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BS EN ISO 10079-2:2014

BS 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Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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

Available format(s)

Hardcopy , PDF

Superseded date

06-13-2022

Language(s)

English

Published date

05-31-2014

Publisher

British Standards Institution

Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Cleaning, disinfection and sterilization
6 Design requirements
7 Operational requirements
8 Physical requirements for field and transport use
   suction equipment
9 Performance requirements for vacuum level and flowrate
10 Resistance to environment of suction equipment for
   field and/or transport use
11 Marking
12 Information to be supplied by the manufacturer
Annex A (normative) - Test methods
Annex B (informative) - Rationale statement
Annex C (informative) - Lumen size and its effect on flowrate
Annex D (informative) - Schematic of suction equipment
Bibliography
Annex ZA (informative) - Relationship between this European
         Standard and the Essential Requirements of EU Directive
         93/42/EEC

Describes safety and performance requirements for manually powered suction equipment intended for oro-pharyngeal suction.

This part of ISO10079 specifies safety and performance requirements for manually powered suction equipment intended for oro-pharyngeal suction. It applies to equipment operated by foot or by hand or both. AnnexD illustrates the three parts of ISO10079 by providing a schematic for typical systems. The commonest use of manually powered suction is in situations outside of health care settings often described as field use or transport use. Use in these situations may involve extreme conditions of weather or terrain. Additional requirements for suction equipment intended for field and/or transport use are included in this part of ISO10079. This part of ISO10079 does not apply to the following: end pieces such as suction catheters, Yankauer sucker and suction tips; dental suction equipment; mucus extractors, including neonatal mucus extractors.

Committee
CH/121
DevelopmentNote
Supersedes and renumbers BS 7259-1(1993). (07/2004) Supersedes 97/565290 DC. (05/2005) Supersedes 08/30192501 DC. (04/2009)
DocumentType
Standard
Pages
32
PublisherName
British Standards Institution
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 - English
PDF - English
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