Source: https://www.adinstruments.com/support/safety-quality-standards
Timestamp: 2020-08-14 16:48:40
Document Index: 226982855

Matched Legal Cases: ['art 1', 'art 1', 'art 1', 'art 1', 'art 1', 'art 1', 'art 11']

Safety and Quality Standards | ADInstruments
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 ISO9001:2015 quality management system.
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.
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) symbol
This 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) symbol
This 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) Symbol
Appears 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.
All PowerLab systems and front-end amplifiers carry the CE mark and meet the appropriate EU directives.
ADInstruments 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)
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.
International Standard - Medical Electrical Equipment
IEC60601-1:1998 General requirements for safety
IEC60601-1-1:1992 Safety requirements for medical electrical systems
IEC60601-1-2:1993 Electromagnetic compatibility
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.
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 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.
ADInstruments manufactures products under a quality system certified as complying with ISO 9001:2015 by an accredited certification body. ADInstruments ISO 9001:2015 certificate.
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.