I.S. EN ISO 80601-2-55:2018
Current
The latest, up-to-date edition.
MEDICAL ELECTRICAL EQUIPMENT - PART 2-55: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS (ISO 80601-2-55:2018)
Hardcopy , PDF
English
01-01-2018
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National Foreword
European foreword
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
201.10Protection against unwanted and
excessive radiation HAZARDS
201.11Protection against excessive temperatures
and other HAZARDS
201.12Accuracy of controls and instruments
and protection against hazardous outputs
201.13HAZARDOUS SITUATIONS and fault conditions
201.14PROGRAMMABLE ELECTRICAL MEDICAL
SYSTEMS (PEMS)
201.15Construction of ME EQUIPMENT
201.16ME SYSTEMS
201.17Electromagnetic compatibility of ME
EQUIPMENT and ME SYSTEMS
201.101 Interfering gas and vapour effects
201.102 Gas leakage
201.103 Port connectors for DIVERTING RGMs
201.104 Sampling flowrate
201.105 Contamination of breathing systems
201.106 FUNCTIONAL CONNECTION
202 Electromagnetic disturbances - Requirements and tests
206 USABILITY
208 General requirements, tests and guidance for
ALARM SYSTEMS in MEDICAL ELECTRICAL
EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS
211 General requirements, tests and guidance
for medical electrical equipment and medical
electrical systems used in the home healthcare environment
212 General requirements, tests and guidance for
MEDICAL ELECTRICAL EQUIPMENT and
MEDICAL ELECTRICAL SYSTEMS intended
for use in the EMERGENCY MEDICAL SERVICES
ENVIRONMENT
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) - Test gas mixtures for calibration
Annex CC (informative) - Data interface requirements
Annex DD (informative) - Alphabetized index of defined
terms used in this document
Bibliography
Annex ZA (informative) - Relationship between this
European Standard and the essential requirements
of Directive 93/42/EEC [OJ L 169] aimed to be covered
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 I.S. EN ISO 21647. (01/2013)
|
| DocumentType |
Standard
|
| Pages |
82
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| ISO 80601-2-55:2011 | Identical |
| EN ISO 80601-2-55:2018 | Identical |
| 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 |
| EN 15986:2011 | Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates |
| 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 |
| 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 |
| 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 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 62570:2014 | Standard practice for marking medical devices and other items for safety in the magnetic resonance environment |
| IEC 60068-2-64:2008 | Environmental testing - Part 2-64: Tests - Test Fh: Vibration, broadband random and guidance |
| 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 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 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 |
| NFPA 53M : 1990 | FIRE HAZARDS IN OXYGEN-ENRICHED ATMOSPHERES |
| ISO 80000-1:2009 | Quantities and units — Part 1: General |
| 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 6142-1:2015 | Gas analysis Preparation of calibration gas mixtures Part 1: Gravimetric method for Class I mixtures |
| 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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