IS 13812-19: Medical electrical equipment - Particular requirements for safety, Part 19: Baby incubators

32 Pages·1994·2.5 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 13812-19 (1994): Medical electrical equipment -
Particular requirements for safety, Part 19: Baby
incubators [MHD 19: Immuno-Biological Diagnostic Kits]
“!ा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”

IS 13812 ( Part 19 ) : 1994
IEC Pub 601-2-19 ( 1990 )

MEDICALELECTRTCALEQUIPMENT-
PARTICULARREQUIREMENTSFORSAFETY
PART 19 BABY INCUBATORS
UDC 615478.5 : 614.825

@ BlS 1994
BUREAU OF INDIAN STANDARDS
MANAK BHAVAN, 9 BAHADUR SHAH ZAFAR MARG
NEW DELHI 110002
March 1994 Price Greup 10
Elictromedical Equipment Sectional Committee, MHD 19
NATIONAL FOREWORD
This Indian Standard ( Part 19 ) which is identical to IEC Pub 601-2-19 ( 1990 ) ‘Medical electri-
cal equipment - -Part 2 : Particular requirements for safety of baby incubators’ ( First edition ),
issued by the International Electrotechnical Commission ( IEC ) was adopted by the Bureau of
Indian Standards on the recommendations of the Electromedical Equipment Sectional Committee
( MHD 19 ) and approval of the Medical Equipment and Hospital Planning Division Council.
This series of standards will consist of several parts and will cover the particular requirements
for safety of various medical elec_trical equipment. Part 19 of this standard covers the require-
ments of baby incubators. The other parts will cover the requirements of other medical electrical
equipment. This standard ( Part 19 ) is being issued in eleven sections which are listed below:
Section 1 General
Section 2 Safety requirements
Section 3 Protection against electric shock hazards
Section 4 Protection against mechanical hazards
Section 5 Protection agianst hazards from unwanted or excessive radiation
Section 6 Protection against hazards of explosions in medically used rooms
Section 7 ;Protection against excessive temperatures, fires and other hazards, such as human
errors
Section 8 Accuracy of operating data and protection against incorrect ouiput
Szction 9 Fault conditions causing overheating and/or mechanical damage; Environmental
tests
Section 10 Constructional requirements
Section 11 Additional requirements
The text of IEC Standard has been approved as suitable for publication ar Indian Standard with-
out deviations. Certain coventions are, however, not identical to those used in the Indian
. Standards. Attention is particularly drawn to the following:
a) Wherever the words ‘International Standard’ or ‘IEC Publication’ appear referring to
this standard, they should be read as ‘Indian Standard’;
b) Comma ( , ) has been used as decimal marker at some of the places while in Indian
Standards, the current practice is to use a point ( . ) as the decimal marker.
In this adopted standard, reference appears to certain international standards-for which Indian
Standards also exist. The corresponding Indian Standards which are to be substituted in their
place are listed below along w ith their degree of equivalence for the editions indicated:

International Standard Indian Standard Degree of
Equivalence
IEC Pub 601-l ( 1988 ) IS 13450 ( Part I ) : 1994 Medical Identical
electrical equipment : Part 1 General
requirements for safety
IEC Pub 65 1 ( 1979 ) IS 9779 : 1981 Sound level meters Identical
The technical committee responsible for the preparation of this standard has reviewed the
provisions of following international standards referred to in this adopted standard and has
decided that they are acceptable for use in conjunction with this standard.
IEC Pub 601-2-20 ( 1990 ) Medical electrical equipment - Part 2 : Particular requirements for
safety of transport incubators
IS0 3743 : 1988 Acoustics - Determination of sound power level of noise sources. Engineer-
ing methods for special reverberation test rooms
IS0 7767 : 1988 Oxygen analyzers for monitoring patient breathing mixtures - Safety require-
ments
Only the English language text of the International Standard has been retained while adopting
it in this Indian Standard.
For the purposes of deciding whether a particular requirement of this standard is complied with,
the final value, observed or calculated, expressing the result of a test, shall be rounded off in

accordance with IS 2 : 1960 ‘Rules for rounding off numerical values ( revised )‘. The number of
significant places retained in the rounded off value should be the same as that of the specified value
in this standard.
( Continued on third cover )
IS 13812 (Part 19) : 1994
IEC Pub 601-2-19 (1990)
Indian Standard
MEDICAL ELECTRICAL EQUIPMENT -
PARTICULAR REQUIREMENTS FOR SAFETY
PART 19 BABY INCUBATORS
SECTION ONE - GENERAL
1. Scope and object
This clause of the General Standard applies except as follows:
1. I Scope
Addition:
This Particular Standard specifies safety requirements for INCUBATORS, as defined in Sub-
clause 2.1.101 of this standard.
This standard does not apply to EQUIPMENT which uses radiant heaters.
It also does not apply to transport incubators* used for the transportation of infants.
1.2 Object
Addition:
The object of this Particular Standard is to establish requirements for INCUBATORS which
minimize hazards to PATIENT and USER, and to specify tests by which compliance with the require-
ments can be verified.
2. Teqminology and definitions
‘This clause of the General Standard applies except as follows:
2.1.5 APPLIED PAKT

Replacement:

All parts within the BABY COMPARTMENT, which can intentionally or unintentionally come into
contact with the baby, shall be considered an APPLIED PART.
Additional definitions:
2.1.101 i~cUi3~7DR
An enclosure, intended to contain a baby and having transparent section(s) which allow(s) for
viewing of the baby, provided with means to control the environment of the baby primarily by
heated air within the enclosure.
2.1.102 BABY COMPARTMENT
The portion of an INCUBATOR intended to contain a baby.
2.1.103 AIR CONROLLED INCUBATOR
INCUBATOR in which the air temperature is automatically controlled by an air temperature
sensor close to a value set by the USER.
2.1.104 BABYCONTROLLED INCUBATOR
An air controlled INCUBATOR which has the additional capability of automatically controlling
the INCUBATOR air temperature in order to maintain the temperature as measured by a SKIN TEM-
PERATURE SENSOR close to a value set by the USER.

1
IS 13812 (Part 19) : 1994
IEC: Pub 601-2-19 (1990)
2.9 Contr-o/s and limiting devices
Additional defiinitions:
2.9.101 SKMTEMPERATURE SENSOR
A sensing device intended to measure the baby’s SKIN TEMPERATURE.
2.9.102 SKIN TEMPERATURE
The temperature of the skin of the baby at a point on which the SUN TEMPERATURE SENSOR
is placed.
2.9.103 A VERAGF TEMPERATURE
The average of the maximum and minimum temperatures at any specified point in the BABY
COMPARTMENT achieved during STEADY TEMPERATURE CONDITION.
2.9.104 CONTROL TEMPERATURE
Temperature selected at the temperature control.
2.9.105 INCUBATOR TEMPERATURE
Temperature of the air at a point 10 cm ~above the centre of the mattress surface in the baby
compartment (see figure 102, point A).
2.9.106 A .VERAGEINCUBAi'-ORT EMPERATURE
The average of the maximum and minimum INCUBATOR TEMPERA~JRES achieved during
STEADY TEMPERATURE CONDITION (See figure 101).
2.10 Operation of EQUIPMENT
Additional definition:
2.10.101 STEXDYTEh4PERATURECONDITION
The condition reached when the INCUBATOR TEMPERATURE does not vary by more than 1 “C
over a period of one hour (see figure 101).
3. GeneA requirements

This clause of the General Standard applies except as follows:

3.6* Addition:
Applicable SINGL.E FAULT CONDITICNS are short and open circuiting of components or wiring,
which
_. cause sparks to occur, or
-- increase the energy of sparks, or
- increase temperatures.
4. General requirements for tests
This clause of the General Standard applies except as follows:
4.5 Ambient temperature, humidity and atmospheric pressure
Replacement:
a) * If not otherwisespecified in this Particular Standar-d, all tests shall be carried out at an
ambient temperature within the range of 21 “C to 26 “C.

2
IS 13812 (Fart 19) : 1994
IEC Pub 601-2-19( 1990)
4.6 Other conditions
Additional item:
aa) If not otherwise specified the CONTROL TEMPERATURE shall be 34 “C +- 1 “C and shall
always exceed the ambient temperature by at least 3 “C.
5. Classification
This clause of the General Standard applies.
6. Identification, marking and documents
This clause of the General Standard applies except as follows:
6.1 Addition:
6.1.101 * An INCUBATOR not equipped with an integral oxygen analyzer and which provides means
for oxygen administration shall be marked in a prominent position with a text which states: “An
oxygen analyzer should be used when oxygen is administered”
6.1.102 If a heater is accessible without the use of a tool a notice or marking shall be displayed adjacent
to the heater giving warning of high surface temperature.
6.3 Addition:
b) * Temperature controls shall be clearly marked with temperature settings on or adjacent
to the control. The markings shall be provided at intervals of not greater than 0.5 “C for
AIRCONTROLLEDINCUBATORS and notgreaterthan0.25 “C for BABYCONTROLLEDINCUBA-
TORS.
Marking of the maximum and the minimum values of controls and -indicators shall be
such that no confusion can arise with regard to the position of the ccntrol and/or the indicated
values.
6.7 Addition:

‘a) An INCUBATOR shall be equipped with a yellow light according to Sub-clause 54.101 when

applicable.
6.8 ACCOMPANYING DOCUA4Eh’7s
6.8.2 Instructions for use
Addition:
aa) The instructions for use shall additionally contain:
- A recommended preventive maintenance procedure and frequency for verifying confor-
mity with product specifications.
*1. A statement that an INCUBATOR should be used only by appropriately trained person-
nel and under the direction of qualified medical personnel familiar with currently
known risks and benefits of INCUBATOR use.
*2. A warning that direct sunlight or other radiant heat sources can cause an increase in
INCUBATOR temperature to dangerous levels.
*3. A statement that the use of oxygen increases the danger of fire and that auxiliary equip-
ment producing sparks shall not be placed in the INCUBATOR.

3
IS 13812 (Part 19) : 1994
IEC Pub 601-2-19 (1990)
*4. A warning that even small quanc~t&$~f flammable agents, such x ether, ?Il;d~ li~~h1.
left in the INCUBATOR can cause fire in connection with oxygen.
*5. A specification of the warm-up time of the INCUBATOR measured as specified in Sub-
clause 50.108.
*6. A recommendation of the position and method of use of the SKIN TEMPERATURESEN-
SOR, including a warning against possible use as a rectal temperature sensor, if such
a warning is applicable.
*7. Information about the range of control temperature and relative humidity of the INCU-
BATOR. If the INCUBATOR is not supplied with means for control of the degree of
humidity this shall be stated in the instructions for use.
*8. Recommented methods of establishing acceptable conditions according to Sub-
clause 44.7.
*9. When applicable, a statement qf the maximum allowed weight of additional equipment
which might be placed on shelves connected to the INCUBATOR.
- For TYPE B EQUIPMENT, where the baby may not be isolated from earth, a warning
that particular care must be taken to ensure that additional equipment connected
to the baby is electrically safe.
- When applicable, aninformation about how the audible agd visual alarms can be
checked.
- A warning stating that administration of oxygen may increase the noise level for.
the baby within the INCUBATOR.
- An explanation of the operation of supplementary oxygen equipment supplied for
use with the INCUBATOR or as specified in the ACCOMPANYING DOCUMENTS.
- A statement that an oxygen analyzer shall be used when oxygen is delivered to the
baby.
7. Power Input

This clause of the General Standard applies.
SECIION TWO - SAFETY REQUIREMENTS
10. Special environmental conditions
10.2.1 Environnernent
Replacement:
a) An ambient temperature between +20 “C and +30 “C.
11. Special measures with respect to safety
This clause of the General Standard applies.
IS 13812 (Part 19) : 1994
IEC Pub 601-2-19 (1990)
SEC-‘-ION THREE - PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
Clauses 13 to 19 of the General Standard apply.
20. Dielectric strength
This clause of the General Sta_n-d ard applies except as follows:
20.2 Particular requirements for EQUIPMENT with an APPLIED PART
Item B-b
Amendment:
This is not applicable to INCUB+TORS.
Item B-d
Addition:
The reference voltage shall be a minimum of 250 V.
Item B-e
Addition:
The test voltage shall be a minimum of 1500 V.
SEC-I-ION FOUR - PROTECTION AGAINST MECHANICAL HAZARDS
21. Mechanical strength
This clause of the General Standard applies except as follows:
Additional sub-clauses:
21.101 * The baby shall be safely retained ~within the BABY. COMPARTMENT by barriers such as
walls or side panels. Barriers intended to be opened or removed to allow access to the baby, such

as doors, ports etc., shall close so as not to open under the test conditions specified below. It

shall not be possible for barri ers to be insecurely closed or latched whilst appearing to be engaged.
The mechanical integrity of the INCUBATOR shall be maintained under the following test
conditions.
Compliance is checked by inspection and by the following tests:
Test I:
With all access port doors deliberately made as insecure as possible, without the use of a TOOL,
whilst still appearing to be engaged, a horizontal force shall be applied to the centre of the access
port door. The force shall be increased gradually from zero to 20 N in an interval of 5 s - IO s
and shall be held at maximum for 5 s.