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Sterilization of health care products - Biological and chemical indicators - Test equipment (ISO 18472:2006, IDT)
MS ISO 18472:2011
Status : Original
Format : PDF

This Malaysian Standard specifies the requirements for test equipment to be used to test chemical and biological indicators for steam, ethylene oxide, dry heat and vaporized hydrogen peroxide processe ....Read more s for conformity to the requirements given in MS ISO 11140-1 for chemical indicators, or the requirements given in the MS ISO 11138 series for biological indicators. This standard also provides informative methods useful in characterizing the performance of biological and chemical indicators for intended use and for routine quality control testing. Close

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OPHTHALMIC OPTICS - CONTACT LENSES - PART 3: MEASUREMENT METHODS (ISO 18369-3:2006, IDT)
MS ISO 18369-3:2009
Status : Original
Format : PDF

This Malaysian Standard specifies the methods for measuring the physical and optical properties of contact lenses specified in MS ISO 18369-2, i.e. radius of curvature, back vertex power, diameter, th ....Read more ickness, inspection of edges, inclusions and surface imperfections, and determination of spectral and luminous transmittances. This Malaysian Standard also specifies the equilibrating solution, standard saline solution, for testing of contact lenses. Close

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OPHTHALMIC OPTICS - CONTACT LENSES - PART 1: VOCABULARY, CLASSIFICATION SYSTEM AND RECOMMENDATIONS FOR LABELLING SPECIFICATIONS (ISO 18369-1:2006, IDT)
MS ISO 18369-1:2009
Status : Original
Format : PDF

This Malaysian Standard establishes and identifies and defines the terms applicable to the physical, chemical and optical properties of contact lenses, their manufacture and uses. It provides a vocabu ....Read more lary of terms and, when appropriate, the international symbol and abbreviation associated with a specific term. This Malaysian Standard also defines the terms relating to contact lens care products. It also incorporates the classifications of contact lens materials and gives recommendations for the labelling of the specifications of contact lenses. Close

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OPHTHALMIC OPTICS - CONTACT LENSES - PART 4: PHYSICOCHEMICAL PROPERTIES OF CONTACT LENS MATERIALS (ISO 18369-4:2006, IDT)
MS ISO 18369-4:2009
Status : Original
Format : PDF

This Malaysian Standard specifies the methods of testing the physicochemical properties of contact lens materials. These are extraction, rigid lens flexure and breakage, oxygen permeability, refractiv ....Read more e index and water content. Close

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In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control materials (ISO 18153:2003, IDT)
MS ISO 18153:2008 (CONFIRMED:2015)
Status : Withdrawn
Format : PDF

This Malaysian Standard specifies how to assure the metrological traceability of values assigned to calibrators and control materials intended to establish or verify trueness of measurement of the cat ....Read more alytic concentration of enzymes. The calibrators and control materials are those provided by the manufacturers as part of, or to be used together with, in vitro diagnostic medical devices. Close

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In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2009, IDT)
MS ISO 18113-2:2010 (CONFIRMED:2015)
Status : Withdrawn
Format : PDF

This Malaysian Standard specifies requirements for information supplied by the manufacturer of IVD reagents for professional use.

This standard also applies to information supplied by th ....Read more e manufacturer with calibrators and control materials intended for use with IVD medical devices for professional use. Close

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In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009, IDT)
MS ISO 18113-5:2010 (CONFIRMED:2015)
Status : Withdrawn
Format : PDF

This Malaysian Standard specifies requirements for information supplied by the manufacturer of IVD instruments for self-testing.

This Malaysian Standard also applies to apparatus and equ ....Read more ipment intended to be used with IVD instruments for self-testing.

This Malaysian Standard can also be applied to accessories.

?This Malaysian Standard does not apply to

a) instructions for instrument servicing or repair,
b) IVD reagents, including calibrators and control materials for use in control of the reagent,
c) IVD instruments for professional use. Close

NOT FOR SALE

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In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2009, IDT)
MS ISO 18113-4:2010 (CONFIRMED:2015)
Status : Withdrawn
Format : PDF

This Malaysian Standard specifies requirements for information supplied by the manufacturer of IVD reagents for self-testing.

This Malaysian Standard also applies to information supplied ....Read more by the manufacturer with calibrators and control materials intended for use with IVD medical devices for self-testing.

This Malaysian Standard can also be applied to accessories.

?This Malaysian Standard applies to the labels for outer and immediate containers and to the instructions for use.

This Malaysian Standard does not apply to:
a) IVD instruments or equipment,
b) IVD reagents for professional use. Close

NOT FOR SALE

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In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2009, IDT)
MS ISO 18113-3:2010 (CONFIRMED:2015)
Status : Withdrawn
Format : PDF

This Malaysian Standard specifies requirements for information supplied by the manufacturer of IVD instruments for professional use.

This Malaysian Standard also applies to apparatus and ....Read more equipment intended to be used with IVD instruments for professional use.

This Malaysian Standard can also be applied to accessories.

?This Malaysian Standard does not apply to:

a) instructions for instrument servicing or repair,
b) IVD reagents, including calibrators and control materials for use in control of the reagent,
c) IVD instruments for self-testing. Close

NOT FOR SALE

Please contact us if you are interested to purchase for reference.



In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009, IDT)
MS ISO 18113-1:2010 (CONFIRMED:2015)
Status : Withdrawn
Format : PDF

This Malaysian Standard defines concepts, establishes general principles and specifies essential requirements for information supplied by the manufacturer of IVD medical devices.

This st ....Read more andard does not address language requirements, since that is the domain of national laws and regulations. This standard does not apply to
a) IVD devices for performance evaluation (e.g., for investigational use only),
b) instrument marking,
c) material safety data sheets. Close

NOT FOR SALE

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