Standards Development

Scope

201.1 Scope, object and related standards

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

201.1.1 * Scope

Replacement:

This part of IEC 60601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of TRANSCUTANEOUS PARTIAL PRESSURE MONITORS as defined in 201.3.203 hereinafter also referred to as ME EQUIPMENT or ME SYSTEM.

This document applies to TRANSCUTANEOUS PARTIAL PRESSURE MONITORS intended for use in professional healthcare facilities in the EMERGENCY MEDICAL SERVICE ENVIRONMENT or the HOME HEALTHCARE ENVIRONMENT.

This standard applies to TRANSCUTANEOUS PARTIAL PRESSURE MONITORS used with adults, children and neonates, and it includes the use of these devices in foetal monitoring during birth.

This standard does not apply to haemoglobin saturation oximeters or to devices applied to surfaces of the body other than the skin (for example conjunctiva, mucosa).

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 follows:

The clause or subclause applies to ME EQUIPMENT, as default. For ME EQUIPMENT with the corresponding safety measure or function not completely integrated into the ME EQUIPMENT but instead implemented in an ME SYSTEM, the ME EQUIPMENT MANUFACTURER shall specify in the ACCOMPANYING DOCUMENTS which functionality and safety requirements shall be provided by the ME SYSTEM to comply with this standard. The ME SYSTEM has to be verified accordingly.

HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this document are not covered by specific requirements in this document.

NOTE See also 4.2 of the General Standard.