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DIN EN ISO 80369-20 E : 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

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

Defines the test methods to evaluate the performance requirements for SMALL-BORE CONNECTORS specified in the ISO 80369- series.

DocumentType
Standard
Pages
38
PublisherName
German Institute for Standardisation (Deutsches Institut für Normung)
Status
Current

Standards Relationship
EN ISO 80369-20:2015 Identical
ISO 80369-20:2015 Identical

DIN EN 80369-5:2017-10 SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 5: CONNECTORS FOR LIMB CUFF INFLATION APPLICATIONS (IEC 80369-5:2016 + COR.1:2017)
DIN EN 80369-5 E : 2017 SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 5: CONNECTORS FOR LIMB CUFF INFLATION APPLICATIONS (IEC 80369-5:2016 + COR.1:2017)
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
DIN ISO 5479:2004-01 STATISTICAL INTERPRETATION OF DATA - TESTS FOR DEPARTURE FROM THE NORMAL DISTRIBUTION
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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