AAMI/ISO TIR16775:2023
Current
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
Available format(s)
Hardcopy , PDF
Language(s)
English
Published date
04-06-2023
This document provides guidance for the application of the requirements contained in ISO 11607-1 and ISO 11607-2.
| DocumentType |
Standard
|
| ISBN |
978-1-57020-875-1
|
| Pages |
162
|
| ProductNote |
This standard is identical to ISO TIR16775
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Current
|
| Supersedes |
| ISO 3951-1:2013 | Sampling procedures for inspection by variables — Part 1: Specification for single sampling plans indexed by acceptance quality limit (AQL) for lot-by-lot inspection for a single quality characteristic and a single AQL |
| ISO 14971:2019 | Medical devices — Application of risk management to medical devices |
| ISO 13485:2016 | Medical devices — Quality management systems — Requirements for regulatory purposes |
| ISO 16142-1:2016 | Medical devices — Recognized essential principles of safety and performance of medical devices — Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards |
| ASTM F 3263 : 2017 | Standard Guide for Packaging Test Method Validation |
| ISO 22514-2:2017 | Statistical methods in process management — Capability and performance — Part 2: Process capability and performance of time-dependent process models |
| ASTM D 4321 : 2024 | Standard Test Method for Package Yield of Plastic Film |
| ASTM D 4754 : 2018 | Standard Test Method for Two-Sided Liquid Extraction of Plastic Materials Using FDA Migration Cell |
| ISO 11139:2018 | Sterilization of health care products — Vocabulary of terms used in sterilization and related equipment and process standards |
| ISO 2859-1:1999 | Sampling procedures for inspection by attributes — Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection |
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