Search Harmonised Standards in ASEAN: HS

Determination of limits for industrial, scientific and medical equipment / CISPR 16-4-4 Ed2.0 (2007-06)

This Technical Report contains a recommendation on how to deal with statistics of radio interference complaints. Furthermore it describes the calculation of limits for disturbance…  [More Details+]

Incandescent lamps - Safety specifications - Part 1: Tungsten filament lamps for domestic and similar general lighting purposes / IEC 60432-1 Ed.2.1 (2005)

International Standard IEC 60432 1 specifies the safety and interchangeability requirements of tungsten filament incandescent lamps for general lighting service It bears the edition number…  [More Details+]

Incandescent lamps - Safety specifications - Part 2: Tungsten halogen lamps for domestic and similar general lighting purposes / IEC 60432-2 Ed.2.0 (1999)

Specifies the safety and the related interchangeability requirements of tungsten halogen lamps for general lighting service. Covers those tungsten halogen lamps that are used as…  [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+]

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+]

Self-ballasted lamps for general lighting services - Performance requirements / IEC 60969 Ed.1.2 (2001)

Specifies the performance requirements together with the test methods and conditions required to show compliance of tubular fluorescent and other gas-discharge lamps with integrated means…  [More Details+]

Self-ballasted lamps for general lighting services - Performance requirements / IEC 60929 : 2011 Ed 4.0

IEC 60929:2011 specifies performance requirements for electronic control gear for use on a.c. at 50 Hz or 60 Hz and/or d.c. supplies, both up 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+]