I.S. 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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 (ISO 80601-2-12:2011/COR 1:2011)
Hardcopy , PDF
English
01-01-2011
16-05-2020
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
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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 I.S. EN 794-1. (05/2011)
|
| DocumentType |
Standard
|
| Pages |
105
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| ISO 80601-2-12:2011 | Identical |
| EN ISO 80601-2-12:2011 | Equivalent |
| BS EN ISO 80601-2-12:2011 | Equivalent |
| UNE-EN ISO 80601-2-12:2011 | Equivalent |
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