09/30155521 DC : 0
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
BS EN 60601-1-11 ED.1 - MEDICAL ELECTRICAL EQUIPMENT - PART 1-11: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS USED IN THE HOME HEALTHCARE ENVIRONMENT
Hardcopy , PDF
31-07-2010
English
Important note : Users cannot be edited or removed once added to your Multi user PDF.
FOREWORD
INTRODUCTION
1 Scope, object and related standards
1.1 Scope
1.2 Object
1.3 Related standards
2 Normative references
3 Terms and definitions
4 General requirements
4.1 Additional requirements for SUPPLY MAINS
for ME EQUIPMENT and ME SYSTEMS
4.2 Environmental conditions for ME EQUIPMENT
5 General requirements for testing ME EQUIPMENT
6 Classification of ME EQUIPMENT and ME SYSTEMS
7 ME EQUIPMENT identification, marking and documents
7.1 USABILITY of the ACCOMPANYING DOCUMENTS
7.2 Additional requirements for marking of IP
classification
7.3 ACCOMPANYING DOCUMENTS
7.4 Instructions for use
7.5 Technical description
8 Protection against excessive temperatures
and other HAZARDS
8.1 Additional requirements for cleaning, disinfection
of ME EQUIPMENT and ME SYSTEMS
8.2 Additional requirements for sterilization of ME
EQUIPMENT and ME SYSTEMS
8.3 Additional requirements for ingress of water or
particulate matter into ME EQUIPMENT and ME SYSTEMS
8.4 Additional requirements for interruption of the power
supply/SUPPLY MAINS to ME EQUIPMENT
9 Accuracy of controls and instruments and protection against
hazardous outputs
10 Construction of ME EQUIPMENT
10.1 Additional requirements for mechanical strength
10.2 Additional requirements for an INTERNAL ELECTRICAL
POWER SOURCE
10.3 Additional requirements for actuating parts of controls
of ME EQUIPMENT
11 Protection against strangulation or asphyxiation
12 Additional requirements for electromagnetic compatibility
of ME EQUIPMENT and ME SYSTEMS
12.1 Additional technical description requirements
applicable to ME EQUIPMENT and ME SYSTEMS
12.2 Additional requirements applicable to ME EQUIPMENT
and ME SYSTEMS specified for use only in a shielded
location
12.3 Additional requirements for ELECTROSTATIC DISCHARGE
(ESD) tests
Annex A (informative) - General guidance and rationale
Annex B (informative) - Guide to marking and labelling
requirements for ME EQUIPMENT and ME SYSTEMS
Bibliography
Index of defined terms used in this collateral standard
BS EN 60601-1-11 ED.1
| Committee |
CH/62/1
|
| DocumentType |
Draft
|
| Pages |
51
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy |
| IEC 60950-1:2005+AMD1:2009+AMD2:2013 CSV | Information technology equipment - Safety - Part 1: General requirements |
| IEC 60038:2009 | IEC standard voltages |
| IEC 60068-2-27:2008 | Environmental testing - Part 2-27: Tests - Test Ea and guidance: Shock |
| EN 13718-1:2014 | Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances |
| ISO 10651-2:2004 | Lung ventilators for medical use Particular requirements for basic safety and essential performance Part 2: Home care ventilators for ventilator-dependent patients |
| MIL-STD-810 Revision G:2008 | ENVIRONMENTAL ENGINEERING CONSIDERATIONS AND LABORATORY TESTS |
| IEC 60601-1:2005+AMD1:2012 CSV | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
| IEC 60601-1-6:2010+AMD1:2013 CSV | Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability |
| IEC 60721-3-7:1995+AMD1:1996 CSV | Classification of environmental conditions - Part 3-7: Classification of groups of environmental parameters and their severities - Portable and non-stationary use |
| IEC 60601-1-8:2006+AMD1:2012 CSV | Medical electrical equipment - Part 1-8: General requirements forbasic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems inmedical electrical equipment and medical electrical systems |
| IEC 60068-2-31:2008 | Environmental testing - Part 2-31: Tests - Test Ec: Rough handling shocks, primarily for equipment-type specimens |
| IEC 60068-2-64:2008 | Environmental testing - Part 2-64: Tests - Test Fh: Vibration, broadband random and guidance |
| IEC 60601-1-2:2014 | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests |
| ISO/TR 16142:2006 | Medical devices Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices |
| IEC 60529:1989+AMD1:1999+AMD2:2013 CSV | Degrees of protection provided by enclosures (IP Code) |
| IEC TR 60721-4-7:2001+AMD1:2003 CSV | Classification of environmental conditions - Part 4-7: Guidance for the correlation and transformation of environmental condition classes of IEC 60721-3 to the environmental tests of IEC 60068 - Portable and non-stationary use |
| IEC 61032:1997 | Protection of persons and equipment by enclosures - Probes for verification |
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.