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Medical electrical equipment - Part 2-67: Particular requirements for basic safety and essential performance of oxygenconserving equipment (ISO 80601-2- 67:2020)

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Hardcopy , PDF

Language(s)

English

Published date

12-07-2020

Publisher

National Standards Authority of Ireland

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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 parts and accessories
201.103 Oxygen pressure regulators
202 Electromagnetic disturbances – Requirements and tests
202.4.3.1 * Configurations
206 Usability
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 IMDRF essential principles and labelling guidances
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 is applicable to the basic safety and essential performance of oxygen conserving equipment, hereafter referred to as ME equipment, in combination with its accessories intended to conserve supplemental oxygen by delivering gas intermittently and synchronized with the patient's inspiratory cycle, when used in the home healthcare environment.

Committee	TC 121
DocumentType	Standard
Pages	76
ProductNote	The date of any NSAI previous adoption may not match the date of its original CEN/CENELEC document THIS STANDARD ALSO REFERS TO :ISO 80369-2
PublisherName	National Standards Authority of Ireland
Status	Current
Supersedes	I.S. EN ISO 18779:2005

Standards	Relationship
ISO 80601-2-67:2020	Identical
EN ISO 80601-2-67:2020	Identical

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I.S. EN ISO 80601-2-67:2020

Medical electrical equipment - Part 2-67: Particular requirements for basic safety and essential performance of oxygenconserving equipment (ISO 80601-2- 67:2020)

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