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
Important note : Users cannot be edited or removed once added to your Multi user PDF.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 |
Access your standards online with a subscription
Features
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.