ANSI/AAMI/ISO 80369-5:2016
Current
The latest, up-to-date edition.
SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 5: CONNECTORS FOR LIMB CUFF INFLATION APPLICATIONS
English
01-07-2016
Glossary of equivalent standards
Committee representation
Background of ANSI/AAMI/ISO 80369-5:2016
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Dimensional requirements for sphygmomanometer and cuff
SMALL-BORE CONNECTORS
6 Performance requirements
Annex A (informative) - Rationale and guidance
Annex B (normative) - SMALL-BORE CONNECTORS for the
limb cuff inflation APPLICATION
Annex C (normative) - Reference CONNECTORS
Annex D (informative) - Assessment of MEDICAL DEVICES
and their attributes with CONNECTIONS within this
APPLICATION
Annex E (informative) - Summary of the usability requirements
for SMALL-BORE CONNECTORS for limb cuff inflation
APPLICATIONS
Annex F (informative) - Summary of SMALL-BORE CONNECTOR
design requirements for limb cuff inflation
APPLICATIONS
Annex G (informative) - Summary of assessment of the design
of the CONNECTORS for limb cuff inflation
APPLICATION
Annex H (informative) - Obsolete limb cuff inflation CONNECTOR
Annex I (informative) - Air leakage by pressure decay TEST METHOD
Annex J (informative) - Resistance to separation from axial load
TEST METHOD
Annex K (informative) - Reference to the essential principles
Index of defined terms
Bibliography
Describes dimensions and requirements for the design and functional performance of SMALL-BORE CONNECTORS intended to be used for CONNECTIONS in limb cuff inflation APPLICATIONS of MEDICAL DEVICES and ACCESSORIES.
| Committee |
ISO/TC 210
|
| DocumentType |
Standard
|
| ISBN |
1-57020-609-0
|
| Pages |
47
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Current
|
| ISO 80369-20:2015 | Small-bore connectors for liquids and gases in healthcare applications — Part 20: Common test methods |
| ISO 81060-1:2007 | Non-invasive sphygmomanometers — Part 1: Requirements and test methods for non-automated measurement type |
| ISO 5356-1:2015 | Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and sockets |
| ISO 3040:2016 | Geometrical product specifications (GPS) — Dimensioning and tolerancing — Cones |
| ISO 5356-2:2012 | Anaesthetic and respiratory equipment — Conical connectors — Part 2: Screw-threaded weight-bearing connectors |
| 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 |
| ISO 80369-6:2016 | Small bore connectors for liquids and gases in healthcare applications — Part 6: Connectors for neuraxial applications |
| ASTM D 790 : 2017 : REDLINE | Standard Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials |
| IEC 80601-2-30:2009+AMD1:2013 CSV | Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers |
| ISO 80369-1:2010 | Small-bore connectors for liquids and gases in healthcare applications — Part 1: General requirements |
| ISO 14971:2007 | Medical devices — Application of risk management to medical devices |
| ISO 594-2:1998 | Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment — Part 2: Lock fittings |
| ISO 594-1:1986 | Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment — Part 1: General requirements |
| EN 13544-2:2002+A1:2009 | Respiratory therapy equipment - Part 2: Tubing and connectors |
| ASTM D 638 : 2014 : REDLINE | Standard Test Method for Tensile Properties of Plastics |
| ISO 80369-3:2016 | Small-bore connectors for liquids and gases in healthcare applications — Part 3: Connectors for enteral applications |
Please Login or Create an Account so you can add users to your Multi user PDF Later.
Important note : All end users must be registered with an Account prior to user licenses being assigned.
Users cannot be edited or removed once added to your Multi user PDF.