I.S. EN ISO 80601-2-13:2012
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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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
01-01-2012
17-12-2019
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
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
pause
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 the home healthcare
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 CC (informative) - Environmental aspects
Annex DD (informative) - Reference to the essential principles
Annex ZA (informative) - Relationship between this
European Standard and the Essential
Requirements of EU Directive 93/42/EEC
Bibliography
Alphabetized index of defined terms used in this particular
standard
Pertains to the BASIC SAFETY and ESSENTIAL PERFORMANCE of an ANAESTHETIC WORKSTATION for administering inhalational anaesthesia whilst continuously attended by a professional OPERATOR.
| DevelopmentNote |
Supersedes I.S. EN ISO 8835-2, I.S. EN ISO 8835-3, I.S. EN ISO 8835-4, I.S. EN ISO 8835-5 & I.S. EN 60601-2-13. (02/2013)
|
| DocumentType |
Standard
|
| Pages |
119
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| ISO 80601-2-13:2011 | Identical |
| EN ISO 80601-2-13:2012 | Identical |
| BS EN ISO 80601-2-13:2012 | Equivalent |
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