220
Chapter 15: Use of Standards in Medical Device Global Regulatory Strategy
globally, coordinate any potential overlaps in work
and ensure international standards are seamless
and complementary with each other. Some signif-
icant SDOs are profiled in this chapter.
International Organization for
Standardization (ISO): ISO develops and
publishes international standards.5 Created in
1947, ISO is an independent, nongovernmental
organization with 164 member countries. Each
member has a national committee representing
ISO in its country. For example, the American
National Standards Institute (ANSI) represents
ISO in the US. Through ANSI, the US par-
ticipates heavily in ISO technical committees
(TC), such as ISO/TC 194 Biological and
Clinical Evaluation of Medical Devices. ISO/TC
194 is responsible for publications such as ISO
10993 Biological Evaluation of Medical Devices
and ISO 14155:2011 Clinical Investigation
of Medical Devices for Human Subjects—Good
Clinical Practice series. The British Standards
Institute (BSI) represents ISO in the UK. ISO
representatives in specific jurisdictions can be
found on the ISO members’ web page.6
International Electrotechnical
Commission (IEC): IEC prepares and pub-
lishes international standards for electrical,
electronic and related technologies, known
collectively as electrotechnology.7 IEC mem-
bers are called national committees (NCs) who
represent all electrotechnical standardization
concerns and conformity assessments in their
countries. IEC’s objective is to promote interna-
tional cooperation on all questions concerning
standardization in the electrical and electronic
fields. IEC publishes international standards,
technical specifications, technical reports, pub-
licly available specifications (PAS) and guides,
and collaborates closely with ISO. The US par-
ticipates through ANSI in the medical device
standards development subcommittees (SCs).
American National Standards Institute
(ANSI): ANSI is a private, nonprofit entity
coordinating and administering the US vol-
untary standards and conformity assessment
systems. ANSI, itself, is not an SDO but accred-
its SDOs that adhere consistently to the ANSI
Essential Requirements for openness, balance,
consensus and due process, a set of procedures
governing the consensus standards development
process. ANSI is a founding member of ISO,
and the ANSI Essential Requirements embrace
ISO and IEC’s globally accepted standard-
ization principles. As the US member body of
ISO, ANSI accredits US Technical Advisory
Groups (TAGs). US TAGs, through ANSI,
promote the use of US standards, policies and
technical positions internationally and advo-
cate the adoption of international standards
as US national standards when they meet the
healthcare community’s needs. Because ANSI
is a leader in ISO’s governing body and an IEC
participant, via the US National Committee,
the US has immediate access to both the ISO
and IEC standards development processes. As
the accreditor of US voluntary consensus SDOs,
ANSI ensures SDOs maintain integrity in
developing American national standards.
Clinical and Laboratory Standards
Institute (CLSI): CLSI, successor to the
National Committee for Clinical Laboratory
Standards, exists to develop applicable clin-
ical and laboratory consensus standards and
guidelines for clinical laboratories and promote
their use globally.8 CLSI is accredited by ANSI
and actively promotes global harmonization of
clinical laboratory testing standards through
its participation as the Secretariat of ISO TC
212, Clinical Laboratory Testing and In Vitro
Diagnostic (IVD) Test Systems. CLSI also
serves as the administrator for the US TAG
for ISO TC 212. The CLSI consensus process
includes stakeholder experts from industry,
government and healthcare professions, gather-
ing to develop standards for improved clinical
laboratory testing quality, safety and efficiency.
An example of a CLSI published guideline is
Point-of-Care IVD Testing, providing guidance
to IVD device users outside a clinical laboratory
setting on how to ensure results are comparable
to those obtained in laboratories.
Underwriters Laboratories (UL): In
addition to these organizations, other SDOs
exist that either publish technical standards in
a wide range of industries or collaborate with
ISO and IEC in standards development and
publications. UL develops a wide variety of
standards to measure and validate performance,
Chapter 15: Use of Standards in Medical Device Global Regulatory Strategy
globally, coordinate any potential overlaps in work
and ensure international standards are seamless
and complementary with each other. Some signif-
icant SDOs are profiled in this chapter.
International Organization for
Standardization (ISO): ISO develops and
publishes international standards.5 Created in
1947, ISO is an independent, nongovernmental
organization with 164 member countries. Each
member has a national committee representing
ISO in its country. For example, the American
National Standards Institute (ANSI) represents
ISO in the US. Through ANSI, the US par-
ticipates heavily in ISO technical committees
(TC), such as ISO/TC 194 Biological and
Clinical Evaluation of Medical Devices. ISO/TC
194 is responsible for publications such as ISO
10993 Biological Evaluation of Medical Devices
and ISO 14155:2011 Clinical Investigation
of Medical Devices for Human Subjects—Good
Clinical Practice series. The British Standards
Institute (BSI) represents ISO in the UK. ISO
representatives in specific jurisdictions can be
found on the ISO members’ web page.6
International Electrotechnical
Commission (IEC): IEC prepares and pub-
lishes international standards for electrical,
electronic and related technologies, known
collectively as electrotechnology.7 IEC mem-
bers are called national committees (NCs) who
represent all electrotechnical standardization
concerns and conformity assessments in their
countries. IEC’s objective is to promote interna-
tional cooperation on all questions concerning
standardization in the electrical and electronic
fields. IEC publishes international standards,
technical specifications, technical reports, pub-
licly available specifications (PAS) and guides,
and collaborates closely with ISO. The US par-
ticipates through ANSI in the medical device
standards development subcommittees (SCs).
American National Standards Institute
(ANSI): ANSI is a private, nonprofit entity
coordinating and administering the US vol-
untary standards and conformity assessment
systems. ANSI, itself, is not an SDO but accred-
its SDOs that adhere consistently to the ANSI
Essential Requirements for openness, balance,
consensus and due process, a set of procedures
governing the consensus standards development
process. ANSI is a founding member of ISO,
and the ANSI Essential Requirements embrace
ISO and IEC’s globally accepted standard-
ization principles. As the US member body of
ISO, ANSI accredits US Technical Advisory
Groups (TAGs). US TAGs, through ANSI,
promote the use of US standards, policies and
technical positions internationally and advo-
cate the adoption of international standards
as US national standards when they meet the
healthcare community’s needs. Because ANSI
is a leader in ISO’s governing body and an IEC
participant, via the US National Committee,
the US has immediate access to both the ISO
and IEC standards development processes. As
the accreditor of US voluntary consensus SDOs,
ANSI ensures SDOs maintain integrity in
developing American national standards.
Clinical and Laboratory Standards
Institute (CLSI): CLSI, successor to the
National Committee for Clinical Laboratory
Standards, exists to develop applicable clin-
ical and laboratory consensus standards and
guidelines for clinical laboratories and promote
their use globally.8 CLSI is accredited by ANSI
and actively promotes global harmonization of
clinical laboratory testing standards through
its participation as the Secretariat of ISO TC
212, Clinical Laboratory Testing and In Vitro
Diagnostic (IVD) Test Systems. CLSI also
serves as the administrator for the US TAG
for ISO TC 212. The CLSI consensus process
includes stakeholder experts from industry,
government and healthcare professions, gather-
ing to develop standards for improved clinical
laboratory testing quality, safety and efficiency.
An example of a CLSI published guideline is
Point-of-Care IVD Testing, providing guidance
to IVD device users outside a clinical laboratory
setting on how to ensure results are comparable
to those obtained in laboratories.
Underwriters Laboratories (UL): In
addition to these organizations, other SDOs
exist that either publish technical standards in
a wide range of industries or collaborate with
ISO and IEC in standards development and
publications. UL develops a wide variety of
standards to measure and validate performance,