I.S. EN ISO 80601-2-12:2020
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 80601-2-12:2020)
Hardcopy , PDF
16-11-2023
English
29-03-2020
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.
Dates of withdrawal of national standards are available from NSAI.
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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 for ME equipment
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 * Indication of duration of operation
201.105 Functional connection
201.106 Display loops
201.107 * Timed ventilatory pause
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
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) Data interfaces
Annex CC (informative) Reference to the essential principles
Annex DD (informative) Reference to the general safety and performance requirements
Annex EE (informative) Terminology — Alphabetized index of defined terms
Bibliography
This document applies to the basic safety and essential performance of a ventilator in combination with its accessories, hereafter referred to as ME equipment: intended for use in an environment that provides specialized care for patients whose conditions can be life-threatening and who can require comprehensive care and constant monitoring in a professional healthcare facility; intended to be operated by a healthcare professional operator; and intended for those patients who need differing levels of support from artificial ventilation including for ventilator-dependent patients.
| Committee |
TC 121
|
| DocumentType |
Standard
|
| Pages |
160
|
| ProductNote |
The date of any NSAI previous adoption may not match the date of its original CEN/CENELEC document. THIS STANDARD IS ALSO REFERS TO ISO 80601-2-84, ASTM F2761-09, IEC 80001-2-5:2014, ISO 80601-2-87
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| ISO 80601-2-12:2020 | Identical |
| EN ISO 80601-2-12:2020 | Identical |
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