ISO 8835-7:2011

Inhalational anaesthesia systems — Part 7: Anaesthetic systems for use in areas with limited logistical supplies of electricity and anaesthetic gases

ISO 8835-7:2011 specifies safety and performance requirements for anaesthetic systems and components that: · can function in the absence of a supply of compressed medical gases or mains electricity; · can withstand a challenging environment, including high temperatures, humidity, shocks and vibration, and dust; · allow local servicing and maintenance; · may be suitable for use with flammable anaesthetic agents.

Systèmes d'anesthésie par inhalation — Partie 7: Systèmes d'anesthésie pour utilisation dans des zones avec équipement logistique limité en électricité et en gaz anesthésiques

General Information

• Status: Published
• Publication Date: 27-Oct-2011
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: ISO/TC 121/SC 1 - Breathing attachments and anaesthetic machines
• Drafting Committee: ISO/TC 121/SC 1 - Breathing attachments and anaesthetic machines
• Current Stage: 9093 - International Standard confirmed
• Completion Date: 09-Dec-2022

Standards Content (Sample)

INTERNATIONAL  ISO
STANDARD 8835-7
First edition
2011-11-01
Inhalational anaesthesia systems —
Part 7:
Anaesthetic systems for use in areas with
limited logistical supplies of electricity
and anaesthetic gases
Systèmes d’anesthésie par inhalation —
Partie 7: Systèmes d’anesthésie pour utilisation dans des zones avec
équipement logistique limité en électricité et en gaz anesthésiques
Reference number
ISO 8835-7:2011(E)
©
 ISO 2011

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ISO 8835-7:2011(E)
COPYRIGHT PROTECTED DOCUMENT
©  ISO 2011
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
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Published in Switzerland
ii © ISO 2011 – All rights reserved

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ISO 8835-7:2011(E)
Contents Page
Foreword . v
* Introduction .vi
1 * Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General requirements . 2
4.1 Electrical safety . 2
4.2 Mechanical hazards . 2
4.3 Risk management . 2
5 * Essential functions . 2
6 Oxygen concentrators . 3
7 Performance requirements . 3
7.1 Electrical supply . 3
7.2 Gas supply . 3
7.3 Flammable anaesthetic agents . 3
8 Construction requirements . 3
8.1 Servicing . 3
8.2 Materials . 3
9 Environmental conditions . 3
10 Marking . 4
11 Information to be provided by the manufacturer . 4
Annex A (informative) Rationale . 5
A.1 General . 5
A.2 Introduction and Clause 5 . 5
A.3 Clause 1 . 5
Annex B (informative) Reference to the essential principles . 6
Bibliography . 7
© ISO 2011 – All rights reserved  iii

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ISO 8835-7:2011(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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. 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.
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.
ISO 8835-7 was prepared by Technical Committee ISO/TC 121,  Anaesthetic and respiratory equipment,
Subcommittee SC 1, Breathing attachments and anaesthetic machines.
ISO 8835 consists of the following parts, under the general title Inhalational anaesthesia systems:
—  Part 7: Anaesthetic systems for use in areas with limited logistical supplies of electricity and anaesthetic
gases
The following parts are withdrawn and replaced by ISO 80601-2-13:
—  Part 2: Anaesthetic breathing systems
—  Part 3: Transfer and receiving systems of active anaesthetic gas scavenging systems
—  Part 4: Anaesthetic vapour delivery devices
—  Part 5: Anaesthetic ventilators
Draw-over vaporizers are described in ISO/TS 18835.
iv © ISO 2011 – All rights reserved

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ISO 8835-7:2011(E)
* Introduction
The World Health Organisation (WHO) and the World Federation of Societies of Anaesthesiologists (WFSA)
are concerned about the provision of safe anaesthesia, using appropriately designed anaesthetic equipment,
in the large numbers of countries in the world where economics or infrastructure lead to a situation where
complex technology is unlikely to function well, if at all, and might introduce hazards of its own.
A total of 152 countries have been identified where the infrastructure or economic restrictions prevent the use
of complex equipment, creating a need for an appropriate standard.
Equipment designed for use in these countries should meet the following minimum criteria:
a)  ability to function in the absence of a regular supply of compressed medical gases;
b)  ability to continue to function safely when the supply of medical gases fails;
c)  ability to function if mains electrical supplies are interrupted, or are subject to unpredictable increases or
decreases in voltage;
d)  ability to function in a challenging environment, including high temperatures, humidity, shocks, vibration,
and dust.
This part of ISO 8835 allows for the construction of an anaesthetic system, using the components identified in
this part of ISO 8835, to suit the specific economic and environmental issues of each country.
Throughout this part of ISO 8835, text for which a rationale is provided in Annex A is indicated by an asterisk
(*).
© ISO 2011 – All rights reserved  v

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INTERNATIONAL STANDARD ISO 8835-7:2011(E)
Inhalational anaesthesia systems —
Part 7:
Anaesthetic systems for use in areas with limited logistical
supplies of electricity and anaesthetic gases
1 * Scope
This part of ISO 8835 specifies safety and performance requirements for anaesthetic systems and components
that:
a)  can function in the absence of a supply of compressed medical gases or mains electricity;
b)  can withstand a challenging environment, including high temperatures, humidity, shocks and vibration,
and dust;
c)  allow local servicing and maintenance;
d)  may be suitable for use with flammable anaesthetic agents.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced document
(including any amendments) applies.
ISO 4135, Anaesthetic and respiratory equipment — Vocabulary
ISO 8359, Oxygen concentrators for medical use — Safety requirements
ISO 10083, Oxygen concentrator supply systems for use with medical gas pipeline sy
...