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IEC 60601-1-9:2007+AMD1:2013 CSV
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 1-9: General requirements forbasic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
25-07-2020
English - French
18-06-2013
FOREWORD
INTRODUCTION
INTRODUCTION TO THE AMENDMENT
1 Scope, object and related standards
2 Normative references
3 Terms and definitions
4 Protection of the ENVIRONMENT
Annex A (informative) - General guidance and rationale
Annex B (informative) - Guide to marking and labelling
requirements for ME EQUIPMENT
Bibliography
Index of defined terms used in this collateral standard
IEC 60601-1-9:2007+A1:2013 The objective of this collateral standard is to improve the environmental impact for the entire range of medical electrical equipment, taking into account all stages of the product life cycle:
- product specification;
- design;
- manufacturing;
- sales, logistics, installation;
- use;
- end of life management. This means protecting the environment and human health from hazardous substances, conserving raw materials and energy, minimizing the generation of waste, as well as minimizing the adverse environmental impacts associated with waste. The criteria needed to reach this goal must be integrated into all stages of the medical electrical equipment life cycle from the specification stage to end of life management. The environmental impacts of me equipment through all life-cycle stages are determined from the medical electrical equipment's environmental aspects defined during the identification of need, product planning, and design stages. Consideration of environmental aspects as early as possible in these stages can produce numerous benefits that might include lower costs, stimulation of innovation and creativity, and increased knowledge about the product. It can also provide new business opportunities, and improved product quality as well as reduction of adverse environmental impacts. The assessment of the environmental aspects and impacts of medical electrical equipment is a developing science and it is anticipated that this collateral standard will require periodic updating as the science develops. The requirements given in this collateral standard do not replace national or international laws and regulations. Environmental protection is one element of the overall risk management process as required by the general standard. The acceptability of medical electrical equipment's environmental impacts are balanced against other factors, such as the product's intended function, performance, safety, cost, marketability, quality, legal and regulatory requirements. This balance can differ depending on the intended function of the medical electrical equipment. For example, a solution appropriate for life-saving or life-supporting medical electrical equipment might not be appropriate for a device intended to correct a minor ailment. A manufacturer of medical electrical equipment might have to justify, as a result of risk management, that a medical benefit outweighs the associated adverse environmental impacts. This consolidated version consists of the first edition (2007) and its amendment 1 (2013). Therefore, no need to order amendment in addition to this publication.
Committee |
TC 62/SC 62A
|
DevelopmentNote |
Stability Date: 2019. (09/2017)
|
DocumentType |
Standard
|
Pages |
61
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PublisherName |
International Electrotechnical Committee
|
Status |
Superseded
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SupersededBy |
Standards | Relationship |
OVE/ONORM EN 60601-1-9 : 2014 | Identical |
UNE-EN 60601-1-9:2008 | Identical |
NF EN 60601-1-9 : 2008 AMD 1 2014 | Identical |
NEN EN IEC 60601-1-9 : 2008 AMD 1 2013 | Identical |
I.S. EN 60601-1-9:2008 | Identical |
AS IEC 60601.1.9:2017 | Identical |
PN EN 60601-1-9 : 2008 AMD 1 2014 | Identical |
DIN EN 60601-1-9 : 2014 | Identical |
VDE 0750-1-9 : 2014 | Identical |
BS EN 60601-1-9 : 2008 | Identical |
EN 60601-1-9:2008/A1:2013 | Identical |
BS EN 60601-1-11:2015 | Medical electrical equipment 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 |
15/30328959 DC : 0 | BS ISO 16142-2 - MEDICAL DEVICES - RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES - PART 2: GENERAL ESSENTIAL PRINCIPLES AND ADDITIONAL SPECIFIC ESSENTIAL PRINCIPLES FOR ALL IVD MEDICAL DEVICES AND GUIDANCE ON THE SELECTION OF STANDARDS |
PREN ISO 80601-2-61 : DRAFT 2009 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-61: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT FOR MEDICAL USE |
BS EN ISO 80601-2-56:2017 | Medical electrical equipment Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement |
BS ISO 11197 : 2016 | MEDICAL SUPPLY UNITS |
UNI EN ISO 80601-2-61 : 2011 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-61: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT |
ISO 16142-1:2016 | Medical devices — Recognized essential principles of safety and performance of medical devices — Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards |
09/30203808 DC : 0 | BS EN ISO 80601-2-12 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-12: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CRITICAL CARE VENTILATORS |
16/30346073 DC : 0 | BS ISO 16142-2 - MEDICAL DEVICES - RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES - PART 2: GENERAL ESSENTIAL PRINCIPLES AND ADDITIONAL SPECIFIC ESSENTIAL PRINCIPLES FOR ALL IVD MEDICAL DEVICES AND GUIDANCE ON THE SELECTION OF STANDARDS |
15/30312454 DC : 0 | BS EN ISO 80601-2-56 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-56: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CLINICAL THERMOMETERS FOR BODY TEMPERATURE MEASUREMENT |
ISO 11197:2016 | Medical supply units |
I.S. EN 60601-2-66:2015 | MEDICAL ELECTRICAL EQUIPMENT - PART-2-66: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HEARING INSTRUMENTS AND HEARING INSTRUMENT SYSTEMS |
BS EN ISO 80601-2-61:2011 | Medical electrical equipment Particular requirements for basic safety and essential performance of pulse oximeter equipment |
ISO 16142-2:2017 | Medical devices — Recognized essential principles of safety and performance of medical devices — Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards |
CAN/CSA-C22.2 NO. 80601-2-67:17 | Medical electrical equipment — Part 2-67: Particular requirements for basic safety and essential performance of oxygen conserving equipment (Adopted ISO 80601-2-67:2014, first edition, 2014-06-01, with Canadian deviations) |
BS EN ISO 80601-2-13:2012+A2:2019 | Medical electrical equipment Particular requirements for basic safety and essential performance of an anaesthetic workstation |
UNE-EN ISO 11197:2016 | Medical supply units (ISO 11197:2016) |
UNE-EN ISO 11608-1:2015 | Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems (ISO 11608-1:2014) |
I.S. EN ISO 11608-1:2015 | NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 1: NEEDLE-BASED INJECTION SYSTEMS (ISO 11608-1:2014) |
EN ISO 80601-2-13:2012 | Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation (ISO 80601-2-13:2011) |
EN 60601-2-39:2008/A11:2011 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-39: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PERITONEAL DIALYSIS EQUIPMENT (IEC 60601-2-39:2007) |
IEC 60601-2-28:2017 | Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis |
CEI EN IEC 60601-2-43 :2023 | Medical electrical equipment Part 2: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures |
BS EN ISO 80601-2-13:2012 | Medical electrical equipment Particular requirements for basic safety and essential performance of an anaesthetic workstation |
07/30168223 DC : 0 | BS IEC 80601-2-59 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-59: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF SCREENING THERMOGRAPHS FOR HUMAN FEBRILE TEMPERATURE SCREENING |
UNE-EN 60601-2-66:2016 | Medical electrical equipment - Part 2-66: Particular requirements for the basic safety and essential performance of hearing instruments and hearing instrument systems |
BS EN 60601-2-66:2015 | Medical electrical equipment Particular requirements for the basic safety and essential performance of hearing instruments and hearing instrument systems |
ANSI/AAMI/ISO 16142-2:2017 | MEDICAL DEVICES - RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES - PART 2: GENERAL ESSENTIAL PRINCIPLES AND ADDITIONAL SPECIFIC ESSENTIAL PRINCIPLES FOR ALL IVD MEDICAL DEVICES AND GUIDANCE ON THE SELECTION OF STANDARDS |
IEC 60601-2-28 : 3.0 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-28: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY TUBE ASSEMBLIES FOR MEDICAL DIAGNOSIS |
I.S. EN ISO 80601-2-56:2017 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-56: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CLINICAL THERMOMETERS FOR BODY TEMPERATURE MEASUREMENT (ISO 80601-2-56:2017) |
09/30181956 DC : DRAFT MAY 2009 | BS ISO 80601-2-61 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-61: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT FOR MEDICAL USE |
UNI EN ISO 80601-2-55 : 2012 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-55: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS |
CSA C22.2 No. 80601-2-55 : 2014(R2019) | MEDICAL ELECTRICAL EQUIPMENT - PART 2-55: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS |
NF EN ISO 80601-2-13 : 2013 AMD 1 2016 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-13: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AN ANAESTHETIC WORKSTATION |
CSA C22.2 No. 80601-2-61 : 2014(R2019) | MEDICAL ELECTRICAL EQUIPMENT - PART 2-61: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT |
IEC 80601-2-30:2018 | Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers |
IEC 60601-2-28:2017 RLV | Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis |
DIN EN 12182:2012-07 | Assistive products for persons with disability - General requirements and test methods |
UNE-EN ISO 80601-2-13:2013 | Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation (ISO 80601-2-13:2011) |
I.S. EN 12182:2012 | ASSISTIVE PRODUCTS FOR PERSONS WITH DISABILITY - GENERAL REQUIREMENTS AND TEST METHODS |
VDE 0750-2-64 : 2018 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-64: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF LIGHT ION BEAM MEDICAL ELECTRICAL EQUIPMENT |
DIN EN 60601-2-64 : 2018 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-64: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF LIGHT ION BEAM MEDICAL ELECTRICAL EQUIPMENT |
09/30197590 DC : 0 | BS EN ISO 80601-2-55 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-55: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS |
16/30312315 DC : 0 | BS EN ISO 80601-2-55 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-55: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS |
17/30346995 DC : 0 | BS EN ISO 80601-2-13:2012/A2 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-13: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AN ANAESTHETIC WORKSTATION |
BS ISO 16142-1:2016 | Medical devices. Recognized essential principles of safety and performance of medical devices General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards |
14/30290166 DC : 0 | BS ISO 16142-1 - MEDICAL DEVICES - RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES - PART 1: GENERAL ESSENTIAL PRINCIPLES AND ADDITIONAL SPECIFIC ESSENTIAL PRINCIPLES FOR ALL NON-IVD MEDICAL DEVICES AND GUIDANCE ON THE SELECTION OF STANDARDS |
UNE-EN ISO 80601-2-56:2013 | Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement (ISO 80601-2-56:2009) |
I.S. EN 60601-2-39:2008 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-39: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PERITONEAL DIALYSIS EQUIPMENT (IEC 60601-2-39:2007 (EQV)) |
I.S. EN ISO 80601-2-13:2012 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-13: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AN ANAESTHETIC WORKSTATION (ISO 80601-2-13:2011) |
EN ISO 80601-2-61:2011 | Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment (ISO 80601-2-61:2011) |
NF EN ISO 80601-2-61 : 2011 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-61: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT |
EN ISO 80601-2-55:2018 | Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors (ISO 80601-2-55:2018) |
NF EN ISO 11197 : 2016 | MEDICAL SUPPLY UNITS |
DIN EN ISO 11608-1:2015-04 | Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems (ISO 11608-1:2014) |
IEC 60601-2-66:2015 | Medical electrical equipment - Part 2-66: Particular requirements for the basic safety and essential performance of hearing instruments and hearing instrument systems |
UNI EN 12182 : 2012 | ASSISTIVE PRODUCTS FOR PERSONS WITH DISABILITY - GENERAL REQUIREMENTS AND TEST METHODS |
ANSI/AAMI HA60601-1-11:2015 | 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 |
14/30281087 DC : 0 | BS EN 80601-2-71 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-71: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF FUNCTIONAL NEAR-INFRARED SPECTROSCOPY (NIRS) EQUIPMENT |
BS ISO 16142-2:2017 | Medical devices. Recognized essential principles of safety and performance of medical devices General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards |
14/30302072 DC : 0 | BS EN 80601-2-71 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-71: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF FUNCTIONAL NEAR-INFRARED SPECTROSCOPY (NIRS) EQUIPMENT |
PREN ISO 11197 : DRAFT 2012 | MEDICAL SUPPLY UNITS (ISO/DIS 11197:2012) |
CSA C22.2 No. 60601-1-11 : 2015 | 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 |
08/30149952 DC : DRAFT MAY 2008 | BS EN 60601-2-54 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-54: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR RADIOGRAPHY AND RADIOSCOPY |
PREN ISO 80601-2-55 : DRAFT 2009 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-55: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS |
ISO 80601-2-56:2017 | Medical electrical equipment — Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement |
ISO 80601-2-67:2014 | Medical electrical equipment Part 2-67: Particular requirements for basic safety and essential performance of oxygen-conserving equipment |
EN ISO 11197:2016 | Medical supply units (ISO 11197:2016) |
I.S. EN 60601-1-11:2015 | 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 |
DIN EN ISO 11608-1 E : 2015 | NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 1: NEEDLE-BASED INJECTION SYSTEMS (ISO 11608-1:2014) |
ISO 80601-2-13:2011 | Medical electrical equipment Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation |
ISO 11608-1:2014 | Needle-based injection systems for medical use Requirements and test methods Part 1: Needle-based injection systems |
UNI EN ISO 80601-2-13 : 2013 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-13: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AN ANAESTHETIC WORKSTATION |
BS EN 12182:2012 | Assistive products for persons with disability. General requirements and test methods |
IEC 80601-2-30:2018 RLV | Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers |
EN ISO 11608-1:2015 | Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems (ISO 11608-1:2014) |
I.S. EN ISO 80601-2-61:2011 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-61: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT |
12/30262133 DC : 0 | BS ISO 11197 - MEDICAL SUPPLY UNITS |
BS EN 60601-2-39:2008 | Medical electrical equipment Particular requirements for basic safety and essential performance of peritoneal dialysis equipment |
IEC 80601-2-30 REDLINE : 2ED 2018 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-30: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AUTOMATED NON-INVASIVE SPHYGMOMANOMETERS |
EN 60601-1-11:2015 | 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 |
I.S. EN ISO 80601-2-55:2018 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-55: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS (ISO 80601-2-55:2018) |
AAMI TIR65 : 2015 | SUSTAINABILITY OF MEDICAL DEVICES - ELEMENTS OF A RESPONSIBLE PRODUCT LIFE CYCLE |
I.S. EN ISO 11197:2016 | MEDICAL SUPPLY UNITS (ISO 11197:2016) |
ISO 80601-2-55:2018 | Medical electrical equipment — Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors |
EN ISO 80601-2-56:2017 | Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement (ISO 80601-2-56:2017) |
EN 60601-2-66:2015 | Medical electrical equipment - Part 2-66: Particular requirements for the basic safety and essential performance of hearing instruments and hearing instrument systems |
BS EN ISO 11608-1:2015 | Needle-based injection systems for medical use. Requirements and test methods Needle-based injection systems |
EN 12182:2012 | Assistive products for persons with disability - General requirements and test methods |
CSA C22.2 No. 60601.2.39 : 2009 : R2014 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-39: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PERITONEAL DIALYSIS EQUIPMENT |
CSA C22.2 NO. 60601-2-39:09 (R2019) | Medical electrical equipment - Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment (Adopted IEC 60601-2-39:2007, second edition, 2007-11) | Appareils électromédicaux - Partie 2-39: Exigences particulières pour la sécurité de base et les performances essentielles des appareils de dialyse péritonéale (norme IEC 60601-2-39:2007 adoptée, deuxième édition, 2007-11) |
IEC GUIDE 109:2012 | Environmental aspects - Inclusion in electrotechnical product standards |
IEC GUIDE 113:2000 | Materials declaration questionnaires - Basic guidelines |
IEC 60601-1:2005+AMD1:2012 CSV | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
ISO 14021:2016 | Environmental labels and declarations — Self-declared environmental claims (Type II environmental labelling) |
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 |
IEC PAS 61906:2005 | Procedure for the declaration of materials in products of the electrotechnical and electronic industry |
ISO 14040:2006 | Environmental management Life cycle assessment Principles and framework |
IEC GUIDE 114:2005 | Environmentally conscious design - Integrating environmental aspects into design and development of electrotechnical products |
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