I.S. EN ISO 80601-2-13:2012/A2:2019
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation - Amendment 2 (ISO 80601-2- 13:2011/Amd 2:2018)
Hardcopy , PDF
19-12-2019
English
18-12-2019
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.
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 Additional requirements for ANAESTHETIC GAS DELIVERY SYSTEMS
201.102 Additional requirements for an ANAESTHETIC BREATHING SYSTEM
201.103 Additional requirements for an ANAESTHETIC GAS SCAVENGING SYSTEM
201.104 Additional requirements for an ANAESTHETIC VAPOUR DELIVERY SYSTEM
201.105 Additional requirements for an ANAESTHETIC VENTILATOR
201.106 Display loops
201.107 Clinical evaluation
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 environmentally conscious design
210 PROCESS requirements for the development of physiologic closed-loop controllers
211 Requirements for MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS used in
Annex C (informative) Guide to marking and labelling requirements for ME EQUIPMENT and ME SYSTEMS or their parts
Annex D (informative) Symbols on marking
Annex AA (informative) Particular guidance and rationale
Annex BB (normative) Test for flammability of anaesthetic agent
Annex DD (informative) Reference to the essential principles
Bibliography
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