ISO 8600-2:2015
(Main)Endoscopes - Medical endoscopes and endotherapy devices — Part 2: Particular requirements for rigid bronchoscopes
Endoscopes - Medical endoscopes and endotherapy devices — Part 2: Particular requirements for rigid bronchoscopes
ISO 8600-2:2015 specifies requirements for rigid bronchoscopes and their endoscopic accessories used in the practice of anaesthesia and medical endoscopy.
Endoscopes - Endoscopes médicaux et dispositifs d'endothérapie — Partie 2: Exigences particulières pour bronchoscopes rigides
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INTERNATIONAL ISO
STANDARD 8600-2
Second edition
2015-04-01
Endoscopes - Medical endoscopes and
endotherapy devices —
Part 2:
Particular requirements for rigid
bronchoscopes
Endoscopes - Endoscopes médicaux et dispositifs d’endothérapie —
Partie 2: Exigences particulières pour bronchoscopes rigides
Reference number
©
ISO 2015
© ISO 2015
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ii © ISO 2015 – All rights reserved
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Requirements . 2
4.1 General . 2
4.2 Dimensions . 2
4.2.1 Working length . 2
4.2.2 Total length . 2
4.2.3 Maximum insertion portion width . 2
4.3 Rigid ventilation bronchoscopes . 3
4.4 Rigid jet-ventilation bronchoscopes . 3
4.5 Side apertures . 3
5 Testing . 7
5.1 General . 7
5.2 Test method for pressure drop . 7
5.2.1 Purpose . 7
5.2.2 Apparatus . 7
5.2.3 Procedure . 8
5.2.4 Expression of results . 8
5.3 Test method for security of attachment of a jet-injector to the rigid bronchoscope . 9
5.3.1 Purpose . 9
5.3.2 Apparatus . 9
5.3.3 Procedure . 9
5.3.4 Expression of results .10
5.4 Test method for container pressure with an open-ended jet-injector bronchoscope .10
5.4.1 Purpose .10
5.4.2 Apparatus .10
5.4.3 Procedure .10
5.4.4 Expression of results .10
5.5 Test method for minimum instrument channel width .11
5.5.1 Purpose .11
5.5.2 Apparatus .11
5.5.3 Procedure .11
5.5.4 Expression of results .12
6 Marking .12
7 Instruction manual .12
8 Packaging .12
Annex A (informative) Rationale .13
Bibliography .15
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any
patent rights identified during the development of the document will be in the Introduction and/or on
the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO’s adherence to the WTO principles in the Technical Barriers
to Trade (TBT), see the following URL: Foreword — Supplementary information.
The committee responsible for this document is ISO/TC 172, Optics and photonics, Subcommittee SC 5,
Microscopes and endoscopes.
This second edition cancels and replaces the first edition (ISO 8600-2:2002), of which it constitutes a
minor revision.
ISO 8600 consists of the following parts, under the general title Endoscopes — Medical endoscopes and
endoscopic accessories:
— Part 1: General requirements
— Part 2: Particular requirements for rigid bronchoscopes
— Part 3: Determination of field of view and direction of view of endoscopes with optics
— Part 4: Determination of maximum width of insertion portion
— Part 5: Determination of optical resolution of rigid endoscopes with optics
— Part 6: Vocabulary
— Part 7: Basic requirements for medical endoscopes of water-resistant type
iv © ISO 2015 – All rights reserved
Introduction
Rigid bronchoscopes need to serve three simultaneous functions during endoscopic procedures
— as an endoscope with distal illumination to allow visualization of the larynx, trachea and bronchi,
and views into the bronchial trees,
— as a sheath for a flexible or rigid endoscope, aspirator (suction channel), biopsy forceps, scissors,
etc., and
— as a gas passage (airway) for the terminal part of an anaesthesia ventilation system or the upper
respiratory tract.
Rigid bronchoscopes, therefore, are to have sufficiently large channels with low gas-flow resistance
and an adequate gas supply from the breathing system of an anaesthetic and/or breathing machine, or
from compressed air/oxygen gas sources. Particular attention therefore is paid to the life-sustaining
ventilatory aspects of this part of ISO 8600.
Ideally, all rigid bronchoscopes are to be usable to ventilate the patient whenever clinically necessary
either under general anaesthesia or not, by means of a ventilation connector and an end-cap for
assisted/controlled ventilation or by means of a jet-injector for intermittent jet ventilation. In addition
to the general features of rigid bronchoscopes, the ventilatory aspects of both rigid ventilation
bronchoscopes and rigid jet-ventilation bronchoscopes are especially included in this part of ISO 8600.
Test methods other than those specified in this part of ISO 8600, but of equal or greater accuracy, may be
used to verify compliance with the given requirements. However, in the event of a dispute, the methods
specified in this part of ISO 8600 are to be used as the reference methods.
A rationale for the most important requirements is given in Annex A. It is considered that knowledge of
the reasons for the requirements will not only facilitate the proper application of this part of ISO 8600,
but will expedite any subsequent revision.
INTERNATIONAL STANDARD ISO 8600-2:2015(E)
Endoscopes - Medical endoscopes and endotherapy
devices —
Part 2:
Particular requirements for rigid bronchoscopes
1 Scope
This part of ISO 8600 specifies requirements for rigid bronchoscopes and their endoscopic accessories
used in the practice of anaesthesia and medical endoscopy.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
ISO 5356-1:1996, Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and sockets
ISO 8600-1:2013, Endoscopes — Medical endoscopes and endotherapy devices — Part 1: General
requirements
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 8600-1 and the following
apply.
3.1
rigid bro
...
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