ANSI/AAMI/ISO 80369-20:2015
Current
The latest, up-to-date edition.
SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 20: COMMON TEST METHODS
English
20-04-2015
Glossary of equivalent standards
Committee representation
Background of AAMI/ISO 80369-20:2015
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 TEST METHODS for SMALL-BORE CONNECTORS
Annex A (informative) - Rationale and guidance
Annex B (normative) - Leakage by pressure
decay TEST METHOD
Annex C (normative) - Falling drop positive-pressure
liquid leakage TEST METHOD
Annex D (normative) - Subatmospheric-pressure
air leakage TEST METHOD
Annex E (normative) - Stress cracking TEST METHOD
Annex F (normative) - Resistance to separation
from axial load TEST METHOD
Annex G (normative) - Resistance to separation
from unscrewing TEST METHOD
Annex H (normative) - Resistance to overriding
TEST METHOD
Annex I (normative) - Disconnection by unscrewing
TEST METHOD
Annex J (informative) - Modification of the TEST
METHODS to generate variable data for
statistical analysis
Annex K (informative) - Terminology - alphabetized
index of defined terms
Bibliography
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.
| DocumentType |
Test Method
|
| ISBN |
1-57020-591-4
|
| Pages |
40
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Current
|
| Standards | Relationship |
| ISO 80369-20:2015 | Identical |
| ISO/IEC TR 10000-1:1998 | Information technology — Framework and taxonomy of International Standardized Profiles — Part 1: General principles and documentation framework |
| ISO 10241-2:2012 | Terminological entries in standards — Part 2: Adoption of standardized terminological entries |
| ISO 16269-6:2014 | Statistical interpretation of data — Part 6: Determination of statistical tolerance intervals |
| ISO 80369-1:2010 | Small-bore connectors for liquids and gases in healthcare applications — Part 1: General requirements |
| ISO 5479:1997 | Statistical interpretation of data — Tests for departure from the normal distribution |
| ISO 10241-1:2011 | Terminological entries in standards — Part 1: General requirements and examples of presentation |
| ISO 14971:2007 | Medical devices — Application of risk management to medical devices |
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