CSA C22.2 No. 60601-1-10:2009
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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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
07-04-2020
01-01-2014
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
Bibliography
Index of defined terms used in this collateral standard
Pertains to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS.
| DevelopmentNote |
Amendment 1 is available separately, see CSA C22.2.60601-1-10A. (01/2015) NEW CHILD AMD 1 2020 IS ADDED NEW CHILD AMD 2 2021 IS NOW ADDED
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| DocumentType |
Standard
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| ProductNote |
NEW CHILD AMD 1 2020 IS ADDED NEW CHILD AMD 2 2021 IS NOW ADDED
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| PublisherName |
Canadian Standards Association
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| Status |
Superseded
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| SupersededBy |
| CSA C22.2 No. 80601-2-35 : 2012(R2016) | MEDICAL ELECTRICAL EQUIPMENT - PART 2-35: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HEATING DEVICES USING BLANKETS, PADS OR MATTRESSES AND INTENDED FOR HEATING IN MEDICAL USE |
| CSA C22.2 No. 80601-2-35 : 2012 : INC : COR 1 : 2012 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-35: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HEATING DEVICES USING BLANKETS, PADS OR MATTRESSES AND INTENDED FOR HEATING IN MEDICAL USE |
| CSA C22.2 No. 80601-2-35 : 2012 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-35: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HEATING DEVICES USING BLANKETS, PADS OR MATTRESSES AND INTENDED FOR HEATING IN MEDICAL USE |
| IEC GUIDE 109:2012 | Environmental aspects - Inclusion in electrotechnical product standards |
| IEC 60050-351:2013 | International Electrotechnical Vocabulary (IEV) - Part 351: Control technology |
| 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) |
| 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 |
| 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 |
| 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 |
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