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AAMI 80369 20 2015

AAMI 80369 20 2015

$131.66

ANSI/AAMI/ISO 80369-20:2015. – Small-bore connectors for liquids and gases in healthcare applications – Part 20: Common test methods

Published By Publication Date Number of Pages
AAMI 2015 40
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Specifies the TEST METHODS to support the functional requirements for SMALL-BORE CONNECTORS intended to be used for CONNECTIONS of MEDICAL DEVICES and related ACCESSORIES.

PDF Catalog

PDF Pages PDF Title
1 ANSI/AAMI/ISO 80369-20:2015, Small-bore connectors for liquids and gases in healthcare applications— Part 20: Common test methods
2 Objectives and uses of AAMI standards and recommended practices
3 Title page
4 Copyright information
5 Contents
6 Glossary of equivalent standards
7 Committee representation
9 Background of AAMI/ISO 80369-20:2015
10 Foreword
11 Introduction
13 1 *Scope
2 Normative references
3 Terms and definitions
14 4 Test methods for small-bore connectors
Table 1 — Test methods and corresponding Annex of this part of ISO 80369
15 Annex A: Rationale and guidance
A.1 General guidance
A.2 Rationale for particular clauses and subclauses
18 Annex B: *Leakage by pressure decay test method
B.1 Principle
B.2 *Test conditions
B.2.1 Test sample preconditioning
B.2.2 Environmental test conditions
B.3 Apparatus
B.4 Procedure
19 B.5 Test report
21 Annex C: Falling drop positive-pressure liquid leakage test method
C.1 Principle
C.2 *Test conditions
C.2.1 Test sample preconditioning
C.2.2 Environmental test conditions
C.3 Apparatus
C.4 Procedure
22 C.5 Test report
23 Annex D: Subatmospheric-pressure air leakage test method
D.1 Principle
D.2 *Test conditions
D.2.1 Test sample preconditioning
D.2.2 Environmental test conditions
D.3 Apparatus
24 D.4 Procedure
25 Figure D.1 — Example subatmospheric-pressure air leakage test apparatus
D.5 Test report
27 Annex E: Stress cracking test method
E.1 Principle
E.2 *Test conditions
E.2.1 Test sample preconditioning
E.2.2 Environmental test conditions
E.3 Apparatus
E.4 Procedure
28 E.5 Test report
29 Annex F: Resistance to separation from axial load test method
F.1 Principle
F.2 * Test conditions
F.2.1 Test sample preconditioning
F.2.2 Environmental test conditions
F.3 Apparatus
F.4 Procedure
30 F.5 Test report
31 Annex G: Resistance to separation from unscrewing test method
G.1 Principle
G.2 *Test conditions
G.2.1 Test sample preconditioning
G.2.2 Environmental test conditions
G.3 Apparatus
G.4 Procedure
32 G.5 Test report
33 Annex H: Resistance to overriding test method
H.1 Principle
H.2 *Test conditions
H.2.1 Test sample preconditioning
H.2.2 Environmental test conditions
H.3 Apparatus
H.4 Procedure
34 H.5 Test report
35 Annex I: Disconnection by unscrewing test method
I.1 Principle
I.2 *Test conditions
I.2.1 Test sample preconditioning
I.2.2 Environmental test conditions
I.3 Apparatus
I.4 Procedure
36 I.5 Test report
37 Annex J: Modification of the test methods to generate variable data for statistical analysis
J.1 Principle
J.2 Test method variations
J.2.1 Fluid leakage test by pressure decay test method
J.2.2 Falling drop positive pressure liquid leakage test method
J.2.3 Subatmospheric-pressure air leakage test method
J.2.4 Resistance to separation from axial load test method
J.2.5 Resistance to separation from unscrewing test method
38 J.2.6 Resistance to overriding test method
J.2.7 Disconnection by unscrewing test method
J.3 Statistical analysis of variable data
J.3.1 Test for normality
J.3.2 Tolerance limit calculation
39 Annex K: Terminology — alphabetized index of defined terms
40 Bibliography

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AAMI 80369 20 2015
$131.66