PREN ISO 80601-2-55 : DRAFT 2009
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
MEDICAL ELECTRICAL EQUIPMENT - PART 2-55: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS
12-01-2013
23-07-2013
Foreword
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 Interfering gas and vapour effects
201.102 Gas leakage
201.103 Port connector for DIVERTING RESPIRATORY GAS MONITOR
201.104 Minimum sampling flowrate
201.105 Contamination of breathing systems
202 Medical electrical equipment - Part 1-2: General
requirements for safety - Collateral standard:
Electromagnetic compatibility - Requirements and tests
206 Medical electrical equipment - Part 1-6: General
requirements for safety - Collateral standard: Usability
208 Medical electrical equipment - Part 1-8: General
requirements for safety - 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) - Test gas mixtures for calibration
Annex CC (informative) - Reference to the Essential Principles
Annex DD (informative) - Environmental aspects
Annex ZA (informative) - Relationship between this International
Standard and the Essential Requirements of EU
Directive 93/42/EEC
Bibliography
Describes particular requirements for the BASIC SAFETY and ESSENTIAL PERFORMANCE of RESPIRATORY GAS MONITORS, RGM, hereafter referred to as ME EQUIPMENT, intended for CONTINUOUS OPERATION for use with a PATIENT.
| Committee |
TC 215
|
| DocumentType |
Draft
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Superseded
|
| Standards | Relationship |
| 09/30197590 DC : 0 | Identical |