Safety and Quality Standards
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. Our systems are tested by external and independent certification bodies to ensure that our products fully comply with international certifications.
In addition, ADInstruments products are designed, manufactured, and serviced under the internationally recognized ISO9001:2015 quality management system.
Statement of Intended Use
Products supplied by ADInstruments are intended for use in teaching and research applications and environments only. 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:
- 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.
ADInstruments Quality Policy
ADInstruments is totally committed to maintaining and continually improving our Quality Managements System to meet the requirements of ISO 9001:2015 and the regulatory requirements in each region, along with other requirements imposed by our customers. This is reflected in our "playing-to-win" strategy and our plan to achieve it.
We shall focus our resources, both technical and human, to achieve the organisational goals to be a fundamental part of our customers' success by delivering the best products, services and support.
The successful operation of the business relies upon the collaboration of our people globally. Our commitment to quality will ensure the continued success of our business and the satisfaction of customers and staff.
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 PowerLab/4ST, PowerLab 4/20T, PowerLab 4/25T, ML818 PowerLab 15T, ML856 PowerLab 26T and the FE132 Bio Amp, FE135 Dual Bio Amp, ML408 Dual Bio Amp/Stimulator, FE116 GSR Amp, FE117 BP Amp and FE180 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 and EN61326, which satisfy the EMC directive.
These symbols appear next to those applied parts that can be directly connected to human and animal subjects. An applied part is defined as part of the equipment that necessarily comes in contact with the subject in order to perform its function. See below for their definitions.
B-type (body protected symbol) symbolThis means that the applied part(s) so marked are suitable for connection to humans and animals (provided there is no direct electrical connection to the heart) and gives a basic level of protection against electric shock. This applied part is not electrically isolated from mains earth.
BF-type (body-protected floating) symbolThis means that the applied part(s) so marked are suitable for connection to humans and animals provided there is no direct electrical connection to the heart) and gives greater protection from electric shock than B-type applied parts. This applied part is electrically isolated from mains earth.
CF (cardiac protected) SymbolAppears on some older models of Dual Bio Amp and BP Amps but no current equipment. This means that the applied parts so marked are suitable for connection to human and animal subjects even when there is direct electrical connection to the heart. This applied part is electrically isolated from mains earth.
CE MarkAll PowerLab systems and front-end amplifiers carry the CE mark and meet the appropriate EU directives.
CSA MarkADInstruments ML series isolated preamplifiers, 15T, 26 series 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 MarkADInstruments 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||General requirements for safety|
|IEC60601-1-1:1992||Safety requirements for medical electrical systems|
|IEC61326:2002||Electrical equipment for measurement, control and laboratory use - EMC requirements|
|IEC61010-1ED2.0||Safety requirements for electrical equipment for measurement, control and laboratory use.|
|CSA Standard||Medical Electrical Equipment|
|CAN/USA C22.2 No 601.1-M90||Safety of Medical Electrical Equipment, Part 1: General Requirements for Safety|
|CSA 601.1 supplement 1:1994||Safety of Medical Electrical Equipment, Part 1: General Requirements for Safety|
|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|
|UL Standard||Medical Electrical Equipment|
|UL 60601-1||Medical Electrical Equipment, Part 1: General Requirements for Safety - Edition 1|
|CSA C22.2 No.601.1||Medical Electrical Equipment, Part 1: General Requirements for Safety - Edition 1|
ADInstruments Commitment to RoHS Directive
The European Parliament's Restriction of the Use of Certain Hazardous Substances directive (now in its second publishing, RoHS2) aims to restrict the use of hazardous substances in electrical and electronic equipment, and contribute to the protection of human health and the environment. Although ADInstruments products are in a category which only needs to be compliant by July 2017, we place high value on its principles. In conjunction with our product component suppliers, we are actively seeking to fully comply with the directive well before the required date to ensure that our products are beneficial to our employees, customers and the environment.
Quality Management System ISO 9001:2015
ADInstruments manufactures products under a quality system certified as complying with ISO 9001:2015 by an accredited certification body.
ADInstruments ISO 9001:2015 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.