BS EN 60601-1-10 : 2008
Current
The latest, up-to-date edition.
MEDICAL ELECTRICAL EQUIPMENT - PART 1-10: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR THE DEVELOPMENT OF PHYSIOLOGIC CLOSED-LOOP CONTROLLERS
Hardcopy , PDF
English
01-01-2008
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FOREWORD
INTRODUCTION
1 Scope, object and related standards
2 Normative references
3 Terms and definitions
4 General requirements
5 ME EQUIPMENT identification, marking and documents
6 Accuracy of controls and instruments and protection against
hazardous outputs
7 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)
8 Requirements for PHYSIOLOGIC CLOSED-LOOP CONTROLLER (PCLC)
development
Annex A (informative) - General guidance and rationale
Annex B (informative) - Description of dynamic performance of a PCLCS
Annex C (informative) - Guide to marking and labelling requirements
for ME EQUIPMENT and ME SYSTEMS
Annex ZA (normative) - Normative references to international
publications with their corresponding European
publications
Annex ZZ (informative) - Coverage of Essential Requirements
of EC Directives
Bibliography
Index of defined terms used with this collateral standard
Pertains to the BASIC SAFETY a nd ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS.
| Committee |
CH/62/1
|
| DevelopmentNote |
Supersedes 06/30147232 DC. (09/2008) 2008 Edition remains active & will be withdrawn on 31/12/2018. 2008 Edition Re-Issued in June 2015 & incorporates AMD 1 2015. Supersedes 12/30271196 DC. (07/2015)
|
| DocumentType |
Standard
|
| Pages |
44
|
| PublisherName |
British Standards Institution
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| IEC 60601-1-10:2007+AMD1:2013 CSV | Identical |
| EN 60601-1-10:2008/A1:2015 | Identical |
| IEC GUIDE 109:2012 | Environmental aspects - Inclusion in electrotechnical product standards |
| IEC 60050-351:2013 | International Electrotechnical Vocabulary (IEV) - Part 351: Control technology |
| EN ISO 14021:2016 | Environmental labels and declarations - Self-declared environmental claims (Type II environmental labelling) (ISO 14021:2016) |
| 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 |
| ISO 14021:2016 | Environmental labels and declarations — Self-declared environmental claims (Type II environmental labelling) |
| 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 62366:2007+AMD1:2014 CSV | Medical devices - Application of usability engineering to medical devices |
| EN ISO 14040:2006 | Environmental management - Life cycle assessment - Principles and framework (ISO 14040:2006) |
| ISO/IEC Guide 51:2014 | Safety aspects — Guidelines for their inclusion in standards |
| ISO/TR 14062:2002 | Environmental management Integrating environmental aspects into product design and development |
| ISO 14001:2015 | Environmental management systems — Requirements with guidance for use |
| EN 62366 : 2008 AMD 1 2015 | MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES (IEC 62366:2007/A1:2014) |
| EN ISO 14001:2015 | Environmental management systems - Requirements with guidance for use (ISO 14001:2015) |
| EN ISO 14971:2012 | Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01) |
| ISO 9000:2015 | Quality management systems — Fundamentals and vocabulary |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
| ISO 14040:2006 | Environmental management Life cycle assessment Principles and framework |
| EN ISO 9000:2015 | Quality management systems - Fundamentals and vocabulary (ISO 9000:2015) |
| 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) |
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