ГОСТ Р ИСО 20916—2022
Библиография
[4]
ISO 14971
[5]
ISO 14155
[
6
]
ISO 15193:2009
[7]
ISO 16142-2:2017
[
8
]
ISO 18113-1:2009
[
1
]
ISO 15190:2003
[
2
]
ISO 13131:2014
[3]
ISO 13485
[9]
ISO/TR 24971
[Ю]
ISO/IEC Guide 51:2014
Medical laboratories — Requirements for safety
Health informatics — Telehealth services — Quality planning guidelines
Medical devices — Quality management systems — Requirements for regulatory
purposes
Medical devices — Application of risk management to medical devices
Clinical investigation of medical devices for human subjects — Good clinical practice
Invitro diagnostic medical devices — Measurement of quantities in samples of biological
origin — Requirements for content and presentation of reference measurement
procedures
Medical devices— Recognized essential principles of safety and performance of medical
devices — Part 2: General essential principles and additional specific essential principles
for all IVD medical devices and guidance on the selection of standards
In vitro diagnostic medical devices— Information supplied bythe manufacturer (labelling)
— Part 1: Terms, definitions and general requirements
Medical devices — Guidance on the application of ISO 14971
Safety aspects — Guidelines for their inclusion in standards
[
11
]
Global Harmonization Task Force. Definition of the Terms «Medical Device» and «In Vitro Diagnostic (IVD) Medical
Device» [GHTF/SG1/N071:2012] available at:
http://www.imdrf.org/docs/ghtf/final/sg1/technical-docs/ghtf-sg1-
n071
-2012-definition-of-terms-120516.pdf
[
12
]
CLSI. Protection of Laboratory Workers from Occupationally Acquired Infections; Approved Guideline — Fourth
Edition. CLSI document M29-A4. Wayne, PA: Clinical and Laboratory Standards Institute; 2014
[13]United States Department of Labor. Occupational Safety and Health Administration. Part 1910.1030 — Bloodborne
pathogens. (Codified at 29 CFR § 1910.1030). US Government Printing Office; published annually, available at:
https://www.osha
.gov/pls/oshaweb/owadisp.show_document?p_id=10051&p_table= STANDARDS
[14]Declaration of Helsinki, available at:
https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-
principles-for-medical-research-involving-human-subjects
[15]Global Harmonization Task Force, Principles of In Vitro Diagnostic (IVD) Medical Devices Classification [GHTF/SG1/
N077:2012], available at:
http://www.imdrf.org/docs/
ghtf/final/sg1/technical-docs/ghtf-sg1-n071-2012-definition-of-
terms-120516.docx
[16]Global Harmonization Task Force, Essential Principles of Safety and Performance of Medical Devices [GHTF/
SG1/N68:2012], available at:
http://www.imdrf.org/
docs/ghtf/final/sg1/technical-docs/ghtf-sg1-n68-2012-safety-
performance-medical — devices-121102.pdf
[17]Global Harmonization Task Force. Clinical Evidence for IVD medical devices — Key Definitions and Concepts
[GHTF/SG5/N6:2012], available at:
http://www.imdrf
,org/docs/ghtf/final/sg5/technical-docs/ghtf-sg5-n6-2012-clini-
cal-evidence-ivd-medical—devices-121102.pdf
[18]Global Harmonization Task Force. Clinical Evidence for IVD medical devices — Scientific Validity Determination and
Performance Evaluation [GHTF/SG5/N7:2012], available at:
http://www.imdrf.org/docs/ghtf/final/sg5/technical-docs/
ghtf-sg5-n7-2012-scientific-validity-determination-evaluation-121102.pdf
[19] Global Harmonization Task Force. Clinical Evidence for IVD Medical Devices — Clinical Performance Studies for In
Vitro Diagnostic Medical Devices [GHTF/SG5/N8:2012], available at:
http://www.imdrf.org/docs/ghtf/final/sg5/tech-
nical-docs/ghtf-sg5-n8-2012-clinical-performance-studies-ivd-medical-devices-121102.
pdfmay
[
20
]
Global Harmonization Task Force. Quality Management Systems — Process Validation Guidance [GHTF/SG3/N99-
10:2004], available at:
http://www.imdrf.org/docs/ghtf/final/sg3/technical-docs/ghtf-sg3-n99-10-2004-qms-process-
guidance-04010.pdf
[
21
]
European Commission Guidelines on Medical Devices. Clinical Evaluation: A Guide For Manufacturers And No
tified Bodies Under Directives 93/42/EEC and 90/385/EEC [MEDDEV 2.7/1 revision 4, June 2016], available at:
http://ec.europa.eu/DocsRoom/documents/17522/attachments/1
/translations/
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