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AAMI IEC 60601-2-16 pdf free download

AAMI IEC 60601-2-16 pdf free download.Medical electrical equipment—Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafltration and haemofltration equipment.
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 .6.3 Spillage on ME EQUIPMENT and ME SYSTEMS Addition: Compliance is checked by test according to code IPX1 of IEC 60529. 201 .1 1 .6.6 * Cleaning and disinfection of ME EQUIPMENT and ME SYSTEMS Addition: For HAEMODIALYSIS EQUIPMENT employing non-disposable (e.g. non-single-use) fluid paths and fluid contacting components where the fluid comes into contact with the PATIENT directly or indirectly, means shall be provided for their disinfection. The operating conditions and the microbial control PROCESS for HAEMODIALYSIS EQUIPMENT shall be developed and validated by the MANUFACTURER for HAEMODIALYSIS EQUIPMENT using a RISK based approach considering EXPECTED SERVICE LIFE , disposability, filtration, cleaning/disinfection, system maintenance and/or relevant DIALYSIS FLUID quality standards. Compliance is checked by inspection of the validation documentation, the RISK MANAGEMENT FILE , ACCOMPANYING DOCUMENTS and of the HAEMODIALYSIS EQUIPMENT.a) The HAEMODIALYSIS EQUIPMENT shall include a PROTECTIVE SYSTEM , independent of any fluid preparation control system, which prevents DIALYSIS FLUID from reaching the DIALYSER that, due to its composition, may cause a HAZARDOUS SITUATION . NOTE A PROTECTIVE SYSTEM is not necessary for HAEMODIALYSIS EQUIPMENT using only pre-manufactured DIALYSIS FLUID , which is quality controlled for the DIALYSIS FLUID composition, and is not changed in composition by the HAEMODIALYSIS EQUIPMENT , for example using pre-manufactured DIALYSIS FLUID bags. The design of the PROTECTIVE SYSTEM to prevent a hazardous composition of the DIALYSIS FLUID shall consider a potential failure in any phase of preparation or regeneration of the DIALYSIS FLUID . Activation of the PROTECTIVE SYSTEM shall achieve the following safe conditions: – activation of auditory and visual ALARM SIGNALS (see 208.6.3.1 , 208.6.3.3.2, 208.6.3.3.1 01 ). The auditory ALARM SIGNAL may be delayed as specified in 208.6.3.3.1 01 b); – stopping of the DIALYSIS FLUID flow to the DIALYSER ; – in ONLINE HDF or ONLINE HF mode, stopping of the SUBSTITUTION FLUID flow to the EXTRACORPOREAL CIRCUIT . b) Conductivity profiles and PHYSIOLOGIC CLOSED – LOOP CONTROLLERS : In case of pre-programmed time-dependent variation of the DIALYSIS FLUID composition or in case of feedback control of the DIALYSIS FLUID composition by measuring a physiologic relevant parameter of the PATIENT , the HAEMODIALYSIS EQUIPMENT shall include a PROTECTIVE SYSTEM , independent of the control system, which prevents any unintentional changes in the control system that could cause a HAZARDOUS SITUATION . Activation of the PROTECTIVE SYSTEM shall achieve the following safe conditions: – activation of auditory and visual ALARM SIGNALS (see 208.6.3.1 , 208.6.3.3.2, 208.6.3.3.1 01 ); – other measures, if defined by MANUFACTURER ’ S RISK MANAGEMENT PROCESS .The following IMMUNITY pass/fail criteria for BASIC SAFETY and ESSENTIAL PERFORMANCE with regard to EM DISTURBANCES shall be met by HEMODIALYSIS EQUIPMENT : • BASIC SAFETY functions listed in 201 .1 2: The ME EQUIPMENT or ME SYSTEM BASIC SAFETY shall continue to operate as intended without OPERATOR intervention. No degradation of BASIC SAFETY function is allowed below a performance level specified by the MANUFACTURER when the ME EQUIPMENT or ME SYSTEM is used as intended. Alternatively, the ME EQUIPMENT or ME SYSTEM shall reach and remain in the safe state of the device. • ESSENTIAL PERFORMANCE functions: After the test, the ME EQUIPMENT or ME SYSTEM shall continue to operate as intended without OPERATOR intervention. During the test, degradation of performance is allowed, but no degradation of performance is allowed below a performance level specified by the MANUFACTURER , when the ME EQUIPMENT or ME SYSTEM is used as intended. • Other functions: Loss of function is allowed, provided the function is self-recoverable, or can be restored by the operation of the controls by the OPERATOR in accordance with the MANUFACTURER ’ S instructions.AAMI IEC 60601-2-16 pdf download.

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