Brief History of International Organisation for
Standardization (ISO)
Standardization (ISO)
In
October 1946, International Federation of the National Standardizing
Associations (ISA) and United Nations Standards Coordinating Committee (UNSCC)
delegates from 25 countries met in London and agreed to join forces to create
the new International Organization for Standardization; the new organization
officially began operations in February 1947. Even the name of the
organization is standardized.
October 1946, International Federation of the National Standardizing
Associations (ISA) and United Nations Standards Coordinating Committee (UNSCC)
delegates from 25 countries met in London and agreed to join forces to create
the new International Organization for Standardization; the new organization
officially began operations in February 1947. Even the name of the
organization is standardized.
The name, “ISO” is not an acronym but was
derived from the Greek word “isos” meaning “equal”. (The
relation to standards is that if two objects meet the same standard, they
should be equal.) This name eliminates any confusion that could result from the
translation of “International Organization For Standardization” into
different languages which would lead to different acronyms.
derived from the Greek word “isos” meaning “equal”. (The
relation to standards is that if two objects meet the same standard, they
should be equal.) This name eliminates any confusion that could result from the
translation of “International Organization For Standardization” into
different languages which would lead to different acronyms.
Founder of ISO
National
Standardizing Associations (ISA) and United Nations Standards Coordinating
Committee (UNSCC) delegates
Standardizing Associations (ISA) and United Nations Standards Coordinating
Committee (UNSCC) delegates
Number of Countries involved in ISO
163
countries.
countries.
Some countries that adopted the ISO standards
include: Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Rwanda, San Marino, Saudi Arabia, Senegal, Serbia, Sierra Leone, Singapore, Nigeria, Slovakia, Slovenia, Somalia, South Africa, Spain, etc.
include: Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Rwanda, San Marino, Saudi Arabia, Senegal, Serbia, Sierra Leone, Singapore, Nigeria, Slovakia, Slovenia, Somalia, South Africa, Spain, etc.
Number of ISO we have
19 500
International Standards
International Standards
Examples
of health informatics ISO standards include:
of health informatics ISO standards include:
1.
ISO 1828:2012(Health informatics — Categorical structure for
terminological systems of surgical procedures)
ISO 1828:2012(Health informatics — Categorical structure for
terminological systems of surgical procedures)
2.
ISO 10159:2011 (Health informatics — Messages and communication — Web
access reference manifest)
ISO 10159:2011 (Health informatics — Messages and communication — Web
access reference manifest)
3.
ISO/HL7 10781:2015 (Health Informatics — HL7 Electronic Health
Records-System Functional Model, Release 2 (EHR FM))
ISO/HL7 10781:2015 (Health Informatics — HL7 Electronic Health
Records-System Functional Model, Release 2 (EHR FM))
4.
ISO/IEEE 11073-00103:2015 (Health informatics — Personal health device
communication — Part 00103: Overview)
ISO/IEEE 11073-00103:2015 (Health informatics — Personal health device
communication — Part 00103: Overview)
5.
ISO/IEEE 11073-10101:2004 (Health informatics — Point-of-care medical
device communication — Part 10101: Nomenclature)
ISO/IEEE 11073-10101:2004 (Health informatics — Point-of-care medical
device communication — Part 10101: Nomenclature)
6.
ISO/IEEE 11073-10102:2014 (Health informatics — Point-of-care medical
device communication — Part 10102: Nomenclature — Annotated ECG)
ISO/IEEE 11073-10102:2014 (Health informatics — Point-of-care medical
device communication — Part 10102: Nomenclature — Annotated ECG)
7.
ISO/IEEE 11073-10103:2014 (Health informatics — Point-of-care medical
device communication — Part 10103: Nomenclature — Implantable device, cardiac)
ISO/IEEE 11073-10103:2014 (Health informatics — Point-of-care medical
device communication — Part 10103: Nomenclature — Implantable device, cardiac)
8.
ISO/IEEE 11073-10201:2004 (Health informatics — Point-of-care medical
device communication — Part 10201: Domain information model)
ISO/IEEE 11073-10201:2004 (Health informatics — Point-of-care medical
device communication — Part 10201: Domain information model)
9.
ISO/IEEE 11073-10404:2010 (Health informatics — Personal health device
communication — Part 10404: Device specialization — Pulse oximeter
ISO/IEEE 11073-10404:2010 (Health informatics — Personal health device
communication — Part 10404: Device specialization — Pulse oximeter
10.
ISO/IEEE NP 11073-10404 (Health informatics — Personal health device
communication — Part 10404: Device specialization — Pulse oximeter)
ISO/IEEE NP 11073-10404 (Health informatics — Personal health device
communication — Part 10404: Device specialization — Pulse oximeter)
11.
ISO/IEEE 11073-10406:2012 (Health informatics — Personal health device
communication — Part 10406: Device specialization — Basic electrocardiograph
(ECG) (1- to 3-lead ECG))
ISO/IEEE 11073-10406:2012 (Health informatics — Personal health device
communication — Part 10406: Device specialization — Basic electrocardiograph
(ECG) (1- to 3-lead ECG))
12.
ISO/IEEE 11073-10407:2010 (Health informatics — Personal health device
communication — Part 10407: Device specialization — Blood pressure monitor)
ISO/IEEE 11073-10407:2010 (Health informatics — Personal health device
communication — Part 10407: Device specialization — Blood pressure monitor)
13.
ISO/IEEE 11073-10408:2010 (Health informatics — Personal health device
communication — Part 10408: Device specialization – Thermometer)
ISO/IEEE 11073-10408:2010 (Health informatics — Personal health device
communication — Part 10408: Device specialization – Thermometer)
14.
ISO/IEEE 11073-10415:2010 (Health informatics — Personal health device
communication — Part 10415: Device specialization — Weighing scale)
ISO/IEEE 11073-10415:2010 (Health informatics — Personal health device
communication — Part 10415: Device specialization — Weighing scale)
15.
ISO/IEEE 11073-10417:2014 (Health informatics — Personal health device
communication — Part 10417: Device specialization — Glucose meter)
ISO/IEEE 11073-10417:2014 (Health informatics — Personal health device
communication — Part 10417: Device specialization — Glucose meter)
16.
ISO/IEEE 11073-10418:2014 (Health informatics — Personal health device
communication — Part 10418: Device specialization — International Normalized
Ratio (INR) monitor)
ISO/IEEE 11073-10418:2014 (Health informatics — Personal health device
communication — Part 10418: Device specialization — International Normalized
Ratio (INR) monitor)
17.
ISO/IEEE FDIS 11073-10419 (Health informatics — Personal health device
communication — Part 10419: Device specialization — Insulin pump)
ISO/IEEE FDIS 11073-10419 (Health informatics — Personal health device
communication — Part 10419: Device specialization — Insulin pump)
18.
ISO/IEEE 11073-10420:2012 (Health informatics — Personal health device
communication — Part 10420: Device specialization — Body composition analyzer)
ISO/IEEE 11073-10420:2012 (Health informatics — Personal health device
communication — Part 10420: Device specialization — Body composition analyzer)
19.
ISO/IEEE 11073-10421:2012 (Health informatics — Personal health device
communication — Part 10421: Device specialization — Peak expiratory flow
monitor (peak flow))
ISO/IEEE 11073-10421:2012 (Health informatics — Personal health device
communication — Part 10421: Device specialization — Peak expiratory flow
monitor (peak flow))
20.
ISO/IEEE FDIS 11073-10424 (Health informatics — Personal health device
communication — Part 10424: Device Specialization¿ — Sleep Apnoea Breathing
Therapy Equipment (SABTE))
ISO/IEEE FDIS 11073-10424 (Health informatics — Personal health device
communication — Part 10424: Device Specialization¿ — Sleep Apnoea Breathing
Therapy Equipment (SABTE))
21.
ISO/IEEE FDIS 11073-10425 (Health informatics — Personal health device
communication — Part 10425: Device specialization — Continuous glucose
monitor (CGM))
ISO/IEEE FDIS 11073-10425 (Health informatics — Personal health device
communication — Part 10425: Device specialization — Continuous glucose
monitor (CGM))
22.
ISO/IEEE 11073-10441:2015 (Health informatics — Personal health device
communication — Part 10441: Device specialization — Cardiovascular fitness
and activity monitor)
ISO/IEEE 11073-10441:2015 (Health informatics — Personal health device
communication — Part 10441: Device specialization — Cardiovascular fitness
and activity monitor)
23.
ISO/IEEE 11073-10442:2015 (Health informatics — Personal health device
communication — Part 10442: Device specialization — Strength fitness
equipment)
ISO/IEEE 11073-10442:2015 (Health informatics — Personal health device
communication — Part 10442: Device specialization — Strength fitness
equipment)
24.
ISO/IEEE NP 11073-10471 (Health informatics — Personal health device
communication — Part 10471: Device specialization – Independent living
activity hub)
ISO/IEEE NP 11073-10471 (Health informatics — Personal health device
communication — Part 10471: Device specialization – Independent living
activity hub)
25.
ISO/IEEE 11073-10471:2010 (Health informatics — Personal health device
communication — Part 10471: Device specialization – Independant living
activity hub)
ISO/IEEE 11073-10471:2010 (Health informatics — Personal health device
communication — Part 10471: Device specialization – Independant living
activity hub)
26.
ISO/IEEE 11073-10472:2012 (Health Informatics — Personal health device
communication — Part 10472: Device specialization — Medication monitor)
ISO/IEEE 11073-10472:2012 (Health Informatics — Personal health device
communication — Part 10472: Device specialization — Medication monitor)
27.
ISO/IEEE 11073-20101:2004 (Health informatics — Point-of-care medical
device communication — Part 20101: Application profiles — Base standard)
ISO/IEEE 11073-20101:2004 (Health informatics — Point-of-care medical
device communication — Part 20101: Application profiles — Base standard)
28.
ISO/IEEE FDIS 11073-20601 (Health informatics — Personal health device
communication — Part 20601: Application profile — Optimized exchange protocol)
ISO/IEEE FDIS 11073-20601 (Health informatics — Personal health device
communication — Part 20601: Application profile — Optimized exchange protocol)
29.
ISO/IEEE 11073-20601:2010 (Health informatics — Personal health device
communication — Part 20601: Application profile — Optimized exchange
protocol)
ISO/IEEE 11073-20601:2010 (Health informatics — Personal health device
communication — Part 20601: Application profile — Optimized exchange
protocol)
30.
ISO/IEEE 11073-30200:2004 (Health informatics — Point-of-care medical
device communication — Part 30200: Transport profile — Cable connected)
ISO/IEEE 11073-30200:2004 (Health informatics — Point-of-care medical
device communication — Part 30200: Transport profile — Cable connected)
Brief Write up on ISO/TR 27809:2007
ISO/TR
27809:2007 is referred to as health informatics ISO standard responsible for measures
for ensuring patient safety of health software.
Scope of ISO/TR 27809:2007
ISO/TR 27809:2007 considers
the control measures required to ensure patient safety in respect to health
software products. It does not apply to software which is:
the control measures required to ensure patient safety in respect to health
software products. It does not apply to software which is:
·
necessary for the proper
application of a medical device or
necessary for the proper
application of a medical device or
·
an accessory to a medical
device or
an accessory to a medical
device or
·
a medical device in its own
right.
a medical device in its own
right.
ISO/TR
27809:2007 is aimed at identifying what standards might best be used or
created, and their nature, if health software products were to be regulated or
controlled in some other formal or informal or voluntary manner whether
national, regional or local. However, it is not the purpose of ISO/TR
27809:2007 to recommend whether or not health software products should be
regulated.
27809:2007 is aimed at identifying what standards might best be used or
created, and their nature, if health software products were to be regulated or
controlled in some other formal or informal or voluntary manner whether
national, regional or local. However, it is not the purpose of ISO/TR
27809:2007 to recommend whether or not health software products should be
regulated.
ISO/TR 27809:2007 applies to any health software
product whether or not it is placed on the market and whether or not it is for
sale or free of charge. It is addressed to manufacturers of health software
products.
product whether or not it is placed on the market and whether or not it is for
sale or free of charge. It is addressed to manufacturers of health software
products.
The Objectives of ISO/TR 27809:2007
The objectives of this
standard is to draw the attention of health care professional and others responsible
for healthcare organizations need to recognize that:
standard is to draw the attention of health care professional and others responsible
for healthcare organizations need to recognize that:
·
health software products have the potential to
harm patients;
health software products have the potential to
harm patients;
·
this potential is growing
as the complexity of implementations grows;
this potential is growing
as the complexity of implementations grows;
·
healthcare organizations
are increasingly reliant on health software products.
healthcare organizations
are increasingly reliant on health software products.
This means that, unless
these risks are recognized and controlled, harm to patients may result with
consequent damage to the reputation of a health organization and substantial
financial consequences in terms of legal damages.
these risks are recognized and controlled, harm to patients may result with
consequent damage to the reputation of a health organization and substantial
financial consequences in terms of legal damages.
Professionals that make used of ISO/TR 27809:2007
ISO/TR
27809:2007 is target at professional responsible for:
27809:2007 is target at professional responsible for:
·
diagnosis, prevention,
monitoring, treatment or alleviation of disease;
diagnosis, prevention,
monitoring, treatment or alleviation of disease;
·
diagnosis, monitoring,
treatment, alleviation of or compensation for an injury;
diagnosis, monitoring,
treatment, alleviation of or compensation for an injury;
·
investigation, replacement,
modification, or support of the anatomy or of a physiological process;
investigation, replacement,
modification, or support of the anatomy or of a physiological process;
·
supporting or sustaining
life;
supporting or sustaining
life;
·
control of conception;
control of conception;
·
disinfection of medical
devices;
disinfection of medical
devices;
·
providing information for
medical or diagnostic purposes by means of in vitro examination of specimens derived from the human body.
providing information for
medical or diagnostic purposes by means of in vitro examination of specimens derived from the human body.
