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OPHTHALMIC IMPLANTS - OCULAR ENDOTAMPONADES (ISO 16672:2003, IDT)
MS ISO 16672:2010
Status : Original
Format : PDF

This Malaysian Standard applies to ocular endotamponades (OEs), a group of non-solid implants used in ophthalmology to flatten and position a detached retina onto the choroid, or to tamponade the reti ....Read more na.

With regard to the safety and efficacy of OEs, this standard specifies requirements for their intended performance, design attributes, pre-clinical and clinical evaluation, sterilisation, product packaging, product labelling and the information supplied by the manufacturer.
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OPHTHALMIC IMPLANTS - IRRIGATING SOLUTIONS FOR OPHTHALMIC SURGERY (ISO 16671:2003, IDT)
MS ISO 16671:2010
Status : Original
Format : PDF

This Malaysian Standard defines requirements with regards to safety for the intended performance, design attributes, preclinical and clinical evaluation, sterilization, product packaging, product labe ....Read more lling and the information supplied by the manufacturer.

This Malaysian Standard applies to ophthalmic irrigating solutions (OISs), used during ophthalmic surgery. These solutions do not provide any primary immunological, pharmacological or metabolic function.
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GAS ANALYSIS - HANDLING OF CALIBRATION GASES AND GAS MIXTURES - GUIDELINES (ISO 16664:2004, IDT)
MS ISO 16664:2010
Status : Original
Format : PDF

This Malaysian Standard describes factors that may influence the composition of pure gases and homogeneous gas mixtures used for calibration purposes. This Malaysian Standard only applies to gases or ....Read more gas mixtures that are within the "Utilization period", and it pays special attention to

- storage of calibration gas cylinders;

- calibration gas withdrawal from cylinders;

- transfer of calibration gas from cylinders to the point of calibration.

It also outlines a method of assessing the stability for a gas mixture, and takes into account the gas composition uncertainty given on the certificate and the users measurement uncertainty.
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Tracheobronchial tubes - Sizing and marking (ISO 16628:2008, IDT)
MS ISO 16628:2010 (CONFIRMED:2015)
Status : 1st Confirmation
Format : PDF

This Malaysian Standard provides requirements for size designation and labelling of tracheobronchial tubes, including colour coding of the bronchial cuff and its associated pilot balloon. Tracheobronc ....Read more hial tubes that include bronchus blockers are excluded from the scope of this standard. Close

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METEOROLOGY – SONIC ANEMOMETERS/ THERMOMETERS – ACCEPTANCE TEST METHODS FOR MEAN WIND MEASUREMENTS (ISO 16622:2002, IDT)
MS ISO 16622:2007 (CONFIRMED:2023)
Status : 2nd Confirmation
Format : PDF

This Malaysian Standard defines test methods of the performance of sonic anemometers/thermometers which employ the inverse time measurement for velocity of sound along differently oriented paths. It i ....Read more s applicable to designs measuring two or three components of the wind vector within an unlimited (360°) azimuthal acceptance angle. Close

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Clothing for protection against contact with blood and body fluids - Determination of resistance of protective clothing materials to penetration by blood-borne pathogens - Test method using Phi-X174 bacteriophage (ISO 16604:2004, IDT)
MS ISO 16604:2011 (CONFIRMED:2022)
Status : 2nd Confirmation
Format : PDF

This Malaysian Standard describes a laboratory test method for measuring the resistance of materials used in protective clothing to penetration by blood-borne pathogens. This test method uses a surrog ....Read more ate microbe under conditions of continuous liquid contact. Protective clothing "pass/fail" determinations are based on the detection of viral penetration at a specific hydrostatic pressure using the ISO 13994 test apparatus.

This test method is not always effective in testing protective clothing materials having thick, inner liners which readily absorb the challenge fluid.

This test method involves a sensitive assay procedure. Because of the length of time required to complete this test method, it might not be suitable for use as a material or protective clothing quality control or assurance procedure.
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Clothing for protection against contact with blood and body fluids - Determination of the resistance of protective clothing materials to penetration by blood and body fluids - Test method using synthetic blood (ISO 16603:2004, IDT)
MS ISO 16603:2011 (CONFIRMED:2022)
Status : 2nd Confirmation
Format : PDF

This Malaysian Standard describes a laboratory test method for measuring the penetration resistance of clothing materials to blood and body fluids. This test method uses a synthetic blood in continuou ....Read more s contact with the material specimen at specified set of conditions using the ISO 13994 test apparatus.

This test method is not always effective in testing protective clothing materials having thick, inner liners which readily absorb the synthetic blood.
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ANIMAL FEEDING STUFFS - DETERMINATIONOF AMYLASE-TREATED NEUTRAL DETERGENT FIBRE CONTENT (aNDF) (ISO 16472:2006, IDT)
MS ISO 16472:2007
Status : Original
Format : PDF

This Malaysian Standard specifies methods for the determination of amylase-treated neutral detergent insoluble fibrous residue content in all types of animal feed.

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Implants for surgery - Measurements of open-circuit potential to assess corrosion behaviour of metallic implantable materials and medical devices over extended time periods (ISO 16429:2004, IDT)
MS ISO 16429:2011 (CONFIRMED:2024)
Status : 2nd Confirmation
Format : PDF

This Malaysian Standard specifies a test method for measurements over extended time periods of the open circuit potential of implant materials and surgically implantable devices immersed in a test env ....Read more ironment related to body fluid, using a standard corrosion test cell to study the electrochemical corrosion properties of the devices.

This method of monitoring the open-circuit potential can also be combined with mechanical static or dynamic loading tests.

This standard is applicable in particular to metallic materials which form passive layers with protective properties against corrosion, as typical for surgical implant materials.

This test method is intended for the investigation of single metallic materials or alloys.
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AMBIENT AIR - DETERMINATION OF PARTICLE-PHASE POLYCYCLIC AROMATIC HYDROCARBONS BY HIGH PERFORMANCE LIQUID CHROMATOGRAPHY (ISO 16362:2005, IDT)
MS ISO 16362:2007 (CONFIRMED:2023)
Status : 1st Confirmation
Format : PDF

This Malaysian Standard specifies sampling, clean-up and analysis procedures for the quantitative determination of low volatility (particle-bound) polycyclic aromatic hydrocarbons (PAHs) in ambient ai ....Read more r. For sampling, a low-volume or a medium/high-volume sampling device may be used. Sampling times between 1 h and 24 h are possible. The sampling volume flowrates can range from 1 m3/h to 4 m3/h (“low volume sampler”) or from 10 m3/h to about 90 m3/h (“medium/high-volume sampler”). In any case, the linear face velocity at the collection filter should range between about 0,5 m/s and 0,9 m/s.

The method has been validated for sampling periods up to 24 h. The detection limits for single PAHs and the standard deviations resulting from duplicate measurements are listed in 9.2 and Annex D respectively.

This Malaysian Standard describes a sampling and analysis procedure for PAH that involves collection from air onto a filter followed by analysis using high performance liquid chromatography u
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