• There are no items in your cart

BS EN 60601-2-1:2015

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Medical electrical equipment Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV
Available format(s)

Hardcopy , PDF

Superseded date

12-29-2021

Language(s)

English

Published date

10-31-2016

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
206 Usability
Annexes
Annex B (informative) - Sequence of testing
Annex I (informative) - ME SYSTEMS aspects
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 EU
         Directives

Pertains 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
CH/62/3
DevelopmentNote
Supersedes 01/561347 DC, 95/563441 DC, BS 5724-2.1(1989) and BS 5724-2.1:SUPP1(1991). (08/2003) 1998 Edition along with it's amendment remains active & will be withdrawn on 15/09/2018. Supersedes BS 5724-2.1(1998), 08/30168475 DC & 11/30253577 DC. (11/2015)
DocumentType
Standard
Pages
70
PublisherName
British Standards Institution
Status
Superseded
SupersededBy
Supersedes

BS 5724-3.1:Supplement No. 1:1990 Medical electrical equipment. Particular requirements for performance Methods of declaring functional performance characteristics of medical electron accelerators in the range 1 MeV to 50 MeV. Guide to functional performance values

EN 61217:2012 Radiotherapy equipment - Coordinates, movements and scales
IEC TR 60788:2004 Medical electrical equipment - Glossary of defined terms
IEC 60976:2007 Medical electrical equipment - Medical electron accelerators - Functional performance characteristics
IEC TR 60977:2008 Medical electrical equipment - Medical electron accelerators - Guidelines for functional performance characteristics
EN 62366 : 2008 AMD 1 2015 MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES (IEC 62366:2007/A1:2014)
IEC 61217:2011 Radiotherapy equipment - Coordinates, movements and scales
EN 60976:2007 Medical electrical equipment - Medical electron accelerators - Functional performance characteristics

View more information
US$330.61
Excluding Tax where applicable

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.