IS/ISO 15197: In Vitro DiAGNOSTIC Test Systems - Requirements for Bloos-Glucose Monitoring Systems for Self - Testing in Managing Diabetes Mellitus

42 Pages·2003·2.5 MB·English

by  Bureau of Indian Standards

इंटरनेट मानक
Disclosure to Promote the Right To Information
Whereas the Parliament of India has set out to provide a practical regime of right to
information for citizens to secure access to information under the control of public authorities,
in order to promote transparency and accountability in the working of every public authority,
and whereas the attached publication of the Bureau of Indian Standards is of particular interest
to the public, particularly disadvantaged communities and those engaged in the pursuit of
education and knowledge, the attached public safety standard is made available to promote the
timely dissemination of this information in an accurate manner to the public.
“जान1 का अ+धकार, जी1 का अ+धकार” “प0रा1 को छोड न’ 5 तरफ”
Mazdoor Kisan Shakti Sangathan Jawaharlal Nehru
“The Right to Information, The Right to Live” “Step Out From the Old to the New”
IS/ISO 15197 (2003): In Vitro DiAGNOSTIC Test Systems -
Requirements for Bloos-Glucose Monitoring Systems for Self
- Testing in Managing Diabetes Mellitus [MHD 16: Surgical
Dressings and Disposable Products]
“!ान $ एक न’ भारत का +नम-ण”
Satyanarayan Gangaram Pitroda
““IInnvveenntt aa NNeeww IInnddiiaa UUssiinngg KKnnoowwlleeddggee””
“!ान एक ऐसा खजाना > जो कभी च0राया नहB जा सकता हहहहै””ै”
Bhartṛhari—Nītiśatakam
“Knowledge is such a treasure which cannot be stolen”

ISIISO 15197:2003
~ ftrtt~ qfr~ -~ - ~ ~

cFi ~ -q ~ ~-qfr~ CfiB cFi ~ ~ -q
~etr.~%g0N~
Indian Standard
IN VITRO DIAGNOSTIC TEST SYSTEMS
REQUIREMENTS FOR BLOOD-GLUCOSE
MONITORING SYSTEMS FOR SELF-TESTING IN
MANAGING DIABETES MELLITUS
ICS 11.100
© BIS 2010
BUREAU OF INDIAN STANDARDS
MANAK BHAVAN, 9 BAHA£?UR SHAH ZAFAR MARG
NEWDELHI110002

May 2010 PriceGroyp11
IS/ISO 15197: 2003
Surgical Disposables and DressingsSectionalCommittee. MHO 16
NATIONALFOREWORD
This Indian Standardwhich isidenticalwith ISO 15197:2003'In vitrodiagnostictest systems- Requirements
forblood-glucosemonitoringsystemsforself-testinginmanagingdiabetesmellitus'issuedbythe International
OrganizationforStandardization(ISO)wasadopted bytheBureau ofIndianStandardsontherecommendation
ofthe Surgical Disposablesand DressingsSectionalCommitteeand approvalofthe MedicalEquipmentand
HospitalPlanning DivisionCouncil.
Blood-glucosemonitoringsystemsare invitrodiagnosticmedicaldevicesusedpredominantlyby individuals
affected by diabetes mellitus. Diabetes mellitus is caused by a relative or absolute deficiency in insulin
secretion or by insulin resistance leading to abnormal concentrations of glucose in the blood, which may
result in acute and chronic health complications.When used properly a glucose monitoring system allows
the userto monitorand take action to control the concentration of glucose present inthe blood.
This standardisintendedfor blood-glucosemonitoringsystemsused bylaypersons.Theprimaryobjectives
aretoestablish requirementsthatresultinacceptableperformanceandtospecifyproceduresfordemonstrating
conformanceto this standard.
Performance criteria for blood-glucose monitoring systems were established from the accuracy (precision
and trueness) required for individual glucose results. System accuracy criteria, also known in the in vitro
diagnostics(IVD) industryas total errorcriteria[seeNeClSEP21-P(35)], are used inthis standardbecause
some of the metrological terms commonly used in this standard (for example, uncertainty) would not'be
familiarto lay users.System accuracy, which isaffected by systematic bias and measurement uncertainty,
describes the degree to which individual results produced by a glucose monitoring system agree with the
true glucose values when the system is used as intended by laypersons.
The criteriafor systemaccuracyare based onthree considerations:
a) Theeffectivenessofcurrenttechnologyformonitoring patientswithdiabetesmellitus, asdemonstrated
inclinical outcome studies using state-of-the-art monitoringdevices;
b) Recommendations of diabetes researchers as well as existing product standards and regulatory
guidelines;and
c) The state-of-the-art of currently available technology, as evidenced by the performance of existing
commercialproducts.
Inarriving atthe performancecriteria, desirablegoals hasto be weighedagainstthe capabilities ofexisting
devices (the currentstate-of-the-art) and theireffectivenessinclinicaloutcomestudies. Itwas decidedthat
overlydemandingperformancerequirementswould causemanufacturerstofocusdesign improvementson
analytical performance at the expense of other important attributes. For example frequency of testing by
diabetic patients can be as important as the accuracy of an individual result, and greaterconvenience of
glucose self-testingimprovespatientcompliance.The system accuracycriteriadefinetheminimumacceptable
performanceofablood-glucosemeasuringdeviceintendedfor self-monitoring.
Futureadvances intechnologyareexpected, whichshouldresultinimprovedperformanceofglucosemonitoring
devices.Such performanceimprovementswillbedrivenbythe competitivemarketplace,particularlythrough
reductionofdependenceon usertechnique.
Requirementsthatare uniquetoself-monitoringdevicesforblood-glucose,includingthecontentofinformation
suppliedbythe manufacturer, are addressedinthis standard.General requirementsthatapplytoall invitro
ISIISO 15197: 2003
diagnosticmedical devicesand arecovered byother standards (forexample, IS15579 and ISO 14971)are
incorporatedbyreference where appropriate.
Although this standard does not apply to measurement procedures with results on an ordinal scale (for
example, visual, semi-quantitative measurement procedures), it may be useful as a guide for developing
procedures to evaluatethe performance ofsuch systems.
The text of ISO Standard has been approved as suitable for publication as an Indian Standard without
deviations. Certain conventions are, however, not identical to those used in Indian Standards. Attention is
particularlydrawn tothe following:
.a) Wherever thewords'InternationalStandard'appear referringtothisstandard, theyshouldbereadas
'IndianStandard'.
b) Comma(,)hasbeenusedasadecimalmarkerintheInternationalStandardwhileinIndianStandards,
the current practice isto use apoint (.)as the decimal marker.
Inthisadopted standard, reference appears tothetollowinq InternationalStandard forwhich IndianStandard
also exists. The corresponding Indian Standard which isto be substituted in its place is listed below along
with itsdegree ofequivalence forthe edition indicated:
InternationalStandard CorrespondingIndianStandard Degree of Equivalence
ISO13485:2003 Medicaldevices IS 15579 : 2005 Medical devices Identical
Quality management systems Quality management systems
Requirementsforregulatory purposes Requirementsforregulatory purposes
Thetechnical committee has reviewed theprovisions ofthefollowing InternationalStandards referred inthis
adopted standard and has decidedthat they areacceptablefor use inconjunction with this standard:
International/OtherStandard Title
ISO14971 :2007 Medical devices - Application of risk management to medical devices
ISO17511:2003 Invitrodiagnosticmedicaldevices- Measurementofquantitiesinbiological
samples - Metrological traceability ofvalues assigned tocalibrators and
controlled materials
IEC60068-2-64 :1993 Environmentaltesting - Part2:Testmethods- TestFh:Vibration, broad
band random (digital control) andguidance
IEC61010-1 :2001 Safety requirementsforelectrical equipmentformeasurement,controland
laboratoryuse- Part 1:General requirements
IEC61010-2-101 :2002 Safety requirements for electrical equipment for electrical equipment for
measurement, control and laboratory use - Part 2-101: Particular.
requirements for invitrodiagnostic (IVD) medical equipment
IEC61000-4-2 :2008 Electromagnetic compatibility (EMC)- Part4-2:Testingandmeasurement
techniques - Electrostatic discharge immunity test
IEC61000-4-3:2006 Electromagnetic compatibility (EMC)- Part4-3:Testingandmeasurement
techniques - Radiated, radio-frequency electromagnetic field immunity
test
llSince revised in various parts and sections.

ii
ISIISO 15197: 2003
International/OtherStandard Title
IEC61326: 2002 Electricalequipmentformeasurement,.controlandlaboratory use- EMC
requirements
EN376:2002 Information suppliedbythemanufactures with invitrodiagnostic reagents
for self-testing
EN13612:2002 Performance evaluation of in vitrodiagnostic medical devices
EN13640:2002 Stability testing of in vitrodiagnostic reagents
The Standard also makes a reference to the SIS certification marking of the product. Details of which is
giveninNational Annex A.
For the purpose of deciding whether a particular requirement of this standard is complied with, the final
value,observed orcalculated, expressing theresultofatestoranalysis, shallberounded offinaccordance
withIS2:1960'Rules forroundingoffnumericalvalues(revised)'. Thenumberofsignificant placesretained
intherounded off value should besame asthat ofthe specified value inthis standard.

iii .
IS/ISO 15197: 2003
Indian Standard
IN VITRO DIAGNOSTIC TEST SYSTEMS
REQUIREMENTS FOR BLOOD-GLUCOSE
MONITORING SYSTEMS FOR SELF-TESTING IN
MANAGING DIABETES MELLITUS
1 Scope
This International Standard specifies requirements for in vitro glucose monitoring systems that measure
glucose concentrations in capillary blood samples and procedures for the verification and the validation of
performance by the intended users. These systems are intended for self-testing by laypersons for
management of diabetes mellitus.
This International Standard is applicable to manufacturers of such systems and those other organizations
(e.g. requlatory authorities and conformity assessment bodies) having the responsibility for assessing the
performance of these systems.
This International Standard does not
provide a comprehensive evaluation of all possible factors that could affect the performance of these
systems,
pertain to glucose concentration measurementfor the purpose of diagnosing diabetes mellitus,
address the medical aspects of diabetes mellitus management, or
apply to measurement procedures with results on an ordinal scale (e.g. visual, semiquantitative test
methods).
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document(including any amendments) applies.
ISO 13485, Medical devices - Qualitymanagementsystems - Requirements forregulatory purposes
ISO 14971, Medical devices- Application ofriskmanagementtomedical devices
ISO 17511:_1) In vitro diagnostic medical devices- Measurement of quantities in biological samples
Metrological traceability ofvaluesassignedto calibrators andcontrol materials
IEC60068-2-64:1993, Environmental testing- Part 2: Test methods- Test Fh: Vibration, broad-band
random (digital control) andguidance
o
~
~ IEC61010-1:2001, Safety requirements for electrical equipment for measurement, control, and laboratory
en use- Part 1:Generalrequirements
iii
~ IEC 61010-2-101:2002, Safety requirements for electrical equipment for measurement, controland laboratory
C~D
use- Part 2-101: Particularrequirements for in vitro diagnostic (IVD)medicalequipment

1) Tobepublished.
1
ISIISO 15197: 2003
IEC 61000-4-2, Electromagnetic compatibility (EMC) - Part 4-2: Testing and measurement techniques
Electrostatic discharge immunity test
IEC 61000-4-3, Electromagnetic compatibility (EMC) - Part4-3: Testing and measurement techniques
Radiated, radio-frequency, electromagnetic field immunity test
IEC 61326, Electrical equipment-for measurement, controlandlaboratory use - EMC requirements
EN 376, Information suppliedby the manufacturerwith in vitro diagnostic reagents for self-testing
EN 13612, Performance evaluation ofin vitro diagnostic medical devices
EN 13640, Stability testing ofin vitro diagnostic reagents
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
accuracy
closeness of agreement between atest result and the accepted reference value
[ISO 3534-1:1993]
NOTE 1 The term "accuracy", when applied toasetoftest results, involves acombination ofrandom error components
and acommon systematicerror orbiascomponent. [VIM:1993]
NOTE 2 For ameasure ofthe accuracy of resultsofablood-glucosemonitoringsystem, see 3.24.
3.2
bias
difference between the expectation of the test results and an accepted reference value
[ISO 5725-1:1994]
3.3
blood-qlucose monitoring system
measuring system consisting of a portable instrument and reagents used for the in vitro monitoring ofglucose
concentrations in blood
NOTE Blood-glucose monitoring systems measure glucose in capillary blood samples, but may express results as
either the gl\,:Jcose concentration in blood or the equivalent glucose concentration in plasma. Concentrations in this
International Standard refer tothe type ofresults reported bythesystem.
3.4
blood-glucose meter
component of a blood-glucose monitoring system that converts the result of a chemical reaction into the
glucose concentration of the sample
3.5
commutability ofa material
ability of a material to yield the same numerical relationships between results of measurements by a given set
of measurement procedures,.purportinq to measure the same quantity, as those between the expectations of
the relationships obtained when the same procedures are applied to otherrelevanttypes of material
[ISO 15194:2002]
NOTE For reference materials used to calibrate measurement procedures intended for biological samples, "other
relevant types ofmaterial" include alarge number ofsamples fromhealthyand relevantlydiseased individuals.

2
ISIISO 15197: 2003
3.6
control material
substance, material, or article intended by the manufacturer to be used to verify the performance
characteristics of an in vitro diagnostic medical device
[EN 375:2001]
3.7
information supplied by the manufacturerwith the medical device
all written, printed, or graphic matter on a medical device or any of its containers or wrappers, or
accompanying a medical device, relating to the identification, technical description and use of the medical
device, but excluding shipping documentation and promotional material
NOTE 1 Adapted from EN 1041:1998.
NOTE 2 Insome countries, informationsupplied bythe manufactureriscalled "labelling".
3.8
instructions for use
information supplied by the manufacturer with an in vitro diagnostic medical device concerning the safe and
proper use of the reagent or the safe and correct operation, maintenance, and basic troubleshooting of the
instrument
NOTE 1 Adapted from EN375:2001 and EN 591:2001.
NOTE 2 Instructionsforuse for in vitrodiagnosticreagents for self-testingisdescribed inEN 376.
NOTE 3 Instructionsforuse for in vitrodiagnosticinstrumentsfor self-testing isdescribed inEN592.
NOTE 4 Instructionsfor usemay take the form of package insert sheets and/oruser manuals.
3.9
intermediate precision
precision underconditions intermediate between reproducibility conditions and repeatability conditions
NOTE The conceptof intermediate levels of precision isdescribed inISO 5725-3:1994.
3.10
intermediate precision conditions
conditions where independent test results are obtained with the same method on identical test items in the
same location. but where other variables such as operators. equipment. calibration. environmental conditions
and/ortime intervals differ
NOTE Intended to measure precision in conditions leading to variability representative of actual use. Quantitative
measuresof intermediateprecision depend on the stipulated conditions.
3.11
label
printed. written. or graphic information placed on a deviceor container
NOTE Adapted from EN375:2001.
3.12
layperson
individual who does not have formal'training in a specificfield or discipline
NOTE 1 Adapted from thedefinitionof"lay user" in EN 376:2002.
NOTE2 For the purposes of this"lntemational Standard. a user of a-blood-glucose monitoring device who does not
have specificmedical, scientificor technical knowledqe related toblood-glucosemonitoring.

3