S.R. CEN ISO/TS 16775:2021

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Guidance on Clauses 1-4 of ISO 11607-1:2019 and ISO 11607-2:2019
5 Guidance on Clauses 5-11 of ISO 11607-1:2019
6 Guidance on Clauses 5-8 of ISO 11607-2:2019
Annex A (informative) Design and development for packaging systems – guidance for industry
Annex B (informative) Guidance on the application of the ISO 11607 series in healthcare facilities
Annex C (informative) Risk analysis tools — Guidance for industry and healthcare facilities
Annex D (informative) Considerations for sampling plans – Guidance for healthcare facilities
Annex E (informative) Guidance on establishing process parameters – guidance for industry
Annex F (informative) Sterilization considerations – Guidance for industry and healthcare facilities
Annex G (informative) Use of contract packagers – Guidance for industry and healthcare facilities
Annex H (informative) Example of a handling, distribution and storage checklist – Guidance for healthcare facilities for selecting a sterile barrier system
Annex I (informative) Investigating failure – Guidance for industry and healthcare facilities
Annex J (informative) Validation summary – Guidance for healthcare facilities
Annex K (informative) Validation for wrapping process — Guidance for healthcare facilities
Annex L (informative) Validation for reusable container process – Guidance for healthcare facilities
Annex M (informative) Validation for heat sealing process for preformed sterile barrier systems (PSBS) – Guidance for healthcare facilities
Annex N (informative) Evaluation of sterile packaging by end users — Guidance for healthcare facilities
Bibliography