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IECEE CB Scheme - Laboratory Testing Equipment & IVD Medical Equipment- Comtest Laboratories accreditations - IEC 61010 Series

Comtest has been an IECEE CB Testing Laboratory for the general compliance requirements of IEC 61010-1(including Test & Measurement equipment) for many years and has now extended its capabilities to meet the needs of manufacturers and importers of Laboratory Equipment and In Vitro Diagnostic (IVD) Medical Equipment. 

For Test & Measurement equipment and Laboratory apparatus, Australia established AS 61010-1 as the basis of safety compliance for these items. Internationally IEC 61010 has been expanded to include a number of part 2 standards to address particular requirements of different types of laboratory  devices.  

Internationally, the standard was extended to be more specific to identifiable items, rather than only the generic requirements that may not be applicable, missing in requirements or lacking in consideration for the intended use.

The scope of Comtest's IECEE CB accreditation and capabilities now includes Laboratory Equipment for Heating, Mixing & Stirring of Materials, Analysis of Materials and for In Vitro Diagnostic Medical Equipment.  These capabilities also extend to equipment such IVD Medical Equipment that can be used in the home.

Laboratory Equipment and In Vitro Diagnostic (IVD) Medical Equipmentt is often used in laboratories, pathology facilities, hospitals and educational institutions.  Previously the Australian manufacturers and importers were required to test their equipment outside of Australia.

Comtest is also experienced at assessing electrical and electronic Test & Measurement equipment to the AS 61010-1 requirements.  Comtest has assisted many Australian manufacturers with assessing and proof of safety compliance for those that have targeted the Australian and International markets.

The Comtest testing facilities offer a major benefit in terms of time and cost to the Australian based manufacturers.

The standards encompass:-

Electrical test and measurement equipment

This is equipment which by electrical means, tests, measures, indicates or records one or more electrical or non-electrical quantities, also non-measuring equipment such as signal generators, measurement standards, power supplies, transducers, transmitters, etc. All indicating and recording electrical measuring instruments fall within the scope of IEC 61010 unless they are panel meters designed only for integrating into other equipment. Built-in panel meters are considered to be components and only need to meet the relevant requirements of IEC 61010, or other standards, as part of the equipment into which they are built.

Electrical control equipment

This is equipment which controls one or more output quantities to specific values, with each value determined by manual setting, by local or remote programming, or by one or more input variables.

Electrical laboratory equipment

This is equipment which measures, indicates, monitors or analyses substances, or is used to prepare materials, and includes in vitro diagnostic (IVD) equipment

This equipment may also be used in areas other than laboratories, for example self-test IVD equipment may be used in the home.

Accessories intended for use with the above (for example, sample handling equipment).

Comtest is IECEE CB & NATA accredited for the following standards:-

IEC/EN/AS 61010-1
Safety requirements for electrical equipment for measurement, control and laboratory use - General requirements
IEC 61010-2-010
Safety requirements for electrical equipment for measurement, control, and laboratory use –Particular requirements for laboratory equipment for the heating of materials
IEC 61010-2-051
Safety requirements for electrical equipment for measurement, control, and laboratory use –Particular requirements for laboratory equipment for mixing and stirring
IEC 61010-2-081
Safety requirements for electrical equipment for measurement, control, and laboratory use – Particular requirements for automatic and semi automatic laboratory equipment for analysis and other purposes
IEC 61010-2-101 
Safety requirements for electrical equipment for measurement, control and laboratory use – Particular requirements for in vitro diagnostic (IVD) medical equipment
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