PREN ISO 80369-1 : DRAFT 2009

Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Materials used for small-bore connectors
5 Requirements for small-bore connectors for
  specific applications
  5.1 Small-bore connector incompatibility
  5.2 Intravascular or hypodermic applications
  5.3 Breathing systems and driving gases applications
  5.4 Enteral applications
  5.5 Urethral and urinary applications
  5.6 Limb cuff inflation applications
  5.7 Neuraxial applications
  5.8 Alternative small-bore connectors
6 Procedure to assess a proposed new design of
  small-bore connector for inclusion in this
  series of Standards
  6.1 General
  6.2 Proposal initiation
  6.3 Procedure to assess acceptability and
      non-interconnectable characteristics
      6.3.1 Design
      6.3.2 Design realization
      6.3.3 Design verification
      6.3.4 Design validation
  6.4 Design review
  6.5 Subsequent parts of this series of Standards
Annex A (informative) - Rationale
Annex B (normative) - Mechanical tests for verifying
        non-interconnectable characteristics
Annex C (informative) - Applications of small-bore connectors
Annex D (informative) - Reference to the Essential Principles
Annex ZA (informative) - Relationship between this Document
         and the Essential Requirements of EU Directive
         93/42/EEC
Bibliography
Terminology - Alphabetized index of defined terms

Describes general requirements, by application, for small-bore connectors used in medical devices and accessories that contain or convey liquids or gases to or from a patient.