ONORM EN ISO 5840-1 : 2015

Name: ONORM EN ISO 5840-1 : 2015
Brand: ON

Withdrawn

CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 1: GENERAL REQUIREMENTS (ISO 5840-1:2015)

Withdrawn date

07-15-2021

Published date

01-07-2016

Publisher

Osterreichisches Normungsinstitut/Austrian Standards

DocumentType	Standard
PublisherName	Osterreichisches Normungsinstitut/Austrian Standards
Status	Withdrawn
SupersededBy	ÖNORM EN ISO 5840-1:2021 07 15

ISO 14160:2011	Sterilization of health care products Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives Requirements for characterization, development, validation and routine control of a sterilization process for medical devices
ISO 11135:2014	Sterilization of health-care products Ethylene oxide Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO 14937:2009	Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
ISO 5840-3:2013	Cardiovascular implants Cardiac valve prostheses Part 3: Heart valve substitutes implanted by transcatheter techniques
ISO 14155:2011	Clinical investigation of medical devices for human subjects Good clinical practice
ISO 14971:2007	Medical devices Application of risk management to medical devices
ISO 5840-2:2015	Cardiovascular implants Cardiac valve prostheses Part 2: Surgically implanted heart valve substitutes

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