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Non-active surgical implants - Joint replacement implants - Particular requirements (ISO 21534:2007, IDT)
MS ISO 21534:2010 (CONFIRMED:2015)
Status : 1st Confirmation
Format : PDF

This malaysian Standard specifies particular requirements for total and partial joint replacement implants, artificial ligaments and bone cement, hereaf ....Read more ter referred to as implants. For the purposes of this malaysian Standard, artificial ligaments and their associated fixing devices are included in the term "implant".

?It specifies requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information to be supplied by the manufacturer.

Some tests required to demonstrate conformance to this International Standard are contained in or referenced in level 3 standards. Close

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SAFETY OF MACHINERY - LUBRICANTS WITH INCIDENTAL PRODUCT CONTACT - HYGIENE REQUIREMENTS (ISO 21469:2006, IDT)
MS ISO 21469:2007
Status : Original
Format : PDF

This malaysian Standard specifies hygiene requirements for the formulation, manufacture, use and handling of lubricants which, during manufacture and pr ....Read more ocessing, can come into incidental contact (e.g. through heat transfer, load transmission, lubrication or the corrosion protection of machinery) with products and packaging used in the food, food-processing, cosmetics, pharmaceutical, tobacco or animal-feeding-stuffs industries. Included in this document are registration criteria that can be used to assess conformance with this malaysian standard for lubricants with incidental product contact (see Annex B). It is not applicable to substances used as product additives or to those in direct product contact (see Annex A), but confines itself to hygiene without addressing occupational health and safety matters. Nevertheless, it is considered essential that where occupational health and safety is associated with the processes concerned it be considered along with hygiene so that measures sat Close

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System engineering - Mk II function point analysis - Counting practices manual (ISO/IEC 20968:2002, IDT)
MS ISO/IEC 20968:2006 (CONFIRMED:2015)
Status : 1st Confirmation
Format : PDF

This malaysian Standard specifies the software domains for which Mk II FPA may be applicable, application software requirement components recognised by ....Read more Mk II FPA, Basic Formulae used in Mk II FPA and Terminology used in Mk II FPA. It also defined the process for applying the MkII FPA rules and documenting the result and interpretation of the rules for a variety of software technologies (e.g., GUI, client/server, objects, etc.) Close

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Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 20857:2010, IDT)
MS ISO 20857:2011 (CONFIRMED:2015)
Status : 1st Confirmation
Format : PDF

This malaysian Standard specifies requirements for the development, validation and routine control of a dry heat sterilization process for medical devic ....Read more es.

?NOTE. Although the scope of this International Standard is limited to medical devices, it specifies requirements and provides guidance that might be applicable to other health care products.

Although this malaysian Standard primarily addresses dry heat sterilization, it also specifies requirements and provides guidance in relation to depyrogenation processes using dry heat.

?NOTE Dry heat is often used for the depyrogenation of equipment, components and health care products and its effectiveness has been demonstrated. The process parameters for sterilization and/or depyrogenation are time and temperature. Because the conditions for depyrogenation are typically more severe than those required for sterilization, a process that has been validated for product depyrogenation will result in product sterility without additional val Close

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PETROLEUM PRODUCTS - DETERMINATION OF SULFUR CONTENT OF AUTOMOTIVE FUELS - ULTRAVIOLET FLUORESCENCE METHOD (ISO 20846:2004, IDT)
MS ISO 20846:2009
Status : Original
Format : PDF

This malaysian Standard specifies an ultraviolet (UV) fluorescence test method for the determination of the sulfur content of motor gasolines, including ....Read more those containing up to 2.7 % (m/m) oxygen, and of diesel fuels, including those containing up to 5 % (V/V) fatty acid methyl ester (FAME), having sulfur contents in the range 3 mg/kg to 500 mg/kg. Other products may be analysed and other sulfur contents may be determined according to this test method; however, no precision data for products other than automotive fuels and for results outside the specified range have been established for this standard. Halogens interfere with this detection technique at concentrations above approximately 3 500 mg/kg.

NOTE 1 Some process catalysts used in petroleum and chemical refining might be polluted when trace amounts of sulfur-bearing materials are contained in the feedstocks.

NOTE 2 This test method may be used to determine sulfur in process feeds and may also be used to control sulfur in eff Close

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Clinical laboratory testing and in vitro diagnostic test systems - Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices - Part 2: Evaluation of performance of antimicrobial susceptibility test devices (ISO 20776-2:2007, IDT)
MS ISO 20776-2:2010 (CONFIRMED:2015)
Status : Withdrawn
Format : PDF

This malaysian Standard establishes acceptable performance criteria for antimicrobial susceptibility test (AST) devices that are used to determine minim ....Read more um inhibitory concentrations (MIC) and/or interpretive category determinations of susceptible, intermediate and resistant (SIR) strains of bacteria to antimicrobial agents in medical laboratories. This malaysian Standard specifies requirements for AST devices (including diffusion test systems) and procedures for assessing performance of such devices. It defines how a performance evaluation of an AST device is to be conducted. This malaysian Standard has been developed to guide manufacturers in the conduct of performance evaluation studies. Close

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Cinical laboratory testing and in vitro diagnostic test systems - Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices - Part 1: Reference method for testing the in vitro activity of antimicrobial agents against rapidly growing aerobic bacteria involved in infectious diseases (ISO 20776-1:2006, IDT)
MS ISO 20776-1:2010 (CONFIRMED:2015)
Status : Withdrawn
Format : PDF

This malaysian Standard describes one reference method, broth microdilution, for determination of MICs. The MIC reflects the activity of the drug under ....Read more the described test conditions, and can be interpreted for clinical management purposes by taking into account other factors, such as drug pharmacology or bacterial resistance mechanisms. This allows categorization of bacteria as “susceptible” (S), “intermediate” (I), or “resistant” (R). In addition, MIC distributions can be used to define wild type or non-wild type bacterial populations. Although clinical interpretation of the MIC value is beyond the scope of this malaysian Standard, modifications of the basic method are required for certain antimicrobial agent - bacteria combinations to facilitate clinical interpretation. These modifications are included in a separate table. It is advisable to compare other susceptibility testing methods (e.g. routine methods or diagnostic test devices) with this reference method for validation, in ord Close

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PLASTICS - TEST SPECIMENS (ISO 20753:2008, IDT)
MS ISO 20753:2010
Status : Original
Format : PDF

This malaysian Standard specifies dimensional requirements relating to test specimens prepared from plastics materials intended for processing by mouldi ....Read more ng, as well as to test specimens prepared by machining from sheets or shaped articles. It gives, in one document, the designations and dimensions of test specimens used for the acquisition of comparable data and also other frequently used specimens. Close

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FINE CERAMICS (ADVANCED CERAMICS, ADVANCED TECHNICAL CERAMICS) - DETERMINATION OF OXIDATION RESISTANCE OF NON-OXIDE MONOLITHIC CERAMICS (ISO 20509:2003, IDT)
MS ISO 20509:2006
Status : Original
Format : PDF

This malaysian Standard describes the method of test for determining the oxidation resistance of non-oxide monolithic ceramics, such as silicon nitride ....Read more and silicon carbide at high temperatures.This International Standard is intended to provide an assessment of the mass and dimensional changes of test pieces following oxidation at high temperature in an oxidizing atmosphere, and to assess whether oxidation has a significant effect on the subsequent strength. 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) - DETERMINATION OF LIGHT TRANSMITTANCE OF CERAMIC FILMS WITH TRANSPARENT SUBSTRATE (ISO 20508:2003, IDT)
MS ISO 20508:2008
Status : Original
Format : PDF

This malaysian Standard specifies a test method for determining the visible light transmittance of a transparent coating material, e.g., the transparent ....Read more electrode for display devices, in which a fine ceramic thin film is coated on to a substrate. This malaysian Standard is not applicable to deliberately coloured, uneven or non-parallel faced test pieces. A translucent medium is not included in this malaysian Standard. Close

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