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CSA Z10651.2: 2006

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 2: HOME CARE VENTILATORS FOR VENTILATOR-DEPENDENT PATIENTS
Available format(s)

Hardcopy , PDF

Superseded date

01-07-2017

Language(s)

English

Published date

01-01-2015

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements and 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 Infra-red-radiation
34 Ultraviolet radiation
35 Acoustical energy (including ultrasonics)
36 Electromagnetic compatibility
37 Locations and basic requirements
38 Marking, 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 Alarm systems
102 Appendices of IEC 60601-1:1988
Annex AA (informative) - Rationale
Annex BB (informative) - Reference to the essential principles
Bibliography

Specifies requirements for lung ventilators intended for home applications for those patients who are dependent on ventilatory support.

Committee
50
DocumentType
Standard
Pages
52
ProductNote
Reconfirmed EN
PublisherName
Canadian Standards Association
Status
Superseded
SupersededBy
Supersedes

ISO 18779:2005 Medical devices for conserving oxygen and oxygen mixtures Particular requirements
ISO/IEC TR 10000-1:1998 Information technology Framework and taxonomy of International Standardized Profiles Part 1: General principles and documentation framework
ISO 10241:1992 International terminology standards Preparation and layout
EN 550 : 1994 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF ETHYLENE OXIDE STERILIZATION
ISO 690:2010 Information and documentation Guidelines for bibliographic references and citations to information resources
ISO 9703-1:1992 Anaesthesia and respiratory care alarm signals Part 1: Visual alarm signals
ISO 15002:2008 Flow-metering devices for connection to terminal units of medical gas pipeline systems
IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
ISO 8359:1996 Oxygen concentrators for medical use Safety requirements
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
ISO 5356-1:2015 Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets
ISO 14937:2009 Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
ISO 9703-3:1998 Anaesthesia and respiratory care alarm signals Part 3: Guidance on application of alarms
NFPA 53 : 2016 MATERIALS, EQUIPMENT, AND SYSTEMS USED IN OXYGEN-ENRICHED ATMOSPHERES
ISO 18777:2005 Transportable liquid oxygen systems for medical use — Particular requirements
IEC 60601-1-8:2006+AMD1:2012 CSV Medical electrical equipment - Part 1-8: General requirements forbasic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems inmedical electrical equipment and medical electrical systems
IEC TR 60513:1994 Fundamental aspects of safety standards for medical electrical equipment
ISO 5356-2:2012 Anaesthetic and respiratory equipment — Conical connectors — Part 2: Screw-threaded weight-bearing connectors
ISO 32:1977 Gas cylinders for medical use — Marking for identification of content
ISO 21647:2004 Medical electrical equipment Particular requirements for the basic safety and essential performance of respiratory gas monitors
ISO 5367:2014 Anaesthetic and respiratory equipment — Breathing sets and connectors
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
ISO 5359:2014 Anaesthetic and respiratory equipment Low-pressure hose assemblies for use with medical gases
ISO 5362:2006 Anaesthetic reservoir bags
EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
ISO 8185:2007 Respiratory tract humidifiers for medical use Particular requirements for respiratory humidification systems
ISO/TR 16142:2006 Medical devices Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
ISO 10524-3:2005 Pressure regulators for use with medical gases Part 3: Pressure regulators integrated with cylinder valves
ISO 8835-5:2004 Inhalational anaesthesia systems Part 5: Anaesthetic ventilators
ISO 23328-2:2002 Breathing system filters for anaesthetic and respiratory use — Part 2: Non-filtration aspects
IEC 60601-2-13:2003+AMD1:2006 CSV Medical electrical equipment - Part 2-13: Particular requirements for the safety and essential performance of anaesthetic systems
IEC TR 60878:2015 Graphical symbols for electrical equipment in medical practice
EN 552:1994/A2:2000 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY IRRADIATION
IEC 80416-1:2008 Basic principles for graphical symbols for use on equipment - Part 1: Creation of graphical symbols for registration
ISO 9919:2005 Medical electrical equipment Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use
CSA Z5359 : 2016 ANAESTHETIC AND RESPIRATORY EQUIPMENT - LOW-PRESSURE HOSE ASSEMBLIES FOR USE WITH MEDICAL GASES, MEDICAL VACUUM, MEDICAL SUPPORT GASES, AND ANAESTHETIC GAS SCAVENGING SYSTEMS
ISO 9360-1:2000 Anaesthetic and respiratory equipment — Heat and moisture exchangers (HMEs) for humidifying respired gases in humans — Part 1: HMEs for use with minimum tidal volumes of 250 ml
ISO 14971:2007 Medical devices Application of risk management to medical devices
ISO 4135:2001 Anaesthetic and respiratory equipment Vocabulary
ISO 9360-2:2001 Anaesthetic and respiratory equipment — Heat and moisture exchangers (HMEs) for humidifying respired gases in humans — Part 2: HMEs for use with tracheostomized patients having minimum tidal volumes of 250 ml
EN 13014:2000/AC:2002 CONNECTIONS FOR GAS SAMPLING TUBES TO ANAESTHETIC AND RESPIRATORY EQUIPMENT
ISO 11195:1995 Gas mixers for medical use Stand-alone gas mixers
IEC 60601-1-1:2000 Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems
CSA Z305.1 : 0 NONFLAMMABLE MEDICAL GAS PIPING SYSTEMS
ISO 594-1:1986 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 1: General requirements
IEC 60601-1-4:1996+AMD1:1999 CSV Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems
CSA C22.2 No. 60601.1.2 : 2016 MEDICAL ELECTRICAL EQUIPMENT - PART 1-2: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: ELECTROMAGNETIC DISTURBANCES - REQUIREMENTS AND TESTS
ISO 9703-2:1994 Anaesthesia and respiratory care alarm signals — Part 2: Auditory alarm signals
EN 554 : 1994 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY MOIST HEAT
ISO 10524-2:2005 Pressure regulators for use with medical gases Part 2: Manifold and line pressure regulators
ISO 15223:2000 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied
ISO 7396-1:2016 Medical gas pipeline systems — Part 1: Pipeline systems for compressed medical gases and vacuum

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