AAMI IEC 80601-2-77 pdf free download

AAMI IEC 80601-2-77 pdf free download.Medical electrical equipment—Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment.
201.5 General requirements for testing of ME EQUIPMENT Clause 5 of the general standard applies, except as follows: 201.5.4 Other conditions Addition to a): Before carrying out tests, RASE shall be prepared for operation as specified by the MANUFACTURER . 201.5.7 Humidity preconditioning treatment Addition: Single-use equipment drapes are not subject to humidity preconditioning treatment. 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: 201.7.2.2 Identification Additional subclauses: 201.7.2.2.101 Marking of maximum PATIENT mass and SAFE WORKING LOAD If an operating table is a part of RASE , it shall be marked with the corresponding maximum PATIENT mass and SAFE WORKING LOAD (for symbol, see Figure 201.101).201.7.2.9 * IP classification Addition: If marking an IP classification is required for a RASE , and if a protective cover, for example, an equipment drape, is required to meet the classification, the IP symbol marking shall be applied to the protective cover. R OBOTIC SURGICAL INSTRUMENTS supplied with specific instructions detailing allowable reprocessing methods and parameters are excluded from this requirement. No symbol is required to identify the reprocessing PROCEDURE by this particular standard. See also 7.9.2.12 of the general standard. 201.7.2.10 A PPLIED PARTS Addition: If marking of an APPLIED PART is not practicable and the APPLIED PART is single-use, the required marking shall be on the individual packaging, or on the equipment adjacent to the connector for the APPLIED PART . Compliance is checked by inspection. Additional subclause: 201.7.2.101 Alternative marking Information which is accessible by the OPERATOR on an output device (e.g. display) of ME EQUIPMENT is considered equivalent to marking on the equipment for requirements of 7.2 of the general standard, as long as the marking is visible at the time the information is required. Compliance is checked by inspection.201.9 * Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS Clause 9 of the general standard applies, except as follows: 201.9.2.2.4.4 * Other RISK CONTROL measures Replacement, in the first paragraph, of the first dashed item:  moving parts that start to move while they are in the reach of persons shall not lead to an unacceptable RISK ; Replacement, in the second paragraph, of the introduction sentence to the list: Other RISK CONTROL measures (e.g. electro-mechanical, PEMS ) shall be designed and incorporated into the control system so that: Replacement, in the second paragraph, of the second dashed item:  if the RISK CONTROL measure is defeated in a SINGLE FAULT CONDITION , a second RISK CONTROL measure shall be provided, such as one or more emergency stopping device(s) (see 9.2.4 of the general standard) or RASE PROTECTIVE STOP (s) (see 201.3.212),or the RASE shall otherwise be SINGLE FAULT SAFE (see 4.7 of the general standard).201.9.2.2.6 * Speed of movement(s) Addition: The MANUFACTURER shall consider speed of movement with respect to all RASE movement both within and outside the PATIENT . The MANUFACTURER may apply different limits. NOTE 1 See Annex BB for an example of method to estimate the stopping performance and the minimum distances. NOTE 2 The MANUFACTURER can specify the coordinate frame within which to measure velocity. For example, if the PATIENT can move, the RASE can stop relative to the PATIENT .AAMI IEC 80601-2-77 pdf download.