• There are no items in your cart
We noticed you’re not on the correct regional site. Switch to our AMERICAS site for the best experience.
Dismiss alert

I.S. 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Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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Superseded date

22-06-2022

Language(s)

English

Published date

01-01-2014

Preview

For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.

Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

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.

DocumentType
Standard
Pages
36
PublisherName
National Standards Authority of Ireland
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Superseded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

View more information
£38.44
Excluding VAT

Access your standards online with a subscription

Features

  • Simple online access to standards, technical information and regulations.

  • Critical updates of standards and customisable alerts and notifications.

  • Multi-user online standards collection: secure, flexible and cost effective.