1.1 * Scope
This International Standard applies to the basic safety and essential performance of medical electrical equipment and medical electrical systems, hereafter referred to as me equipment and me systems, which are intended, as indicated in the instructions for use by their manufacturer, for use in the ems environment (emergency medical services environment), as defined in 3.1.
NOTE 1 For the purposes of this standard, the intent of the manufacturer is indicated in the instructions for use. The responsible organization and the operator need to be aware that any other use outside the manufacturer’sintended use can result in a hazardous situation for the patient.
The ems environment includes
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responding to and providing life support at the scene of an emergency to a patient reported as experiencing injury or illness in a pre-hospital setting, and transporting the patient, while continuing such life support care, to an appropriate professional healthcare facility for further care.
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providing monitoring, treatment or diagnosis during transport between professional healthcare facilities.
This International Standard does not apply to me equipment and me systems intended solely for use in the home healthcare environment covered by IEC 60601‑1‑11 or solely for use in professional healthcare facilities covered by IEC 60601‑1 without the additions of IEC 60601‑1‑11 or this collateral standard. me equipment and me systems are often not solely intended for one environment. Such me equipment or me system can be intended for multiple use environments, and as such, if also intended for use in the ems environment, are within the scope of this standard.
EXAMPLE Me equipment or me system intended for both the ems environment and the professional healthcare facility environment.
NOTE 2 Ems environment me equipment and me systems can be used in locations with unreliable electrical sources and outdoor environmental conditions.
1.2 * Object
The object of this collateral standard is to provide general requirements for me equipment and me systems carried to the scene of an emergency and used there, as well as in transport, in situations where the ambient conditions differ from indoor conditions.
The object of this collateral standard is to specify general requirements that are in addition to those of the general standard and to serve as the basis for particular standards.
1.3 Related standards
1.3.1 IEC 60601‑1
For me equipment and me systems, this collateral standard complements IEC 60601‑1.
When referring to IEC 60601‑1 or to this collateral standard, either individually or in combination, the following conventions are used:
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"the general standard" designates IEC 60601‑1 alone, including any amendments;
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"this collateral standard" designates IEC 60601‑1‑12 alone, including any amendments;
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"this standard" designates the combination of the general standard and this collateral standard.
1.3.2 Particular standards
A requirement in a particular standard takes priority over the corresponding requirement in this collateral standard.
