EN ISO 22442-1 : 2015

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Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - PART 1: APPLICATION OF RISK MANAGEMENT (ISO 22442-1:2015)

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Published date: 11-25-2015

Publisher: Comite Europeen de Normalisation

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Table of Contents - (Show below) - (Hide below)

European foreword
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Risk management process
Annex A (informative) - Guidance on the application
        of this part of ISO 22442
Annex B (informative) - Graphical representation of part
        of the risk management process for medical devices
        utilizing animal material
Annex C (normative) - Special requirements for some
        animal materials considering the risk
        management for TSE agents
Annex D (informative) - Information relevant to the
        management of TSE risk
Bibliography
Annex ZA (informative) - Relationship between this
         European Standard and the Essential
         Requirements of EU Directive 93/42/EEC

Abstract - (Show below) - (Hide below)

Pertains to medical devices other than in vitro diagnostic medical devices manufactured utilizing materials of animal origin, which are non-viable or have been rendered non-viable.

General Product Information - (Show below) - (Hide below)

Published
Document Type	Standard
Status	Superseded
Publisher	Comite Europeen de Normalisation
Development Note	Supersedes EN 12442-1. (02/2008)
Pages
ISBN
Committee	TC 316
Superseded By	EN ISO 22442-1 : 2020

National Adoptions - (Show below) - (Hide below)

Equivalent Standard(s)	Relationship
DS EN ISO 22442-1 : 2015	Identical
SN EN ISO 22442-1 : 2016	Identical
UNI EN ISO 22442-1 : 2008	Identical
DIN EN ISO 22442-1 E : 2016	Identical
NF EN ISO 22442-1 : 2016	Identical
NBN EN ISO 22442-1 : 2015	Identical
NS EN ISO 22442-1 : 2007	Identical
UNE EN ISO 22442-1 : 2016	Identical
DIN EN ISO 22442-1:2016-05	Identical
ISO 22442-1 : 2015	Identical
I.S. EN ISO 22442-1:2015	Identical
NEN EN ISO 22442-1 : 2015	Identical
PN EN ISO 22442-1 : 2016	Identical
BS EN ISO 22442-1 : 2015	Identical
SS-EN ISO 22442-1:2015	Identical
UNI EN ISO 22442-1 : 2016	Identical

Standards Referenced By This Book - (Show below) - (Hide below)

I.S. EN ISO 15798:2013	OPHTHALMIC IMPLANTS - OPHTHALMIC VISCOSURGICAL DEVICES (ISO 15798:2013)
EN ISO 16671 : 2015 AMD 1 2017	OPHTHALMIC IMPLANTS - IRRIGATING SOLUTIONS FOR OPHTHALMIC SURGERY (ISO 16671:2015/AMD 1:2017)
UNE EN ISO 16671 : 2016	OPHTHALMIC IMPLANTS - IRRIGATING SOLUTIONS FOR OPHTHALMIC SURGERY (ISO 16671:2015)
09/30201992 DC : 0	BS EN 12182 - ASSISTIVE PRODUCTS FOR PERSONS WITH DISABILITY - GENERAL REQUIREMENTS AND TEST METHODS
BS EN ISO 15798 : 2013	OPHTHALMIC IMPLANTS - OPHTHALMIC VISCOSURGICAL DEVICES
BS EN ISO 16671 : 2015	OPHTHALMIC IMPLANTS - IRRIGATING SOLUTIONS FOR OPHTHALMIC SURGERY
08/30184615 DC : DRAFT SEP 2008	BS EN 1642 - DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - DENTAL IMPLANTS
ISO 16671 : 2015	OPHTHALMIC IMPLANTS - IRRIGATING SOLUTIONS FOR OPHTHALMIC SURGERY
EN ISO 15798 : 2013 AMD 1 2017	OPHTHALMIC IMPLANTS - OPHTHALMIC VISCOSURGICAL DEVICES (ISO 15798:2013/AMD 1:2017)
PREN 12182 : 2009-06	ASSISTIVE PRODUCTS FOR PERSONS WITH DISABILITY - GENERAL REQUIREMENTS AND TEST METHODS
I.S. EN ISO 16671:2015	OPHTHALMIC IMPLANTS - IRRIGATING SOLUTIONS FOR OPHTHALMIC SURGERY (ISO 16671:2015)
DIN EN 12182:2012-07	ASSISTIVE PRODUCTS FOR PERSONS WITH DISABILITY - GENERAL REQUIREMENTS AND TEST METHODS
DIN EN 12182 E : 2012	ASSISTIVE PRODUCTS FOR PERSONS WITH DISABILITY - GENERAL REQUIREMENTS AND TEST METHODS
DIN EN 1642:2012-06	DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - DENTAL IMPLANTS
BS EN ISO 22442-2 : 2015	MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - PART 2: CONTROLS ON SOURCING, COLLECTION AND HANDLING
BS EN 1642 : 2011	DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - DENTAL IMPLANTS
DIN EN 1642 E : 2012	DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - DENTAL IMPLANTS
ISO 16672 : 2015	OPHTHALMIC IMPLANTS - OCULAR ENDOTAMPONADES
UNE-EN 1642:2012	DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - DENTAL IMPLANTS
BS EN 12182 : 2012	ASSISTIVE PRODUCTS FOR PERSONS WITH DISABILITY - GENERAL REQUIREMENTS AND TEST METHODS
(INACTIVE RECORD) DIN EN 1642:2012-06	DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - DENTAL IMPLANTS
I.S. EN 12182:2012	ASSISTIVE PRODUCTS FOR PERSONS WITH DISABILITY - GENERAL REQUIREMENTS AND TEST METHODS
I.S. EN ISO 22442-2:2015	MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - PART 2: CONTROLS ON SOURCING, COLLECTION AND HANDLING (ISO 22442-2:2015)
I.S. EN 1642:2011	DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - DENTAL IMPLANTS
(INACTIVE RECORD) DIN EN 12182:2012-07	ASSISTIVE PRODUCTS FOR PERSONS WITH DISABILITY - GENERAL REQUIREMENTS AND TEST METHODS
EN ISO 22442-2 : 2015	MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - PART 2: CONTROLS ON SOURCING, COLLECTION AND HANDLING (ISO 22442-2:2015)
I.S. EN ISO 16672:2015	OPHTHALMIC IMPLANTS - OCULAR ENDOTAMPONADES (ISO 16672:2015)

Standards Referencing This Book - (Show below) - (Hide below)

ISO 13408-4 : 2005(R2019)	ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 4: CLEAN-IN-PLACE TECHNOLOGIES
EN ISO 22442-2 : 2015	MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - PART 2: CONTROLS ON SOURCING, COLLECTION AND HANDLING (ISO 22442-2:2015)
ISO 13408-7 : 2012(R2018)	ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 7: ALTERNATIVE PROCESSES FOR MEDICAL DEVICES AND COMBINATION PRODUCTS
ISO 10993-3 : 2014	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 3: TESTS FOR GENOTOXICITY, CARCINOGENICITY AND REPRODUCTIVE TOXICITY
ISO 10993-4 : 2017	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 4: SELECTION OF TESTS FOR INTERACTIONS WITH BLOOD
ISO 10993-16 : 2017	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 16: TOXICOKINETIC STUDY DESIGN FOR DEGRADATION PRODUCTS AND LEACHABLES
ISO TS 10993-20 : 2006	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 20: PRINCIPLES AND METHODS FOR IMMUNOTOXICOLOGY TESTING OF MEDICAL DEVICES
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 10993-13 : 2010(R2013)	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 13: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM POLYMERIC MEDICAL DEVICES
ISO 13408-2 : 2003	ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 2: STERILIZING FILTRATION
ISO 13485 : 2016(R2020)	MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR REGULATORY PURPOSES
ISO 14937 : 2009(R2015)	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 10993-2 : 2006(R2015)	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 2: ANIMAL WELFARE REQUIREMENTS
ISO 10993-14 : 2001(R2019)	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 14: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM CERAMICS
ISO 13408-3 : 2006(R2016)	ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 3: LYOPHILIZATION
EN ISO 22442-3 : 2007	MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - PART 3: VALIDATION OF THE ELIMINATION AND/OR INACTIVATION OF VIRUSES AND TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHY (TSE) AGENTS
ISO 10993-18 : 2005(R2013)	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 18: CHEMICAL CHARACTERIZATION OF MATERIALS
ISO TS 10993-19 : 2006(R2017)	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 19: PHYSICO-CHEMICAL, MORPHOLOGICAL AND TOPOGRAPHICAL CHARACTERIZATION OF MATERIALS
ISO 10993-10 : 2010(R2016)	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 10: TESTS FOR IRRITATION AND SKIN SENSITIZATION
ISO 13408-1 : 2008(R2017)	ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS
ISO 10993-11 : 2017	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 11: TESTS FOR SYSTEMIC TOXICITY
ISO 10993-12 : 2012	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 12: SAMPLE PREPARATION AND REFERENCE MATERIALS
ISO 10993-7 : 2008(R2016)	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 7: ETHYLENE OXIDE STERILIZATION RESIDUALS
ISO 10993-17 : 2002(R2016)	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 17: ESTABLISHMENT OF ALLOWABLE LIMITS FOR LEACHABLE SUBSTANCES
ISO 10993-1 : 2009	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS
ISO 10993-15 : 2001	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 15: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM METALS AND ALLOYS
ISO 22442-2 : 2015	MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - PART 2: CONTROLS ON SOURCING, COLLECTION AND HANDLING
ISO 10993-9 : 2009(R2013)	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 9: FRAMEWORK FOR IDENTIFICATION AND QUANTIFICATION OF POTENTIAL DEGRADATION PRODUCTS
ISO 22442-3 : 2007(R2015)	MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - PART 3: VALIDATION OF THE ELIMINATION AND/OR INACTIVATION OF VIRUSES AND TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHY (TSE) AGENTS
ISO 14971 : 2007(R2010)	MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES
ISO 13408-6 : 2005(R2014)	ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 6: ISOLATOR SYSTEMS
ISO 17664 : 2017	PROCESSING OF HEALTH CARE PRODUCTS - INFORMATION TO BE PROVIDED BY THE MEDICAL DEVICE MANUFACTURER FOR THE PROCESSING OF MEDICAL DEVICES
EN ISO 10993-1 : 2009 COR 2010	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS (ISO 10993-1:2009/COR 1:2010)
ISO 10993-6 : 2016	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 6: TESTS FOR LOCAL EFFECTS AFTER IMPLANTATION
ISO 17665-1 : 2006(R2016)	STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
ISO 13408-5 : 2006(R2015)	ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 5: STERILIZATION IN PLACE

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EN ISO 22442-1 : 2015

Table of Contents - (Show below) - (Hide below)

Abstract - (Show below) - (Hide below)

General Product Information - (Show below) - (Hide below)

National Adoptions - (Show below) - (Hide below)

Standards Referenced By This Book - (Show below) - (Hide below)

Standards Referencing This Book - (Show below) - (Hide below)

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