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Global Medical Device Regulatory Strategy
Medical Device Software. ISO website. https://www.iso.
org/standard/54146.html. Accessed 13 July 2020.
• IEC 62 Electrical Equipment in Medical
Practice. IEC website. https://www.iec.ch/dyn/
www/f?p=103:7:0::::FSP_ORG_ID,FSP_LANG_
ID:1245,25 Accessed 13 July 2020.
• IEC SC 62A Common Aspects of Electrical Equipment
Used in Medical Practice. IEC website. https://www.
iec.ch/dyn/www/f?p=103:7:0::::FSP_ORG_ID,FSP_
LANG_ID:1359,25. Accessed 13 July 2020.
• IEC 62366-1:2015 Medical Devices: Part 1: Application
of Usability Engineering to Medical Devices. ISO
website. https://www.iso.org/standard/63179.html.
Accessed 13 July 2020.
• IEEE 1012-2012 Standard for System and Software
Verification and Validation. IEEE website. https://
ieeexplore.ieee.org/document/6204026. Accessed 13
July 2020.
• BS EN 1041:2008+A1:2013 Information Supplied by
the Manufacturer of the Medical Device. https://www.
en-standard.eu/bs-en-1041-2008-a1-2013-informa-
tion-supplied-by-the-manufacturer-of-medical-devic-
es/?gclid=Cj0KCQjw0rr4BRCtARIsAB0_48PmX-
pWsIDsSqyidWyLEa_h3-p-TBBpveRMnSNR0e-
1Q7G5axP4JYXEcaAhBXEALw_wcB. Accessed 13
July 2020.
• Essential Principles of Safety and Performance of
Medical Devices and IVD Medical Devices. IMDRF
website. imdrf.org/docs/imdrf/final/technical/
imdrf-tech-181031-grrp-essential-principles-n47.pdf.
Accessed 13 July 2020.
• ISO 15223-1:2016 Medical Devices: Symbols to Be Used
With Medical Device Labels, Labelling and Information
to be Supplied—Part 1: General Requirements. ISO
website. https://www.iso.org/standard/69081.html.
Accessed 13 July 2020.
• ISO 14001:2015 Environmental Management Systems:
Requirements With Guidance for use. ISO website.
https://www.iso.org/standard/60857.html. Accessed
13 July 2020.
• ISO 11137-3:2017 Sterilization of Health Care
Products—Radiation—Part 3: Guidance on Dosimetric
Aspects of Development, Validation and Routine Control.
ISO website. https://www.iso.org/standard/63841.
html. Accessed 13 July 2020.
• ISO 11607 Packaging for Terminally Sterilized Devices
— Part 1: Requirements for Materials, Sterile Barrier
Systems and Packaging Systems. ISO website. https://
www.iso.org/standard/70799.html. Accessed 13 July
2020.
• ISO 27185:2012 Cardiac Rhythm Management
Devices—Symbols to be Used With Cardiac Rhythm
Management Device Labels and Information to be
Supplied—General Requirements. ISO website. https://
www.iso.org/standard/52552.html. Accessed 13 July
2020.
• ISO 14155:2011 Clinical Investigation of Medical
Devices for Human Subjects—Good Clinical Practice.
ISO website. https://www.iso.org/standard/45557.
html. Accessed 13 July 2020.
• ISO 10993 -1:2018 Biological Evaluation of Medical
Devices: Part 1: Evaluation and Testing Within a Risk
Management Process. ISO website. https://www.iso.
org/standard/64750.html. Accessed 13 July 2020.
• ISO TC 210 Quality Management and Corresponding
General Aspects for Medical Devices. ISO website.
https://www.iso.org/committee/54892.html. Accessed
13 July 2020.
• ISO TC 212 Clinical Laboratory Testing and In Vitro
Diagnostic (IVD) Test Systems. ISO website. https://
www.iso.org/committee/54916.html. Accessed 13 July
2020.
• NEMA XR 26-2012 Access Controls for Computed
Tomography—Identification, Interlocks and Logs.
National Electrical Manufacturers Association
(NEMA) website. https://www.nema.org/Standards/
Pages/Access-Controls-for-Computed-Tomography-
Identification-Interlocks-and-Logs.aspx. Accessed 13
July 2020.
• NEMA MS-10-2010 Determination of Local
Specific Absorption Rate (SAR) in Diagnostic
Magnetic Resonance Imaging (MRI). NEMA web-
site. https://www.nema.org/Standards/Pages/
Determination-of-Local-Specific-Absorption-Rate-
in-Diagnostic-Magnetic-Resonance-Imaging.aspx.
Accessed 13 July 2020.
• Regulation (EU) 2017/745 of the European
Parliament and of the Council of 5 April 2017 on
medical devices, amending Directive 2001/83/EC,
Regulation (EC) No. 178/2002 and Regulation (EC)
No. 1223/2009 and repealing Council Directives
90/385/EEC and 93/42/EEC (EU MDR). EUR-Lex
website. http://eur-lex.europa.eu/legal-content/EN/
TXT/?uri=CELEX%3A32017R0745. Accessed 13
July 2020.
• Standard UL 60601-1 Medical Electrical Equipment,
Part 1: General Requirements for Safety. https://
standardscatalog.ul.com/ProductDetail.aspx?produc-
tId=UL60601-1. Accessed 13 July 2020.
References
1. ISO/IEC Directives, Part 2:2011-04, Definition 3.1.1.
IEC website. https://www.iec.ch/members_experts/
refdocs/iec/isoiecdir2%7Bed8.0.RLV%7Den.pdf.
Accessed 13 July 2020.
2. Radio Frequency Wireless Technology in Medical
Devices—Guidance for Industry and Food and Drug
Administration Staff. FDA website. http://www.fda.
gov/MedicalDevices/DeviceRegulationandGuidance/
GuidanceDocuments/ucm077210.htm. Accessed 13
July 2020.
3. Principles of Conformity Assessment for Medical Devices,
GHTF/SG1/N78:2012. Global Harmonization Task
Force. IMDRF website. http://www.imdrf.org/docs/
ghtf/final/sg1/technical-docs/ghtf-sg1-n78-2012-con-
formity-assessment-medical-devices-121102.pdf.
Accessed 13 July 2020.
4. Danish Standards Foundation website. http://www.
ds.dk/da. Accessed 13 July 2020.
5. ISO Homepage. ISO website. http://www.iso.org/iso/
home.html. Accessed 13 July 2020.
6. ISO Members. ISO website. http://www.iso.org/
iso/home/about/iso_members.htm. Accessed 13 July
2020.
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
19
16
20
17
21
18
22
Global Medical Device Regulatory Strategy
Medical Device Software. ISO website. https://www.iso.
org/standard/54146.html. Accessed 13 July 2020.
• IEC 62 Electrical Equipment in Medical
Practice. IEC website. https://www.iec.ch/dyn/
www/f?p=103:7:0::::FSP_ORG_ID,FSP_LANG_
ID:1245,25 Accessed 13 July 2020.
• IEC SC 62A Common Aspects of Electrical Equipment
Used in Medical Practice. IEC website. https://www.
iec.ch/dyn/www/f?p=103:7:0::::FSP_ORG_ID,FSP_
LANG_ID:1359,25. Accessed 13 July 2020.
• IEC 62366-1:2015 Medical Devices: Part 1: Application
of Usability Engineering to Medical Devices. ISO
website. https://www.iso.org/standard/63179.html.
Accessed 13 July 2020.
• IEEE 1012-2012 Standard for System and Software
Verification and Validation. IEEE website. https://
ieeexplore.ieee.org/document/6204026. Accessed 13
July 2020.
• BS EN 1041:2008+A1:2013 Information Supplied by
the Manufacturer of the Medical Device. https://www.
en-standard.eu/bs-en-1041-2008-a1-2013-informa-
tion-supplied-by-the-manufacturer-of-medical-devic-
es/?gclid=Cj0KCQjw0rr4BRCtARIsAB0_48PmX-
pWsIDsSqyidWyLEa_h3-p-TBBpveRMnSNR0e-
1Q7G5axP4JYXEcaAhBXEALw_wcB. Accessed 13
July 2020.
• Essential Principles of Safety and Performance of
Medical Devices and IVD Medical Devices. IMDRF
website. imdrf.org/docs/imdrf/final/technical/
imdrf-tech-181031-grrp-essential-principles-n47.pdf.
Accessed 13 July 2020.
• ISO 15223-1:2016 Medical Devices: Symbols to Be Used
With Medical Device Labels, Labelling and Information
to be Supplied—Part 1: General Requirements. ISO
website. https://www.iso.org/standard/69081.html.
Accessed 13 July 2020.
• ISO 14001:2015 Environmental Management Systems:
Requirements With Guidance for use. ISO website.
https://www.iso.org/standard/60857.html. Accessed
13 July 2020.
• ISO 11137-3:2017 Sterilization of Health Care
Products—Radiation—Part 3: Guidance on Dosimetric
Aspects of Development, Validation and Routine Control.
ISO website. https://www.iso.org/standard/63841.
html. Accessed 13 July 2020.
• ISO 11607 Packaging for Terminally Sterilized Devices
— Part 1: Requirements for Materials, Sterile Barrier
Systems and Packaging Systems. ISO website. https://
www.iso.org/standard/70799.html. Accessed 13 July
2020.
• ISO 27185:2012 Cardiac Rhythm Management
Devices—Symbols to be Used With Cardiac Rhythm
Management Device Labels and Information to be
Supplied—General Requirements. ISO website. https://
www.iso.org/standard/52552.html. Accessed 13 July
2020.
• ISO 14155:2011 Clinical Investigation of Medical
Devices for Human Subjects—Good Clinical Practice.
ISO website. https://www.iso.org/standard/45557.
html. Accessed 13 July 2020.
• ISO 10993 -1:2018 Biological Evaluation of Medical
Devices: Part 1: Evaluation and Testing Within a Risk
Management Process. ISO website. https://www.iso.
org/standard/64750.html. Accessed 13 July 2020.
• ISO TC 210 Quality Management and Corresponding
General Aspects for Medical Devices. ISO website.
https://www.iso.org/committee/54892.html. Accessed
13 July 2020.
• ISO TC 212 Clinical Laboratory Testing and In Vitro
Diagnostic (IVD) Test Systems. ISO website. https://
www.iso.org/committee/54916.html. Accessed 13 July
2020.
• NEMA XR 26-2012 Access Controls for Computed
Tomography—Identification, Interlocks and Logs.
National Electrical Manufacturers Association
(NEMA) website. https://www.nema.org/Standards/
Pages/Access-Controls-for-Computed-Tomography-
Identification-Interlocks-and-Logs.aspx. Accessed 13
July 2020.
• NEMA MS-10-2010 Determination of Local
Specific Absorption Rate (SAR) in Diagnostic
Magnetic Resonance Imaging (MRI). NEMA web-
site. https://www.nema.org/Standards/Pages/
Determination-of-Local-Specific-Absorption-Rate-
in-Diagnostic-Magnetic-Resonance-Imaging.aspx.
Accessed 13 July 2020.
• Regulation (EU) 2017/745 of the European
Parliament and of the Council of 5 April 2017 on
medical devices, amending Directive 2001/83/EC,
Regulation (EC) No. 178/2002 and Regulation (EC)
No. 1223/2009 and repealing Council Directives
90/385/EEC and 93/42/EEC (EU MDR). EUR-Lex
website. http://eur-lex.europa.eu/legal-content/EN/
TXT/?uri=CELEX%3A32017R0745. Accessed 13
July 2020.
• Standard UL 60601-1 Medical Electrical Equipment,
Part 1: General Requirements for Safety. https://
standardscatalog.ul.com/ProductDetail.aspx?produc-
tId=UL60601-1. Accessed 13 July 2020.
References
1. ISO/IEC Directives, Part 2:2011-04, Definition 3.1.1.
IEC website. https://www.iec.ch/members_experts/
refdocs/iec/isoiecdir2%7Bed8.0.RLV%7Den.pdf.
Accessed 13 July 2020.
2. Radio Frequency Wireless Technology in Medical
Devices—Guidance for Industry and Food and Drug
Administration Staff. FDA website. http://www.fda.
gov/MedicalDevices/DeviceRegulationandGuidance/
GuidanceDocuments/ucm077210.htm. Accessed 13
July 2020.
3. Principles of Conformity Assessment for Medical Devices,
GHTF/SG1/N78:2012. Global Harmonization Task
Force. IMDRF website. http://www.imdrf.org/docs/
ghtf/final/sg1/technical-docs/ghtf-sg1-n78-2012-con-
formity-assessment-medical-devices-121102.pdf.
Accessed 13 July 2020.
4. Danish Standards Foundation website. http://www.
ds.dk/da. Accessed 13 July 2020.
5. ISO Homepage. ISO website. http://www.iso.org/iso/
home.html. Accessed 13 July 2020.
6. ISO Members. ISO website. http://www.iso.org/
iso/home/about/iso_members.htm. Accessed 13 July
2020.