🔥🔥 Don’t Miss Out on Our End of Autumn Sale. If you have any questions, feel free to click the bottom right corner to contact our customer service..

Concat us[email protected]
Shopping Cart

No products in the cart.

🔍
AAMI 80369 3 2016

AAMI 80369 3 2016

$140.32

ANSI/AAMI/ISO 80369-3:2016 – Small-bore connectors for liquids and gases in healthcare applications-Part 3: Connectors for enteral applications.

Published By Publication Date Number of Pages
AAMI 2016 50
PDF Format Searchable Printable Preview Now
Guaranteed Safe Checkout
Category:

If you have any questions, feel free to reach out to our online customer service team by clicking on the bottom right corner. We’re here to assist you 24/7.
Email:[email protected]

Specifies the dimensions and requirements for the design and functional performance of SMALLBORE CONNECTORS intended to be used for CONNECTIONS on ENTERAL MEDICAL DEVICES and ACCESSORIES.

PDF Catalog

PDF Pages PDF Title
1 ANSI/AAMI/ISO 80369-3:2016; Small-bore connectors for liquids and gases in healthcare applications—Part 3: Connectors for enteral applications
2 Objectives and uses of AAMI standards and recommended practices
4 AAMI Standard
Copyright information
5 Contents
6 Glossary of equivalent standards
7 Committee representation
9 Background on ANSI/AAMI adoption of ISO 80369-3:2016
10 Foreword
11 Introduction
13 1 * Scope
2 Normative references
14 3 Terms and definitions
15 4 General requirements
4.1 General requirements for the enteral application
4.2 Material used for enteral small-bore connectors
16 4.3 Type tests
5 Dimensional requirements for enteral small-bore connectors
6 Performance requirements
6.1 Fluid leakage
6.1.1 Fluid leakage requirement
6.1.2 Leakage by pressure decay
6.1.3 Positive pressure liquid leakage
6.2 Stress cracking
6.3 Resistance to separation from axial load
17 6.4 Resistance to separation from unscrewing
6.5 Resistance to overriding
6.6 Disconnection by unscrewing
18 Annex A (informative) Rationale and guidance
A.1 General guidance
A.1.1 Guidance
A.1.2 Connector selection
A.1.3 Colour coding
A.2 Rationale for particular clauses and subclauses
22 Annex B (normative) Enteral small-bore connectors
Figure B.1—Male E1 small-bore connector
23 Table B.1—Male E1 small-bore connector dimensions
24 Figure B.2—Female E1 small-bore connector
26 Figure B.3—E1 connector assembly
27 Annex C (normative) Reference connectors
C.1 General requirements for reference connectors
C.2 Reference connectors
28 Figure C.1—Female reference CONNECTOR for testing male ENTERAL CONNECTOR for leakage, disconnection byunscrewing, separation from unscrewing, stress cracking, and NON-INTERCONNECTABLE characteristics
29 Figure C.2—Female reference connector for testing male enteral connector for separation from axial load, resistance to overriding, and non-interconnectable characteristics
30 Figure C.3—Male reference connector for testing female enteral connector for leakage, disconnection by unscrewing, separation from unscrewing, stress cracking, and non-interconnectable characteristics
31 Figure C.4—Male reference CONNECTOR for testing female ENTERAL CONNECTOR for separation from axial load,resistance to overriding, and NON-INTERCONNECTABLE characteristics
32 Annex D (informative) Assessment of medical devices and their attributes with connections within this application
Table D.1—Examples of medical devices with connections within this application and their attributes
33 Annex E (informative) Summary of the usability requirements for small-bore connectors for enteral applications
E.1 User profile
Table E.1—User profile
E.2 Use scenarios
34 Table E.2—Use scenarios, enteral feeding
Table E.3—Use scenarios, medication delivery
35 Table E.4—Use scenarios, decompression, and suction of GI content
Table E.5—Use scenarios, delivery of radiologic contrast material
E.3 Use environments
E.3.1 Facilities
E.3.2 Use temperature
36 E.4 Other attributes
E.5 Generic user needs
38 Annex F (informative) Summary of small-bore connector criteria and requirements for enteral applications
Table F.1—Enteral connector-specific design criteria and requirements
41 Annex G (informative) Summary of assessment of the design of the connectors for enteral applications
G.1 General
G.2 Summary of the engineering analysis of the design
G.2.1 Non-interconnectable analysis
Table G.1—Summary of possible misconnection from CAD analysis
G.2.2 E1 male to N1 male
G.2.3 E1 female to luer slip connector female
42 G.2.4 E1 female to N1 female
G.3 Summary of the design verification
43 G.4 Summary of the design validation
G.4.1 General
G.4.2 Test procedure
G.4.3 Test participants
44 G.4.4 Test results
45 Table G.2—Summary of findings for the failed participant
G.4.5 Summative validation study conclusions
G.5 Summary of the design review
47 Annex H (informative) Reference to the essential principles
Table H.1—Correspondence between this part of ISO 80369 and the essential principles
49 Annex I (informative) Terminology—Alphabetized index of defined terms
50 Bibliography

Related products

AAMI 80369 3 2016
$140.32