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Non-active sUrgical implants - Joint replacement implants - Specific reqUirements for knee-joint replacement implants (ISO 21536:2007, IDT)
MS ISO 21536:2010 (CONFIRMED:2015)
Status : 1st Confirmation
Format : PDF

This Malaysian Standard provides specific reqUirements for knee joint replacement implants. With regard to safety, this standard specifies req....Read more e='background-color : #c4c5cf'>Uirements for intended performance, design attribUtes, materials, design evalUation, manUfactUre, sterilization, packaging, information sUpplied by the manUfactUrer and methods of test. Close

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Non-active sUrgical implants - Joint replacement implants - Specific reqUirements for hip-joint replacement implants (ISO 21535:2007, IDT)
MS ISO 21535:2010 (CONFIRMED:2015)
Status : 1st Confirmation
Format : PDF

This Malaysian Standard provides specific reqUirements for hip joint replacement implants. With regard to safety, this Malaysian Standard specifies req< ....Read more span style='background-color : #c4c5cf'>Uirements for intended performance, design attribUtes, materials, design evalUation, manUfactUre, sterilization, packaging, information sUpplied by the manUfactUrer, and methods of test. Close

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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 implan ....Read more ts, artificial ligaments and bone cement, hereafter 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 processing, 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 ....Read more dry heat sterilization process for medical devices.

?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) flU....Read more >orescence test method for the determination of the sUlfUr content of motor gasolines, inclUding 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 minimUm 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 dr....Read more le='background-color : #c4c5cf'>Ug Under 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 mo....Read more n style='background-color : #c4c5cf'>Ulding, 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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