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63 items

 Most recent

ANSI/AAMI/ISO 13004:2022

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

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

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)

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

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

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)

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)

CONTENT PROVIDER
Austrian Standards Institute [on]

 Most recent

AAMI/ISO TIR11137-4:2022 (R2023)

Sterilization of health care products -Radiation - Part 4: Guidance on process control

CONTENT PROVIDER
Association for the Advancement of Medical Instrumentation [aami]

 Most recent

ANSI/AAMI/ISO 11137-1:2006 (R2015) and A1:2013

Sterilization of health care products-Radiation-Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices, 2ed and Amendment 1.

CONTENT PROVIDER
Association for the Advancement of Medical Instrumentation [aami]

 Most recent

ANSI/AAMI/ISO 11137-1:2006 (R2015) and A1:2013 and A2:2019

(Consolidated Text)

CONTENT PROVIDER
Association for the Advancement of Medical Instrumentation [aami]

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