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EN ISO 80369-20:2015

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)
Published date

05-20-2015

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
Annex ZA (informative) - Relationship between this part of
         EN ISO 80369 and the essential requirements of EU
         Directive 93/42/EEC

ISO 80369-20:2015 specifies the test methods to evaluate the performance requirements for small-bore connectors specified in the ISO 80369‑ series.

Committee
CEN/CLC/JTC 3
DocumentType
Standard
PublisherName
Comite Europeen de Normalisation
Status
Current

UNE-EN ISO 80369-7:2017 Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications (ISO 80369-7:2016, Corrected version 2016-12-01)
UNE-EN 80369-5:2017 Small-bore connectors for liquids and gases in healthcare applications - Part 5: Connectors for limb cuff inflation applications
DIN EN ISO 80369-7 E : 2017 SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 7: CONNECTORS FOR INTRAVASCULAR OR HYPODERMIC APPLICATIONS (ISO 80369-7:2016, CORRECTED VERSION 2016-12-01)
DIN EN ISO 80369-7:2017-10 Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications (ISO 80369-7:2016, Corrected version 2016-12-01)

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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