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Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009, IDT)
MS ISO 10993-5:2013
Status : Withdrawn
Format : PDF

This Malaysian Standard describes test methods to assess the in vitro cytotoxicity of medical devices. 
These methods specify the incubation of cultured cells in contact with a device and/or ex ....Read more tracts of a device either directly or through diffusion.

These methods are designed to determine the biological response of mammalian cells in vitro using appropriate biological parameters. Close

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BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 17: ESTABLISHMENT OF ALLOWABLE LIMITS FOR LEACHABLE SUBSTANCES (ISO 10993-17:2002, IDT)
MS ISO 10993-17:2005 (CONFIRMED:2011)
Status : 1st Confirmation
Format : PDF

This Malaysian Standard specifies a method for the determination of allowable limits for substances leach able from medical devices. It is intended for use in deriving standards and estimating appropr ....Read more iate limits where standards do not exist. It describes a systematic process through which identified risks arising from toxicologically hazardous substances present in medical devices can be quantified. 
This Malaysian Standard is not applicable to devices that have no patient contact (e.g. in vitro diagnostic devices).

Exposure to a particular chemical substance may arise from sources other than the device, such as food, water or air. This Malaysian Standard does not address the potential for exposure from such sources. Close

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Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics (ISO 10993-14:2001, IDT)
MS ISO 10993-14:2005 (CONFIRMED:2015)
Status : 1st Confirmation
Format : PDF

This Malaysian Standard specifies two methods of obtaining solutions of degradation products from ceramics (including glasses) for the purposes of quantification. It also gives guidance on the analysi ....Read more s of these solutions in order to identify the degradation products. Because of the generalized nature of this standard, product specific standards, when available, that address degradation product formation under more relevant conditions of use, should be considered first. 
This Malaysian Standard considers only those degradation products generated by a chemical dissociation of ceramics during in vitro testing. No degradation induced by mechanical stress or external energy is covered.

Because of the range of ceramics used in medical devices and the different requirements for accuracy and precision of the results, no specific analytical techniques are identified.

Although these materials are intended for biomedical applications, the biological activity of these degradation products is n Close

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Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2009, IDT)
MS ISO 10993-9:2013
Status : Withdrawn
Format : PDF

This Malaysian Standard provides general principles for the systematic evaluation of the potential and observed biodegradation of medical devices and for the design and performance of biodegradation s ....Read more tudies. Information obtained from these studies can be used in the biological evaluation described in the MS ISO 10993 series. This standard considers both non-resorbable and resorbable materials. 
This standard is not applicable to:

a) evaluation of degradation which occurs by purely mechanical processes; methodologies for the production of this type of degradation product are described in specific product standards, where available;

b) leachable components which are not degradation products;

c) medical devices or components that do not contact the patient's body directly or indirectly. Close

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Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (First revision) (ISO 10993-16:2010, IDT)
MS ISO 10993-16:2011 (CONFIRMED:2015)
Status : 1st Confirmation
Format : PDF

This Malaysian Standard gives principles on how toxicokinetic studies relevant to medical devices should be designed and performed. Annex A describes the considerations for inclusion of toxicokinetic ....Read more studies in the biological evaluation of medical devices. Close

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OPHTHALMIC INSTRUMENTS - INDIRECT OPHTHALMOSCOPES (ISO 10943:2006, IDT)
MS ISO 10943:2011
Status : Original
Format : PDF

This Malaysian Standard gives principles on how toxicokinetic studies relevant to medical devices should be designed and performed. Annex A describes the considerations for inclusion of toxicokinetic ....Read more studies in the biological evaluation of medical devices. Close

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Ophthalmic instruments - Direct ophthalmoscopes (ISO 10942:2006, IDT)
MS ISO 10942:2010 (CONFIRMED:2015)
Status : 1st Confirmation
Format : PDF

This Malaysian Standard specifies the minimum requirements and test methods for hand-held direct ophthalmoscopes designed for directly observing the eye fundus.

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PLASTICS PIPING SYSTEMS FOR INDUSTRIAL APPLICATIONS - POLY(VINYLIDENE FLUORIDE) (PVDF) - SPECIFICATIONS FOR COMPONENTS AND THE SYSTEM (ISO 10931:2005, IDT)
MS ISO 10931:2010
Status : Original
Format : PDF

This Malaysian Standard specifies the characteristics and requirements for components such as pipes, fittings and valves made from poly(vinylidene fluoride) (PVDF), intended to be used for thermoplast ....Read more ics piping systems in the field of industrial applications above-ground. 
It is applicable to PVDF pipes, fittings, valves and ancillary equipment, their joints and to joints with components of other plastics and non-plastics materials, depending on their suitability, intended to be used for the conveyance of liquid and gaseous fluids as well as of solid matters in fluids for industrial applications including

- chemical plants,

- industrial sewerage engineering,

- power engineering (cooling and general purpose water),

- electroplating and pickling plants,

- semiconductor industry,

- agricultural production plants, and

- water treatment.

This Malaysian Standard is applicable to PVDF piping systems for use at temperatures up to 150 °C. However, for applications above 120 °C, Close

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Nanotechnologies - Characterization of single-wall carbon nanotubes using near infrared photoluminescence spectroscopy (ISO/TS 10867:2010, IDT)
MS ISO/TS 10867:2012
Status : Original
Format : PDF

This Malaysian Standard specifies guidelines for the characterization of single-wall carbon nanotubes (SWCNTs) using near infrared (NIR) photoluminescence (PL) spectroscopy, measurement method for the ....Read more determination of the chiral indices of the semi-conducting SWCNT in a sample and their relative integrated PL intensities and the method can be expanded to estimate relative mass concentrations of semi-conducting SWCNTs in a sample from measured integrated PL intensities and knowledge of their PL cross-sections. Close

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STATIONARY SOURCE EMISSIONS - DETERMINATION OF THE MASS CONCENTRATION OF NITROGEN OXIDES - PERFORMANCE CHARACTERISTICS OF AUTOMATED MEASURING SYSTEMS (ISO 10849:1996, IDT)
MS ISO 10849:2011
Status : Original
Format : PDF

This Malaysian Standard specifies the fundamental structure and the most important performance characteristics of automated measuring systems for oxides of nitrogen to be used on stationary source emi ....Read more ssions, for example combustion plants. The procedures to determine the performance characteristics are also specified. Furthermore, it describes methods and equipment to determine NO or NOx, (NO + NO2,) in flue gases including the sampling system and sample gas conditioning system. Dinitrogen monoxide 

(N2O) is not determined by the methods described in this standard. The given performance characteristics refer to the complete measuring system, from sampling to analyser. Close

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