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BSI 21/30435755 DC:2021 Edition

BSI 21/30435755 DC:2021 Edition

$13.70

BS EN ISO 80369-20. Small-bore connectors for liquids and gases in healthcare applications – Part 20. Common test methods

Published By Publication Date Number of Pages
BSI 2021 43
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PDF Pages PDF Title
3 62D/1848/CD
COMMITTEE DRAFT (CD)
Project number:
ISO 80369-20 ED2
Date of circulation:
Closing date for comments:
2021-04-09
2021-06-04
Supersedes documents:
62D/1845A/RR
IEC SC 62D : Electromedical equipment
Secretariat:
Secretary:
United States of America
Ms Hae Choe
Of interest to the following committees:
Proposed horizontal standard:
Other TC/SCs are requested to indicate their interest, if any, in this CD to the secretary.
Functions concerned:
EMC
Environment
Quality assurance
Safety
This document is still under study and subject to change. It should not be used for reference purposes.
Recipients of this document are invited to submit, with their comments, notification of any relevant patent rights of which they are aware and to provide supporting documentation.
Title:
Small-bore connectors for liquids and gases in healthcare applications – Part 20: Common test methods
Note from TC/SC officers:
HORIZONTAL_STD
FUNCTION_EMC
FUNCTION_ENV
FUNCTION_QUA
FUNCTION_SAFETY
10 Foreword
11 Introduction
12 1 Scope
2 Normative references
3 Terms and definitions
13 4 Test methods for small-bore connectors
Table 1 — Test methods and corresponding Annex of this document
14 Annex A (informative) Rationale and guidance
A.1 General guidance
A.2 Rationale for particular clauses and subclauses
17 Annex B (normative) 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
18 Table B.1 — Connector minimum test volume
19 B.4 Procedure
20 B.5 Test report
22 Annex C (normative) 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
23 C.5 Test report
24 Annex D (normative) 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
25 Table D.1 — Connector minimum test volume
26 Figure D.1 — Example subatmospheric-pressure air leakage test apparatus
D.4 Procedure
27 D.5 Test report
29 Annex E (normative) 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
30 E.5 Test report
31 Annex F (normative) 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
32 F.5 Test report
33 Annex G (normative) 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
34 G.5 Test report
35 Annex H (normative) 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
36 H.5 Test report
37 Annex I (normative) 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
38 I.5 Test report
39 Annex J (informative) 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
40 J.2.5 Resistance to separation from unscrewing test method
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
42 Bibliography
43 Terminology — Alphabetized index of defined terms

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