- Category
- Classification
- Source publication
- Spanish
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- 1 language version
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Guía de Clasificación por Riesgo de Dispositivos Médicos
ARSA guidance presents 28 risk classification rules for human medical devices, including IVDs, using Classes I, IIA, IIB and III. It covers definitions, non-invasive and invasive devices, active devices, special rules, examples and graphical summaries, and cites Title V of Acuerdo 0631-ARSA-2023. The source prints publication year 2025 without a full legal effective date. Conflicting class labels and rule wording are preserved for review; the guide does not establish a universal rule for all laboratory products.
O01-P02-S02-DDM-G-001 is the official identifier ARSA uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.