ISO 27427:2013 pdf free

ISO 27427:2013 pdf free.Anaesthetic and respiratory equipment一Nebulizing systems and components
Materials compatibility information
a) the information about any precautions to be taken if there is a specific unusual risk associated with the compatibility between the materials of the components and the dispensed liquids;
b) if applicable, a statement that the materials used in the components could not be compatible with solutions/suspensions/emulsions that have not been evaluated;
c) a statement that identifies the residual risk if phthalates are incorporated in parts of the medical devices coming directly or indirectly into contact with the patient and if the device is used in the treatment of children or pregnant or nursing women;
d) for single-use devices, the risks associated with the reuse or reprocessing of single-use devices.
NOTE  For devices imported into the European Union, the manufacturer’s attention is drawn to the regulatory provision, requiring that the indication of single use be consistent across the European Community.
Cleaning, disinfection, and sterilization information
a) for nebulizing systems intended for single-patient reuse, recommended methods of cleaning and,if indicated, disinfection prior to reuse;
b) for nebulizing systems intended for multi-patient reuse, recommended methods of cleaning and either disinfection or sterilization prior to reuse;
c) the number of cycles of cleaning, disinfection, and/or sterilizations the nebulizing system will withstand;
d) for nebulizing systems intended to be connected to a power source (electrical or pneumatic) cleaning, disinfection, and sterilization shall be carried out with the power source disconnected;
e) for nebulizing systems not intended for reuse, the risks associated with cleaning and disinfection and/or sterilization prior to reuse.
Dismantling and reassembling information
a)if applicable, procedures for disconnecting the nebulizing system from the power source (electrical or pneumatic), dismantling, and reassembly;
b) recommended functional test(s) to be carried out after reassembly and before use;
c) for nebulizing systems intended to be connected to a power source (electrical or pneumatic),dismantling and reassembling shall be carried out with the power source disconnected.ISO 27427 pdf download.