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Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006, IDT)
MS ISO 17665-1:2010 (CONFIRMED:2015)
Status : 1st Confirmation
Format : PDF

This Malaysian Standard specifies requirements for the development, validation and routine control of a moist heat sterilization process for medical devices.

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STERILIZATION OF MEDICAL DEVICES - INFORMATION TO BE PROVIDED BY THE MANUFACTURER FOR THE PROCESSING OF RESTERILIZABLE MEDICAL DEVICES (ISO 17664:2004, IDT)
MS ISO 17664:2010
Status : Original
Format : PDF

This Malaysian Standard specifies the information to be provided by the medical device manufacturer on the processing of medical devices claimed to be resterilizable, and medical devices intended to b ....Read more e sterilized by the processor.

This standard specifies requirements for the information to be provided by the medical device manufacturer, so that the medical device can be processed safely and will continue to meet its performance specification. Close

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Non-destructive testing of welds - Radiographic testing - Part 1: X- and gamma-ray techniques with film (Third revision) (ISO 17636-1:2013, IDT)
MS ISO 17636-1:2017
Status : 3rd Revision
Format : PDF

This Malaysian Standard specifies techniques of radiographic examination of fusion welded joints in metallic materials using industrial radiographic film techniques.

This Malaysian Stand ....Read more ard applies to the joints of plates and pipes. Besides its conventional meaning, "pipe" as used in this standard covers other cylindrical bodies such as tubes, penstocks, boiler drums, and pressure vessels. Close

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Meat and meat products - Carcass sampling for microbiological analysis (ISO 17604:2003, AMD. 1:2009, IDT)
MS ISO 17604:2012
Status : Original
Format : PDF

This Malaysian Standard specifies sampling methods for the detection and enumeration of microorganisms on the carcass surface of freshly slaughtered (red) meat animals. The microbiological sampling ca ....Read more n be carried out as part of
a) the process control (and to verify process control) in slaughter establishments for cattle, horses, pigs, sheep, goats and game raised in captivity,
b) risk-based assurance systems for product safety, and
c) surveillance programmes for the prevalence of pathogenic microorganisms.

This Malaysian Standard includes the use of destructive and non-destructive techniques depending on the reason for the sample collection.

It does not consider the use of sampling plans.

When national legislation on the topic exists, this prevails over this Malaysian Standard.

Annex A shows sampling sites on the carcass, and Annex B gives requirements for microbiological
examination. Annex C compares destructive and non-destructive methods. Close

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Clinical laboratory testing and in vitro medical devices - Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy (ISO 17593:2007, IDT)
MS ISO 17593:2010 (CONFIRMED:2015)
Status : Withdrawn
Format : PDF

This Malaysian Standard specifies requirements for in vitro measuring systems for self-monitoring of vitamin-K antagonist therapy, including performance, quality assurance and user training and proced ....Read more ures for the verification and validation of performance by the intended users under actual and simulated conditions of use. Close

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FINE CERAMICS (ADVANCED CERAMICS, ADVANCED TECHNICAL CERAMICS) - TEST METHOD FOR FLEXURAL STRENGTH OF MONOLITHIC CERAMICS AT ELEVATED TEMPERATURE (ISO 17565:2003, IDT)
MS ISO 17565:2008
Status : Original
Format : PDF

This Malaysian Standard describes the method of test for determining the flexural strength of monolithic fine ceramics and whisker- or particulate-reinforced ceramic composites at elevated temperature ....Read more . Flexural strength is one measure of the uniaxial strength of fine ceramics. This test method may be used for materials development, quality control, characterization and design data generation purposes. Close

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FINE CERAMICS (ADVANCED CERAMICS, ADVANCED TECHNICAL CERAMICS) -TEST METHOD FOR LINEAR THERMAL EXPANSION OF MONOLITHIC CERAMICS BY PUSH-ROD TECHNIQUE (ISO 17562:2001, IDT)
MS ISO 17562:2005
Status : Withdrawn
Format : PDF

This Malaysian Standard specifies a method for the determination of the linear thermal expansion and the linear thermal expansion coefficient of monolithic ceramics from near liquid nitrogen temperatu ....Read more re up to a maximum temperature of 1 500 °C. Close

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FINE CERAMICS (ADVANCED CERAMICS, ADVANCED TECHNICAL CERAMICS) - TEST METHOD FOR ELASTIC MODULI OF MONOLITHIC CERAMICS AT ROOM TEMPERATURE BY SONIC RESONANCE (ISO 17561:2002/COR. 1:2007, IDT)
MS ISO 17561:2008
Status : Withdrawn
Format : PDF

This Malaysian Standard describes the method of test for determining the dynamic elastic moduli of fine ceramics at room temperature by sonic resonance. This Malaysian Standard is for fine ceramics th ....Read more at are elastic, homogeneous and isotropic. Close

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Plastics - Film and sheeting - Cast polypropylene (PP) films (ISO 17557:2003, IDT)
MS ISO 17557:2013
Status : Withdrawn
Format : PDF

This Malaysian Standard specifies the specification for cast polypropylene (PP) film in the thickness range from 10 to 120 µm. The film may contain additive for the improvement of surface properties ....Read more or thermal stability. This is not suitable for embossed film, sheeting and flexible plastics laminates. Close

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In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control material (ISO 17511:2003, IDT)
MS ISO 17511:2008 (CONFIRMED:2015)
Status : Withdrawn
Format : PDF

This Malaysian Standard specifies how to assure the metrological traceability of values assigned to calibrators and control materials intended to establish or verify trueness of measurement. The calib ....Read more rators and control materials are those provided by the manufacturers as part of, or to be used together with, in vitro diagnostic medical devices.

External quality assessment (survey) samples, with proven commutability, whose values have been assigned by means of internationally agreed reference measurement systems or internationally agreed conventional reference measurement systems fall within the scope of this Malaysian Standard. Close

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