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Laboratory Equipment, Industrial Control and Measurement Equipment

Laboratory Equipment, Industrial Control and Measurement Equipment

File 364Biotechnology is one of the fastest moving branches in the economy. Growing knowledge and new inventions in medicine and other industries cause a rapid advancement in laboratory devices as well as testing and measuring instruments.

In addition, the increased needs for quality and safety drive the development. Highly specialized technical equipment like industrial control and measurement devices are in high demand for solving exact testing requirements.

  • Nemko follows these developments and is expanding the corresponding services for testing and certification.
  • Special emphasis is devoted to Pre-compliance – a special service for manufacturers and importers in the design phase.
  • Nemko assists customers to identify applicable directives, standards and rules in order to implement the requirements as early as possible in the development cycle.

Any risk exposure of such equipment due to electricity, high voltage or energy must be contained. Depending on the function and the technology employed additional risk factors may be encountered like:

  • Mechanical (e.g. centrifuges)
  • Radiation (e.g. laser)
  • Heat (e.g. sintering furnace)
  • Chemical (e.g. chemical material analyser)

Laboratory, industrial control and measurement equipment fall under the scope of the Low Voltage directive (2006/95/EG) and the EMC directive (2004/108/EG). Conformity with the Machinery Directive (2006/42/EG) has to be declared and demonstratedfor devices with primarily electrical risks. The new machinery directive no longer excludes devices with primarily electrical risks. Therefore, all devices causing mechanical risk need to demonstrate compliance.

Special regulations have been established for medical appliances used as in-vitro-diagnostics – here the IVD Directive (In-Vitro-Diagnostics 98/79/EG) is the applicable directive.

A risk analysis shall be performed and a complete risk management file must be available for equipment with high potential risk. Applicable standards are:

  • DIN EN ISO 14971 (for IVD equipment)
  • DIN EN ISO 14121 (for mechanical risk)

Nemko maintains test labs around the world to support our customers in the Safety and EMC testing of laboratory and measurement equipment. Our long experience and the close co-operation with well-known manufacturers of laboratory equipment and industrial controls enable us to deliver comprehensive services in these areas. Nemko has accreditations for most of the related standards.

Standard

Title

Safety

 

IEC 61010-1

Safety requirements for electrical equipment for measurement, control, and laboratory use

Part 1: General requirements

IEC 61010-2-010

Particular requirements for laboratory equipment for the heating of materials

IEC 61010-2-020

Particular requirements for laboratory centrifuges

IEC 61010-2-031

Particular requirements for hand-held and hand manipulated current sensors for electrical test and measurement

IEC 61010-2-040

Particular requirements for sterilizers and washer-disinfectors used to treat medical materials

IEC 61010-2-051

Particular requirements for laboratory equipment for mixing and stirring

IEC 61010-2-061

Particular requirements for laboratory atomic spectrometers with thermal atomization and ionization

IEC 61010-2-081

Particular requirements for automatic and semi-automatic laboratory equipment for analysis and other purposes

IEC 61010-2-101

Particular requirements for in vitro diagnostic (IVD)medical equipment

EMC

 

IEC 61326-1

Electrical equipment for measurement, control and laboratory use - EMC requirements

Part 1: General requirements

IEC 61326-2-1

Particular requirements - Test configurations, operational conditions and performance criteria for sensitive test and measurement equipment for EMC unprotected applications

IEC 61326-2-2

Particular requirements - Test configurations, operational conditions and performance criteria for portable test, measuring and monitoring equipment used in low-voltage distribution systems

IEC 61326-2-3

Particular requirements - Test configuration, operational conditions and performance

IEC 61326-2-4

Particular requirements - Test configurations, operational conditions and performance criteria for insulation monitoring devices according to IEC 61557-8 and for equipment for insulation fault location according to IEC 61557-9

IEC 61326-2-5

Particular requirements - Test configurations, operational conditions and performance criteria for field devices with interfaces according to IEC 61784-1, CP 3/2

IEC 61326-2-6

Particular requirements - In vitro diagnostic (IVD) medical equipment

IEC 61326-3-1

Immunity requirements for safety-related systems and for equipment intended to perform safety-related functions (functional safety) - General industrial applications

IEC 61326-3-2

Immunity requirements for safety-related systems and for equipment intended to perform safety-related functions (functional safety) - Industrial applications with specified electromagnetic environment

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