UNI EN ISO 80601-2-55 : 2012
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 2-55: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS
13-09-2022
01-01-2012
Foreword
Introduction
1 Scope
201.1 Scope, object and related standards
201.2 Normative references
201.3 Terms and definitions
201.5 General requirements for testing 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 Interfering gas and vapour effects
201.102 Gas leakage
201.103 Port connector for DIVERTING RGM
201.104 Minimum sampling flowrate
201.105 Contamination of breathing systems
202 Electromagnetic compatibility - Requirements
and tests
206 Usability
208 General requirements, tests and guidance for
alarm systems in medical electrical
equipment and medical electrical systems
209 Requirements for environmentally conscious design
210 Requirements for the development of physiologic
closed-loop controllers
211 Requirements for MEDICAL ELECTRICAL EQUIPMENT
and MEDICAL ELECTRICAL SYSTEMS used in
the home healthcare environment
Annex C (informative) - Guide to marking and labeling
requirements for ME EQUIPMENT and ME SYSTEMS
Annex D (informative) - Symbols on marking
Annex AA (informative) - Particular guidance and rationale
Annex BB (informative) - Environmental aspects
Annex CC (informative) - Test gas mixtures for calibration
Annex DD (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 particular requirements for the BASIC SAFETY and ESSENTIAL PERFORMANCE of a RESPIRATORY GAS MONITOR (RGM), hereafter referred to as ME EQUIPMENT, intended for CONTINUOUS OPERATION for use with a PATIENT.
| DevelopmentNote |
Supersedes UNI EN ISO 21647. (06/2012)
|
| DocumentType |
Standard
|
| PublisherName |
Ente Nazionale Italiano di Unificazione (UNI)
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| ISO 80601-2-55:2011 | Identical |
| EN ISO 80601-2-55:2018 | Identical |
| IEC 60950-1:2005+AMD1:2009+AMD2:2013 CSV | Information technology equipment - Safety - Part 1: General requirements |
| IEC 60038:2009 | IEC standard voltages |
| ISO 7010:2011 | Graphical symbols Safety colours and safety signs Registered safety signs |
| ASTM F 1452 : 2001 | Standard Specification for Minimum Performance and Safety Requirements for Anesthetic Gas Monitors |
| ISO 80601-2-13:2011 | Medical electrical equipment Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation |
| ISO/TS 29041:2008 | Gas mixtures — Gravimetric preparation — Mastering correlations in composition |
| IEC 60068-2-27:2008 | Environmental testing - Part 2-27: Tests - Test Ea and guidance: Shock |
| EN 13718-1:2014 | Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances |
| 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 |
| MIL-STD-810 Revision G:2008 | ENVIRONMENTAL ENGINEERING CONSIDERATIONS AND LABORATORY TESTS |
| IEC 60601-1:2005+AMD1:2012 CSV | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
| EN 12598 : 1999 | OXYGEN MONITORS FOR PATIENT BREATHING MIXTURES - PARTICULAR REQUIREMENTS |
| 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 |
| ISO 7767:1997 | Oxygen monitors for monitoring patient breathing mixtures — Safety requirements |
| 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 |
| IEC 60601-1-10:2007+AMD1:2013 CSV | Medical electrical equipment - Part 1-10: General requirements forbasic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loopcontrollers |
| 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 |
| ISO 9918:1993 | Capnometers for use with humans Requirements |
| 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 |
| EN 864 : 1996 | MEDICAL ELECTRICAL EQUIPMENT - CAPNOMETERS FOR USE WITH HUMANS - PARTICULAR REQUIREMENTS |
| ISO 21647:2004 | Medical electrical equipment Particular requirements for the basic safety and essential performance of respiratory gas monitors |
| 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 6143:2001 | Gas analysis — Comparison methods for determining and checking the composition of calibration gas mixtures |
| 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 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) |
| ISO 6142:2001 | Gas analysis Preparation of calibration gas mixtures Gravimetric method |
| 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 61000-4-3:2006+AMD1:2007+AMD2:2010 CSV | Electromagnetic compatibility (EMC) - Part 4-3: Testing and measurement techniques - Radiated, radio-frequency, electromagnetic field immunity test |
| ISO 80369-1:2010 | Small-bore connectors for liquids and gases in healthcare applications Part 1: General requirements |
| NFPA 53M : 1990 | FIRE HAZARDS IN OXYGEN-ENRICHED ATMOSPHERES |
| 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 23328-1:2003 | Breathing system filters for anaesthetic and respiratory use — Part 1: Salt test method to assess filtration performance |
| ISO 14155:2011 | Clinical investigation of medical devices for human subjects Good clinical practice |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
| ISO 7000:2014 | Graphical symbols for use on equipment Registered symbols |
| ISO 15223-1:2016 | Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements |
| IEC 60601-1-9:2007+AMD1:2013 CSV | Medical electrical equipment - Part 1-9: General requirements forbasic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design |
| ISO 17664:2017 | Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices |
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