EN 15986:2011
Current
Current
The latest, up-to-date edition.
Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
Published date
02-03-2011
Publisher
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Foreword
1 Scope
2 Terms and definitions
3 Requirements for usage
4 Symbol labelling phthalates
Annex A (informative) - Examples of uses of the symbol
given in this European Standard
Annex B (informative) - Use of the negation symbol
Annex ZA (informative) - Relationship between this European
Standard and the Essential Requirements of EU
Directive 93/42/EEC
Bibliography
This European Standard specifies requirements for the labelling of a medical device or parts of a medical device to indicate the presence of phthalates, when required by Annex I of Directive 93/42/EEC Section 7.5, 2nd paragraph. This specifically includes the format of a symbol to be used in the labelling. This European Standard does not specify the requirements for information to be supplied with medical devices, which are addressed by EN 980 and EN 1041.This European Standard does not specify the requirements of the 1st and of the 3rd paragraphs of Essential Requirement 7.5.
| Committee |
CEN/CLC/JTC 3
|
| DevelopmentNote |
Supersedes PREN 15986. (08/2011)
|
| DocumentType |
Standard
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Current
|
| Standards | Relationship |
| PN EN 15986 : 2011 | Identical |
| BS EN 15986:2011 | Identical |
| UNI CEI EN 15986 : 2011 | Identical |
| NS EN 15986 : 2011 | Identical |
| I.S. EN 15986:2011 | Identical |
| NBN EN 15986 : 2011 | Identical |
| UNE-EN 15986:2011 | Identical |
| SS-EN 15986:2011 | Identical |
| NF EN 15986 : 2011 | Identical |
| CEI UNI EN 15986 : 2011 | Identical |
| DIN EN 15986:2011-05 | Identical |
| SN EN 15986 : 2011 | Identical |
| NEN EN 15986 : 2011 | Identical |
| 13/30283691 DC : 0 | BS EN ISO 1135-4 - TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 4: TRANSFUSION SETS FOR SINGLE USE, GRAVITY FEED |
| 13/30273308 DC : 0 | BS EN ISO 3826-4 - PLASTICS COLLAPSIBLE CONTAINERS FOR HUMAN BLOOD AND BLOOD COMPONENTS - PART 4: APHAERESIS BLOOD BAG SYSTEMS WITH INTEGRATED FEATURES |
| I.S. EN ISO 1135-5:2015 | TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 5: TRANSFUSION SETS FOR SINGLE USE WITH PRESSURE INFUSION APPARATUS (ISO 1135-5:2015) |
| 13/30284721 DC : 0 | BS EN ISO 8536-8 - INFUSION EQUIPMENT FOR MEDICAL USE - PART 8: INFUSION EQUIPMENT FOR USE WITH PRESSURE INFUSION APPARATUS |
| 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 |
| UNE-EN ISO 80601-2-69:2015 | Medical electrical equipment - Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment (ISO 80601-2-69:2014) |
| CAN/CSA-C22.2 NO. 80601-2-72:17 | Medical electrical equipment — Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients (Adopted ISO 80601-2-72:2015, first edition, 2015-09-01, with Canadian deviations) |
| DIN EN ISO 8836:2015-02 | Suction catheters for use in the respiratory tract (ISO 8836:2014); German version EN ISO 8836:2014 |
| CAN/CSA-ISO 5360:16 | ANAESTHETIC VAPORIZERS - AGENT-SPECIFIC FILLING SYSTEMS |
| ISO 80601-2-74:2017 | Medical electrical equipment Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment |
| I.S. EN ISO 3826-1:2013 | PLASTICS COLLAPSIBLE CONTAINERS FOR HUMAN BLOOD AND BLOOD COMPONENTS - PART 1: CONVENTIONAL CONTAINERS (ISO 3826-1:2013) |
| BS EN ISO 5360:2016 | Anaesthetic vaporizers. Agent-specific filling systems |
| BS EN ISO 8536-9:2015 | Infusion equipment for medical use Fluid lines for single use with pressure infusion equipment |
| I.S. EN ISO 8536-9:2015 | INFUSION EQUIPMENT FOR MEDICAL USE - PART 9: FLUID LINES FOR SINGLE USE WITH PRESSURE INFUSION EQUIPMENT (ISO 8536-9:2015) |
| EN ISO 5360:2016 | Anaesthetic vaporizers - Agent-specific filling systems (ISO 5360:2016) |
| 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) |
| BS EN ISO 80601-2-13:2012 | Medical electrical equipment Particular requirements for basic safety and essential performance of an anaesthetic workstation |
| BS EN ISO 5359 : 2014 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - LOW-PRESSURE HOSE ASSEMBLIES FOR USE WITH MEDICAL GASES |
| BS EN ISO 8836:2014 | Suction catheters for use in the respiratory tract |
| DIN EN ISO 1135-5:2016-06 | TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 5: TRANSFUSION SETS FOR SINGLE USE WITH PRESSURE INFUSION APPARATUS (ISO 1135-5:2015) |
| DIN EN ISO 80601-2-72:2016-04 | Medical electrical equipment - Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients (ISO 80601-2-72:2015) |
| 13/30278952 DC : 0 | BS EN 16372 - AESTHETIC SURGERY AND AESTHETIC NON-SURGICAL MEDICAL SERVICES |
| 13/30284770 DC : 0 | BS EN ISO 8536-9 - INFUSION EQUIPMENT FOR MEDICAL USE - PART 9: FLUID LINES FOR USE WITH PRESSURE INFUSION EQUIPMENT |
| 15/30280904 DC : 0 | BS ISO 18190 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - GENERAL REQUIREMENTS FOR AIRWAYS AND RELATED EQUIPMENT |
| CSA Z8836 :2011 | SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT |
| AAMI ISO 8836 : 2015 | SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT |
| CSA C22.2 No. 80601-2-69 : 2016 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-69: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF OXYGEN CONCENTRATOR EQUIPMENT |
| DIN EN ISO 3826-1:2013-09 | PLASTICS COLLAPSIBLE CONTAINERS FOR HUMAN BLOOD AND BLOOD COMPONENTS - PART 1: CONVENTIONAL CONTAINERS (ISO 3826-1:2013) |
| ISO 8836:2014 | Suction catheters for use in the respiratory tract |
| DIN EN ISO 1135-4:2016-06 | TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 4: TRANSFUSION SETS FOR SINGLE USE, GRAVITY FEED (ISO 1135-4:2015) |
| 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) |
| BS EN ISO 8536-8:2015 | Infusion equipment for medical use Infusion sets for single use with pressure infusion apparatus |
| I.S. EN ISO 8536-11:2015 | INFUSION EQUIPMENT FOR MEDICAL USE - PART 11: INFUSION FILTERS FOR SINGLE USE WITH PRESSURE INFUSION EQUIPMENT (ISO 8536-11:2015) |
| I.S. EN ISO 8536-10:2015 | INFUSION EQUIPMENT FOR MEDICAL USE - PART 10: ACCESSORIES FOR FLUID LINES FOR SINGLE USE WITH PRESSURE INFUSION EQUIPMENT (ISO 8536-10:2015) |
| I.S. EN ISO 1135-4:2015 | TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 4: TRANSFUSION SETS FOR SINGLE USE, GRAVITY FEED (ISO 1135-4:2015) |
| I.S. EN ISO 5360:2016 | ANAESTHETIC VAPORIZERS - AGENT-SPECIFIC FILLING SYSTEMS (ISO 5360:2016) |
| I.S. EN ISO 8536-8:2015 | INFUSION EQUIPMENT FOR MEDICAL USE - PART 8: INFUSION SETS FOR SINGLE USE WITH PRESSURE INFUSION APPARATUS (ISO 8536-8:2015) |
| 13/30260084 DC : 0 | BS ISO 17256 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - RESPIRATORY THERAPY TUBING AND CONNECTORS |
| 15/30317874 DC : 0 | BS EN 16844 - AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL PROCEDURES |
| 15/30300279 DC : 0 | BS ISO 80601-2-74 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-74: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY HUMIDIFYING EQUIPMENT |
| BS ISO 18190:2016 | Anaesthetic and respiratory equipment. General requirements for airways and related equipment |
| 13/30284773 DC : 0 | BS EN ISO 8536-10 - INFUSION EQUIPMENT FOR MEDICAL USE - PART 10: ACCESSORIES FOR FLUID LINES FOR USE WITH PRESSURE INFUSION EQUIPMENT |
| UNI EN ISO 80601-2-69 : 2014 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-69: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF OXYGEN CONCENTRATOR EQUIPMENT |
| 13/30284776 DC : 0 | BS EN ISO 8536-11 - INFUSION EQUIPMENT FOR MEDICAL USE - PART 11: INFUSION FILTERS FOR SINGLE USE WITH PRESSURE INFUSION EQUIPMENT |
| UNE-EN 16372:2015 | Aesthetic surgery services |
| 16/30346835 DC : 0 | BS ISO 20789 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - PASSIVE HUMIDIFIERS |
| CSA Z8836 : 2011 : FR | SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT |
| UNI EN ISO 8836 : 2015 | A SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT |
| ISO 11195:2018 | Gas mixers for medical use — Stand-alone gas mixers |
| UNE-EN ISO 8836:2015 | Suction catheters for use in the respiratory tract (ISO 8836:2014) |
| 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) |
| CSA Z8836 : 2011 : R2015 | SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT |
| I.S. EN 16372:2014 | AESTHETIC SURGERY SERVICES |
| CSA Z5359 : 2016 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - LOW-PRESSURE HOSE ASSEMBLIES FOR USE WITH MEDICAL GASES, MEDICAL VACUUM, MEDICAL SUPPORT GASES, AND ANAESTHETIC GAS SCAVENGING SYSTEMS |
| 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 80601-2-55:2018 | Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors (ISO 80601-2-55:2018) |
| EN 16844:2017 | Aesthetic medicine services - Non-surgical medical treatments |
| ISO 80601-2-55:2018 | Medical electrical equipment — Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors |
| I.S. EN ISO 8836:2014 | SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT (ISO 8836:2014) |
| DIN EN ISO 8536-10:2015-11 | INFUSION EQUIPMENT FOR MEDICAL USE - PART 10: ACCESSORIES FOR FLUID LINES FOR SINGLE USE WITH PRESSURE INFUSION EQUIPMENT (ISO 8536-10:2015) |
| DIN EN ISO 8536-9:2015-11 | INFUSION EQUIPMENT FOR MEDICAL USE - PART 9: FLUID LINES FOR SINGLE USE WITH PRESSURE INFUSION EQUIPMENT (ISO 8536-9:2015) |
| BS EN ISO 8536-10:2015 | Infusion equipment for medical use Accessories for fluid lines for single use with pressure infusion equipment |
| ISO 1135-5:2015 | Transfusion equipment for medical use — Part 5: Transfusion sets for single use with pressure infusion apparatus |
| BS EN ISO 1135-4:2015 | Transfusion equipment for medical use Transfusion sets for single use, gravity feed |
| ISO 80601-2-69:2014 | Medical electrical equipment Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment |
| UNE-EN ISO 8536-8:2015 | Infusion equipment for medical use - Part 8: Infusion sets for single use with pressure infusion apparatus (ISO 8536-8:2015) |
| EN ISO 8836:2014 | Suction catheters for use in the respiratory tract (ISO 8836:2014) |
| EN ISO 3826-4:2015 | Plastics collapsible containers for human blood and blood components - Part 4: Aphaeresis blood bag systems with integrated features (ISO 3826-4:2015) |
| EN ISO 8536-9:2015 | Infusion equipment for medical use - Part 9: Fluid lines for single use with pressure infusion equipment (ISO 8536-9:2015) |
| 17/30338753 DC : 0 | BS ISO 80601-2-79 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-79: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF VENTILATORY SUPPORT EQUIPMENT FOR VENTILATORY IMPAIRMENT |
| BS EN ISO 80601-2-72:2015 | Medical electrical equipment Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients |
| I.S. EN 16844:2017 | AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL PROCEDURES |
| 17/30338756 DC : 0 | BS ISO 80601-2-80 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-80: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF VENTILATORY SUPPORT EQUIPMENT FOR VENTILATORY INSUFFICIENCY |
| 13/30264413 DC : 0 | BS EN ISO 80601-2-72 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-72: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HOME HEALTHCARE ENVIRONMENT VENTILATORS FOR VENTILATOR-DEPENDENT PATIENTS |
| BS EN ISO 80601-2-69:2014 | Medical electrical equipment Particular requirements for basic safety and essential performance of oxygen concentrator equipment |
| BS EN ISO 3826-4:2015 | Plastics collapsible containers for human blood and blood components Aphaeresis blood bag systems with integrated features |
| CAN/CSA-C22.2 NO. 80601-2-70:17 | Medical electrical equipment — Part 2-70: Particular requirements for basic safety and essential performance of sleep apnoea breathing therapy equipment (Adopted ISO 80601-2-70:2015, first edition, 2015-01 , with Canadian deviations) |
| I.S. EN ISO 5359:2014 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - LOW-PRESSURE HOSE ASSEMBLIES FOR USE WITH MEDICAL GASES (ISO 5359:2014) |
| I.S. EN ISO 80601-2-72:2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-72: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HOME HEALTHCARE ENVIRONMENT VENTILATORS FOR VENTILATOR-DEPENDENT PATIENTS (ISO 80601-2-72:2015) |
| ISO 5359:2014 | Anaesthetic and respiratory equipment — Low-pressure hose assemblies for use with medical gases |
| DIN EN ISO 5359:2015-02 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - LOW-PRESSURE HOSE ASSEMBLIES FOR USE WITH MEDICAL GASES (ISO 5359:2014) |
| ISO 80601-2-70:2015 | Medical electrical equipment Part 2-70: Particular requirements for basic safety and essential performance of sleep apnoea breathing therapy equipment |
| DIN EN ISO 8536-11:2015-11 | INFUSION EQUIPMENT FOR MEDICAL USE - PART 11: INFUSION FILTERS FOR SINGLE USE WITH PRESSURE INFUSION EQUIPMENT (ISO 8536-11:2015) |
| UNE-EN ISO 1135-4:2016 | Transfusion equipment for medical use - Part 4: Transfusion sets for single use, gravity feed (ISO 1135-4:2015) |
| ISO 8536-10:2015 | Infusion equipment for medical use Part 10: Accessories for fluid lines for single use with pressure infusion equipment |
| ISO 3826-1:2013 | Plastics collapsible containers for human blood and blood components Part 1: Conventional containers |
| BS EN ISO 3826-1:2013 | Plastics collapsible containers for human blood and blood components Conventional containers |
| ISO 80601-2-72:2015 | Medical electrical equipment — Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients |
| UNE-EN ISO 5360:2016 | Anaesthetic vaporizers - Agent-specific filling systems (ISO 5360:2016) |
| ISO 1135-4:2015 | Transfusion equipment for medical use — Part 4: Transfusion sets for single use, gravity feed |
| UNE-EN ISO 8536-10:2015 | Infusion equipment for medical use - Part 10: Accessories for fluid lines for single use with pressure infusion equipment (ISO 8536-10:2015) |
| UNE-EN ISO 3826-1:2013 | Plastics collapsible containers for human blood and blood components - Part 1: Conventional containers (ISO 3826-1:2013) |
| ISO 8536-9:2015 | Infusion equipment for medical use Part 9: Fluid lines for single use with pressure infusion equipment |
| ISO 8536-8:2015 | Infusion equipment for medical use Part 8: Infusion sets for single use with pressure infusion apparatus |
| ISO 80601-2-13:2011 | Medical electrical equipment Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation |
| ISO 8536-11:2015 | Infusion equipment for medical use Part 11: Infusion filters for single use with pressure infusion equipment |
| 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 |
| EN 16372:2014 | Aesthetic surgery services |
| EN ISO 80601-2-72:2015 | Medical electrical equipment - Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients (ISO 80601-2-72:2015) |
| EN ISO 8536-10:2015 | Infusion equipment for medical use - Part 10: Accessories for fluid lines for single use with pressure infusion equipment (ISO 8536-10:2015) |
| EN ISO 8536-8:2015 | Infusion equipment for medical use - Part 8: Infusion sets for single use with pressure infusion apparatus (ISO 8536-8:2015) |
| EN ISO 8536-11:2015 | Infusion equipment for medical use - Part 11: Infusion filters for single use with pressure infusion equipment (ISO 8536-11:2015) |
| EN ISO 1135-5:2015 | Transfusion equipment for medical use - Part 5: Transfusion sets for single use with pressure infusion apparatus (ISO 1135-5:2015) |
| EN ISO 3826-1:2013 | Plastics collapsible containers for human blood and blood components - Part 1: Conventional containers (ISO 3826-1:2013) |
| BS EN 16372:2014 | Aesthetic surgery services |
| BS EN ISO 1135-5:2015 | Transfusion equipment for medical use Transfusion sets for single use with pressure infusion apparatus |
| 13/30283694 DC : 0 | BS EN ISO 1135-5 - TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 5: TRANSFUSION SETS FOR SINGLE USE WITH PRESSURE INFUSION APPARATUS |
| I.S. EN ISO 3826-4:2015 | PLASTICS COLLAPSIBLE CONTAINERS FOR HUMAN BLOOD AND BLOOD COMPONENTS - PART 4: APHAERESIS BLOOD BAG SYSTEMS WITH INTEGRATED FEATURES (ISO 3826-4:2015) |
| I.S. EN 16844:2017+A2:2019 | Aesthetic medicine services - Non-surgical medical treatments |
| 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 |
| DIN EN ISO 80601-2-69:2014-12 | Medical electrical equipment - Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment (ISO 80601-2-69:2014) |
| 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) |
| ISO 80601-2-67:2014 | Medical electrical equipment Part 2-67: Particular requirements for basic safety and essential performance of oxygen-conserving equipment |
| I.S. EN ISO 80601-2-69:2014 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-69: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF OXYGEN CONCENTRATOR EQUIPMENT (ISO 80601-2-69:2014) |
| ISO 18190:2016 | Anaesthetic and respiratory equipment — General requirements for airways and related equipment |
| BS EN 16844 : 2017 | AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL TREATMENTS |
| BS EN ISO 80601-2-13:2012+A2:2019 | Medical electrical equipment Particular requirements for basic safety and essential performance of an anaesthetic workstation |
| DIN EN ISO 8536-8:2015-11 | INFUSION EQUIPMENT FOR MEDICAL USE - PART 8: INFUSION SETS FOR SINGLE USE WITH PRESSURE INFUSION APPARATUS (ISO 8536-8:2015) |
| UNE-EN ISO 8536-11:2015 | Infusion equipment for medical use - Part 11: Infusion filters for single use with pressure infusion equipment (ISO 8536-11:2015) |
| UNE-EN ISO 8536-9:2015 | Infusion equipment for medical use - Part 9: Fluid lines for single use with pressure infusion equipment (ISO 8536-9:2015) |
| BS EN ISO 8536-11:2015 | Infusion equipment for medical use Infusion filters for single use with pressure infusion equipment |
| ISO 5360:2016 | Anaesthetic vaporizers Agent-specific filling systems |
| ISO 3826-4:2015 | Plastics collapsible containers for human blood and blood components — Part 4: Aphaeresis blood bag systems with integrated features |
| DIN EN ISO 5360:2016-07 | ANAESTHETIC VAPORIZERS - AGENT-SPECIFIC FILLING SYSTEMS (ISO 5360:2016) |
| EN ISO 1135-4 : 2015 COR 2016 | TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 4: TRANSFUSION SETS FOR SINGLE USE, GRAVITY FEED (ISO 1135-4:2015) |
| EN 80416-3:2002/A1:2011 | BASIC PRINCIPLES FOR GRAPHICAL SYMBOLS FOR USE ON EQUIPMENT - PART 3: GUIDELINES FOR THE APPLICATION OF GRAPHICAL SYMBOLS |
| EN 1041:2008+A1:2013 | Information supplied by the manufacturer of medical devices |
| IEC 80416-3:2002+AMD1:2011 CSV | Basic principles for graphical symbols for use on equipment - Part 3: Guidelines for the application of graphical symbols |
| 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 980:2008 | Symbols for use in the labelling of medical devices |
| EN 12264:2005 | Health informatics - Categorial structures for systems of concepts |
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