S.R. CEN ISO/TS 16775:2021
Current
The latest, up-to-date edition.
Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2 (ISO/TS 16775:2021)
Hardcopy , PDF
English
13-12-2021
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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
This document provides guidance for the application of the requirements contained in ISO 11607-1 and ISO 11607-2.
| Committee |
ISO/TC 198
|
| DocumentType |
Standard Recommendation
|
| Pages |
162
|
| ProductNote |
The date of any NSAI previous adoption may not match the date of its original CEN/CENELEC document.
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| ISO/TS 16775:2021 | Identical |
| CEN ISO/TS 16775:2021 | Identical |
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