CEI EN 60601-1-11 : 2016
Current
The latest, up-to-date edition.
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
English
01-01-2016
Important note : Users cannot be edited or removed once added to your Multi user PDF.
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 excessive temperatures and other HAZARDS
9 Accuracy of controls and instruments and protection against
hazardous outputs
10 Construction of ME EQUIPMENT
11 Protection against strangulation or asphyxiation
12 Additional requirements for ELECTROMAGNETIC EMISSIONS
of ME EQUIPMENT and ME SYSTEMS
13 Additional requirements for ALARM SYSTEMS of ME EQUIPMENT
and ME SYSTEMS
Annex A (informative) - General guidance and rationale
Annex B (informative) - Guide to marking and labelling
requirements for ME EQUIPMENT and ME SYSTEMS
Annex C (informative) - Symbols on marking
Bibliography
Index of defined terms used in this collateral standard
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 MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS for use in the HOME HEALTHCARE ENVIRONMENT, and specified by the MANUFACTURER in the instructions for use.
| Committee |
CT 62
|
| DevelopmentNote |
Classificazione CEI 62-228. (08/2011) New child AMD 1 2022 is added
|
| DocumentType |
Standard
|
| Pages |
88
|
| ProductNote |
New child AMD 1 2022 is added
|
| PublisherName |
Comitato Elettrotecnico Italiano
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| EN 60601-1-11:2015 | Identical |
| ISO 7010:2011 | Graphical symbols Safety colours and safety signs Registered safety signs |
| IEC 60068-2-27:2008 | Environmental testing - Part 2-27: Tests - Test Ea and guidance: Shock |
| 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 |
| EN 60068-2-64:2008 | ENVIRONMENTAL TESTING - PART 2-64: TESTS - TEST FH: VIBRATION, BROADBAND RANDOM AND GUIDANCE |
| EN 60601-1-6:2010/A1:2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-6: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: USABILITY (IEC 60601-1-6:2010/A1:2013) |
| 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 62366:2007+AMD1:2014 CSV | Medical devices - Application of usability engineering to medical devices |
| 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 |
| EN 60601-1-2:2015 | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests |
| EN 60068-2-27:2009 | Environmental testing - Part 2-27: Tests - Test Ea and guidance: Shock |
| EN 60601-1-12:2015 | Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment |
| IEC 60529:1989+AMD1:1999+AMD2:2013 CSV | Degrees of protection provided by enclosures (IP Code) |
| EN 62366 : 2008 AMD 1 2015 | MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES (IEC 62366:2007/A1:2014) |
| CISPR 11:2015 RLV | Industrial, scientific and medical equipment - Radio-frequency disturbance characteristics - Limits and methods of measurement |
| EN 60529:1991/AC:2016-12 | DEGREES OF PROTECTION PROVIDED BY ENCLOSURES (IP CODE) (IEC 60529 EDITION 2.2 CORRIGENDUM 2:2015) |
| ISO 7000:2014 | Graphical symbols for use on equipment Registered symbols |
| ISO 15223-1:2016 | Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements |
| EN ISO 7010 : 2012 AMD 7 2017 | GRAPHICAL SYMBOLS - SAFETY COLOURS AND SAFETY SIGNS - REGISTERED SAFETY SIGNS (ISO 7010:2011/AMD 7:2016) |
| EN 60601-1-8:2007/A11:2017 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-8: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: GENERAL REQUIREMENTS, TESTS AND GUIDANCE FOR ALARM SYSTEMS IN MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS (IEC 60601-1-8:2006/A1:2012) |
| EN 60068-2-31:2008 | ENVIRONMENTAL TESTING - PART 2-31: TESTS - TEST EC: ROUGH HANDLING SHOCKS, PRIMARILY FOR EQUIPMENT-TYPE SPECIMENS |
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.