ISO 8600-8:2021 Endoscopes — Medical endoscopes and endotherapy devices — Part 8: Particular requirements for capsule endoscopes.
3? Terms? and? definitions
For the purposes of this document, the terms and definitions given in ISO 8600-1, ISO 8600-6 and the
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
maximum diameter at all cross sectional surfaces which is perpendicular to the longer axis of capsule-shaped body
Note 1 to entry: Note to entry 1: The maximum diameter is measured in millimetres.
maximum length at the longer axis of capsule-shaped body
Note 1 to entry: Note to entry 1: The maximum length is measured in millimetres.
time in which observation images can be recorded under the environments stated in the instruction manual
5.2.3 Field of view and direction of view
Direction of view and field of view of a capsule endoscope should be determined in accordance with
method B in the ISO 8600-3.
The requirements given in ISO 8600-1:2015, Clause 6 apply, where applicable.
6.2? Minimum? marking? specific? for? capsule? endoscopes
Each individual capsule endoscope shall have at least the following minimum marking:
a) model number and/or other mark sufficient to identify the capsule endoscope and its manufacturer;
b) maximum diameter and maximum length, measured in millimetres;
c) field of view and/or direction of view, where such identification is necessary for the intended use of
the capsule endoscope;
d) lot numbers or serial numbers, if applicable;
e) expiration date for use.
7 Instruction manual
The requirements given in ISO 8600-1:2015, Clause 7 apply where applicable.
7.2? Information? specific? for? capsule? endoscopes
The instruction manual for capsule endoscopes shall contain the following information:
a) The technology for data transfer (e.g. radio transmission, body communication) between the
capsule endoscope and receiving unit;
b) Modulation method and transmitting and receiving frequency characteristic of capsule endoscopes
and receiving units when applicable;
c) recording time;
d) storage environment (temperature and humidity);
e) type and rated watt-hours of batteries.
The requirements given in ISO 8600-1:2015, Clause 8 apply.
ISO 8600-8 pdf download.