ANSI AAMI ISO 8836 pdf free download

ANSI AAMI ISO 8836 pdf free download.Suction catheters for use in the respiratory tract.
4 *General requirements for open and closed suction catheters 4.1 Risk management 4.1.1 An established risk management process in accordance with ISO 1 4971 shall be applied to the design of the device. Check compliance by inspection of the risk management file. NOTE See Annex E.
4.1.2 The manufacturer shall apply a usability engineering process to assess and mitigate risks caused by usability problems associated with correct use and use errors. EXAMPLES IEC 60601 –1 and IEC 62366–1 . Check compliance by inspection of the usability engineering file. 4.1.3 Clinical evaluation shall be performed. Clinical evaluation is the assessment and analysis of clinical data pertaining to a medical device in order to verify the clinical safety and performance of the device. Clinical data may be sourced from — clinical investigation(s) of the device concerned, or — clinical investigation(s) or other studies reported in the scientific literature, of a similar device for which equivalence to the device in question can be demonstrated, or — published and/or unpublished reports on other clinical experience with either the device in question or a similar device for which equivalence to the device in question can be demonstrated. If required, clinical investigations shall be performed under the conditions for which performance is claimed and documented in the risk management file. The clinical studies shall comply with the requirements of ISO 1 41 55. Check compliance by inspection of the risk management file. 4.2 Safety The manufacturer may use type tests different from those detailed within this International Standard, if an equivalent degree of safety is obtained. Alternative test methods shall be validated against the test methods specified in this International Standard.5 Specific requirements for open and closed suction catheters 5.1 Size and length designations 5.1.1 The size of suction catheters shall be designated by the nominal outside diameter of the shaft, expressed in millimetres; it may additionally be expressed in French (Charriere) gauge size (see Table 1 ). NOTE 1 For the purposes of this International Standard, the French gauge system of size (F) is based on the outside diameter of the shaft gauged in steps of thirds of a millimetre (1 mm corresponds to 3F). NOTE 2 The French gauge size is not an SI unit. Size designation in millimetres facilitates matching the suction catheter outside diameter to the inside diameter of the tracheal or tracheostomy tube. 5.1.2 The size of the suction catheter shall also be designated by use of colour identification at the machine end in accordance with Table 1 , for the designated sizes listed. 5.1.3 The use and choice of colour identification for designated sizes not listed in Table 1 are at the manufacturer’s discretion. 5.1.4 The length of the suction catheter shall be designated by the nominal shaft length, expressed in millimetres. 5.2 *Dimensions 5.2.1 The outside diameter of the shaft shall be the designated nominal outside diameter, subject to a tolerance in accordance with Table 1 .5.2.2 The minimum inside diameter of the shaft, excluding the tip, shall be in accordance with Table 1 . 5.2.3 The minimum inside diameter of the terminal orifice at the tip shall be not less than 90 % of the minimum inside diameter in accordance with Table 1 . 5.2.4 The shaft length shall be the designated nominal shaft length subject to a tolerance of ±5 %.ANSI AAMI ISO 8836 pdf download.