CEI EN 60601-2-12 : 2007
Current
The latest, up-to-date edition.
MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF LUNG VENTILATORS - CRITICAL CARE VENTILATORS
Hardcopy , PDF
English - Italian
01-11-2007
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
The Standard deals with the safety of ventilators, defined as automatic devices that are intended to augment or provide ventilation to the patient's lungs when inserted into his or her airways, set up for intensive care treatments.
| Committee |
CT 62
|
| DevelopmentNote |
Classificazione CEI 62-141. (12/2006)
|
| DocumentType |
Standard
|
| Pages |
98
|
| PublisherName |
Comitato Elettrotecnico Italiano
|
| Status |
Current
|
| Supersedes |
| 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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