Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Quality verification
5 Design
6 Barrier properties
7 Biocompatibility
8 Surface finish
9 Tensile properties
10 Tests for stability and shelf life
11 Freedom from holes
12 Visible defects
13 Packaging and labelling
14 Data sheets
Annex A (normative) - Sampling plans intended for assessing
compliance of a continuing series of lots of
sufficient number to allow the switching rules to be
applied
Annex B (normative) - Sampling plans intended for assessing
compliance of isolated lots
Annex C (normative) - Determination of length and width
Annex D (normative) - Determination of dam thickness
Annex E (normative) - Guidance for risk assessment
Annex F (normative) - Determination of barrier properties
using the bacteriophage method
Annex G (normative) - Determination of tensile properties
Annex H (normative) - Oven conditioning
Annex I (normative) - Determination of shelf life by real-time
stability studies
Annex J (normative) - Guidance on conducting and analyzing
accelerated ageing studies
Annex K (normative) - Testing for holes
Annex L (normative) - Testing for prophylactic dam package
integrity
Bibliography