I.S. EN ISO 80601-2-13:2012/A1:2019
Current
The latest, up-to-date edition.
Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation (ISO 80601-2- 13:2011)
Hardcopy , PDF
English
19-12-2019
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.
Foreword
Introduction
1 Scope, object and related standards
2 Normative references
3 Terms and definitions
4 General requirements
5 General requirements for testing ME EQUIPMENT
6 Classification of ME EQUIPMENT and ME SYSTEMS
7 ME EQUIPMENT identification, marking and documents
8 Protection against electrical HAZARDS from ME EQUIPMENT
9 Protection against mechanical HAZARDS of ME EQUIPMENT and ME SYSTEMS
10 Protection against unwanted and excessive radiation HAZARDS
11 Protection against excessive temperatures and other HAZARDS
12 Accuracy of controls and instruments and protection against hazardous outputs
13 HAZARDOUS SITUATIONS and fault conditions
14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)
15 Construction of ME EQUIPMENT
16 ME SYSTEMS
17 Electromagnetic compatibility of ME EQUIPMENT AND ME SYSTEMS
101 Additional requirements for ANAESTHETIC GAS DELIVERY SYSTEMS
102 Additional requirements for an ANAESTHETIC BREATHING SYSTEM
103 Additional requirements for an ANAESTHETIC GAS SCAVENGING SYSTEM
104 Additional requirements for an ANAESTHETIC VAPOUR DELIVERY SYSTEM
105 Additional requirements for an ANAESTHETIC VENTILATOR
106 Display loops
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
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
Annex D (informative) Symbols on marking
Annex AA (informative) Particular guidance and rationale
Annex BB (normative) Test for flammability of anaesthetic agent
Annex CC (informative) Environmental aspects
Annex DD (informative) Reference to the essential principles
Bibliography
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