ISO 5356-1:1987/Amd 1:1993
(Amendment)Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and sockets — Amendment 1
Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and sockets — Amendment 1
Matériel respiratoire et d'anesthésie — Raccords coniques — Partie 1: Raccords mâles et femelles — Amendement 1
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Standards Content (Sample)
IS0
INTERNATIONAL
5356-1
STANDARD
First edition
1987-06-15
AMENDMENT 1
1993-07-0 1
Anaesthetic and respiratory equipment - Conical
connectors -
Part 1:
Cones and sockets
AMENDMENT 1
Matériel respiratoire et d'anesthésie - Raccords coniques -
Partie I: Raccords mâles et femelles
AMENDEMENT 1
e
Reference number
IS0 5356-1 : 1987/Amd. 1 : 1993(E)
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IS0 5356-1: 1987/Amd. 1: 1993(E)
Foreword
IS0 (the International Organization for Standardization) is a worldwide federation
of national standards bodies (IS0 member bodies). The work of preparing Inter-
national Standards is normally carried out through IS0 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. IS0 collaborates closely with the International Electro-
technical Commission (IEC) on all matters of electrotechnical standardization.
Draft International Standards adopted by the technical committees are circulated
to the member bodies for voting. Publication as an International Standard
requires approval by at least 75 % of the member bodies casting a vote.
Amendment 1 to International Standard IS0 5356-1 was prepared by Technical
Committee ISOflC 121, Anaesthetic and respiratory equipment, Sub-Committee
SC 1, Breathing attachments and anaesthetic machines.
Annexes C, D and E form an integral part of this part of IS0 5356. Annex F is for
information only.
(P IS0 1993
All rights reserved. No part of this publication may be reproduced or utilized in any form or by
any means, electronic or mechanical, including photocopying and microfilm, without
permission in writing from the publisher.
International Organization for Standardization
Case postale 56 CH-I21 1 Genève 20 Switzerland
Printed in Switzerland
ii
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IS0 5356-1: 1987/Amd. 1: 1993(E)
Anaesthetic and respiratory equipment - Conical
connectors -
Part I :
Cones and sockets
AMENDMENT 1
Page 2, 3 Definitions
Page 1, O introduction
Add a new definition 3.3 as follows.
Add the following to the end of the second paragraph
of 0.2.
3.3 22mm latching connector: 22 mm female con-
nector which incorporates a latching mechanism to
This part of IS0 5356 also gives requirements for one
reduce the possibility of accidental disconnection from
size (22 mm) of latching connector which is intended to
a male 22 mm conical connector complying with
reduce the possibility of accidental disconnection
clauses 5 and 6, and figure 3 a).
between a 22mm female latching connector and a
22 mm male conical connector.
Clause 6
Add the following to 0.4.
Correct the clause heading to read:
Conical connectors made of materials other than
Annexes C, D and E form normative parts of this
metal
International Standard. Annex F is given for infor-
mation only.
Page 3, 8 Information to be supplied by the manufac-
turer
2 References
Delete existing clause 8, and substitute the following.
Change the heading of the clause to "ormative refer-
The following information shall be supplied with the
ences" and add the following beneath the clause heading.
connector:
The following standards contain provisions, which,
a) technical information (including operating and
through reference in this text, constitute provisions of
storage conditions) and instructions for connecting
this International Standard. At the time of publication,
and disconnecting;
the editions indicated were valid. All standards are
subject to revision, and parties to agreements based on
b) if appropriate, details of a pre-use test to con-
this International Standard are encouraged to in-
firm correct operation;
vestigate the possibility of applying the most recent
editions of the standards indicated below. Members of
c) if appropriate, recommended methods for
IEC and IS0 maintain registers of currently valid
cleaning and disinfection or sterilization;
International Standards.
d) instructions in the event of damage to the
packaging of connectors supplied sterile and, if
Add the following to the list of standards cited:
appropriate, methods of re-sterilization;
e) any special precautions related to the disposal
IS0 5367:1991, Breathing tubes intended for use with
of the connector.
anaesthetic apparatus and ventilators. \
1
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IS0 5356-1:1987/Amd.l:1993( E)
9 Bibliography
11 Marking
Add to the list of standards cited
The connector and/or its packaging shall be marked, as
applicable, with the following information:
IS0 7000:1989, Graphical symbols for use on equipment -
Index and synopsis
a) a description of the product including its in-
tended use;
Delete from the list of standards cited:
IS0 5367.
b) the name and/or trademark of the manufacturer
and/or supplier;
Add the following new clauses 10 and 11.
c) a differentiation between the packaging and/or
10 22 mm latching connectors
labelling of the same or similar products from the
same manufacturer supplied sterile and supplied
non-sterile, and the word "sterile" if appropriate;
10.1 The 22 mm latching connector shall engage with
a male 22 mm conical connector as specified in clauses
d) an indication if the connector is for single use,
5 and 6, and figure 3 a).
e.g. symbol 1051 of ISO7OOO; the words "single
patient use";
10.2 When tested as described in annex C, the en-
gaged connection shall not become disconnected.
e) if not supplied as a permanently attached
component of a medical device, and if made of
antistatic or conductive materials, the word "anti-
10.3 When tested as described in annexD, the leak-
static".
age from the engaged connectors shall not exceed
5 ml/min (corrected to 20 "C and 101,3 kPa).
R the expiry date expressed as year/month;
10.4 After being subjected to the procedure described
g) an identification reference to the type, batch or
in annex E, the latching connector shall still meet the
serial number.
requirements specified in 10.1, 10.2 and 10.3.
10.5 22 mm latching connectors intended for reuse
shall meet the requirements specified in 10.1, 10.2, 10.3
Page 16
and 10.4 after being subjected to 20 cycles of cleaning
and disinfection or sterilization as recommended by Following the existing figure 12, add new annexes C, D, E
the manufacturer.
and F, and figures 13 and 14.
2
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IS0 5356-1:1987/Amd.l:1993(E)
Annex C
(normative)
Test method for security of engagement of 22 mm latching connectors
NOTE - Examples of suitable apparatus that may be used, togaher
C.3 Apply for 10 s, without activation of any disen-
with a more detailed test procsdure, are given for information
gagement mechanism, an separation force of
in annex F.
(50 i 5) N and, unless the design of the 22 mm latching
connector permits free rotation, a torque of (25 I 5) N-cm
first in one direction of rotation and then in the other.
c.1 Precondition a male 22 mm conical connector,
complying with clauses 5 and 6 and figure3 a), and the
22 mm latching connector for 1 h at a temperature of
(37 i 3) OC and a
...
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