Introduction
Standards applied
1
VOLISTA
IFU 01781 EN 19
25 / 106
Quality management:
Reference Year Title
ISO 13485
EN ISO 13485
2016
2016
ISO 13485:2016
EN ISO 13485:2016
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 2021 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.4: 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/EU 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
Directive 2016/585/EU 2016 Exemption for lead, cadmium, hexavalent chromium and
PBDEs on medical devices
Directive 2017/2102 2017 Limitation of the use of certain hazardous substances in
electrical and electronic equipment
IEC 63000 2022 Technical documentation for the assessment of electrical
and electronic products with respect to the restriction of haz-
ardous substances
Regulation 1907/2006 2006 Registration, evaluation and authorization of chemical sub-
stances, as well as the restrictions applicable to these sub-
stances
US California Proposi-
tion 65 Act
1986 The Safe Drinking Water and Toxic Enforcement Act of 1986
Directive 2018/851 2018 Directive amending Directive 2008/98/CE concerning waste
Directive 94/62/EC 1994 Packaging and Waste Management
SJ/T 11365-2006 2006 Administrative Measure on the Control of Pollution caused
by Electronic Information Products Chines RoHS (Restriction
of Hazardous Substances)
Tab.5: Environmental standards and regulations
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