Search Harmonised Standards in ASEAN: ICS

ISO 13485:2016 Medical devices -- Quality management systems -- Requirements for regulatory purposes / ISO 13485:2016

ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that…  [More Details+]

Medical devices -- Application of risk management to medical devices / ISO 14971:2007

ISO 14971:2007 specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate…  [More Details+]

Medical devices -- Quality management systems -- Guidance on the application of ISO 13485: 2003 / ISO/TR 14969:2004

ISO/TR 14969:2004 provides guidance for the application of the requirements for quality management systems contained in ISO 13485. It does not add to, or otherwise…  [More Details+]

Medical devices -- Quality management systems -- Requirements for regulatory purposes / ISO 13485:2003

ISO 13485:2003 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that…  [More Details+]

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance / IEC 60601-1:2005

IEC 60601-1:2005 contains requirements concerning basic safety and essential performance that are generally applicable to medical electrical equipment. For certain types of medical electrical equipment,…  [More Details+]

Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators / IEC 60601-2-19:2009

IEC 60601-2-19:2009 specifies safety requirements for infant incubators. This particular standard amends and supplements IEC 60601-1:2005, Medical electrical equipment - Part 1: General requirements for…  [More Details+]

Non-invasive sphygmomanometers -- Part 1: Requirements and test methods for non-automated measurement type / ISO 81060-1:2007

ISO 81060-1:2007 specifies requirements for non-automated sphygmomanometers and their accessories, which, by means of inflatable cuffs, are used for the non-invasive blood pressure measurement by…  [More Details+]

Ophthalmic optics -- Contact lens care products -- Microbiological requirements and test methods for products and regimens for hygienic management of contact lenses / ISO 14729:2001

This International Standard specifies two test methods for evaluating the antimicrobial activity of products to be marketed for contact lens disinfection by chemical means and…  [More Details+]