ISO 8600-1-2013 pdf free download.Endoscopes – Medical endoscopes and endotherapy devices – Part 1: General requirements.
6 Marking
6.1 Minimum marking
Iach individual endoscope or endotherapy device shall have the lollowing minimum marking:
a) model number and/or other mark sufficient to identify the endoscope or endotherapy device and its manufacturer;
b) maximum insertion portion width, minimum instrument channel width, working length, field of view and/or direction of view where such identification is necessary for the intended use of the endoscope or endotherapy device. The Insertion portion width and instrument channel width units shall be in millimetres. The insertion portion width and instrument channel width can also be marked in French size as defined in 3.5, shown by either ‘Fr or an encircled number;
c) wherever reasonable and practicable. the endoscope or endotherapy device and detachable component(s) shall be identified in terms of lot numbers or serial numbers, etc.
6.2 Marking legibility
The marking shall remain legible over the lifetime of the device when the endoscope or endotherapy device is used, cleaned, disinlected, sterilized and stored in accordance with the instruction manual.
6.3 Marking exceptions
When marking on the endoscope or endotherapy device or detachable component(s) is impossible to achieve due to size or configuration, the required marking shall be part of the packaging or part of the accompanying instruction manual.
7 Instruction manual
The instruction manual for endoscopes or endotherapy devices shall contain at least the following information:
a) identification including the following:
1) manufacturer’s or distributor’s name and address;
2) model number and name;
b) a statement of the intended uses;
c) instructions on the functions and proper use;
d) annotated illustration as appropriate to permit the user to identify pertinent parts and characteristics which are referenced in the instruction manual, and are consistent with Clause 3:
e) specifications, including the following:
1) direction of view;
2) field of view, if specified;
3) maximum insertion portion width and working length; the following precaution shall be given in the instruction manual, if necessary: “There is no guarantee that instruments selected solely using maximum insertion portion width and working length will be compatible in combination.”;
4) minimum instrument channel width; the following precaution shall be given in the instruction manual, if necessary: “There is no guarantee that instruments selected solely using this minimum instrument channel width will be compatible in combination.”;
1) remote controls and associated controllable portion positions available to the user;
g) instructions as required for assembling for its intended use, and for the disassembling and reassembling after cleaning, disinfection and/or sterilization processes;
h) precautions and instructions applicable to the intended use, including those related to electrical. electronic, electro-optical, electro-medical, or electro-acoustical apparatus intended to be used with the endoscope or endotherapy device and in conformance with IEC 60601-2-18;
1) any permitted liquids intended to be used with the endoscope, e.g. contrast medium, sclerosing therapy medium, lubricant and anaesthetic medium, and warnings concerning the usage of liquids not mentioned here;
2) precautions for use in flammable atmospheres;
i) inspection instructions to provide reasonable assurance that the endoscope and endotherapy device are in working order;
j) instructions for the cleaning of reusable endoscopes and endotherapy devices and identification of any specific cleaning tools or equipment;
k) instructions for the specific disinfection and sterilization environments in which the equipment can survive;
I) recommended procedures for storage prior to use and, for reusable equipment, procedures for storage between uses;
m) identification of any user-replaceable parts and instructions for their replacement;
n) identification of where the user can obtain authorized service.
8 Packaging
The manufacturer should package the endoscope or endotherapy device so as to protect the endoscope or endotherapy device from damage by the adverse effects of storage and shipping environments.ISO 8600-1 pdf download.
Tags: Endoscopes
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