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I.S. EN ISO 10651-6:2009

Withdrawn
Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 6: HOME-CARE VENTILATORY SUPPORT DEVICES
Available format(s)

Hardcopy , PDF

Withdrawn date

13-05-2021

Language(s)

English

Published date

01-01-2009

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
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
    6.1 Marking on the outside of equipment or
           equipment parts
    6.3 Marking of controls and instruments
    6.6 Identification of medical gas cylinders and
           connections
    6.101 Test method for legibility
7 Power input
    7.101 Pneumatic power
8 Basic safety categories
9 Removable protective means
10 Environmental conditions
     10.101 Pneumatic driving power supplies
13 General
14 Requirements related to classification
    14.2 Class II Equipment
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
   19.4 Tests
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 Ultra-violet 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
    43.2 Oxygen enriched atmospheres
    43.101 Compatibility with pressurized oxygen
44 Overflow, spillage, leakage, humidity, ingress of liquids,
    cleaning, sterilization, disinfection and compatibility
    44.3 Spillage
    44.7 Cleaning, sterilization and disinfection
    44.8 Compatibility with substances used with
           the equipment
45 Pressure vessels and parts subject to pressure
46 Human errors
47 Electrostatic charges
48 Biocompatibility
49 Interruption of the power supply
    49.101 Internal electrical power source
    49.102 Spontaneous breathing during power failure
    49.103 Accidental operation of the on/off-switch
50 Accuracy of operating data
51 Protection against hazardous output
    51.101 Maximum ventilator breathing system
           pressure limitation
    51.102 Measurement of airway pressure
    51.103 High-inspiratory pressure alarm condition
    51.104 Expiratory monitoring
    51.105 Respiration rate alarm condition
52 Abnormal operation and fault conditions
53 Environmental tests
54 General
    54.3 Protection against inadvertent adjustments
55 Enclosures and covers
56 Components and general assembly
    56.3 Connections - General
    56.101 Reservoir bags and breathing tubes
57 Mains parts, components and layout
    57.3 Power supply cords
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
Annex ZA (informative) - Relationship between this European
         Standard and the Essential Requirements of EU
         Directive 93/42 EEC

Describes the basic safety and essential performance requirements for home-care ventilatory support devices, intended mainly for use in home care but which could be used elsewhere (e.g. in healthcare facilities) for appropriate patients for whom the use of a home-care ventilator complying with ISO 10651-2 is not required.

DocumentType
Standard
Pages
46
PublisherName
National Standards Authority of Ireland
Status
Withdrawn
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 8835-3:2007 Inhalational anaesthesia systems Part 3: Transfer and receiving systems of active anaesthetic gas scavenging systems
ISO 8359:1996 Oxygen concentrators for medical use Safety requirements
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 TR 60513:1994 Fundamental aspects of safety standards for medical electrical equipment
EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
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 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
IEEE DRAFT 1073 : D3.6 SEP 95 STANDARD FOR MEDICAL DEVICE COMMUNICATIONS OVERVIEW AND FRAMEWORK
ISO 14971:2007 Medical devices Application of risk management to medical devices
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
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
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

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