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61 items

Most Recent

AAMI TIR104:2022

Guidance on transferring health care products between radiation sterilization sources

Available for Subscriptions

Content Provider
Association for the Advancement of Medical Instrumentation [aami]

Most Recent

AAMI TIR29:2012 (R2017)

Guide for process characterization and control in radiation sterilization of medical devices

Available for Subscriptions

Content Provider
Association for the Advancement of Medical Instrumentation [aami]

Most Recent

ASTM 52303-24

Standard Guide for Absorbed-Dose Mapping in Radiation Processing Facilities

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Content Provider
ASTM International [astm]

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AAMI TIR37:2013 (AAMI TIR 37:2013)

Sterilization of health care products-Radiation-Guidance on sterilization of biologics and tissue-based products

Available for Subscriptions

Content Provider
Association for the Advancement of Medical Instrumentation [aami]

Most Recent

ONORM EN ISO 11137-2:2023

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)

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Content Provider
Austrian Standards Institute [on]

Most Recent

GB 16383-2014

Quality control for radiation sterilization of medical and hygienical products (TEXT OF DOCUMENT IS IN CHINESE)

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Content Provider
CHINESE GB Standards [spc]

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AAMI TIR35:2016 (R2021)

Sterilization of health care products - Radiation sterilization - Product adoption and alternative sampling plans for verification dose experiments and sterilization dose audits

Available for Subscriptions

Content Provider
Association for the Advancement of Medical Instrumentation [aami]

Most Recent

ONORM EN ISO 11137-3:2017

Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control (ISO 11137-3:2017)

Available for Subscriptions

Content Provider
Austrian Standards Institute [on]

Most Recent

ANSI/AAMI/ISO 13004:2022

Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD

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Content Provider
Association for the Advancement of Medical Instrumentation [aami]

Most Recent

AAMI TIR76:2021

Sterilization of health care products - Radiation - Substantiation of a selected sterilization dose at a specified sterility assurance level: Method Vdmax SD-S

Available for Subscriptions

Content Provider
Association for the Advancement of Medical Instrumentation [aami]

Most Recent

ONORM EN ISO 11137-1:2020

Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006 + Amd.1:2013 + Amd.2:2018) (consolidated version)

Available for Subscriptions

Content Provider
Austrian Standards Institute [on]

Most Recent

ANSI/AAMI/ISO 11137-2: 2013 (R2019)

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose

Available for Subscriptions Available in Packages

Content Provider
Association for the Advancement of Medical Instrumentation [aami]

Most Recent

DIN EN ISO 11137-3:2017

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

Available for Subscriptions

Content Provider
Deutsches Institut für Normung [din]

Most Recent

CAN/CSA Z11137-1-07 (R2021)

Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (Adopted ISO 11137-1:2006, first edition, 2006-04-15)

Available for Subscriptions

Content Provider
CSA America, Inc. [csa]

Most Recent

ONR CEN ISO/TS 11137-4:2023

Sterilization of health care products - Radiation - Part 4: Guidance on process control (ISO/TS 11137-4:2020)

Available for Subscriptions

Content Provider
Austrian Standards Institute [on]


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