Search Harmonised Standards in ASEAN: ASEAN BODY

Conformity assessment -- General requirements for accreditation bodies accrediting conformity assessment bodies / ISO/IEC 17011

ISO/IEC 17011:2004 specifies general requirements for accreditation bodies assessing and accrediting conformity assessment bodies (CABs). It is also appropriate as a requirements document for the…  [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+]

Medical laboratories -- Requirements for safety / ISO 15190:2003

ISO 15190:2003 specifies requirements for safe practices in the medical laboratory.  [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+]

Packaging for terminally sterilized medical devices -- Part 2: Validation requirements for forming, sealing and assembly processes / ISO 11607-2:2006

ISO 11607-2:2006 specifies the requirements for development and validation of processes for packaging medical devices that are terminally sterilized. These processes include forming, sealing, and…  [More Details+]

Single-use medical examination gloves -- Part 1: Specification for gloves made from rubber latex or rubber solution / ISO 11193-1 : 2008 Ed 2

ISO 11193-1:2008 specifies requirements for packaged sterile, or bulked non-sterile, rubber gloves intended for use in medical examinations and diagnostic or therapeutic procedures to protect…  [More Details+]

Single-use medical examination gloves -- Part 2: Specification for gloves made from poly(vinyl chloride) / ISO 11193-2 : 2006 Ed 1

ISO 11193-2:2006 specifies requirements for packaged sterile, or bulked non-sterile, poly(vinyl chloride) gloves intended for use in medical examinations, and diagnostic or therapeutic procedures, to…  [More Details+]

Sterilization of health care products -- Radiation -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices / ISO 11137-1:2006

ISO 11137-1:2006 specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices. Although the scope of ISO 11137-1:2006…  [More Details+]