I.S. EN IEC 60601-2-1:2021
Current
The latest, up-to-date edition.
Medical electrical equipment - Part 2-1: Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV
Hardcopy , PDF
English
02-08-2021
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.
Important note : Users cannot be edited or removed once added to your Multi user PDF.
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 for ME EQUIPMENT
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 * ELECTRONIC IMAGING DEVICES (e.g. EPID)
201.102 Date and time format
201.103 EXTERNAL MONITORING DEVICES
201.104 * LATENCY
201.105 Interfaces
201.106 TREATMENT PLAN retrieval
201.107 Recording of TREATMENT delivery
201.108 ADAPTIVE RADIOTHERAPY
201.109 Imaging dose delivery
201.110 Operation of ME EQUIPMENT from outside the facility
206 USABILITY
Annexes
Annex B (informative) Sequence of testing
Annex AA (informative) Particular guidance and rationale
Annex BB (informative) Electronic imaging devices (e.g. epid)
Annex CC (informative) Latency and accuracy of dose delivery between CONTROL POINTS
Annex DD (informative) Radiobiology considerations
Bibliography
This part of IEC 60601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ELECTRON ACCELERATORS, hereafter referred to as ME EQUIPMENT, in the range 1 MeV to 50 MeV, used for TREATMENT of PATIENTS.
| Committee |
TC 62
|
| DocumentType |
Standard
|
| ISBN |
978-2-8322-8942-6
|
| Pages |
246
|
| ProductNote |
The date of any NSAI previous adoption may not match the date of its original CEN/CENELEC document. THIS STANDARD ALSO REFERS TO IEC/TR 60788,ICRP Publication 33:1982,ICRP Publication 60:1991,ICRP Publication 103:2007,ICRU Report 35:1984,ICRU Report 39:1985,ICRU Report 51:1993,ICRU Report 60:1998,9/618/Euratom,90/641/Euratom,96/29/Euratom,97/43/Euratom,2003/122/Euratom,2013/59/EURATOM
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| IEC 60601-2-1:2020 | Identical |
| EN IEC 60601-2-1:2021 | Identical |
| EN IEC 60601-2-19:2021 | Identical |
Access your standards online with a subscription
Features
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.