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MS ISO 18113-3:2010 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 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)

Description Printed version of this standard is available at Library. To request, please e-mail to adminpk@usm.my and include a copy of this record in your e-mail. Abstract 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 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.

Primary Item Type: Malaysian Standard Identifiers: Standard Number MS ISO 18113-3:2010 ISC ISC R - Medical Devices and Facilities for Healthcare ICS 11.100.10 Language: English Subject Keywords: Medical device; In vitro diagnostic First presented to the public: 7/27/2018 Original Publication Date: 8/6/2015 Previously Published By: Department of Standards Malaysia Place Of Publication: Cyberjaya, Selangor Citation: Extents: Number of Pages - 19 License Grantor / Date Granted:   / ( View License ) Date Deposited 2018-07-27 12:04:08.537 Date Last Updated 2019-01-07 11:24:16.6254 Submitter: Mohamed Yunus Yusof

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