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MS ISO 18113-1:2010 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 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009, 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 defines concepts, establishes general principles and specifies essential requirements for information supplied by the manufacturer of IVD medical devices. This standard 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.

Primary Item Type: Malaysian Standard Identifiers: Standard Number MS ISO 18113-1:2010 ISC ISC R - Medical Devices and Facilities for Healthcare ICS 11.100.10 Language: English Subject Keywords: medical device, in vitro diagnostic, information supplied by the manufacturer, labelling, terms, definitions, general requirements 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 - 59 License Grantor / Date Granted:   / ( View License ) Date Deposited 2018-07-27 16:02:25.174 Date Last Updated 2019-01-07 11:24:16.6254 Submitter: Mohamed Yunus Yusof

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