ISO 8600-2:2015

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 8600-2:2015(E)
©
ISO 2015

---------------------- Page: 1 ----------------------
ISO 8600-2:2015(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2015
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2015 – All rights reserved

---------------------- Page: 2 ----------------------
ISO 8600-2:2015(E)

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
© ISO 2015 – All rights reserved iii

---------------------- Page: 3 ----------------------
ISO 8600-2:2015(E)

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

---------------------- Page: 4 ----------------------
ISO 8600-2:2015(E)

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.
© ISO 2015 – All rights reserved v

---------------------- Page: 5 ----------------------
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 bronchoscope
open straight tube-type rigid endoscope fitted with a means of illumination through the distal end and
intended to be introduced into the tracheobronchial airway, having an internal lumen sufficiently large
to permit free respiration of the patient
3.2
rigid ventilation bronchoscope
rigid bronchoscope, fitted with a removable end-cap at the proximal end of the open straight tube and
having an internal lumen sufficiently large to permit ventilation of the patient through an integral
ventilation connector
3.3
rigid jet ventilation bronchoscope
rigid bronchoscope provided with a jet-injector
Note 1 to entry: Rigid bronchoscopes provided with only a gas nipple should not be included within the category of
jet-ventilation bronchoscopes, because the Venturi principle does not necessarily function sufficiently to ventilate
the patient.
3.4
ventilation connector
breathing system connector
integral part of a rigid-ventilation bronchoscope that permits connection to a breathing system of an
anaesthetic or breathing machine
© ISO 2015 – All rights reserved 1

---------------------- Page: 6 ----------------------
ISO 8600-2:2015(E)

3.5
end-cap
removable fitting at the proximal end of a rigid-ventilation bronchoscope to seal its lumen
3.6
jet-injector
narrow-lumen tubular device utilizing compressed gases (often using the Venturi principle) to provide
intermittent positive gas pressure to the lungs of a patient
Note 1 to entry: Gases selected may include air, oxygen and/or other gases.
3.7
jet ventilation
artificial inflation of the lungs by intermittent release of compressed gases by means of a jet-injector
within or towards the trachea and bronchi of a patient
3.8
maximum insertion portion width
maximum external width of an endoscope or endotherapy device throughout the length of the insertion
portion to be inserted
Note 1 to entry: The maximum width of any expandable or transformable portion of the insertion portion is not
considered as a maximum insertion portion width, such as balloons, controllable parts, jaws and the like having
variable insertion portion widths.
Note 2 to entry: See also ISO 8600-6.
[SOURCE: ISO 8600-1:2013, definition 3.10]
3.9
total length
distance between the proximal and distal ends of a rigid bronchoscope
4 Requirements
4.1 General
Rigid bronchoscopes shall comply with the requirements specified in ISO 8600-1. In addition, rigid
bronchoscopes shall also comply with the requirements specified in 4.2 and 4.5; rigid-ventilation
bronchoscopes shall also comply with the requirements specified in 4.3 and rigid jet-ventilation
bronchoscopes shall also comply with the requirements specified in 4.4.
4.2 Dimensions
4.2.1 Working length
The actual working length of a rigid bronchoscope shall be at least as long as, and not more than, 10 mm
longer than the working length stated in the instructions for use provided by the manufacturer.
4.2.2 Total length
The total length shall be in the range ±10 mm to the length stated in instructions for use.
4.2.3 Maximum insertion portion width
The maximum insertion portion width shall be in the range ±1 mm stated in the instructions for use
provided by the manufacturer.
2 © ISO 2015 – All rights reserved

---------------------- Page: 7 ----------------------
ISO 8600-2:2015(E)

4.3 Rigid ventilation bronchoscopes
4.3.1 A rigid ventilation bronchoscope shall be provided with an integral ventilation connector and
an end-cap at its proximal end. Provision shall be made for insertion of endoscopes and endoscopic
accessories through the end-cap. The end-cap shall not accidentally detach at an airway pressure of less
than 4,0 kPa (40 cmH O).
2
An end-cap may incorporate a transparent window and/or may permit the insertion of an endoscope or
endoscopic accessory through the opening or an airtight gasket. Removal or opening of the end-cap for
accessory insertion may be achieved by the detachment, rotation or sliding of the end-cap.
4.3.2 A rigid ventilation bronchoscope shall be provided, in a side-arm, either with an integ
...