Sterilization of health care products—Radiation—Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-05-2019

Publisher

Association for the Advancement of Medical Instrumentation

Specifies requirements for validation, process control, and routine monitoring in the radiation sterilization for health care products.

Committee	TC 198
DocumentType	Standard
ISBN	1-57020-253-2
Pages	11
ProductNote	THIS STANDARD REFERS:EN 556-1,ANSI/AAMI ST67:
PublisherName	Association for the Advancement of Medical Instrumentation
Status	Current
Supersedes	AAMI ISO 11137-1:2006 AAMI ISO 11137-1 : 2006 : INC : AMD 1 : 2013 : R201000

This part of ISO 11137 specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices.

Standards	Relationship
ISO 11137-1:2006/Amd 2:2018	Identical

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

Sterilization of health care products—Radiation—Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices

Abstract

General Product Information

Scope

International Equivalents

Category

Subcategory