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Safety Standards and Quality Control

ADInstruments is conscious of the important safety issues involved when connecting electrical devices to human subjects. We invest significant resources to ensure that our products are designed to conform with accepted international safety standards and have our systems tested by appropriate certification bodies.

The body and cardiac protection symbols displayed on many of our PowerLabs and front-ends means those models are safe to connect to humans, and have been tested and approved. Researchers and educators alike can be confident that an ADInstruments amplifier is safe for connection to subjects or students.

In addition, ADInstruments products are designed, manufactured and serviced under an ISO 9001:2000 quality management system certified as meeting strict international standards.

Statement of Intended Use

All ADInstruments manufactured products are intended for use in teaching and research applications and environments only. ADInstruments products are NOT intended to be used as medical devices or in medical environments. That is, no product supplied by ADInstruments is intended to be used to diagnose, treat, or monitor a subject. Furthermore no product is intended for the prevention, curing or alleviation of disease, injury or handicap.

Where a product meets IEC 60601-1 it is under the principle that:

it is a more rigorous standard than other standards that could be adopted and
it provides the most appropriate safety level for subjects and operators.

The choice to meet IEC 60601-1 is in no way to be interpreted to mean that a product:

is a medical device;
may be interpreted as a medical device;
is safe to be used as a medical device

Safety and Quality Standards


	BF (body protected) symbol. This means that the input connectors are suitable for connection to humans provided there is no direct electrical connection to the heart.

	CF (cardiac protected) symbol. (Appears on some models of Bio Amp, and every BP Amp). This means that the input connectors are suitable for connection to humans even when there is direct electrical connection to the heart.

	All PowerLab systems and front end amplifiers carry the CE mark and meet the appropriate EU directives.

	ADInstruments isolated preamplifiers and 30 series PowerLab data acquisition units meet the standards set by the Canadian Standards Association. Class 8750 01 - Medical Electrical Equipment Class 8750 81 - Medical Electrical Equipment (Certified to U.S. Standards)

When used with ADInstruments isolated front-ends, PowerLab systems are safe for human connection. The Bio Amp and the Isolated Stimulator built into the ML760 PowerLab/4ST, ML860 PowerLab 4/20T, ML865 PowerLab 4/25T, and the ML132 Bio Amp, ML135 Dual Bio Amp, ML408 Dual Bio Amp/Stimulator, ML116 GSR Amp, ML117 BP Amp and ML180 Front-ends, conform to international safety requirements. Specifically these are IEC60601-1 and its addenda (see the table below), and various harmonised standards world-wide (CSA601.1 in Canada and AS/NZS 3200.1 in Australia and New Zealand). In accordance with European standards they also comply with the electromagnetic compatibility requirements under EN60601-1, which encompasses the EMC directive.

IEC Standard	International Standard - Medical Electrical Equipment
IEC60601-1:1998 IEC60601-1-1:1992 IEC60601-1-2:1993 IEC61326:2002 IEC61010-1ED2.0	General requirements for safety Safety requirements for medical electrical systems Electromagnetic compatibility Electrical equipment for measurement, control and laboratory use - EMC requirements Safety requirements for electrical equipment for measurement, control and laboratory use.

CSA Standard	Medical Electrical Equipment
CAN/USA C22.2 No 601.1-M90 CSA 601.1 supplement 1:1994 CSA 601.1 Amendment 2:1998	Safety of Medical Electrical Equipment, Part 1: General Requirements for Safety
UL Std No 2601-1	Safety of Medical Electrical Equipment, Part 1: General Requirements for Safety

Quality Control and GLP

PowerLab systems are manufactured under a quality system certified as complying with ISO 9001:2000 by an accredited certification body.

This certification along with many features of PowerLab systems, such as date and time stamping, automatic storage of experimental settings, and retention of raw data, will assist your laboratory in meeting its 'Good Laboratory Practice' requirements.

Click here to view our ISO 9001:2000 certificate.