Source: https://standards.globalspec.com/std/10189392/aami-tir29
Timestamp: 2020-04-08 09:39:19
Document Index: 618662461

Matched Legal Cases: ['art 1', 'art 3', 'art 1', 'art 2', 'art 3', 'art 3']

AAMI TIR29 - Guide for process characterization and control in radiation sterilization of medical devices | Engineering360
Guide for process characterization and control in radiation sterilization of medical devices
This technical information report (TIR) provides additional guidance for establishing and meeting the irradiator Operational Qualification (OQ), Performance Qualification (PQ), and routine control requirements for radiation sterilization as defined in ANSI/AAMI/ISO 11137-1 for gamma, electron beam, and X-ray sterilization.
NOTE-This TIR is intended to be used in conjunction with ANSI/AAMI/ISO 11137-1, Sterilization of health care products-- Radiation - Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices. Because a TIR is considered "informative" and is not subject to the same formal approval process as a standard, the process steps are described in the TIR as "should" rather than "shall." Readers are reminded that many of this TIR's "shoulds" are "shalls" in ANSI/AAMI/ISO 11137-1.
This technical information report (TIR) provides additional guidance for establishing and meeting the irradiator Operational Qualification (OQ), Performance Qualification (PQ), and routine control...
GUIDE FOR PROCESS CONTROL IN RADIATION STERILIZATION
AAMI 11137-3 - Sterilization of health care products-Radiation-Part 3: Guidance on dosimetric aspects of development, validation and routine
AAMI 11137-1 - Sterilization of health care products - Radiation - Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices
AAMI 11137-2 - Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
ASTM E2232 - Standard Guide for Selection and Use of Mathematical Methods for Calculating Absorbed Dose in Radiation Processing Applications
This guide describes different mathematical methods that may be used to calculate absorbed dose and criteria for their selection. Absorbed-dose calculations can determine the effectiveness of the...
DIN EN ISO 11137-3 - Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control (ISO 11137-3:2017); German version EN ISO 11137-3:2017
DIN EN ISO 11137-3 - Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control (ISO 11137-3:2017)
CSA ISO/TS 16775 - Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2
This Technical Specification provides guidance for the application of the requirements contained in ISO 11607‑1 and ISO 11607‑2. It does not add to, or otherwise change, the requirements of ISO...
BS PD CEN ISO/TS 16775 - Packaging for terminally sterilized medical devices — Guidance on the application of ISO 11607-1 and ISO 11607-2