I.S. EN 80601-2-30:2010
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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
06-13-2019
English
01-01-2010
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
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
201.101 Requirements for CUFFS
201.102 Connection tubing and CUFF connectors
201.103 Unauthorized access
201.104 Maximum inflating time
201.105 Automatic cycling modes
201.106 Clinical accuracy
202 Electromagnetic compatibility - Requirements and tests
206 Usability
211 Requirement for MEDICAL ELECTRICAL EQUPIMENT and MEDICAL
ELECTRICAL SYSTEMS used in the HOME HEALTHCARE ENVIROMENT
Annexes
Annex C (informative) - Guide to marking and labelling requirements
for ME EQUIPMENT and ME SYSTEMS
Annex AA (informative) - Particular guidance and rationale
Annex BB (informative) - Environmental aspects
Annex CC (informative) - Reference to the essential principles
Bibliography
Index of defined terms
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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