This standard specifies the requirement for package and information supplied by manufacturer of medical polymer products.
Note: The requirements of the national laws and regulations as well as product standards have priority over those specified in this standard.
Foreword i
1 Scope
2 Normative References
3 Terminologies and Definitions
4 Product Categorization
5 Package Requirements
6 Requirements for Information Supplied by Manufacturer
Appendix A (Informative) Guide for Necessary Information of Medical Equipment Required for Meeting the Requirements of European Directive 93/42/EEC
Bibliography