Medical suction equipment - Part 1: Electrically powered suction equipment (ISO 10079-1:2022)

This document specifies safety and performance requirements for electrically powered medical and surgical suction equipment. It applies to equipment used in health care facilities such as hospitals, for domiciliary care of patients and for field use and transport use.

Medizinische Absauggeräte - Teil 1: Elektrisch betriebene Absauggeräte (ISO 10079-1:2022)

Dieses Dokument legt Anforderungen für die Sicherheit und für die Leistung von elektrisch betriebenen medizinischen und chirurgischen Absauggeräten fest. Es gilt für Geräte, die in Gesundheitseinrichtungen wie Krankenhäusern eingesetzt werden, für Geräte für die Heimpflege von Patienten und für Geräte zur Verwendung im Freien und zur Verwendung beim Transport.

Appareils d'aspiration médicale - Partie 1: Appareils électriques d'aspiration (ISO 10079-1:2022)

Le présent document spécifie les exigences de sécurité et de performance pour les appareils électriques d’aspiration médicale et chirurgicale. Il s’applique aux appareils utilisés dans les établissements de soins tels que les hôpitaux, pour les soins des patients à domicile, ainsi que pour une utilisation sur le terrain et lors d’un transport.

Medicinska sukcijska (aspiracijska) oprema - 1. del: Električna sukcijska (aspiracijska) oprema (ISO 10079-1:2022)

General Information

Status
Published
Public Enquiry End Date
24-Apr-2021
Publication Date
11-May-2022
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
25-Apr-2022
Due Date
30-Jun-2022
Completion Date
12-May-2022

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Standards Content (sample)

SLOVENSKI STANDARD
SIST EN ISO 10079-1:2022
01-junij-2022
Nadomešča:
SIST EN ISO 10079-1:2016
SIST EN ISO 10079-1:2016/A1:2019
Medicinska sukcijska (aspiracijska) oprema - 1. del: Električna sukcijska
(aspiracijska) oprema (ISO 10079-1:2022)

Medical suction equipment - Part 1: Electrically powered suction equipment (ISO 10079-

1:2022)

Medizinische Absauggeräte - Teil 1: Elektrisch betriebene Absauggeräte (ISO 10079-

1:2022)

Appareils d'aspiration médicale - Partie 1: Appareils électriques d'aspiration (ISO 10079-

1:2022)
Ta slovenski standard je istoveten z: EN ISO 10079-1:2022
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN ISO 10079-1:2022 en,fr,de

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN ISO 10079-1:2022
---------------------- Page: 2 ----------------------
SIST EN ISO 10079-1:2022
EN ISO 10079-1
EUROPEAN STANDARD
NORME EUROPÉENNE
March 2022
EUROPÄISCHE NORM
ICS 11.040.10 Supersedes EN ISO 10079-1:2015, EN ISO 10079-
1:2015/A1:2019
English Version
Medical suction equipment - Part 1: Electrically powered
suction equipment (ISO 10079-1:2022)

Appareils d'aspiration médicale - Partie 1: Appareils Medizinische Absauggeräte - Teil 1: Elektrisch

électriques d'aspiration (ISO 10079-1:2022) betriebene Absauggeräte (ISO 10079-1:2022)

This European Standard was approved by CEN on 3 January 2022.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this

European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references

concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN

member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by

translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management

Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,

Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,

Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and

United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels

© 2022 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10079-1:2022 E

worldwide for CEN national Members.
---------------------- Page: 3 ----------------------
SIST EN ISO 10079-1:2022
EN ISO 10079-1:2022 (E)
Contents Page

European foreword ....................................................................................................................................................... 3

---------------------- Page: 4 ----------------------
SIST EN ISO 10079-1:2022
EN ISO 10079-1:2022 (E)
European foreword

This document (EN ISO 10079-1:2022) has been prepared by Technical Committee ISO/TC 121

"Anaesthetic and respiratory equipment" in collaboration with Technical Committee CEN/TC 215

“Respiratory and anaesthetic equipment” the secretariat of which is held by BSI.

This European Standard shall be given the status of a national standard, either by publication of an

identical text or by endorsement, at the latest by September 2022, and conflicting national standards

shall be withdrawn at the latest by September 2022.

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. CEN shall not be held responsible for identifying any or all such patent rights.

This document supersedes EN ISO 10079-1:2015.

Any feedback and questions on this document should be directed to the users’ national standards

body/national committee. A complete listing of these bodies can be found on the CEN website.

According to the CEN-CENELEC Internal Regulations, the national standards organizations of the

following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,

Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,

Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of

North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the

United Kingdom.
Endorsement notice

The text of ISO 10079-1:2022 has been approved by CEN as EN ISO 10079-1:2022 without any

modification.
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SIST EN ISO 10079-1:2022
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SIST EN ISO 10079-1:2022
INTERNATIONAL ISO
STANDARD 10079-1
Fourth edition
2022-03
Medical suction equipment —
Part 1:
Electrically powered suction
equipment
Appareils d'aspiration médicale —
Partie 1: Appareils électriques d'aspiration
Reference number
ISO 10079-1:2022(E)
© ISO 2022
---------------------- Page: 7 ----------------------
SIST EN ISO 10079-1:2022
ISO 10079-1:2022(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2022

All rights reserved. Unless otherwise specified, or required in the context of its implementation, 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
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
© ISO 2022 – All rights reserved
---------------------- Page: 8 ----------------------
SIST EN ISO 10079-1:2022
ISO 10079-1:2022(E)
Contents Page

Foreword ........................................................................................................................................................................................................................................iv

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ..................................................................................................................................................................................... 1

3 Terms and definitions .................................................................................................................................................................................... 1

4 General requirements .................................................................................................................................................................................... 1

5 Materials ....................................................................................................................................................................................................................... 1

6 Design requirements .......................................................................................................................................................................................1

6.1 General ........................................................................................................................................................................................................... 1

6.2 Protection against ingress of solid objects and liquids ...................................................................................... 2

6.3 Battery powered suction equipment ................................................................................................................................... 2

7 Performance requirements ........................................................................................................................................... ...........................2

7.1 General ........................................................................................................................................................................................................... 2

7.2 Effect of an interruption of power supply on the vacuum level and free air flow

...

SLOVENSKI STANDARD
oSIST prEN ISO 10079-1:2021
01-april-2021
Medicinska sukcijska (aspiracijska) oprema - 1. del: Električna sukcijska
(aspiracijska) oprema (ISO/DIS 10079-1:2021)

Medical suction equipment - Part 1: Electrically powered suction equipment (ISO/DIS

10079-1:2021)

Medizinische Absauggeräte - Teil 1: Elektrisch betriebene Absauggeräte (ISO/DIS 10079

-1:2021)

Appareils d'aspiration médicale - Partie 1: Appareils électriques d'aspiration (ISO/DIS

10079-1:2021)
Ta slovenski standard je istoveten z: prEN ISO 10079-1
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
oSIST prEN ISO 10079-1:2021 en,fr,de

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
oSIST prEN ISO 10079-1:2021
---------------------- Page: 2 ----------------------
oSIST prEN ISO 10079-1:2021
DRAFT INTERNATIONAL STANDARD
ISO/DIS 10079-1
ISO/TC 121/SC 8 Secretariat: SA
Voting begins on: Voting terminates on:
2021-02-22 2021-05-17
Medical suction equipment —
Part 1:
Electrically powered suction equipment
Appareils d'aspiration médicale —
Partie 1: Appareils électriques d'aspiration
ICS: 11.040.10
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
ISO/CEN PARALLEL PROCESSING
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 10079-1:2021(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION. ISO 2021
---------------------- Page: 3 ----------------------
oSIST prEN ISO 10079-1:2021
ISO/DIS 10079-1:2021(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2021

All rights reserved. Unless otherwise specified, or required in the context of its implementation, 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
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2021 – All rights reserved
---------------------- Page: 4 ----------------------
oSIST prEN ISO 10079-1:2021
ISO/DIS 10079-1:2021(E)
Contents Page

Foreword ........................................................................................................................................................................................................................................iv

Introduction ..................................................................................................................................................................................................................................v

1 Scope (mandatory) ............................................................................................................................................................................................. 1

2 Normative references (mandatory) .................................................................................................................................................. 1

3 Terms and definitions (mandatory) ................................................................................................................................................. 1

4 General requirements ..................................................................................................................................................................................... 1

5 Materials ....................................................................................................................................................................................................................... 1

6 Design requirements ........................................................................................................................................................................................ 2

6.1 General ........................................................................................................................................................................................................... 2

6.2 Protection against ingress of solid objects and liquids ........................................................................................ 2

7 Performance requirements ....................................................................................................................................................................... 2

7.1 General ........................................................................................................................................................................................................... 2

7.2 Effect of an interruption of power supply on the vacuum level and free air flow ..................... 2

8 Additional/alternative requirements for suction equipment and suction tubing

designed for field use or transport use .......................................................................................................................................... 3

8.1 General ........................................................................................................................................................................................................... 3

8.2 Operating time of battery-powered equipment ......................................................................................................... 3

9 Information to be supplied by the manufacturer ............................................................................................................... 3

© ISO 2021 – All rights reserved iii
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oSIST prEN ISO 10079-1:2021
ISO/DIS 10079-1:2021(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
...

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