I.S. EN ISO 11197:2019
Current
The latest, up-to-date edition.
Medical supply units (ISO 11197:2019)
Hardcopy , PDF
English
16-12-2019
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.
Important note : Users cannot be edited or removed once added to your Multi user PDF.
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 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
202 Medical electrical equipment — Parts 1-2 General requirements for basic safety and
essential performance — Collateral standard: Electromagnetic disturbances — Requirements
and tests
206 Medical electrical equipment — Parts 1-6 General requirements for basic safety and
essential performance — Collateral standard: Usability
Annex A A (informative) Rationale
Annex B B (informative) Tests during production
Annex C C (informative) Documentation
Annex D D (informative) Terminology — Alphabetical index of defined terms
Bibliography
This document applies to the basic safety and essential performance of medical supply units, hereafter also referred to as ME equipment.
| Committee |
TC 121
|
| DocumentType |
Standard
|
| Pages |
54
|
| 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 19054:2006. |
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| EN ISO 11197:2019 | Identical |
| ISO 11197:2019 | Identical |
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