UNI EN ISO 80601-2-69 : 2014
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
05-28-2022
01-01-2014
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 Outlet connector
201.102 Requirements for parts and ACCESSORIES
201.103 SIGNAL INPUT/OUTPUT PART
201.104 Indication of duration of operation
201.105 Integrated CONSERVING EQUIPMENT
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
211 Medical electrical equipment - Part 1-11: General requirements
for basic safety and essential performance - Collateral
Standard: 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) - Reference to the Essential Principles
Bibliography
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