FOREWORD
INTRODUCTION
1 Scope
2 Normative references
3 Terms, definitions and abbreviated terms
4 Quality, and risk assessment
5 General quality and risk assessment requirements
for NE products
6 Special assessment requirements for NE products
Annex A (informative) - General approach and
rationale
Annex B (normative) - General guidance for
stakeholder's declaration
Annex C (informative) - General guidance for
correlative indicators determination
Annex D (informative) - Steps for manufacture to
make the stakeholder's declaration
Bibliography