Introduction
Standards applied
1
LUCEA 50-100
IFU 01741 EN 11
19 / 60
Reference Title
IEC
62366-1:2015+AMD1:2020
EN 62366-1:2015/A1:2020
Medical devices – Part 1: Application of usability engineering to
medical devices
IEC
62304:2006+AMD1:2015
EN 62304:2006/A1:2015
Medical device software – Software life cycle processes
ISO 20417:2020
EN ISO 20417:2021
Medical devices - Information provided by manufacturer
ISO 15223-1:2021
EN ISO 15223-1:2021
Medical devices - Symbols to be used with information to be
provided by manufacturer - Part 1: General requirements
EN 62471:2008 Photobiological safety of lamps and lamp systems
Ordinance 384/2020 INMETRO Certification - Compliance assessment requirements for
equipment under Health Surveillance
Tab.4: Compliance with product standards
Quality management:
Reference Year Title
ISO 13485
EN ISO 13485
2021
2021
ISO 13485:2016 / A11:2021
EN ISO 13485:2016/A11:2021
Medical devices – Quality management systems – Require-
ments for regulatory purposes
ISO 14971
EN ISO 14971
2019
2019
ISO 14971:2019
EN ISO 14971:2019
Medical devices – Application of risk management to med-
ical devices
21 CFR Part 11 2022 Title 21--Food And Drugs
Chapter I--Food and Drug Administration Department of
Health and Human Services
Subchapter A -- General
PART 11 - Electronic records, electronic signatures
21 CFR Part 820 2020 Title 21--Food And Drugs
Chapter I--Food and Drug Administration Department of
Health and Human Services
Subchapter H -- Medical Devices
PART 820 - Quality System Regulation
Tab.5: Compliance with quality management standards
Environmental standards and regulations:
Reference Year Title
Directive 2011/65/EU 2011 Limitation of the use of certain hazardous substances in
electrical and electronic equipment
Directive 2015/863 2015 Directive amending AnnexII of Directive 2001/65/EU of the
European Parliament and of the Council as regards the list
of substances subject to limitation
Tab.6: Environmental standards and regulations
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