I.S. EN ISO 80369-20:2015&LC:2015
Current
The latest, up-to-date edition.
SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 20: COMMON TEST METHODS (ISO 80369-20:2015)
Hardcopy , PDF
English
01-01-2015
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
Dates of withdrawal of national standards are available from NSAI.
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National Foreword
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
Annex ZA (informative) - Relationship between this part of
EN ISO 80369 and the essential requirements of EU
Directive 93/42/EEC
Defines the TEST METHOD to evaluate the performance requirements for SMALL-BORE CONNECTORS specified in the ISO 80369- series.
| Committee |
TC 210
|
| DevelopmentNote |
2015 Edition Incorporates Corrigendum. (07/2016)
|
| DocumentType |
Standard
|
| Pages |
48
|
| ProductNote |
The date of any NSAI previous adoption may not match the date of its original CEN/CENELEC document. CORRECTED VERSION IS NOW AVAILABLE OF THIS STANDARD FROM 06-06-2015
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Standards | Relationship |
| EN ISO 80369-20:2015 | Identical |
| 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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