IEC 60601-1-11:2010 pdf download – Medical electrical equipment – Part 1-11: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
M E EQUIPMENT and ME SYSTEMS intended for the HOME HEALTHCARE ENVIRONMENT should be designed to be simple to use and not require reference to complex ACCOMPANYING DOCUMENTS . Compliance is checked by inspection of the results of the USABILITY ENGINEERING PROCESS .
7.2 * Additional requirements for marking of IP classification Notwithstanding the requirements of 7.2.9 of the general standard, the ENCLOSURE of ME EQUIPMENT shall be marked with the IP classification required by 8.3.1 .
If some or all of the protection against the ingress of water or particulate matter is provided by a carrying case, then the degree of protection provided by the ENCLOSURE shall be marked on the ENCLOSURE and the degree of protection provided by the carrying case shall be marked on the carrying case. A carrying case that is not intended to provide protection against the ingress of water or particulate matter need not be marked. EXAMPLE If for TRANSIT – OPERABLE ME EQUIPMENT , the ENCLOSURE provides the protection against the ingress of particulate matter and the carrying case provides the protection against the ingress of water, the ENCLOSURE of the ME EQUIPMENT would be marked IP20 and the carrying case would be marked IP02. If an ENCLOSURE does not provide the minimum required degree protection against the ingress of water, it shall be marked ‘keep dry’ or with symbol ISO 7000-0626 (2004-01 ) (see Table C 1 , symbol 1 ). Compliance is checked by inspection and by application of the tests and criteria of 7.1.2 and 7.1.3 of the general standard.
7.3 A CCOMPANYING DOCUMENTS
7.3.1 Contact information In addition to the requirements of 7.9.1 and 1 6.2 of the general standard, the ACCOMPANYING DOCUMENTS shall indicate that the LAY OPERATOR or LAY RESPONSIBLE ORGANIZATION should contact the MANUFACTURER or the MANUFACTURER ‘ S representative: – for assistance, if needed, in setting up, using or maintaining the ME EQUIPMENT or ME SYSTEM ; or – to report unexpected operation or events. The ACCOMPANYING DOCUMENTS shall include a postal address and either a telephone number or web address through which the LAY OPERATOR or LAY RESPONSIBLE ORGANIZATION can contact the MANUFACTURER or the MANUFACTURER ‘ S representative.
7.3.2 L AY OPERATOR briefing information When appropriate in addition to the requirements of 7.9.1 and 1 6.2 of the general standard, the ACCOMPANYING DOCUMENTS shall include the details necessary for the healthcare professional to brief the LAY OPERATOR or LAY RESPONSIBLE ORGANIZATION on any known contraindication(s) to the use of the ME EQUIPMENT or ME SYSTEM and any precautions to be taken. This shall include:
– precautions to be taken in the event of changes in the performance of the ME EQUIPMENT or ME SYSTEM ;
– precautions to be taken regarding the exposure of the ME EQUIPMENT or ME SYSTEM to reasonably foreseeable environmental conditions (e.g. to magnetic fields, electromagnetic fields, external electrical influences, ELECTROSTATIC DISCHARGE , pressure or variations in pressure, acceleration, thermal ignition sources);
– adequate information regarding any medicinal substances that the ME EQUIPMENT is designed to administer, including any limitations in the choice of substances to be delivered;
– information on any medicinal substances or human blood derivatives incorporated into the ME EQUIPMENT or ACCESSORIES as an integral part; and
– the degree of accuracy claimed for ME EQUIPMENT with a measuring FUNCTION . Compliance is checked by inspection of the ACCOMPANYING DOCUMENTS .
7.4 Instructions for use 7.4.1 Additional requirements for warning and safety notices In addition to the requirements of 7.9.2.2 and 1 6.2 c) of the general standard, for each warning and safety sign, the instructions for use shall describe the nature of the HAZARD , likely consequences that could occur if the advice is not followed, and the precautions for reducing the RISK
