S.R. CEN ISO/TS 16775:2014
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - GUIDANCE ON THE APPLICATION OF ISO 11607-1 AND ISO 11607-2 (ISO/TS 16775:2014)
Hardcopy , PDF
English
01-01-2014
20-12-2021
Foreword
Introduction
1 Scope
2 Terms and definitions
3 Guidance for health care facilities
4 Guidance for industry
Annex A (informative) - Selection, evaluation
and testing of packaging materials and
sterile barrier systems - Guidance for
industry and health care facilities
Annex B (informative) - Sterilization
considerations - Guidance for industry
and health care facilities
Annex C (informative) - Examples of
wrapping methods - Guidance for health
care facilities
Annex D (informative) - Validation plan
documents - Guidance for health care facilities
Annex E (informative) - Installation qualification
documentation - Guidance for health care facilities
Annex F (informative) - Operational qualification
documentation - Guidance for health care facilities
Annex G (informative) - Performance qualification
documentation - Guidance for health care facilities
Annex H (informative) - Addressing worst-case
requirements - Guidance for industry and health
care facilities
Annex I (informative) - Generating a final packaging
system validation protocol - Guidance for industry
Annex J (informative) - Design inputs - Medical device
attributes - Guidance for industry
Annex K (informative) - Risk analysis tools - Guidance
for industry and health care facilities
Annex L (informative) - Considerations for sampling
plans - Guidance for health care facilities
Annex M (informative) - Stability testing
(ISO 11607-1:2006, 6.4) - Guidance for industry
Annex N (informative) - Use of the Internet - Guidance for
industry and health care facilities
Annex O (informative) - Test method validation -
Guidance for industry
Annex P (informative) - Use of contract packagers -
Guidance for industry and health care facilities
Annex Q (informative) - Guidance on establishing process
parameters - Guidance for industry
Annex R (informative) - Investigation failure -
Guidance for industry and health care facilities
Annex S (informative) - Packaging manufacturing
process and packaging system design feasibility
evaluation - Guidance for industry
Bibliography
Specifies guidance for the application of the requirements contained in ISO 11607-1 and ISO 11607-2.
| DocumentType |
Standard
|
| Pages |
130
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| ISO/TS 16775:2014 | Identical |
| CEN ISO/TS 16775:2014 | Identical |
| PD CEN ISO/TS 16775:2014 | Equivalent |
A newer version of this standard is available.
View Current Edition
Please Login or Create an Account so you can add users to your Multi user PDF Later.
Important note : All end users must be registered with an Account prior to user licenses being assigned.
Users cannot be edited or removed once added to your Multi user PDF.