ANSI/AAMI/ IEC 60601-2- 39:2018 pdf download – Medical electrical equipment—Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment.
201 .7.9.3 Technical description Additional subclause: 201 .7.9.3.1 01 Additional requirements regarding PD EQUIPMENT The technical description shall additionally include the following: p) the particular measures or conditions to be observed when installing the PD EQUIPMENT or bringing it into use, including guidance on the type and number of tests to be carried out; q) the type and accuracy of the PROTECTIVE SYSTEM required in 201 .1 2.4.4.1 01 ; r) the time by which the auditory ALARM SIGNAL required in 201 .1 2.4.4.1 01 b) and 201 .1 2.4.4.1 05 b) may be delayed; s) the AUDIO PAUSED period; t) the range of sound pressure levels of any adjustable auditory ALARM SIGNAL ; u) the maximum positive and/or negative pressures that can be generated by any pumps used to assist the transfer of DIALYSING SOLUTION to and/or from the peritoneal cavity of the PATIENT ; the MANUFACTURER shall specify where and how the maximum pressure was obtained; v) the method and the sensitivity employed for the PROTECTIVE SYSTEM required by 201 .1 2.4.4.1 03; w) the method and the sensitivity employed for the PROTECTIVE SYSTEM required by 201 .1 2.4.4.1 04. Compliance is checked by inspection of the ACCOMPANYING DOCUMENTS . 201.8 Protection against electrical HAZARDS from ME EQUIPMENT Clause 8 of the general standard applies, except as follows: 201 .8.7 L EAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS 201 .8.7.4 Measurements 201 .8.7.4.7 Measurement of the PATIENT LEAKAGE CURRENT Amendment: Delete item h). Addition: aa) The point of measurement shall be where the DIALYSING SOLUTION CIRCUIT connects to a peritoneal catheter. For the duration of the test, DIALYSING SOLUTION shall be flowing in the DIALYSING SOLUTION CIRCUIT .
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS Clause 9 of the general standard applies. 201.10 Protection against unwanted and excessive radiation HAZARDS Clause 1 0 of the general standard applies. 201.11 Protection against excessive temperatures and other HAZARDS Clause 1 1 of the general standard applies, except as follows: 201 .1 1 .6 Overflow, spillage, leakage, ingress of water or particular matter, cleaning, disinfection, sterilization, and compatibility with substances used with the ME EQUIPMENT 201 .1 1 .6.1 General Addition: All the provisions of 1 1 .6.2 to 1 1 .6.4 shall be applied using the DIALYSING SOLUTION . 201 .1 1 .6.3 Spillage on ME EQUIPMENT and ME SYSTEMS Replacement: The PD EQUIPMENT shall be so constructed that, in the event of spillage of liquids from the fluid reservoir or DIALYSING SOLUTION CIRCUIT set when positioned for NORMAL USE , no HAZARDOUS SITUATION shall result. Compliance is checked by the following test. With the PD EQUIPMENT placed in the position of NORMAL USE , 3 l of DIALYSING SOLUTION or the maximum volume present in the fluid reservoir and DIALYSING SOLUTION CIRCUIT (whichever is smaller) shall be poured onto the top surface of the PD EQUIPMENT . The solution shall be poured continuously over a period of 15 s. Immediately after the test, inspection shall show that the DIALYSING SOLUTION which might have entered the PD EQUIPMENT has not wetted parts which might cause a HAZARDOUS SITUATION . In case of doubt, the PD EQUIPMENT shall be subjected to the dielectric strength test described in 8.8.3 of the general standard, and the PD EQUIPMENT shall function as intended.
201.12 Accuracy of controls and instruments and protection against hazardous outputs Clause 1 2 of the general standard applies, except as follows: 201 .1 2.4.4 Incorrect output Addition: 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.