IEC 60601-1-11:2010 pdf – Medical electrical equipment – Part 1-11: General requirements for basic safety and essential performance-Collateral Standard: Requirements for medical electrical equipment and medicalelectrical systems used in the home healthcare environment.
— justified in the RISK MANAGEMENT FILE:
— marked on the ME EQUIPMENT, unless such marking Is not practicable, In which case the more restricted range need only be disclosed in the instructions for use: and
— marked on the carrying case If the Instructions for use Indicate the ME EQUIPMENT IS intended to be operated in a carrying case.
The ME EQUIPMENT shall comply with its specifications and all the requirements of this standard when operated in NORMAL USE under the specified environmental operating conditions.
Compliance is checked by the following test and, when a more restricted range is stated in the instructions for use, inspection of the RISK MANAGEMENT FILE:
a) Expose the ME EQUIPMENT to the ambient conditions for.
— at least 6 h, or
— ensure that the ME EQUIPMENT reaches THERMAL STABILITY for at least 2 h.
b) Evaluate the ME EQUIPMENT to Its specifications and ensure that it provides BASIC SAFETY and ESSENTIAL PERFORMANCE.
c) Evaluate the ME EQUIPMENT to its specifications and ensure that it provides BASIC SAFETY and ESSENTIAL PERFORMANCE While at the lowest specified atmospheric pressure.
d) Evaluate the ME EQUIPMENT to Its specifications and ensure that It provides BASIC SAFETY and ESSENTIAL PERFORMANCE while at the highest specified atmospheric pressure.
e) Cool the ME EQUIPMENT to its lowest specified environmental operating conditions (temperature C and relative humidity less than or equal to 15 %).
I) Hold the ME EQUIPMENT at its lowest specified environmental operating conditions:
— foratteast6h, or
– ensure that the ME EQUIPMENT reaches THERMAL STABILITY for at least 2 h.
g) Evaluate the ME EQUIPMENT to its specifications and ensure that it provides BASIC SAFETY and ESSENTIAL PERFORMANCE.
h) Warm the ME EQUIPMENT to its highest specified environmental operating conditions (temperature C and relative humidity ±3 %)
I) Hold the ME EQUIPMENT at its highest specified environmental operating conditions:
— foratleast6h, or
— ensure that the ME EQUIPMENT reaches THERMAL STABILITY for at least 2 h
j) Evaluate the ME EQUIPMENT to its specifications and ensure that it provides BASIC SAFETY and ESSENTIAL PERFORMANCE.
4.2.3 Environmental shock to TRANSIT-OPERABLE ME EQUIPMENT
If the instructions for use state a wider range of environmental operating conditions than those indicated in 42,2, the TRANSIT-OPERABLE ME EQUIPMENT shall maintain BASIC SAFETY and ESSENTIAL PERFORMANCE in the presence of condensation and thermal shock resulting from rapid changes in environmental temperature and humidity during INTENDED USE.
Compliance is checked by the foilowing test:
a) Set up the ME EQUIPMENT for operation according to INTENDED USE.
b) Expose the ME EOUIPUENT to its lowest specified environmental operating conditions (temperature C and relative humidity less than or equal to 15 %).
C) Hold the ME EQUIPMENT at its lowest specified environmental operating conditions:
— foretleast6h, or
— ensure that the ME EQUIPMENT reaches THERMAL STABILITY for 8t least 2 1,.
d) Expose the ME EQUIPMENT to its highest specified environmental operating conditions within 5 mm (temperature 0 C and relative humidity ± 3%).
a) While maintaining the environment of the ME EQUIPMENT to the conditions in d), evaluate the ME EQUIPMENT to its specifications and ensure that it continues to provide BASIC SAFETY and ESSENTIAL PERFORMANCE until the ME EQUIPMENT reaches THERMAL STABILITY or for at least 2 h. The evaluation of BASiC SAFETY need not Include LEAI 4GE CURRENT and dielectric strength testing because of the pollution degree ratings required by the general standard.
A separate test sample may be used for the following tests.