ANSI AAMI IEC 80601-2-58 pdf free download

ANSI AAMI IEC 80601-2-58 pdf free download.Medical electrical equipment – Part 2-58: Particular requirements for basic safety and essential performance of lens removal and vitrectomy devices for ophthalmic surgery.
201 .8 Protection against electrical HAZARDS from ME EQUIPMENT Clause 8 of the general standard applies. 201 .9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS Clause 9 of the general standard applies. 201 .1 0 Protection against unwanted and excessive radiation HAZARDS Clause 1 0 of the general standard applies. 201 .1 1 Protection against excessive temperatures and other HAZARDS Clause 1 1 of the general standard applies, except as follows: 201 .1 1 .1 .2 Temperature of APPLIED PARTS 201 .1 1 .1 .2.1 A PPLIED PARTS intended to supply heat to a PATIENT Replacement: H ANDPIECES for DIATHERMY , PHACOFRAGMENTATION , LASER and LIQUEFACTION are considered to be APPLIED PARTS intended to supply heat to a PATIENT . The temperature or clinical effects shall be determined and documented in the RISK MANAGEMENT FILE .201 .1 2.4.1 01 .6 Fragmentation The requirements from 201 .1 2.4.1 01 .7 to 201 .1 2.4.1 01 .9 are for methods of performing fragmentation for ophthalmologic surgery. Some of these fragmentation functions may be optional to the ME EQUIPMENT or ME SYSTEM and therefore any functions that are not included with the ME EQUIPMENT or ME SYSTEM shall not be applicable to the appropriate subclauses of 201 .1 2.4.1 01 .7 to 201 .1 2.4.1 01 .9. 201 .1 2.4.1 01 .7 Hazardous output for ultrasonic velocity of TIP If an ultrasonic fragmentation function is provided, the ultrasonic velocity of TIP OUTPUT for ME EQUIPMENT and ME SYSTEM shall not exceed 20 m/s while operated under full power in water. Compliance is checked using the method in subclause 201.12.1.101.7 and verify the reading is within the limit identified above. 201 .1 2.4.1 01 .8 Hazardous output for velocity of fluid entering eye for LIQUEFACTION If a LIQUEFACTION function is provided, the VELOCITY OF FLUID ENTERING THE EYE OUTPUT FOR LIQUEFACTION for ME EQUIPMENT and ME SYSTEM shall not exceed 1 00 m/s while operated under full power. Compliance is checked using the method in subclause 201.12.1.101.8 and verify the reading is within the limit identified above. 201 .1 2.4.1 01 .9 Hazardous output for VITRECTOMY PROBE cut rate If VITRECTOMY PROBE cutting function is provided, the variable output of the VITRECTOMY PROBE cut rate for ME EQUIPMENT and ME SYSTEMS shall have a minimum of 1 0 cuts/min or greater (except in single cut mode, if available) while operated at minimum setting, in water. Compliance is checked using the method in subclause 201.12.1.101.9 and verify the reading is within the limit identified above.201 .1 3 Hazardous situations and fault conditions for ME EQUIPMENT Clause 1 3 of the general standard applies. 201 .1 4 P ROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS ( PEMS ) Clause 1 4 of the general standard applies. 201 .1 5 Construction of ME EQUIPMENT Clause 1 5 of the general standard applies. 201 .1 6 * M E SYSTEMS Clause 1 6 of the general standard applies. 201 .1 7 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS Clause 1 7 of the general standard applies.202.5.2.2.2 Requirements applicable to ME EQUIPMENT and ME SYSTEMS other than those specified for use only in a shielded location Amendment: Tables 4 and 6 apply. Tables 3 and 5 are not applicable to this type of ME EQUIPMENT or ME SYSTEM . 202.5.2.2.3 * Requirements applicable to ME EQUIPMENT and ME SYSTEMS for use only in a shielded location Subclause 5.2.2.3 of the general standard is not applicable.ANSI AAMI IEC 80601-2-58  pdf download.