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BS EN ISO 18777:2009

Current
Current

The latest, up-to-date edition.

Transportable liquid oxygen systems for medical use. Particular requirements
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

31-07-2009

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
Annexes
Annex AA (informative) - Rationale
Annex BB (informative) - Environmental aspects
Annex CC (informative) - Index of defined terms
Bibliography
Annex ZA (informative) - Relationship between this European
         Standard and the Essential Requirements of EU
         Directive 93/42/EEC

Provides requirements for the safety and essential performance of transportable liquid oxygen systems which are used as a supply source for oxygen therapy.

IEC60601-1:1988, Clause1, applies except as follows:

Amendments (add at end of 1.1):

1.1 This International Standard specifies requirements for the safety and essential performance of transportable liquid oxygen systems which are used as a supply source for oxygen therapy. These devices usually consist of a portable unit to be carried by or with the patient whilst in use and the vessel used to refill the portable unit. These devices are mostly used in home care applications and in health care facilities/institutions. These devices are often used without professional supervision.

Liquid oxygen vessels used as a supply source for oxygen pipeline systems are excluded from this International Standard.

The requirements of this International Standard which replace or modify the requirements of IEC60601-1:1998 and its Amendments 1 (1991) and 2 (1995) are intended to take precedence over the corresponding general requirements.

1.4 Addition:

NOTE Planning and design of products complying with this Internatinal Standard can have environmental impact during the product life cycle. Environmental aspects are addressed in Annex BB. Additional aspects of environmental impact are addressed in ISO14971.

Committee
CH/121/5
DevelopmentNote
Supersedes 03/114562 DC. (04/2005) To be read in conjunction with BS EN 60601-1. Supersedes 08/30192553 DC. (07/2009)
DocumentType
Standard
Pages
40
PublisherName
British Standards Institution
Status
Current
Supersedes

ISO 18779:2005 Medical devices for conserving oxygen and oxygen mixtures Particular requirements
IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
EN 1251-2:2000/AC:2006 CRYOGENIC VESSELS - TRANSPORTABLE VACUUM INSULATED VESSELS OF NOT MORE THAN 1000 LITRES VOLUME - PART 2: DESIGN, FABRICATION, INSPECTION AND TESTING
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 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 1251-3:2000 Cryogenic vessels - Transportable vacuum insulated vessels of not more than 1000 litres volume - Part 3: Operational requirements
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 1251-1:2000 Cryogenic vessels - Transportable vacuum insulated vessels of not more than 1000 litres volume - Part 1: Fundamental requirements
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)

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