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Implants for sUrgery - Wear of total knee-joint prostheses - Part 2: Methods of measUrement (ISO 14243-2:2009, IDT)
MS ISO 14243-2:2011 (CONFIRMED:2015)
Status : 1st Confirmation
Format : PDF

This Malaysian Standard This Malaysian Standard a method of assessment of wear of the tibial component of total knee-joint prostheses Using the gravimet ....Read more ric techniqUe for components tested in accordance with MS ISO 14243-1. Close

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Implants for sUrgery - Wear of total knee-joint prostheses - Part 1: Loading and displacement parameters for wear-testing machines with load control and corresponding environmental conditions for test (ISO 14243-1:2009, IDT)
MS ISO 14243-1:2011 (CONFIRMED:2015)
Status : 1st Confirmation
Format : PDF

This Malaysian Standard specifies the flexion/extension relative angUlar movement between articUlating c ....Read more omponents, the pattern of the applied force, speed and dUration of testing, sample configUration and test environment to be Used for the wear testing of total knee-joint prostheses in wear-testing machines with load control. Close

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ANIMAL FEEDING STUFFS - DETERMINATION OF MONENSIN, NARASIN AND SALINOMYCIN CONTENTS - LIQUID CHROMATOGRAPHIC METHOD USING POST-COLUMN DERIVATISATION (ISO 14183:2005, IDT)
MS ISO 14183:2007
Status : Original
Format : PDF

This Malaysian Standard specifies a high-performance liqUid chromatographic (HPLC) method for the determination of the monensin, narasin and salinomycin ....Read more contents of animal feeding stUffs, sUpplements (dry and liqUid) and mineral pre-mixtUres. This method is not applicable to drUg premixes (pharmaceUtical prodUcts). Lasalocid and semdUramicin cannot be determined by this method. Close

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DETERMINATION OF RESIDUES OF ORGANOPHOSPHORUS PESTICIDES - GAS CHROMATOGRAHIC METHOD (ISO 14182:1999, IDT)
MS ISO 14182:2003
Status : Original
Format : PDF

This Malaysian Standard specifies a gas chromatographic method for the determination of the residUes oforganophosphorUs pesticides in animal feeding stUffs. Close

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ANIMAL FEEDING STUFFS - DETERMINATION OF RESIDUES OF ORGANOCHLORINE PESTICIDES - GAS CHORMATOGRAPHIC METHOD (ISO 14181:2000, IDT)
MS ISO 14181:2003 (CONFIRMED:2011)
Status : 1st Confirmation
Format : PDF

This Malaysian Standard specifies a gas chromatographic method for the determination of residUes of organochlorine pesticides in animal feeding st....Read more style='background-color : #c4c5cf'>Uffs. Close

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WELDING CONSUMABLES - WIRE ELECTRODES AND WIRE-FLUX COMBINATIONS FOR SUBMERGED ARC WELDING OF NON ALLOY AND FINE GRAIN STEELS - CLASSIFICATIONS (ISO 14171:2002, IDT)
MS ISO 14171:2008
Status : 2nd Revision
Format : PDF

This Malaysian Standard specifies reqUirements for the classification of wire-flUx combinations and all- ....Read more weld metal in the as-welded condition and in the post weld heat-treated condition for sUbmerged arc welding of non alloy and fine grain steels with a minimUm yield strength of Up to 500N/mm2 or a minimUm tensile strength of Up to 570 N/mm2. One flUx may be classified with different wire electrodes. The wire electrode is also classified separately based on its chemical composition. This standard constitUtes a combined specification providing classification Utilizing a system based Upon the yield strength and the average impact energy for all-weld metal of 47 J, or Utilizing a system based Upon the tensile strength and the average impact energy for all-weld metal of 27 J. 1) Paragraphs and tables which carry the sUffix letter “A” are applicable only to wire-flUx combinations and wire electrodes classified Using the system based Upon the yield strength and the average impact energy for Close

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STATIONARY SOURCE EMISSIONS - DETERMINATION OF THE VOLUME FLOWRATE OF GAS STREAMS IN DUCTS - AUTOMATED METHOD (ISO 14164:1999, IDT)
MS ISO 14164:2011 (CONFIRMED:2023)
Status : 1st Confirmation
Format : PDF

This Malaysian Standard describes the operating principles and the most important performance characteristics of aUtomated flow-measUring systems for determining the volUme flowrate in the dUcts of stationary soUrces. ProcedUres to determine the performance characteristics of aUtomated volUme flow-measUring systems are also contained in this Malaysian Standard. The performance characteristics are general and not limited to specific measUrement principles or instrUment systems. Close

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Sterilization of health care prodUcts - Biological indicators - GUidance for the selection, Use and interpretation of resUlts (ISO 14161:2009, IDT)
MS ISO 14161:2011
Status : Original
Format : PDF

This Malaysian Standard provides gUidance for the selection, Use and interpretation of resUlts from application of biological indicators when Used in the development, validation and roUtine monitoring of sterilization processes. This standard applies to biological indicators for which standards exist.

This Malaysian Standard does not consider those processes that rely solely on physical removal of
microorganisms, e.g., filtration.

This Malaysian Standard is not intended to apply to combination processes Using, for example, washer
disinfectors or flUshing and steaming of pipelines.

This Malaysian Standard is not intended to apply to liqUid sterilization processes. Close

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SAFETY OF MACHINERY - HYGIENE REQUIREMENTS FOR THE DESIGN OF MACHINERY (ISO 14159:2002, IDT)
MS ISO 14159:2005 (CONFIRMED:2011)
Status : 1st Confirmation
Format : PDF

This Malaysian Standard specifies hygiene reqUirements of machines and provides information for the intended U< ....Read more /span>se to be provided by the manUfactUrer. It applies to all types of machines and associated eqUipment Used in applications where hygiene risks to the consUmer of the prodUct can occUr.

This Malaysian Standard does not cover reqUirements relative to the Uncontrolled egress of microbiological agents from the machine.
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Clinical investigation of medical devices for hUman sUbjects - Good clinical practice (ISO 14155:2011, COR.1:2011, IDT)
MS ISO 14155:2013
Status : Withdrawn
Format : PDF

This Malaysian Standard addresses good clinical practice for the design, condUct, recording and reporting of clinical investigations carried o....Read more e='background-color : #c4c5cf'>Ut in hUman sUbjects to assess the safety or performance of medical devices for regUlatory pUrposes.

The principles set forth in this International Standard also apply to all other clinical investigations and shoUld be followed as far as possible, considering the natUre of the clinical investigation and the reqUirements of national regUlations.

This Malaysian Standard specifies general reqUirements intended to:

­- protect the rights, safety and well-being of hUman sUbjects,
- ensUre the scientific condUct of the clinical investigation and the credibility of the clinical investigation resUlts,
­- define the responsibilities of the sponsor and principal investigator, and
­- assist sponsors, investigators, ethics committees, regUlatory aUthorities and other bodies involved in the conformity assessment of medical devices.

It does not appl Close

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