MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF LUNG VENTILATORS - CRITICAL CARE VENTILATORS

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Hardcopy , PDF

Language(s)

English - Italian

Published date

01-01-2007

Publisher

Comitato Elettrotecnico Italiano

INTRODUCTION
SECTION ONE - GENERAL
SECTION TWO - ENVIRONMENTAL
              CONDITIONS
SECTION THREE - PROTECTION
                AGAINST ELECTRIC
                SHOCK HAZARDS
SECTION FOUR - PROTECTION
               AGAINST MECHANICAL
               HAZARDS
SECTION FIVE - PROTECTION
               AGAINST HAZARDS
               FROM UNWANTED OR
               EXCESSIVE RADIATION
SECTION SIX - PROTECTION AGAINST
              HAZARDS OF IGNITION
              OF FLAMMABLE
              ANAESTHETIC MIXTURES
SECTION SEVEN - PROTECTION
                AGAINST EXCESSIVE
                TEMPERATURES AND
                OTHER SAFETY HAZARDS
SECTION EIGHT - ACCURACY OF
                OPERATING DATA
                AND PROTECTION AGAINST
                HAZARDOUS OUTPUT
SECTION NINE - ABNORMAL OPERATION
               AND FAULT CONDITIONS;
               ENVIRONMENTAL TESTS
SECTION TEN - CONSTRUCTIONAL REQUIREMENTS
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
Bibliography
Terminology - Index of defined terms
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

Specifies the safety requirements for VENTILATORS, intended for use in critical care settings.

Committee	CT 62
DevelopmentNote	Classificazione CEI 62-141. (12/2006)
DocumentType	Standard
Pages	98
PublisherName	Comitato Elettrotecnico Italiano
Status	Current

Standards	Relationship
IEC 60601-2-12:2001	Identical
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
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
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
CEI 62-5 : 1ED 1980
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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CEI EN 60601-2-12 : 2007

MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF LUNG VENTILATORS - CRITICAL CARE VENTILATORS

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Abstract

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