I.S. EN 60601-2-12:2006
Current
The latest, up-to-date edition.
MEDICAL ELECTRICAL EQUIPMENT - PART 2-12: PARTICULAR REQUIREMENTS FOR THE SAFETY OF LUNG VENTILATORS - CRITICAL CARE VENTILATORS
Hardcopy , PDF
English
01-01-2006
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.
Dates of withdrawal of national standards are available from NSAI.
FOREWORD
INTRODUCTION
SECTION ONE - GENERAL
1 Scope and object
2 Terminology and definitions
3 General requirements
4 General requirements for tests
5 Classification
6 Identification, marking and documents
7 Power input
SECTION TWO - ENVIRONMENTAL CONDITIONS
8 Basic safety categories
9 Removable protective means
10 Environmental conditions
SECTION THREE - PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
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
SECTION FOUR - PROTECTION AGAINST MECHANICAL HAZARDS
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
SECTION FIVE - PROTECTION AGAINST HAZARDS FROM UNWANTED OR
EXCESSIVE RADIATION
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
SECTION SIX - PROTECTION AGAINST HAZARDS OF IGNITION OF FLAMMABLE
ANAESTHETIC MIXTURES
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
SECTION SEVEN - PROTECTION AGAINST EXCESSIVE TEMPERATURES AND
OTHER SAFETY HAZARDS
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
SECTION EIGHT - ACCURACY OF OPERATING DATAAND PROTECTION
AGAINST HAZARDOUS OUTPUT
50 Accuracy of operating data
51 Protection against hazardous output
SECTION NINE - ABNORMAL OPERATION AND FAULT CONDITIONS;
ENVIRONMENTAL TESTS
52 Abnormal operation and fault conditions
53 Environmental tests
SECTION TEN - CONSTRUCTIONAL REQUIREMENTS
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
Appendix L References - Publications mentioned in this standard
Annex AA (informative) Rationale
Annex BB (normative) Legibility and visibility of visual indications
Annex CC (informative) Intelligent alarm systems
Annex ZA (normative) Normative references to international
publications with their corresponding European publications
Annex ZB (informative) References to international publications
with their corresponding European publications
Annex ZZ (informative) Coverage of Essential Requirements
of EC Directives
Bibliography
Terminology - Index of defined terms
Describes the safety requirements for VENTILATORS, as defined in 2.1.125, intended for use in critical care settings.
DevelopmentNote |
Supersedes I.S. EN 794-1. (07/2008) For CENELEC adoptions of IEC publications, please check www.iec.ch to be sure that you have any corrigenda that may apply. (01/2017)
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DocumentType |
Standard
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Pages |
58
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PublisherName |
National Standards Authority of Ireland
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Status |
Current
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Standards | Relationship |
NBN EN 60601-2-12 : 2007 | Identical |
UNE-EN 60601-2-12:2007 | Identical |
BS EN 60601-2-12:2006 | Identical |
NF EN 60601-2-12 : 2007 | Identical |
EN 60601-2-12:2006 | Identical |
DIN EN 60601-2-12 : 2007 | Identical |
IEC 60601-2-12:2001 | Identical |
SN EN 60601-2-12 : 2006 | Identical |
EN 556:1994 + A1:1998 | STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR TERMINALLY-STERILIZED MEDICAL DEVICES TO BE LABELLED "STERILE" |
EN 550 : 1994 | STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF ETHYLENE OXIDE STERILIZATION |
ISO 8835-3:2007 | Inhalational anaesthesia systems Part 3: Transfer and receiving systems of active anaesthetic gas scavenging systems |
ISO 11138-3:2017 | Sterilization of health care products — Biological indicators — Part 3: Biological indicators for moist heat sterilization processes |
ISO 9703-1:1992 | Anaesthesia and respiratory care alarm signals Part 1: Visual alarm signals |
IEC 60416:1988 | General principles for the formulation of graphical symbols |
IEC 60417-1:2002 | Graphical symbols for use on equipment - Part 1: Overview and application |
ISO 11135:2014 | Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices |
ISO 10651-2:2004 | Lung ventilators for medical use Particular requirements for basic safety and essential performance Part 2: Home care ventilators for ventilator-dependent patients |
IEC 60601-1:2005+AMD1:2012 CSV | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
ISO 7767:1997 | Oxygen monitors for monitoring patient breathing mixtures — Safety requirements |
ISO 5356-1:2015 | Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets |
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 |
EN 60601-1-1:2001 | Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems |
ISO 9918:1993 | Capnometers for use with humans Requirements |
ISO 5356-2:2012 | Anaesthetic and respiratory equipment — Conical connectors — Part 2: Screw-threaded weight-bearing connectors |
ISO 11138-2:2017 | Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes |
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 |
EN 60601-1-2:2015 | 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 10651-3:1997 | Lung ventilators for medical use Part 3: Particular requirements for emergency and transport ventilators |
ISO 8185:2007 | Respiratory tract humidifiers for medical use Particular requirements for respiratory humidification systems |
ISO 7396:1987 | Non-flammable medical gas pipeline systems |
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 60417-2:1998 | Graphical symbols for use on equipment - Part 2: Symbol originals |
ISO 9919:2005 | Medical electrical equipment Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use |
IEEE DRAFT 1073 : D3.6 SEP 95 | STANDARD FOR MEDICAL DEVICE COMMUNICATIONS OVERVIEW AND FRAMEWORK |
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 11138-1:2017 | Sterilization of health care products — Biological indicators — Part 1: General requirements |
ISO 11134:1994 | Sterilization of health care products — Requirements for validation and routine control — Industrial moist heat sterilization |
ISO 14971:2007 | Medical devices Application of risk management to medical devices |
EN 60601-1-4:1996/A1:1999 | MEDICAL ELECTRICAL EQUIPMENT - GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD: PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS |
ISO 7000:2014 | Graphical symbols for use on equipment Registered symbols |
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 |
ISO 11137:1995 | Sterilization of health care products Requirements for validation and routine control Radiation sterilization |
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 |
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 15223:2000 | Medical devices Symbols to be used with medical device labels, labelling and information to be supplied |
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