Safety Standards, Quality System, GLP & 21 CFR Part 11 Compliance

ADInstruments is conscious of the critical safety issues involved when connecting electrical devices to subjects. We invest significant resources to ensure that our products are approved to strict international safety standards, and have our systems tested by independent certification bodies. In addition, ADInstruments products are designed, manufactured and serviced under the internationally recognized ISO9001:2008 quality management system.

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

When used with ADInstruments isolated front-ends, PowerLab systems are safe for connection to subjects. The Bio Amp and the Isolated Stimulator built into the ML760 PowerLab/4ST, ML860 PowerLab 4/20T, ML865 PowerLab 4/25T, ML818 PowerLab 15T, ML856 PowerLab 26T and the ML132 Bio Amp, ML135 Dual Bio Amp, ML408 Dual Bio Amp/Stimulator, ML116 GSR Amp, ML117 BP Amp and ML180 Stimulus Isolator front-ends, conform to international safety requirements. Specifically these are IEC60601-1 and its addenda (see the table below), and various harmonized 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.

	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 subjects even when there is direct electrical connection to the heart.
	CE Mark All PowerLab systems and front-end amplifiers carry the CE mark and meet the appropriate EU directives.
	CSA Mark ADInstruments ML series 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)
	UL Mark ADInstruments 35 series isolated preamplifiers and 35 series PowerLab data acquisition units meet standards for Data Recorders set by UL (Underwriters Laboratories) with respect to electrical shock, fire and mechanical hazards only, in accordance with CAN/CSA-C22.2 No. 601.1 and UL 60601-1. The UL mark shown refers only to the PowerLab. For all other equipment, refer to the relevant documentation.

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 UL Std No 2601-1	Safety of Medical Electrical Equipment, Part 1: General Requirements for Safety Safety of Medical Electrical Equipment, Part 1: General Requirements for Safety

UL Standard	Medical Electrical Equipment
UL 60601-1: CSA C22.2 No. 601.1:	Medical Electrical Equipment, Part 1: General Requirements for Safety - Edition 1 Medical Electrical Equipment, Part 1: General Requirements for Safety - Edition 1

Quality Management System
ISO9001:2008

ADInstruments manufactures products under a quality system certified as complying with ISO9001:2008 by an accredited certification body.

Click here to view our ISO9001:2008 certificate.

GLP and 21 CFR Part 11 Compliance

LabChart features 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. In addition, the optional GLP Client and GLP Server software facilitates 21 CFR Part 11 compliance.

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