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I.S. EN ISO 80369-20:2015&LC:2015

Current

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)

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

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.

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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