EN 13544-2:2002+A1:2009
Current
The latest, up-to-date edition.
Respiratory therapy equipment - Part 2: Tubing and connectors
09-09-2009
Foreword
1 Scope
2 Normative references
3 Nipples
4 Weight-bearing screw-threaded connectors
5 Tubing
6 Marking of tubing, labels and packaging
7 Packaging
8 Usability
9 Clinical evaluation
Annex A (normative) - Test methods
Annex B (normative) - Weight-bearing screw-threaded
connectors for oxygen and air
Annex C (informative) - Information on method of
testing security of connections
Annex ZA (informative) - Relationship between this European
Standard and the Essential Requirements
of EU Directive 93/42/EEC
Bibliography
This part of EN 13544 specifies requirements for tubing to be used with equipment for the therapeutic administration of respirable gases in domiciliary, ambulance and hospital practice including the interface to the equipment i.e. nipples and screw threaded connectors. This tubing is mainly used with oxygen, air or mixtures of these gases.The interface specifications are given to ensure interchangeability of respiratory therapy equipment thereby enabling patients to receive continuous treatment in all these clinical situations.Weight-bearing screw-threaded connectors are specified for use at the outlet of e.g. flowmeters to which devices such as humidifiers or nebulizers can be attached.NOTEThis standard does not specify the devices where these connectors have to be used. It is expected that specific device standards will specify the devices where these connectors are going to the used e.g. EN ISO 10651 4, EN 738-1 and EN 13220.
Committee |
CEN/TC 215
|
DevelopmentNote |
2002 Edition Re-Issued in September 2009 & incorporates AMD 1 2009. (10/2009)
|
DocumentType |
Standard
|
PublisherName |
Comite Europeen de Normalisation
|
Status |
Current
|
Standards | Relationship |
PN EN 13544-2 : 2006 + A1 2010 | Identical |
NS EN 13544-2 : 2002 + A1 2009 | Identical |
NBN EN 13544-2 : 2002 + A1 2009 | Identical |
NEN EN 13544-2 : 2002 + A1 2009 | Identical |
UNE-EN 13544-2:2003 | Identical |
I.S. EN 13544-2:2002 | Identical |
BS EN 13544-2 : 2002 | Identical |
DIN EN 13544-2:2010-01 | Identical |
UNI EN 13544-2 : 2009 | Identical |
NF EN 13544-2 : 2003 + A1 2009 | Identical |
SN EN 13544-2 : 2002 + A1 2010 | Identical |
I.S. EN 13544-2:2002+A1:2009 | Identical |
UNE-EN 13544-2:2003+A1:2010 | Identical |
BS EN 13544-2:2002+A1:2009 | Identical |
DIN EN ISO 10524-4:2008-09 | PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 4: LOW-PRESSURE REGULATORS |
CSA Z10524-3 : 2012 : INC : AMD 1 : 2017 : R201700 | PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 3: PRESSURE REGULATORS INTEGRATED WITH CYLINDER VALVES |
I.S. EN ISO 80369-1:2010 | SMALL BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 1: GENERAL REQUIREMENTS |
17/30337954 DC : 0 | BS ISO 19211 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - FIRE-ACTIVATED OXYGEN SHUT-OFF DEVICES FOR USE DURING OXYGEN THERAPY |
04/30084857 DC : DRAFT JUN 2004 | BS EN ISO 10524-1 - PRESSURE REGULATORS FOR USE WITH MEDICAL GAS SYSTEMS - PART 1: PRESSURE REGULATORS AND PRESSURE REGULATORS WITH FLOW-METERING DEVICES |
DD ISO/TS 18835:2004 | Inhalational anaesthesia systems. Draw-over vaporizers and associated equipment |
CSA Z10524-1 : 2012 | PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 1: PRESSURE REGULATORS AND PRESSURE REGULATORS WITH FLOW-METERING DEVICES |
AAMI ISO 80369-1 : 2010 | SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 1: GENERAL REQUIREMENTS |
ANSI/AAMI/ISO 80369-3:2016 | SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 3: CONNECTORS FOR ENTERAL APPLICATIONS |
ISO 80369-6:2016 | Small bore connectors for liquids and gases in healthcare applications — Part 6: Connectors for neuraxial applications |
UNE-EN ISO 80369-7:2017 | Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications (ISO 80369-7:2016, Corrected version 2016-12-01) |
BIS IS/ISO 10524-1 : 2006 | PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 1: PRESSURE REGULATORS AND PRESSURE REGULATORS WITH FLOW-METERING DEVICES |
17/30303094 DC : 0 | BS EN ISO 10524-3 - PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 3: PRESSURE REGULATORS INTEGRATED WITH CYLINDER VALVES |
CSA Z10651-4 : 2008 | LUNG VENTILATORS - PART 4: PARTICULAR REQUIREMENTS FOR OPERATOR-POWERED RESUSCITATORS |
BIS IS/ISO 10524-3 : 2005 | PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 3: PRESSURE REGULATORS INTEGRATED WITH CYLINDER VALVES |
I.S. EN ISO 10524-4:2008 | PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 4: LOWPRESSURE REGULATORS |
UNI CEI EN ISO 80369-1 : 2011 | SMALL BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 1: GENERAL REQUIREMENTS |
ISO 80369-1:2010 | Small-bore connectors for liquids and gases in healthcare applications Part 1: General requirements |
AAMI CN6 : 2015 | SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 6: CONNECTORS FOR NEURAXIAL APPLICATIONS |
ONORM EN ISO 10524-1 : 2006 | PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 1: PRESSURE REGULATORS AND PRESSURE REGULATORS WITH FLOW-METERING DEVICES |
UNE-EN ISO 80369-6:2016 | Small bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neuraxial applications (ISO 80369-6:2016, Corrected version 2016-11-15) |
ISO 10524-4:2008 | Pressure regulators for use with medical gases — Part 4: Low-pressure regulators |
ISO 80369-3:2016 | Small-bore connectors for liquids and gases in healthcare applications — Part 3: Connectors for enteral applications |
I.S. EN ISO 18777:2009 | TRANSPORTABLE LIQUID OXYGEN SYSTEMS FOR MEDICAL USE - PARTICULAR REQUIREMENTS |
EN ISO 15002:2008 | Flow-metering devices for connection to terminal units of medical gas pipeline systems (ISO 15002:2008) |
BS EN ISO 15002:2008 | Flow-metering devices for connection to terminal units of medical gas pipeline systems |
CSA Z10524-1 : 2012 : R2017 | PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 1: PRESSURE REGULATORS AND PRESSURE REGULATORS WITH FLOW-METERING DEVICES |
09/30173644 DC : 0 | BS EN ISO 80369-1 - SMALL BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 1: GENERAL REQUIREMENTS |
CSA Z10524-3 : 2012 : R2017 | PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 3: PRESSURE REGULATORS INTEGRATED WITH CYLINDER VALVES |
NF EN ISO 80369-1 : 2011 | SMALL BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 1: GENERAL REQUIREMENTS |
I.S. EN ISO 80369-6:2016 | SMALL BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 6: CONNECTORS FOR NEURAXIAL APPLICATIONS (ISO/IEC/DIS 80369-6:2014) |
16/30329598 DC : 0 | BS ISO 11195 - GAS MIXERS FOR MEDICAL USE - STAND-ALONE GAS MIXERS |
BS EN ISO 10524-1:2006 | Pressure regulators for use with medical gases Pressure regulators and pressure regulators with flow-metering devices |
UNE-EN ISO 80369-1:2011 | Small bore connectors for liquids and gases in healthcare applications - Part 1: General requirements (ISO 80369-1:2010) |
EN ISO 80369-6 : 2016 COR 2016 | SMALL BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 6: CONNECTORS FOR NEURAXIAL APPLICATIONS (ISO 80369-6:2016, CORRECTED VERSION 2016-11-15) |
15/30288418 DC : 0 | BS EN ISO 80369-2 - SMALL BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 2: CONNECTORS FOR BREATHING SYSTEMS AND DRIVING GASES APPLICATIONS |
BS EN ISO 80369-1:2010 | Small bore connectors for liquids and gases in healthcare applications General requirements |
DIN EN ISO 15002:2008-11 | FLOW-METERING DEVICES FOR CONNECTION TO TERMINAL UNITS OF MEDICAL GAS PIPELINE SYSTEMS |
CAN/CSA-Z15002:12 (R2017) | Flow-metering devices for connection to terminal units of medical gas pipeline systems (Adopted ISO 15002:2008, second edition, 2008-07-01, with Canadian deviations) |
CSA Z1500:2012 | FLOW-METERING DEVICES FOR CONNECTION TO TERMINAL UNITS OF MEDICAL GAS PIPELINE SYSTEMS |
CEI EN 80369-5 : 1ED 2017 | SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 5: CONNECTORS FOR LIMB CUFF INFLATION APPLICATIONS |
BS EN ISO 80369-3:2016 | Small-bore connectors for liquids and gases in healthcare applications Connectors for enteral applications |
BS EN ISO 10524-3 : 2006 | PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 3: PRESSURE REGULATORS INTEGRATED WITH CYLINDER VALVES |
17/30311331 DC : 0 | BS EN ISO 10524-1 - PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 1: PRESSURE REGULATORS AND PRESSURE REGULATORS WITH FLOW-METERING DEVICES |
I.S. EN ISO 80369-3:2016 | SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 3: CONNECTORS FOR ENTERAL APPLICATIONS (ISO/IEC/DIS 80369-3:2014) |
CEI UNI EN ISO 80369-1 : 2011 | SMALL BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 1: GENERAL REQUIREMENTS |
BS EN ISO 80369-6:2016 | Small bore connectors for liquids and gases in healthcare applications Connectors for neuraxial applications |
DIN EN ISO 18777:2009-07 | TRANSPORTABLE LIQUID OXYGEN SYSTEMS FOR MEDICAL USE - PARTICULAR REQUIREMENTS |
I.S. EN ISO 18779:2005 | MEDICAL DEVICES FOR CONSERVING OXYGEN AND OXYGEN MIXTURES - PARTICULAR REQUIREMENTS |
BS EN ISO 80369-7:2017 | Small-bore connectors for liquids and gases in healthcare applications Connectors for intravascular or hypodermic applications |
I.S. EN ISO 10524-3:2006 | PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 3: PRESSURE REGULATORS INTEGRATED WITH CYLINDER VALVES (ISO 10524-3:2005) |
16/30346835 DC : 0 | BS ISO 20789 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - PASSIVE HUMIDIFIERS |
CSA Z18779 : 2008 : R2013 | MEDICAL DEVICES FOR CONSERVING OXYGEN AND OXYGEN MIXTURES - PARTICULAR REQUIREMENTS |
CSA Z10651-4 : 2008 : R2013 | LUNG VENTILATORS - PART 4: PARTICULAR REQUIREMENTS FOR OPERATOR-POWERED RESUSCITATORS |
UNE-EN 80369-5:2017 | Small-bore connectors for liquids and gases in healthcare applications - Part 5: Connectors for limb cuff inflation applications |
PREN ISO 80369-1 : DRAFT 2009 | SMALL BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 1: GENERAL REQUIREMENTS |
I.S. EN ISO 10524-1:2006 | PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 1: PRESSURE REGULATORS AND PRESSURE REGULATORS WITH FLOW-METERING DEVICES |
ANSI/AAMI/ISO 80369-7:2016 | SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 7: CONNECTORS FOR INTRAVASCULAR OR HYPODERMIC APPLICATIONS |
UNI EN ISO 10524-3 : 2013 | PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 3: PRESSURE REGULATORS INTEGRATED WITH CYLINDER VALVES |
EN ISO 10524-1:2006 | Pressure regulators for use with medical gases - Part 1: Pressure regulators and pressure regulators with flow-metering devices (ISO 10524-1:2006) |
EN ISO 80369-1:2010 | Small bore connectors for liquids and gases in healthcare applications - Part 1: General requirements (ISO 80369-1:2010) |
ISO 15002:2008 | Flow-metering devices for connection to terminal units of medical gas pipeline systems |
ISO 18779:2005 | Medical devices for conserving oxygen and oxygen mixtures Particular requirements |
UNI EN ISO 18777 : 2009 | TRANSPORTABLE LIQUID OXYGEN SYSTEMS FOR MEDICAL USE - PARTICULAR REQUIREMENTS |
CSA Z10524-3 : 2012 | PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 3: PRESSURE REGULATORS INTEGRATED WITH CYLINDER VALVES |
17/30356316 DC : 0 | BS ISO 17256 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - RESPIRATORY THERAPY TUBING AND CONNECTORS |
03/111582 DC : DRAFT JULY 2003 | BS EN ISO 18779 - DEVICES FOR CONSERVING OXYGEN AND OXYGEN MIXTURES - PARTICULAR REQUIREMENTS |
BS ISO 18835:2015 | Inhalational anaesthesia systems. Draw-over anaesthetic systems |
UNE-EN ISO 80369-3:2017 | Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications (ISO 80369-3:2016) |
CSA ISO 27427 : 2014 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - NEBULIZING SYSTEMS AND COMPONENTS |
12/30244415 DC : DRAFT APR 2012 | BS ISO 27427 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - NEBULIZING SYSTEMS AND COMPONENTS |
BIS IS/ISO 15002 : 2008 | FLOW-METERING DEVICES FOR CONNECTION TO TERMINAL UNITS OF MEDICAL GAS PIPELINE SYSTEMS |
CAN/CSA-Z18777-08 (R2018) | Transportable Liquid Oxygen Systems for Medical Use - Particular Requirements (Adopted ISO 18777:2005, first edition, 2005-02-15, with Canadian deviations) |
CSA Z18777 : 2008 | TRANSPORTABLE LIQUID OXYGEN SYSTEMS FOR MEDICAL USE - PARTICULAR REQUIREMENTS |
17/30325386 DC : 0 | BS ISO 18250-1- CONNECTORS FOR RESERVOIR DELIVERY SYSTEMS - PART 1: GENERAL REQUIREMENTS AND COMMON TEST METHODS |
CAN/CSA-Z10651-4-08 (R2018) | Lung Ventilators - Part 4: Particular Requirements for Operator-Powered Resuscitators (Adopted ISO 10651-4:2002, first edition, 2002-03-01, with Canadian deviations) |
CSA ISO TS 18835 : 2014 | INHALATIONAL ANAESTHESIA SYSTEMS - DRAW-OVER VAPORIZERS AND ASSOCIATED EQUIPMENT |
AAMI ISO 10651-4 : 1999 | LUNG VENTILATORS - PART 4: PARTICULAR REQUIREMENTS FOR OPERATOR-POWERED RESUSCITATORS |
ANSI/AAMI/ISO 80369-6:2016 | SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 6: CONNECTORS FOR NEURAXIAL APPLICATIONS |
I.S. EN ISO 15002:2008 | FLOW-METERING DEVICES FOR CONNECTION TO TERMINAL UNITS OF MEDICAL GAS PIPELINE SYSTEMS |
ISO 10524-3:2005 | Pressure regulators for use with medical gases Part 3: Pressure regulators integrated with cylinder valves |
ISO 10524-1:2018 | Pressure regulators for use with medical gases — Part 1: Pressure regulators and pressure regulators with flow-metering devices |
DIN EN ISO 10524-3:2013-06 | PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 3: PRESSURE REGULATORS INTEGRATED WITH CYLINDER VALVES (ISO 10524-3:2005 + AMD 1:2013) |
DIN EN ISO 80369-1:2015-09 (Draft) | SMALL BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 1: GENERAL REQUIREMENTS |
ISO 18835:2015 | Inhalational anaesthesia systems Draw-over anaesthetic systems |
ONORM EN ISO 15002 : 2008 | FLOW-METERING DEVICES FOR CONNECTION TO TERMINAL UNITS OF MEDICAL GAS PIPELINE SYSTEMS |
UNE-EN 13544-3:2001 | Respiratory therapy equipment - Part 3: Air entrainment devices. |
ISO 18777:2005 | Transportable liquid oxygen systems for medical use — Particular requirements |
DIN EN 80369-5:2017-10 | SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 5: CONNECTORS FOR LIMB CUFF INFLATION APPLICATIONS (IEC 80369-5:2016 + COR.1:2017) |
EN ISO 18779:2005 | Medical devices for conserving oxygen and oxygen mixtures - Particular requirements (ISO 18779:2005) |
EN ISO 18777:2009 | Transportable liquid oxygen systems for medical use - Particular requirements (ISO 18777:2005) |
EN ISO 80369-3:2016 | Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications (ISO 80369-3:2016) |
EN ISO 10524-4:2008 | Pressure regulators for use with medical gases - Part 4: Low-pressure regulators (ISO 10524-4:2008) |
06/30116855 DC : 0 | BS ISO 10524-4 - PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 4: LOW-PRESSURE REGULATORS INTENDED FOR INCORPORATION INTO MEDICAL EQUIPMENT |
UNI EN ISO 10524-4 : 2008 | PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 4: LOW-PRESSURE REGULATORS |
BS ISO 27427:2013 | Anaesthetic and respiratory equipment. Nebulizing systems and components |
03/114562 DC : DRAFT SEP 2003 | BS EN ISO 18777 - TRANSPORTABLE LIQUID OXYGEN SYSTEMS FOR MEDICAL USE - PARTICULAR REQUIREMENTS |
BS EN ISO 10524-4:2008 | Pressure regulators for use with medical gases Low-pressure regulators |
ISO/TS 18835:2004 | Inhalational anaesthesia systems Draw-over vaporizers and associated equipment |
BIS IS/ISO 10524-4 : 2008 | PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 4: LOW-PRESSURE REGULATORS |
EN ISO 80369-7:2017 | Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications (ISO 80369-7:2016, Corrected version 2016-12-01) |
ANSI/AAMI/ISO 80369-5:2016 | SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 5: CONNECTORS FOR LIMB CUFF INFLATION APPLICATIONS |
CSA Z10524-4 : 2012 | PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 4: LOW-PRESSURE REGULATORS |
CAN/CSA-Z10524-4:12 (R2017) | Pressure regulators for use with medical gases - Part 4: Low-pressure regulators (Adopted ISO 10524-4:2008, first edition, 2008-06-01, with Canadian deviations) |
CSA Z18779 : 2008 | MEDICAL DEVICES FOR CONSERVING OXYGEN AND OXYGEN MIXTURES - PARTICULAR REQUIREMENTS |
CSA Z18777 : 2008 : R2013 | TRANSPORTABLE LIQUID OXYGEN SYSTEMS FOR MEDICAL USE - PARTICULAR REQUIREMENTS |
I.S. EN ISO 80369-7:2017 COR 2017 | SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 7: CONNECTORS FOR INTRAVASCULAR OR HYPODERMIC APPLICATIONS (ISO 80369-7:2016, CORRECTED VERSION 2016-12-01) |
ISO 11195:2018 | Gas mixers for medical use — Stand-alone gas mixers |
UNI EN ISO 15002 : 2008 | FLOW-METERING DEVICES FOR CONNECTION TO TERMINAL UNITS OF MEDICAL GAS PIPELINE SYSTEMS |
ISO 27427:2013 | Anaesthetic and respiratory equipment — Nebulizing systems and components |
BS EN ISO 18779:2005 | Medical devices for conserving oxygen and oxygen mixtures. Particular requirements |
BS EN ISO 18777:2009 | Transportable liquid oxygen systems for medical use. Particular requirements |
DIN EN ISO 18779:2005-06 | Medical devices for conserving oxygen and oxygen mixtures - Particular requirements (ISO 18779:2005) |
DIN EN ISO 80369-7:2017-10 | Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications (ISO 80369-7:2016, Corrected version 2016-12-01) |
EN 13220 : 1998 | FLOW-METERING DEVICES FOR CONNECTION TO TERMINAL UNITS OF MEDICAL GAS PIPELINE SYSTEMS |
EN 738-1:1997/A1:2002 | PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PRESSURE REGULATORS AND PRESSURE REGULATORS WITH FLOW METERING DEVICES |
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) |
EN 1041:2008+A1:2013 | Information supplied by the manufacturer of medical devices |
EN 62366 : 2008 AMD 1 2015 | MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES (IEC 62366:2007/A1:2014) |
EN ISO 10651-4:2009 | Lung ventilators - Part 4: Particular requirements for operator-powered resuscitators (ISO 10651-4:2002) |
EN 980:2008 | Symbols for use in the labelling of medical devices |
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