Activinsights GENEActiv Manual de instrucciones - Página 18

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Regulatory Compliance

European Compliance

GENEActiv is a Class I Medical Device based on Rules 1 & 12 from Annex IX, conforming to the

Essential Safety & Health requirements and provisions of EC Council Directives 93/42/EEC, Annex

VII. The application of the classification rules is governed by the intended purpose of the device.

US Compliance

GENEActiv is an FDA Regulatory Class II, 21 CFR 882.1400 Neurological Diagnostic Devices and

Class II, 21 CFR 882.5050 Biofeedback Devices.

Applicable Standards

Standards which have been applied in full to document compliance with the Essential Requirements

for Conformance.

Applicable Standards

BS EN ISO 13485:2016

BS EN ISO 14971:2019

BS EN 62366-

1:2015+A1:2020

BS EN 62304:2006+A1:2015 Medical device software – Software lifecycle processes

BS EN 60601-

1:2006+A12:2014

BS EN 60601-1-2:2015

BS EN 60601-1-

6:2010+A1:2015

ISO 10993-1:2018

BS EN 1041:2008 + A1:2013 Information supplied by the manufacturer of medical devices.

BS EN ISO 15223-1:2016

BS EN 60529:1992+A2:2013 Degrees of protection provided by enclosures (IP Code)

Description

Medical devices. Quality management systems.

Requirements for regulatory purposes.

Medical devices. Application of risk management to medical

devices.

Medical devices. Application of usability engineering to medical

devices.

Medical electrical equipment – Part 1: General requirements for

basic safety and essential performance.

Medical electrical equipment. General requirements for

basic safety and essential performance. Collateral Standard.

Electromagnetic disturbances. Requirements and tests.

Medical electrical equipment. General requirements for basic

safety and essential performance. Collateral standard. Usability.

Biological evaluation of medical devices. Evaluation and testing

within a risk management process.

Medical devices. Symbols to be used with medical device labels,

labelling and information to be supplied. General requirements.