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ISO 80369-1:2010

Withdrawn
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withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

Small-bore connectors for liquids and gases in healthcare applications Part 1: General requirements
Available format(s)

Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users

Withdrawn date

03-27-2019

Language(s)

English, French

Published date

12-08-2010

ISO 80369-1:2010 specifies general requirements for small-bore connectors, which convey liquids or gases in healthcare applications. These small-bore connectors are used in medical devices or accessories intended for use with a patient.

ISO 80369-1:2010 also specifies the healthcare fields in which these small-bore connectors are intended to be used.

These healthcare fields of use include, but are not limited to, applications for:

  • breathing systems and driving gases,
  • enteral and gastric,
  • urethral and urinary,
  • limb cuff inflation,
  • neuraxial devices, and
  • intravascular or hypodermic.

Small-bore connectors as specified in ISO 80369-1:2010 are non-interconnectable with:

  • the cones and sockets of ISO 5356-1:2004 and ISO 5356-2:2006;
  • the temperature sensor connector and mating ports specified in Annex DD of ISO 8185:2007; and
  • the nipples of EN 13544-2:2002.

ISO 80369-1:2010 provides the methodology to assess non-interconnectable characteristics of small-bore connectors based on their inherent design and dimensions in order to reduce the risk of misconnections between medical devices or between accessories for different applications and to reduce the risk of misconnections between medical devices with 6 % Luer connectors, and all other non-Luer (6 %) connectors that will be developed under future parts of this series of standards.

It does not specify requirements for the medical devices or accessories that use these small-bore connectors. Such requirements are given in particular International Standards for specific medical devices or accessories.

DevelopmentNote
DRAFT ISO/DIS 80369-1 is also available for this standard. (05/2015)
DocumentType
Standard
Pages
17
PublisherName
International Organization for Standardization
Status
Withdrawn
SupersededBy

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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
BS EN ISO 80601-2-69:2014 Medical electrical equipment Particular requirements for basic safety and essential performance of oxygen concentrator equipment
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)
17/30346437 DC : 0 BS ISO 18250-7 - CONNECTORS FOR RESERVOIR DELIVERY SYSTEMS FOR HEALTHCARE APPLICATIONS - PART 7: CONNECTORS FOR INTRAVASCULAR INFUSION
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DIN EN ISO 80601-2-69 E : 2014 MEDICAL ELECTRICAL EQUIPMENT - PART 2-69: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF OXYGEN CONCENTRATOR EQUIPMENT (ISO 80601-2-69:2014)
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I.S. EN ISO 10555-1:2013 INTRAVASCULAR CATHETERS - STERILE AND SINGLE-USE CATHETERS - PART 1: GENERAL REQUIREMENTS (ISO 10555-1:2013/AMD 1:2017)
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)
ANSI/AAMI/ISO 80369-20:2015 SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 20: COMMON TEST METHODS
ISO 80601-2-74:2017 Medical electrical equipment Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment
AAMI CN6 : 2015 SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 6: CONNECTORS FOR NEURAXIAL APPLICATIONS
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)
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 80369-3:2016 Small-bore connectors for liquids and gases in healthcare applications — Part 3: Connectors for enteral applications
CAN/CSA-ISO 16571:16 SYSTEMS FOR EVACUATION OF PLUME GENERATED BY MEDICAL DEVICES
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
14/30296389 DC : 0 BS EN ISO 7864 - STERILE HYPODERMIC NEEDLES FOR SINGLE USE - REQUIREMENTS AND TEST METHODS
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
NF EN ISO 80369-7 : 2017 SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 7: CONNECTORS FOR INTRAVASCULAR OR HYPODERMIC APPLICATIONS
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)
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)
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)
17/30357741 DC : 0 BS ISO 11040-6 - PREFILLED SYRINGES - PART 6: PLASTIC BARRELS FOR INJECTABLES AND STERILIZED SUBASSEMBLED SYRINGES READY FOR FILLING
13/30268585 DC : 0 BS EN ISO 10079-1 - MEDICAL SUCTION EQUIPMENT - PART 1: ELECTRICALLY POWERED SUCTION EQUIPMENT
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
DIN ISO 11040-4 E : 2017 PREFILLED SYRINGES - PART 4: GLASS BARRELS FOR INJECTABLES AND STERILIZED SUBASSEMBLED SYRINGES READY FOR FILLING (ISO 11040-4:2015)
14/30292519 DC : 0 BS EN 80369-5 ED 1.0 - SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 5: CONNECTORS FOR LIMB CUFF INFLATION APPLICATIONS
15/30280904 DC : 0 BS ISO 18190 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - GENERAL REQUIREMENTS FOR AIRWAYS AND RELATED EQUIPMENT
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 10555-1 : 2013 INTRAVASCULAR CATHETERS - STERILE AND SINGLE-USE CATHETERS - PART 1: GENERAL REQUIREMENTS
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)
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. 80601-2-69 : 2016 MEDICAL ELECTRICAL EQUIPMENT - PART 2-69: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF OXYGEN CONCENTRATOR EQUIPMENT
CEI UNI EN/ISO 80369-7 : 1ED 2017 SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 7: CONNECTORS FOR INTRAVASCULAR OR HYPODERMIC APPLICATIONS
ISO 11040-8:2016 Prefilled syringes — Part 8: Requirements and test methods for finished prefilled syringes
BS EN ISO 80369-6:2016 Small bore connectors for liquids and gases in healthcare applications Connectors for neuraxial applications
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
BS EN ISO 7864:2016 Sterile hypodermic needles for single use. Requirements and test methods
I.S. EN ISO 7864:2016 STERILE HYPODERMIC NEEDLES FOR SINGLE USE - REQUIREMENTS AND TEST METHODS (ISO/DIS 7864:2014)
DIN EN ISO 80601-2-72 E : 2016 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)
BS EN ISO 80369-7:2017 Small-bore connectors for liquids and gases in healthcare applications Connectors for intravascular or hypodermic applications
ISO 20696:2018 Sterile urethral catheters for single use
DIN EN ISO 80369-20 E : 2015 SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 20: COMMON TEST METHODS (ISO 80369-20:2015)
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
ISO 16571:2014 Systems for evacuation of plume generated by medical devices
UNE-EN 80369-5:2017 Small-bore connectors for liquids and gases in healthcare applications - Part 5: Connectors for limb cuff inflation applications
I.S. EN 80369-5:2016 SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 5: CONNECTORS FOR LIMB CUFF INFLATION APPLICATIONS
ANSI/AAMI/ISO 80369-6:2016 SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 6: CONNECTORS FOR NEURAXIAL APPLICATIONS
AMEDP-1.15 : 2016 COMPATIBILITY OF MEDICAL TUBING AND CONNECTORS IN THE FIELD
ANSI/AAMI/ISO 80369-7:2016 SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 7: CONNECTORS FOR INTRAVASCULAR OR HYPODERMIC APPLICATIONS
EN ISO 10555-1:2013/A1:2017 INTRAVASCULAR CATHETERS - STERILE AND SINGLE-USE CATHETERS - PART 1: GENERAL REQUIREMENTS (ISO 10555-1:2013/AMD 1:2017)
ISO 80601-2-69:2014 Medical electrical equipment Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment
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)
BS ISO 16571:2014 Systems for evacuation of plume generated by medical devices
14/30277509 DC : 0 BS ISO 18250-3 - CONNECTORS FOR RESERVOIR DELIVERY SYSTEMS - PART 2: ENTERNAL APPLICATIONS
13/30282550 DC : 0 BS EN ISO 80369-20 - SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 20: COMMON TEST METHODS
15/30304642 DC : 0 BS ISO 11040-8 - PREFILLED SYRINGES - PART 8: REQUIREMENTS AND TEST METHODS FOR FINISHED PRIFILLED SYRINGES
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 ISO 11040-4:2015 Prefilled syringes Glass barrels for injectables and sterilized subassembled syringes ready for filling
BS ISO 18190:2016 Anaesthetic and respiratory equipment. General requirements for airways and related equipment
13/30273499 DC : 0 BS ISO 11040-4 - PREFILLED SYRINGES - PART 4: GLASS BARRELS FOR INJECTABLES AND STERILIZED SUBASSEMBLED SYRINGES READY FOR FILLING
ANSI/AAMI/ISO 80369-5:2016 SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 5: CONNECTORS FOR LIMB CUFF INFLATION APPLICATIONS
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)
BS EN ISO 80369-3:2016 Small-bore connectors for liquids and gases in healthcare applications Connectors for enteral applications
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)
12/30244415 DC : DRAFT APR 2012 BS ISO 27427 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - NEBULIZING SYSTEMS AND COMPONENTS
CSA ISO 27427 : 2014 ANAESTHETIC AND RESPIRATORY EQUIPMENT - NEBULIZING SYSTEMS AND COMPONENTS
16/30346835 DC : 0 BS ISO 20789 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - PASSIVE HUMIDIFIERS
17/30325386 DC : 0 BS ISO 18250-1- CONNECTORS FOR RESERVOIR DELIVERY SYSTEMS - PART 1: GENERAL REQUIREMENTS AND COMMON TEST METHODS
ISO 80601-2-67:2014 Medical electrical equipment Part 2-67: Particular requirements for basic safety and essential performance of oxygen-conserving equipment
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
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)
UNE-EN ISO 80369-20:2015 Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods (ISO 80369-20:2015)
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
ISO 11040-4:2015 Prefilled syringes Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling
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 80369-7:2016 Small-bore connectors for liquids and gases in healthcare applications Part 7: Connectors for intravascular or hypodermic applications
ISO 7864:2016 Sterile hypodermic needles for single use — Requirements and test methods
ISO 80369-20:2015 Small-bore connectors for liquids and gases in healthcare applications Part 20: Common test methods
UNE-EN ISO 7864:2017 Sterile hypodermic needles for single use - Requirements and test methods (ISO 7864:2016)
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
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 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)
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 7864:2016 Sterile hypodermic needles for single use - Requirements and test methods (ISO 7864:2016)
EN ISO 80369-20:2015 Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods (ISO 80369-20:2015)
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)
DIN EN 80369-5 E : 2017 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)
BS ISO 27427:2013 Anaesthetic and respiratory equipment. Nebulizing systems and components
13/30285694 DC : 0 BS EN ISO 80369-3 - SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 3: CONNECTORS FOR ENTERAL APPLICATIONS
DIN EN ISO 80369-20:2015-09 Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods (ISO 80369-20:2015); German version EN ISO 80369-20:2015
13/30255554 DC : 0 BS EN ISO 80369-7 - SMALL BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 7: CONNECTORS WITH 6% (LUER) TAPER FOR INTRAVASCULAR OR HYPODERMIC APPLICATIONS
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)
DIN EN ISO 80369-7 E : 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)
14/30288421 DC : 0 BS EN ISO/IEC 80369-6 - SMALL BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 6: CONNECTORS FOR NEURAXIAL APPLICATIONS
DIN ISO 11040-4:2007-10 PREFILLED SYRINGES - PART 4: GLASS BARRELS FOR INJECTABLES AND STERILIZED SUBASSEMBLED SYRINGES READY FOR FILLING (ISO 11040-4:2015)
I.S. EN ISO 80369-20:2015&LC:2015 SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 20: COMMON TEST METHODS (ISO 80369-20:2015)
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
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)
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)
CEI UNI EN ISO 80369-3 : 2017 SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 3: CONNECTORS FOR ENTERAL APPLICATIONS
ISO 10555-1:2013 Intravascular catheters — Sterile and single-use catheters — Part 1: General requirements
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
13/30254355 DC : 0 BS ISO 80601-2-70 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-70: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF SLEEP APNEOA BREATHING THERAPY EQUIPMENT
ISO 27427:2013 Anaesthetic and respiratory equipment — Nebulizing systems and components
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)
DIN ISO 11040-4:2017-07 PREFILLED SYRINGES - PART 4: GLASS BARRELS FOR INJECTABLES AND STERILIZED SUBASSEMBLED SYRINGES READY FOR FILLING (ISO 11040-4:2015)

IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
ISO 5356-1:2015 Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets
ISO 5356-2:2012 Anaesthetic and respiratory equipment — Conical connectors — Part 2: Screw-threaded weight-bearing connectors
IEC 62366:2007+AMD1:2014 CSV Medical devices - Application of usability engineering to medical devices
ISO 5359:2014 Anaesthetic and respiratory equipment Low-pressure hose assemblies for use with medical gases
CR 13825:2000 Luer connectors - A report to CEN chef from the CEN forum task group "Luer fittings"
ISO 8185:2007 Respiratory tract humidifiers for medical use Particular requirements for respiratory humidification systems
ISO/TR 16142:2006 Medical devices Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
ASTM D 790 : 2017 : REDLINE Standard Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials
ISO 14971:2007 Medical devices Application of risk management to medical devices
EN 13544-2:2002+A1:2009 Respiratory therapy equipment - Part 2: Tubing and connectors

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