Appareils électromédicaux - Partie 2-19: Exigences particulières pour la sécurité de base et les performances essentielles des incubateurs pour nouveau-nés

201. Scope, object and related standards

Clause 1 of the general standard1) applies, except as follows:

201.1. Scope

Replacement:

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of INFANT INCUBATORS, as defined in 201.3.209 of this standard, also referred to as ME EQUIPMENT.

If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.

HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of the general standard.

NOTE See also 4.2 of the general standard.

This particular standard specifies safety requirements for INFANT INCUBATORS but alternate methods of compliance with a specific clause by demonstrating equivalent safety will not be judged as non-compliant if the MANUFACTURER has demonstrated in his RISK MANAGEMENT FILE that the RISK presented by the HAZARD has been found to be of an acceptable level when weighed against the benefit of treatment from the device.

This particular standard does not apply to:

- devices supplying heat via BLANKETS, PADS or MATTRESSES in medical use; for information see IEC 80601-2-35 [3]2);

- INFANT RADIANT WARMERS; for information, see IEC 60601-2-21 [2];

- INFANT TRANSPORT INCUBATORS, for information, see IEC 60601-2-20 [1];

- INFANT PHOTOTHERAPY EQUIPMENT, for information see IEC 60601-2-50 [4].

201.1.2 Object

Replacement: The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for INFANT INCUBATORS as defined in 201.3.208, which minimize HAZARDS to PATIENT and OPERATOR, and to specify tests by which compliance with the requirements can be verified.

201.1.3 Collateral standards

Addition: This particular standard refers to those applicable collateral standards that are listed in Clause 2 of the general standard and Clause 2 of this particular standard. IEC 60601-1-2 and IEC 60601-1-10 apply as modified in Clauses 202 and 210 respectively. IEC 60601-1-3 does not apply. All other published collateral standards in the IEC 60601-1 series apply as published.