I.S. EN 60601-2-39:2008
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
Hardcopy , PDF
05-24-2022
English
01-01-2008
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.
FOREWORD
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 PD EQUIPMENT
201.6 Classification of ME EQUIPMENT and ME SYSTEMS
201.7 PD EQUIPMENT identification, marking and documents
201.8 Protection against electrical HAZARDS from PD 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 Electromagnetic compatibility - Requirements and tests
203 General requirements for radiation protection in diagnostic
X-ray equipment
206 Usability
208 General requirements, tests and guidance for alarm systems
in medical electrical equipment and medical electrical systems
209 Requirements for the reduction of environmental impacts
210 Process requirements for the development of physiologic
closed-loop controllers
Annexes
Annex G (normative) - Protection against HAZARDS of ignition of
flammable anaesthetic mixtures
Annex AA (informative) - Particular guidance and rationale Index
of defined terms used in this particular standard
Index of defined terms used in this particular standard
Annex ZA (normative) - Normative references to international
publications with their corresponding European
publications
Annex ZZ (informative) - Coverage of Essential Requirements of
EC Directives
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