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AENOR-UNE
UNE-EN ISO 10079-2:2014

UNE-EN ISO 10079-2:2014

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Medical suction equipment - Part 2: Manually powered suction equipment (ISO 10079-2:2014)

Available format(s)

Hardcopy , PDF

Superseded date

12-21-2022

Language(s)

Spanish, Castilian, English

Published date

11-19-2014

Publisher

Asociacion Espanola de Normalizacion

1. Scope
2. Normative references
3. Terms and definitions
4. Cleaning and sterilization
5. Design requirements
6. Operational requirements
7. Physical requirements
8. Performance requirements for vacuum and flowrate
9. Resistance to environment
10. Marking
11. Information to be supplied by manufacturer
Annexes
A. (normative) Test methods
B. (informative) Table of typical range of volumes for
    collection containers for specific uses
C. (informative) Rationale statement

Defines safety and performance requirements for manually powered medical suction equipment for oro-pharyngeal suction for establishing and maintaining the patency of the airway. Describes hand or foot operated equipment. Also includes non-electrical suction equipment which may be integrated with electrical equipment.

Committee
CTN 110
DocumentType
Standard
Pages
32
PublisherName
Asociacion Espanola de Normalizacion
Status
Superseded
SupersededBy
Supersedes

ISO 8836:2014 Suction catheters for use in the respiratory tract
ISO 5356-1:2015 Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets
ISO 10651-4:2002 Lung ventilators — Part 4: Particular requirements for operator-powered resuscitators
ISO 10079-1:2015 Medical suction equipment Part 1: Electrically powered suction equipment
IEC 62366:2007+AMD1:2014 CSV Medical devices - Application of usability engineering to medical devices
EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
ISO 10079-3:2014 Medical suction equipment Part 3: Suction equipment powered from a vacuum or positive pressure gas source
ISO 14155:2011 Clinical investigation of medical devices for human subjects Good clinical practice
ISO 14971:2007 Medical devices Application of risk management to medical devices
ISO 7000:2014 Graphical symbols for use on equipment Registered symbols
ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements

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Hardcopy - Spanish
PDF - Spanish
Hardcopy - English
PDF - English
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