I.S. EN ISO 80601-2-70:2020
Current
The latest, up-to-date edition.
Medical electrical equipment - Part 2-70: Particular requirements for the basic safety and essential performance of sleep apnoea breathing therapy equipment (ISO 80601-2-70:2020)
Hardcopy , PDF
English
14-12-2020
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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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 Breathing gas pathway connectors
201.102 Requirements for the breathing gas pathway and accessories
201.103 Functional connection
201.104 Training
202 Electromagnetic disturbances — Requirements and tests
206 Usability
211 Requirements for medical electrical equipment and medical electrical systems used in the home healthcare 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) Data interface requirements
Annex CC (informative) Reference to the IMDRF essential principles and labelling guidances
Annex DD (informative) Reference to the essential principles
Annex EE (informative) Reference to the general safety and performance requirements
Annex FF (informative) Terminology — alphabetized index of defined terms
Bibliography
IEC 60601‐1:2005+Amendment 1:2012, 1.1 is replaced by: This document is applicable to the basic safety and essential performance of sleep apnoea breathing therapy equipment, hereafter referred to as ME equipment, intended to alleviate the symptoms of patients who suffer from obstructive sleep apnoea by delivering a therapeutic breathing pressure to the respiratory tract of the patient. Sleep apnoea breathing therapy equipment is intended for use in the home healthcare environment by lay operators as well as in professional healthcare institutions.
| Committee |
TC 121
|
| DocumentType |
Standard
|
| Pages |
88
|
| ProductNote |
THIS STANDARD IS REFERS TO : IEC 60601‐1:2005+AMD1:2012+AMD2:2020,ISO 5356‐1,ISO 16142‐1:2016,ISO 16142‐1:,ISO 18562‐1,ISO 80369‐1,ISO 80601‐2‐12,ISO 80601‐2‐74,IEC 60601‐1:,ISO/IEEE 11073‐10424,ISO 18562‐2,ISO 80601‐2‐13,ISO 80601‐2‐72,ISO 80601‐2‐79,ISO 80601‐2‐80,ISO 80601‐2‐84,ISO 80601‐2‐87 The date of any NSAI previous adoption may not match the date of its original CEN/CENELEC document.
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| EN ISO 80601-2-70:2020 | Identical |
| ISO 80601-2-70:2020 | Identical |
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