Customer Support: 131 242

  • 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

BS EN ISO 18779:2005

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by

Medical devices for conserving oxygen and oxygen mixtures. Particular requirements

Available format(s)

Hardcopy , PDF

Superseded date

23-11-2020

Language(s)

English

Published date

24-03-2005

$520.16
Including GST where applicable

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements and general requirements for
    tests
5 Classification
6 Identification, marking and documents
7 Power input
8 Basic safety categories
9 Removable protective means
10 Environmental conditions
11 Not used
12 Not used
13 General
14 Requirements related to classification
15 Limitation of voltage and/or energy
16 Enclosures and protective covers
17 Separation
18 Protective earthing, functional earthing and potential
    equalization
19 Continuous leakage currents and patient auxiliary
    currents
20 Dielectric strength
21 Mechanical strength
22 Moving parts
23 Surfaces, corners and edges
24 Stability in normal use
25 Expelled parts
26 Vibration and noise
27 Pneumatic and hydraulic power
28 Suspended masses
29 X-Radiation
30 Alpha, beta, gamma, neutron radiation and other particle
    radiation
31 Microwave radiation
32 Light radiation (including lasers)
33 Infrared radiation
34 Ultraviolet energy
35 Acoustical energy (including ultrasonics)
36 Electromagnetic compatibility
37 Locations and basic requirements
38 Marking and accompanying documents
39 Common requirements for category AP and category APG equipment
40 Requirements and tests for category AP equipment, parts and
    components thereof
41 Requirements and tests for category APG equipment, parts and
    components thereof
42 Excessive temperatures
43 Fire prevention
44 Overflow, spillage, leakage, humidity, ingress of liquids,
    cleaning, sterilization, disinfection and compatibility
45 Pressure vessels and parts subject to pressure
46 Human errors
47 Electrostatic charges
48 Biocompatibility
49 Interruption of the power supply
50 Accuracy of operating data
51 Protection against hazardous output
52 Abnormal operation and fault conditions
53 Environmental tests
54 General
55 Enclosures and covers
56 Components and general assembly
57 Mains parts, components and layout
58 Protective earthing - Terminals and connections
59 Construction and layout
101 Additional requirements
Annex AA (informative) Rationale
Annex BB (informative) Environmental aspects
Annex CC (informative) Index of defined terms
Bibliography
ANNEX ZA (informative) Relationship between this International
         Standard and the Essential Requirements of EU Directive
         93/42 EEC Medical devices

Describes requirements for oxygen and oxygen mixture saving devices (called here conserving devices) that are used to supply respiratory gases during therapy.

Committee
CH/121/5
DocumentType
Standard
Pages
42
PublisherName
British Standards Institution
Status
Superseded
SupersededBy

IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
ISO 15001:2010 Anaesthetic and respiratory equipment Compatibility with oxygen
IEC 60601-1-6:2010+AMD1:2013 CSV Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
IEC 60068-2-64:2008 Environmental testing - Part 2-64: Tests - Test Fh: Vibration, broadband random and guidance
IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
IEC 60529:1989+AMD1:1999+AMD2:2013 CSV Degrees of protection provided by enclosures (IP Code)
NFPA 53M : 1990 FIRE HAZARDS IN OXYGEN-ENRICHED ATMOSPHERES
ISO 7000:2014 Graphical symbols for use on equipment Registered symbols
ISO 4135:2001 Anaesthetic and respiratory equipment Vocabulary
EN 980:2008 Symbols for use in the labelling of medical devices
EN 13544-2:2002+A1:2009 Respiratory therapy equipment - Part 2: Tubing and connectors
EN 60601-1-8:2007/A11:2017 MEDICAL ELECTRICAL EQUIPMENT - PART 1-8: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: GENERAL REQUIREMENTS, TESTS AND GUIDANCE FOR ALARM SYSTEMS IN MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS (IEC 60601-1-8:2006/A1:2012)

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.

Need help?
Call us on 131 242, then click here to start a Screen Sharing session
so we can help right away! Learn more