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"MEDICAL DEVICES - RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES - PART 2: GENERAL ESSENTIAL PRINCIPLES AND ADDITIONAL SPECIFIC ESSENTIAL PRINCIPLES FOR ALL IVD MEDICAL DEVICES AND GUIDANCE ON THE SELECTION OF STANDARDS (ISO 16142-2:2017, IDT)"
MS 16142-2:2019
Status : Original
Format : PDF

standards and guides that can be used in the assessment of conformity of a medical device to the
recognized essential principles that when met, indicate a medical device is safe and performs as< ....Read more br /> intended. This document identifies and describes the six general essential principles of safety and
performance (see Table B.1) that apply to all medical devices, including IVD medical devices (in vitro
diagnostic).
This document also identifies and describes the additional essential principles of safety and
performance which need to be considered during the design and manufacturing process, which are
relevant to IVD medical devices.
NOTE During the design process, the manufacturer selects which of the listed design and manufacturing
principles apply to the particular medical device and documents the reasons for excluding others.
This document is intended for use as guidance by medical device manufacturers, standards development
organizations, authorities having jurisdiction, and conformity assessment bodies. Close

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EUROCODE 3 - DESIGN OF STEEL STRUCTURES - PART 1-3: GENERAL RULES - SUPPLEMENTARY RULES FOR COLD-FORMED MEMBERS AND SHEETING
MS EN 1993-1-3:2019
Status : Original
Format : PDF

(1) EN 1993-1-3 gives design requirements for cold-formed thin gauge members and sheeting. It applies to
cold-formed steel products made from coated or uncoated thin gauge hot or cold rolled she ....Read more et or strip, that have
been cold-formed by such processes as cold-rolled forming or press-braking. It may also be used for the design
of profiled steel sheeting for composite steel and concrete slabs at the construction stage, see EN 1994. The
execution of steel structures made of cold-formed thin gauge members and sheeting is covered in EN 1090.
NOTE: The rules in this part complement the rules in other parts of EN 1993-1.
(2) Methods are also given for stressed-skin design using steel sheeting as a structural diaphragm.
(3) This part does not apply to cold-formed circular and rectangular structural hollow sections supplied to EN
10219, for which reference should be made to EN 1993-1-1 and EN 1993-1-8.
(4) EN 1993-1-3 gives methods for design by calculation and for design assisted by testing. The methods for
design by calculation apply only within stated ranges of material properties and geometrical proportions for
which sufficient experience and test evidence is available. These limitations do not apply to design assisted by
testing.
(5) EN 1993-1-3 does not cover load arrangement for testing for loads during execution and maintenance.
(6) The calculation rules given in this standard are only valid if the tolerances of the cold formed members
comply with EN 1090-2 Close

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Retreaded pneumatic tyres for motor vehicles, commercial vehicles and their trailers - Specification (Third revision)
MS 224:2019
Status : 3rd Revision
Format : PDF

1.1 This Malaysian Standard specifies the requirements for retreading of pneumatic tyres
classification of C1, C2 and C3. This standard does not cover:
a) retreaded tyres with a speed symb ....Read more ol below 120 km/h or above 240 km/h for class C1;
b) retreaded tyres with a speed symbol below 80 km/h for categories C2 and C3;
c) tyres for cycles and motorcycles;
d) tyres originally produced without speed symbols and loadindexes;
e) tyres originally produced without either “MS” or “E” or “DOT” mark;
f) tyres designed exclusively for competition or off road use and marked accordingly; and
g) tyres designated as T-type temporary spare tyre.
1.2 It covers definitions of terms used in the retreading industry, initial inspection criteria for
rejection of casings, acceptance criteria for repair of tyres for retreading, in-process retreading
guidelines, inspection of the finished tyres, quality control testing requirements as well as a
statement of warranty that the finished tyres conform to this standard and will give satisfactory
service under normal operating conditions. Close

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Wired glass - Specification
MS 2676:2019
Status : Original
Format : PDF

This Malaysian Standard specifies the dimensional and minimum quality requirements for wired glass.
The presence of the wire mesh appears to be a strengthening component, to hold the glass fragm ....Read more ent when it breaks.
This specification for wired glass is limited to compliance on safety aspect and excluding fire resistant requirement. Close

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AC and/or DC-supplied electronic control gear for tubular fluorescent lamps - Performance requirements (Second revision) (IEC 60929:2011, AMD.1:2015, IDT)
MS IEC 60929:2019
Status : 2nd Revision
Format : PDF

This international Standard specifies performance requirements for electronic control gear for
use on a.c. at 50 Hz or 60 Hz and/or d.c. supplies, both up to 1 000 V, with operating
freque ....Read more ncies deviating from the supply frequency, associated with fluorescent lamps as
specified in IEC 60081 and IEC 60901, and other fluorescent lamps for high-frequency
operation.
NOTE 1 Tests in this standard are type tests. Requirements for testing individual control gear during production
are not included.
NOTE 2 There are regional standards regarding the regulation of mains current harmonics and immunity for endproducts
like luminaires and independent control gear. In a luminaire, the control gear is dominant in this respect.
Control gear, together with other components, should comply with these standards.
NOTE 3 Requirements for the digital addressable lighting interface of electronic control gear are given in
IEC 62386. Close

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Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads or mattresses and intended for heating in medical use (First revision) (IEC 80601-2-35:2009, IDT)
MS IEC 80601-2-35:2018
Status : 1st Revision
Format : PDF

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of
HEATING DEVICES using BLANKETS, PADS or MATTRESSES in medical use, also referred to as
ME EQUIPMENT. HE ....Read more ATING DEVICES intended to prewarm a bed are included in the scope of this
International Standard.
If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to
ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the
case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.
If a clause or subclause is specifically intended to apply to a specifically defined type of ME
EQUIPMENT, as is the case with FORCED AIR DEVICES, then the clause or subclause is entitled as
such. Clauses or subclauses that apply to all types of ME EQUIPMENT within the scope of this
standard are not specifically entitled.
HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS
within the scope of this standard are not covered by specific requirements in this standard
except in 7.2.13 and 8.4.1 of the general standard.
NOTE See also 4.2 of the general standard.
This particular standard does not apply to:
– HEATING DEVICES intended for physiotherapy;
– radiant warmers; for information, see IEC 60601-2-21 [12]2;
– incubators; for information, see IEC 60601-2-19 [10];
– transport incubators, for information, see IEC 60601-2-20 [11];
– cooling devices Close

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Medical electrical equipmentPart 2-67: Particular requirements for basic safety and essential performance of oxygen conserving equipment (First revision) (ISO 80601-2-67:2014, IDT)
MS ISO 80601-2-67:2018
Status : 1st Revision
Format : PDF

IEC 60601-1:2005+A1:2012, 1.1 is replaced by:
This particular standard is applicable to the BASIC SAFETY and ESSENTIAL PERFORMANCE of oxygen
CONSERVING EQUIPMENT, hereafter referred to as ....Read more ME EQUIPMENT, in combination with its
ACCESSORIES intended to conserve supplemental oxygen by delivering gas intermittently and
synchronized with the PATIENT'S inspiratory cycle, when used in the HOME HEALTHCARE
ENVIRONMENT. Oxygen CONSERVING EQUIPMENT is typically used by a LAY OPERATOR.
NOTE 1 CONSERVING EQUIPMENT can also be used in professional health care facilities.
NOTE 2 CONSERVING EQUIPMENT can be used with an oxygen concentrator.
This particular standard is also applicable to those ACCESSORIES intended by their MANUFACTURER to
be connected to CONSERVING EQUIPMENT, where the characteristics of those ACCESSORIES can affect
the BASIC SAFETY or ESSENTIAL PERFORMANCE of the CONSERVING EQUIPMENT.
This particular standard is only applicable to active devices (e.g. pneumatically or electrically
powered) and is not applicable to non-active devices (e.g. reservoir cannulas).
NOTE 3 CONSERVING EQUIPMENT complying with this particular standard can be incorporated with other
devices that have their own standards, in which case the combination needs to comply with both standards.
EXAMPLES CONSERVING EQUIPMENT combined with a pressure regulator [2], an oxygen concentrator [1] or
liquid oxygen equipment [6].
If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to
ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case,
the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.
HAZARDS inherent in the intended function of ME EQUIPMENT or ME SYSTEMS within the scope of this
standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of the
general standard.
NOTE 4 See also 4.2 of the general standard.
This particular standard is a particular standard in the IEC 60601 series of standards. Close

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Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment (First revision) (IEC 60601-2-50:2016, IDT)
MS IEC 60601-2-50:2018
Status : 1st Revision
Format : PDF

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of INFANT
PHOTOTHERAPY EQUIPMENT, as defined in 201.3.203 of this standard, also referred to as
ME EQUIPME ....Read more NT.
If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to
ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the
case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.
HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS
within the scope of this standard are not covered by specific requirements in this standard
except in 7.2.13 and 8.4.1 of the general standard.
NOTE See also 4.2 of the general standard.
This particular standard specifies safety requirements for INFANT PHOTOTHERAPY EQUIPMENT,
but alternate methods of compliance with a specific clause by demonstrating equivalent safety
will not be judged as non-compliant if the MANUFACTURER has demonstrated in his RISK
MANAGEMENT FILE that the RISK presented by the HAZARD has been found to be of an
acceptable level when weighed against the benefit of treatment from the device.
This particular standard does not apply to:
– devices supplying heat via BLANKETS, PADS or MATTRESSES in medical use, for information
see IEC 80601-2-35;
– INFANT INCUBATORS; for information see IEC 60601-2-19;
– INFANT TRANSPORT INCUBATORS; for information, see IEC 60601-2-20;
– INFANT RADIANT WARMERS; for information see IEC 60601-2-21. Close

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Medical electrical equipment-Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators (First revision) (IEC 60601-2-19:2016, IDT)
MS IEC 60601-2-19:2018
Status : 1st Revision
Format : PDF

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of INFANT
INCUBATORS, as defined in 201.3.209 of this standard, also referred to as ME EQUIPMENT.
If a cla ....Read more use or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to
ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the
case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.
HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS
within the scope of this standard are not covered by specific requirements in this standard
except in 7.2.13 and 8.4.1 of the general standard.
NOTE See also 4.2 of the general standard.
This particular standard specifies safety requirements for INFANT INCUBATORS but alternate
methods of compliance with a specific clause by demonstrating equivalent safety will not be
judged as non-compliant if the MANUFACTURER has demonstrated in his RISK MANAGEMENT FILE
that the RISK presented by the HAZARD has been found to be of an acceptable level when
weighed against the benefit of treatment from the device.
This particular standard does not apply to:
– devices supplying heat via BLANKETS, PADS or MATTRESSES in medical use; for information
see IEC 80601-2-35 [3]2);
– INFANT RADIANT WARMERS; for information, see IEC 60601-2-21 [2];
– INFANT TRANSPORT INCUBATORS, for information, see IEC 60601-2-20 [1];
– INFANT PHOTOTHERAPY EQUIPMENT, for information see IEC 60601-2-50 [4] Close

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FLUIDS FOR ELECTROTECHNICAL APPLICATIONS - UNUSED MINERAL INSULATING OILS FOR TRANSFORMERS AND SWITCHGEAR
MS 2322:2010
Status : Original
Format : PDF

This Malaysian Standard covers specifications and test methods for unused mineral insulating
oils. It applies to oil delivered to the agreed point and time of delivery, intended for use in
....Read more transformers, switchgear and similar electrical equipment in which oil is required as an
insulant and for heat transfer. These oils are obtained by distillation and refining of crude
petroleum. Oils with and without additives are both within the scope of this standard.
This standard is applicable only to unused mineral insulating oils. Reclaimed oils are beyond
the scope of this standard. This standard does not apply to mineral oils used as impregnants
in cables or capacitors.
NOTE. Mineral insulating oils complying with the requirements of this standard, of the same class and containing no
additives (see 3.4), are considered to be compatible with one another and can be mixed in any proportion. This does
not apply to oils containing additives. Where the user wishes to mix such oils, a check is recommended to be made to
ensure that the mixture meets the requirements of this standard. Close

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