UNI EN ISO 80601-2-12 : 2011
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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MEDICAL ELECTRICAL EQUIPMENT - PART 2-12: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CRITICAL CARE VENTILATORS
13-09-2022
01-01-2011
Foreword
Introduction
201.1 Scope, object and related standards
201.2 Normative references
201.3 Terms and definitions
201.4 General requirements
201.5 General requirements for testing of ME EQUIPMENT
201.6 Classification of ME EQUIPMENT and ME SYSTEMS
201.7 ME EQUIPMENT identification, marking and documents
201.8 Protection against electrical HAZARDS from ME
EQUIPMENT
201.9 Protection against mechanical HAZARDS of ME
EQUIPMENT and ME SYSTEMS
201.10 Protection against unwanted and excessive radiation
HAZARDS
201.11 Protection against excessive temperatures and other
HAZARDS
201.12 Accuracy of controls and instruments and protection
against hazardous outputs
201.13 HAZARDOUS SITUATIONS and fault conditions
201.14 PROGRAMMABLE ELECTRICAL MEDICAL
SYSTEMS (PEMS)
201.15 Construction of ME EQUIPMENT
201.16 ME SYSTEMS
201.17 Electromagnetic compatibility of ME EQUIPMENT
and ME SYSTEMS
201.101 Gas connections
201.102 Requirements for the VBS and ACCESSORIES
201.103 Spontaneous breathing during loss of power supply
201.104 Training
201.105 Indication of duration of operation
201.106 SIGNAL INPUT/OUTPUT PART
201.108 Timed ventilatory pause
202 Medical electrical equipment - Part 1-2: General
requirements for basic safety and essential performance
- Collateral standard: Electromagnetic compatibility -
Requirements and tests
206 Medical electrical equipment - Part 1-6: General
requirements for basic safety and essential performance
- Collateral Standard: Usability
208 Medical electrical equipment - Part 1-8: General
requirements for basic safety and essential performance
- Collateral Standard: General requirements, tests and
guidance for alarm systems in medical electrical
equipment and medical electrical systems
Annex C (informative) - Guide to marking and labelling
requirements for ME EQUIPMENT and ME SYSTEMS
Annex D (informative) - Symbols on marking
Annex AA (informative) - Particular guidance and rationale
Annex BB (informative) - Reference to the Essential Principles
Bibliography
Alphabetized index of defined terms used in this particular
standard
Annex ZA (informative) - Relationship between this
Document and the Essential Requirements
of EU Directive 93/42/EEC
Pertains to the BASIC SAFETY and ESSENTIAL PERFORMANCE of a VENTILATOR in combination with its ACCESSORIES, hereafter referred to as ME EQUIPMENT: - intended to be attended by a professional OPERATOR for those PATIENTS who are dependent on mechanical ventilation; and - intended for use in critical care environments in a professional healthcare facility or intended for use in transport within a professional healthcare facility.
| DevelopmentNote |
Supersedes UNI EN 794-1. (09/2011)
|
| DocumentType |
Standard
|
| PublisherName |
Ente Nazionale Italiano di Unificazione (UNI)
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| ISO 80601-2-12:2011 | Identical |
| ISO 8836:2014 | Suction catheters for use in the respiratory tract |
| ISO 7010:2011 | Graphical symbols Safety colours and safety signs Registered safety signs |
| ISO 4871:1996 | Acoustics — Declaration and verification of noise emission values of machinery and equipment |
| ISO 3744:2010 | Acoustics Determination of sound power levels and sound energy levels of noise sources using sound pressure Engineering methods for an essentially free field over a reflecting plane |
| IEC 60068-2-27:2008 | Environmental testing - Part 2-27: Tests - Test Ea and guidance: Shock |
| 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 10651-6:2004 | Lung ventilators for medical use Particular requirements for basic safety and essential performance Part 6: Home-care ventilatory support devices |
| IEC 60601-1:2005+AMD1:2012 CSV | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
| CFR 45(PTS1-199) : OCT 2017 | PUBLIC WELFARE - SUBTITLE A - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL ADMINISTRATION - SUBTITLE B - REGULATIONS RELATING TO PUBLIC WELFARE |
| 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 |
| IEC 60721-3-7:1995+AMD1:1996 CSV | Classification of environmental conditions - Part 3-7: Classification of groups of environmental parameters and their severities - Portable and non-stationary use |
| ISO 5356-1:2015 | Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets |
| ISO 10651-4:2002 | Lung ventilators — Part 4: Particular requirements for operator-powered resuscitators |
| 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 |
| 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 60068-2-31:2008 | Environmental testing - Part 2-31: Tests - Test Ec: Rough handling shocks, primarily for equipment-type specimens |
| IEC 60068-2-64:2008 | Environmental testing - Part 2-64: Tests - Test Fh: Vibration, broadband random and guidance |
| ISO 5356-2:2012 | Anaesthetic and respiratory equipment — Conical connectors — Part 2: Screw-threaded weight-bearing connectors |
| ISO 10079-1:2015 | Medical suction equipment Part 1: Electrically powered suction equipment |
| IEC 62366:2007+AMD1:2014 CSV | Medical devices - Application of usability engineering to medical devices |
| ISO 32:1977 | Gas cylinders for medical use — Marking for identification of content |
| 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 |
| IEC 60601-2-2:2017 | Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories |
| 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/TR 16142:2006 | Medical devices Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices |
| IEC 62304:2006+AMD1:2015 CSV | Medical device software - Software life cycle processes |
| ISO 14159:2002 | Safety of machinery — Hygiene requirements for the design of machinery |
| 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 |
| IEC 60529:1989+AMD1:1999+AMD2:2013 CSV | Degrees of protection provided by enclosures (IP Code) |
| ASTM F 2761 : 2009 : R2013 | Medical Devices and Medical Systems - Essential safety requirements for equipment comprising the patient-centric integrated clinical environment (ICE) - Part 1: General requirements and conceptual model |
| IEC 60601-1-3:2008+AMD1:2013 CSV | Medical electrical equipment - Part 1-3: General requirements forbasic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment |
| IEC TR 60721-4-7:2001+AMD1:2003 CSV | Classification of environmental conditions - Part 4-7: Guidance for the correlation and transformation of environmental condition classes of IEC 60721-3 to the environmental tests of IEC 60068 - Portable and non-stationary use |
| ISO 10079-3:2014 | Medical suction equipment Part 3: Suction equipment powered from a vacuum or positive pressure gas source |
| ISO 23328-1:2003 | Breathing system filters for anaesthetic and respiratory use — Part 1: Salt test method to assess filtration performance |
| 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 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 10524-1:2006 | Pressure regulators for use with medical gases Part 1: Pressure regulators and pressure regulators with flow-metering devices |
| IEC 60601-2-12:2001 | Medical electrical equipment - Part 2-12: Particular requirements for the safety of lung ventilators - Critical care ventilators |
| ISO 594-2:1998 | Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 2: Lock fittings |
| ISO 15223-1:2016 | Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements |
| ISO 11195:1995 | Gas mixers for medical use Stand-alone gas mixers |
| ISO 594-1:1986 | Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 1: General requirements |
| ISO 17664:2017 | Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices |
| ISO 7396-1:2016 | Medical gas pipeline systems — Part 1: Pipeline systems for compressed medical gases and vacuum |
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