Guía

Tecnológica 04 Incubadora Neonatal

Sección II. Normatividad y riesgos
2.1.

Normas.

Las siguientes son algunas de las principales
relación con las incubadoras neonatales:

normas

que

tienen

Tabla 1. Normatividad.
Carácter

Expedida
por

Año

IEC 60601-1-1 Ed. 2.0 b:
2000 Medical electrical
equipment - Part 1-1:
General requirements for
safety - Collateral
standard: Safety
requirements for medical
electrical systems.

IEC1

2000

X

IEC 60601-1 Ed. 3.0 b: 2005
Medical electrical equipment
- Part 1: General
requirements for basic
safety and essential
performance.

IEC1

2005

X

IEC 60601-1 Ed. 3.0 b
CORR2:2007 Corrigendum 2 Medical electrical equipment
- Part 1: General
requirements for basic
safety and essential
performance.

IEC1

2007

X

IEC 60601-1-2 Ed. 3.0 b:
2007 Medical electrical
equipment - Part 1-2:
General requirements for
basic safety and essential
performance - Collateral
standard: Electromagnetic
compatibility - Requirements
and tests.

IEC1

2007

X

IEC 60601-2-19 Ed. 2.0 b:
2009
Medical
electrical
equipment
Part
2-19:
Particular requirements for
the
basic
safety
and
essential
performance
of

IEC1

2009

X

Nombre de la norma

Sección II. Normatividad y riesgos

Nacional

Internacional

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