ADInstruments equipment is quality and safety tested.
We are concerned about the important safety issues regarding the connection
of electrical devices to human subjects. We test our products to ensure that
they conform to recognized international safety standards. We validate our
tests by obtaining safety and quality certifications from external organizations.
In addition, ADInstruments has ISO 9001:2000 accreditation for the design
and manufacture of PowerLab systems, using a quality assurance system that
meets strict international standards.
Safety and Quality Standards
The body and cardiac protection symbols displayed on many of our PowerLabs
and front-ends mean these models are safe to connect to human subjects, and
have been tested and proven so.
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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. |
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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. |
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All PowerLab systems carry the CE mark indicating that the products meet the
European EMC directive. This is equivalent to the FCC Class B standard in the
United States. |
ADInstruments isolated preamplifiers 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 standard insulated transducers or 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 ML180 Stimulus Isolator, 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 worldwide (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.
EC Standard International
Standard - Medical Electrical Equipment
IEC60601-1:1998
IEC60601-1-1:1992
IEC60601-1-2:1993
IEC60601-1-4:1996 General
requirements for safety
Safety requirements for medical electrical systems
Electromagnetic compatibility
Programmable electrical medical systems
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
Statement of Intended Use
Products supplied by ADInstruments are intended for use in teaching and research
applications and environments. Products supplied by ADInstruments 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:
a.It is a more rigorous standard than other standards that could be adopted
and
b.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:
a. Is a medical device;
b. May be interpreted as a medical device;
c. Is safe to be used as a medical device.
Click here to view our ISO 9001:2000 certificate which is accreditation for
the design and manufacture of PowerLab systems, using a quality assurance system
that meets strict international standards.
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