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AAMI IEC 60601-2-39 pdf free download

AAMI IEC 60601-2-39 pdf free download.Medical electrical equipment—Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment.
201.6 Classification of ME EQUIPMENT and ME SYSTEMS Clause 6 of the general standard applies. 201.7 M E EQUIPMENT identification, marking and documents Clause 7 of the general standard applies, except as follows: 201 .7.9 A CCOMPANYING DOCUMENTS 201 .7.9.1 General Addition: The ACCOMPANYING DOCUMENTS shall additionally include – a statement that protective measures should be taken to prevent back syphonage of the OUTFLOW path. EXAMPLE 101 A statement pointing out the importance of an air gap between the DIALYSING SOLUTION circuit and the drain in order to prevent back syphonage of the OUTFLOW path. NOTE 1 01 Since the drainage of the fluid is normally connected by the PATIENT , it is the responsibility of the MANUFACTURER to warn the PATIENT of the need for back syphonage protection and the PATIENT ‘s responsibility to ensure that it is done correctly. 201 .1 2.4.4.1 01 D IALYSING SOLUTION temperature a) If the PD EQUIPMENT includes a means of heating the DIALYSING SOLUTION , the PD EQUIPMENT shall be provided with a PROTECTIVE SYSTEM , independent of any temperature control system, which prevents the DIALYSING SOLUTION from reaching a temperature greater than 41 °C measured at the PATIENT end of the APPLIED PART . This measurement may be taken at an alternative location but shall be demonstrated to be less than 41 °C at the point of infusion to the PATIENT . The need for a lower temperature limit of the DIALYSING SOLUTION shall be addressed in the MANUFACTURER ‘ S RISK MANAGEMENT PROCESS . NOTE It is not practical to measure the temperature at the PATIENT connection. b) Activation of the PROTECTIVE SYSTEM shall achieve the following safe conditions: – stopping of the DIALYSING SOLUTION and thermal flow to the PATIENT ; – activation of auditory and visual ALARM SIGNALS . The auditory ALARM SIGNAL may be delayed, as specified by the MANUFACTURER . Compliance is checked by inspection of the RISK MANAGEMENT FILE and by measuring the temperature of the DIALYSING SOLUTION at the PATIENT end of the APPLIED PART . The test shall be carried out under the most unfavourable flow conditions.201 .1 2.4.4.1 02 Pressures If the PD EQUIPMENT includes a pump designed to assist delivery of the DIALYSING SOLUTION to the peritoneal cavity of the PATIENT , the pump shall be prevented from generating a positive pressure that exceeds the maximum specified by the MANUFACTURER . If the PD EQUIPMENT includes a pump designed to assist the drainage of the used DIALYSING SOLUTION from the PATIENT , then the pump shall be prevented from generating a negative pressure that exceeds the maximum specified by the MANUFACTURER . NOTE 1 Excessive pressures can cause damage to the peritoneum. NOTE 2 Excessive pressures can be prevented by an inherent pump design or by an additional PROTECTIVE SYSTEM . Compliance is checked by functional tests.201 .1 2.4.4.1 06 P ROTECTIVE SYSTEMS Any failure of the PROTECTIVE SYSTEMS required by 201 .1 2.4.4 shall become obvious to the OPERATOR before the start of every treatment. Every failure of a PROTECTIVE SYSTEM required by 201 .1 2.4.4 shall inhibit the corresponding function supervised by the pertaining PROTECTIVE SYSTEM . Compliance is checked by functional tests and failure simulations.AAMI IEC 60601-2-39 pdf download.

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