ISO 10079-2-2014 pdf free.Medical suction equipment – Part 2:Manually powered suction equipment.
This part of Iso 10079 specifies safety and performance requirements for manually powered suction equipment intended for oro-pharyngeal suction. It applies to equipment operated by foot or by hand or both. Annex D illustrates the three parts of ISO 10079 by providing a schematic for typical systems.
The commonest use of manually powered suction is in situations outside of health care settings often described as field use or transport use. Use in these situations may involve extreme conditions of weather or terrain. Additional requirements for suction equipment intended for field and/or transport use are included in this part of ISO 10079.
This part of ISO 10079 does not apply to the following:
a) end pieces such as suction catheters, Yankauer sucker and suction tips;
b) dental suction equipment;
c) mucus extractors, including neonatal mucus extractors.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 5356-1, Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and sockets
ISO 70001). Graphical symbols for use on equipment — Registered symbols
ISO 14155, Clinical investigation of medical devices for human subjects — Good clinical practice
ISO 14971, Medical devices — Application of risk management to medical devices
I SO 15223-1, Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements
ISO 80369 (all parts), Small-bore connectors for liquids and gases in healthcare applications I EC 62366, Medical devices — Application of usability engineering to medical devices
EN 1041, information supplied by the manufacturer of medical devices
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1 collection container container in which liquids and solid particles are collected
3.2 end-piece that part of the suction equipment applied to the patient which begins at the site where material is drawn in and ends at the first detachable connection
Note 1 to entry: Examples of commonly used end-pieces are a Yankauer sucker and a suction catheter.
3.3 exhaust port opening through which exhaust gas is discharged
3.4 field use use of suction equipment in situations outside of the health care facility at the site of accidents or other emergencies
4.1 Risk management
4.1.1 This part of Iso 10079 specifies requirements that are generally applicable to risks associated with manually powered suction equipment. An established risk management process shall be applied to the design of the device. The risk management process shall include the following elements:
— risk analysis;
— risk evaluation;
— risk control;
— production and post-production information.
Check compliance by inspection of the risk management file.
4.1.2 Manually powered suction equipment shall, when transported, stored, installed, operated in normal use and maintained according to the instructions of the manufacturer, present no risks that are not reduced to an acceptable level using risk management procedures in accordance with ISO 14971 and which are associated with their intended application, in normal and in single fault condition.
NOTE A situation In which a fault is not detected is considered a normal condition. Fault conditions/hazardous situations might remain undetected over a period of time and, as a consequence, might lead to an unacceptable risk. In that case, a subsequent detected fault condition needs to be considered as a single fault condition. Specific risk control measures need to be determined within the risk management process to deal with such situations.
Check compliance by inspection of the risk management file.
4.1.3 Where requirements of this part of ISO 10079 refer to freedom from unacceptable risk, the acceptability or unacceptability of this risk shall be determined by the manufacturer in accordance with their policy for determining acceptable risk.
Check compliance by inspection of the risk management file.
4.1.4 The manufacturer may use type tests different from those detailed within this part of ISO 10079,
if an equivalent degree of safety is obtained. Alternative test methods shall be validated against the test
methods specified in Annex A of this part of ISO 10079.
Check compliance by inspection of the technical file.ISO 10079-2 pdf download.