INTRODUCTION TO MEDICAL

DEVICES AND STANDARDS

Prepared by: Revocatus JL Mang’ara,
Bsc. EHS with IT (RUCU),
Msc. TDC (MUHAS)
 OUTLINE
• Definition of medical device
• Definition of standards
• Identification of standards
• National regulatory and standards systems
• International standards systems
• Methods for assessing conformity to standard
 INTRODUCTION
 DEFINITION OF MEDICAL DEVICE
 Type of product
• Any instrument, apparatus, implement, machine,
appliance, implant, in vitro reagent or calibrator,
software, material or other similar or related article, or
accessory ,…
 Intended use
• …intended for use in diagnosis, cure, mitigation,
treatment or prevention of disease or other conditions,
in man or other animals;
• …or investigation, replacement, modification, or support
of anatomy or physiology of man or other animals
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 Mode of action
• …and which does not achieve any of its main intended
purposes by pharmacological, immunological or
metabolic action in human or animal body
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• Example: syringes, tongue depressors, mask,
glucometer, patient monitors, anesthesia machines,
etc
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 DEFINITION OF STANDARDS
• Documented agreements containing technical
specifications or other precise criteria
• Used consistently as rules, guidelines or definitions of
characteristics, to ensure that materials, products,
process and services are fit for their purpose
• Standards are used to ensure the safety and efficacy
of medical devices
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 Example:
• ISO 13485: specifies requirements for a QMS for
organization involved in design, production of medical
devices, raw materials or provide related services
• IEC 60601: specifies requirements for basic safety and
essential performance of medical electrical equipment
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 IDENTIFICATION OF STANDARDS
• Name of the standard is indicated by a combination
of an alphabetical prefix and a number
 Example: ISO 13485: 2016
• Letters at the beginning of a standard are an
abbreviation for the organization that issued or
approved them
• Digits before the colon is the number assigned by its
developers for identification of the specific standard
• Digits after the colon are the year in which standard
developed or issued
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 STANDARDS SYSTEMS
• Several regulatory agencies and standards organizations
collaborate in the development of accepted standards
for medical equipment
• Example:

• TMDA: Regulate safety, quality and effectiveness of

medicines, medical devices and diagnostics
• TBS: Formulate standards, quality control, testing ,
calibration, and training
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• International Organization for Standardization (ISO):
NGO that develops international standards on a wide
range of subject, including medical devices
• International Electrotechnical Commission (IEC): NGO
that prepares and publishes International Standards
for all electrical, electronic and related technologies
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 ASSESSMENT OF CONFORMITY
• Most standards are voluntary, once a standard
mandated by government, it become regulation
• There are four (4) methods for assessing conformity to
standards:
 Certification of product
• Direct testing of a product to assess conformity to
standards then authorize the display of certification
mark
 Certification of process
• Audit of a process to assess conformity to standards
then authorize the display of certification mark
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 Registration of management system
• Audit of a management system to assess conformity
to management standard then issued registration
certificates to organization
• Performed by certified auditors and technical experts
of the domain under audit

• NOTE: Many countries use the

word “certification” for both a
product and an organization
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 Accreditation of organization or a person
• Audit done by an authoritative body to give formal
recognition that an organization or a person is
competent to carry out a specific task
• The organization issued certificate of accreditation
• Example: Accreditation of registrar or organization by
government agency