01/563307 DC : DRAFT AUG 2001

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
  4.1 Physical requirements
      4.1.1 Manufacturing process compatibility
      4.1.2 Resistance to temperature, to pressure, and
             to leakage
      4.1.3 Resistance to dropping
      4.1.4 Transparency
      4.1.5 Water vapour permeability
      4.1.6 Particulate contamination
      4.1.7 Cover
      4.1.8 Access port
      4.1.9 Adhesion strength of the infusion device and
             impermeability of the insertion point
      4.1.10 Injection point
      4.1.11 Hanger
      4.1.12 Identification
  4.2 Chemical requirements
      4.2.1 Requirements for the raw container or the
             sheeting
      4.2.2 Requirements for the test fluid
  4.3 Biological requirements
      4.3.1 Impermeability for micro-organisms
      4.3.2 Migration/tolerance
5 Identification
6 Application of tests
Annex A (normative) Physical tests
      A.1 General
      A.2 Sampling
      A.3 Resistance to temperature stability, pressure,
           and leakage
      A.4 Resistance to dropping
      A.5 Transparency
      A.6 Water vapour permeability
      A.7 Particulate contamination
      A.8 Penetration ability
      A.9 Adhesion strength of the infusion device and
           impermeability of the insertion point
      A.10 Tightness of the injection point
      A.11 Hanger
      A.12 Identification
Annex B (normative) Chemical tests
      B.1 General
      B.2 Determination of the residue on ignition
      B.3 Determination of metals in the plastic
      B.4 Preparation of the test fluid
      B.5 Determination of turbidity and coloration
      B.6 Determination of acidity or alkalinity
      B.7 Determination of the UV absorption
      B.8 Determination of the evaporation residue
      B.9 Determination of the oxidizable constituents
      B.10 Determination of ammonia
      B.11 Determination of metals
      B.12 Testing for heavy metals
Annex C (normative) Biological tests
      C.1 Preparation of the test fluids
           C.1.1 Test fluid I (aqueous extract)
           C.1.2 Test fluid II (oily extract)
      C.2 Testing for impermeability to microorganisms
      C.3 Testing for pyrogens
           C.3.1 Testing for bacterial endotoxins
           C.3.2 Type test for pyrogens
      C.4 Testing for cytotoxicity
           C.4.1 Preparation of the cell culture
           C.4.2 Procedure
           C.4.3 Evaluation
Annex D (informative) Further biological tests
Bibliography