DIN EN ISO 13485:2016-08

Superseded

View Superseded by

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

Amended by

DIN EN ISO 13485 Berichtigung 1:2017-07

Available format(s)

Hardcopy , PDF

Superseded date

01-28-2022

Language(s)

English, German

Published date

08-01-2016

Publisher

German Institute for Standardisation (Deutsches Institut für Normung)

DevelopmentNote	Supersedes DIN EN 46001. (05/2001) Supersedes DIN EN ISO 13488 and DIN ISO 13485. (12/2003) DIN EN ISO 13485 issue 11-2012 remains valid alongside this standard until 31-03-2019. (08/2016)
DocumentType	Standard
Pages	69
PublisherName	German Institute for Standardisation (Deutsches Institut für Normung)
Status	Superseded
SupersededBy	DIN EN ISO 13485:2021-12
Supersedes	DIN EN ISO 13485:2012-11 DIN EN 46001:1996-09 DIN ISO 13485:2002-05 (Draft)

Standards	Relationship
EN ISO 13485:2016	Identical
BS EN ISO 13485:2016	Identical
UNI EN ISO 13485 : 2004	Identical
EN ISO 13485:2016/AC:2018	Identical
UNE-EN ISO 13485:2016	Identical
I.S. EN ISO 13485:2016	Identical
NEN EN ISO 13485 : 2016 C11 2017	Identical
NBN EN ISO 13485 : 2016	Identical
NF EN ISO 13485 : 2016	Identical
SN EN ISO 13485:2016	Identical
ISO 13485:2016	Identical

DIN HDBK 463 : 3ED 2014	MEDIZINISCHE GERAETE UND BEHAELTNISSE FUER TRANSFUSION, INFUSION UND INJEKTION
DIN HDBK 475 : 2ED 2013
DIN EN ISO 11135:2014-10	STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES (ISO 11135:2014)
DIN EN ISO 13408-7:2015-11	ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 7: ALTERNATIVE PROCESSES FOR MEDICAL DEVICES AND COMBINATION PRODUCTS (ISO 13408-7:2012)
DIN EN ISO 5840-3:2013-06	Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques (ISO 5840-3:2013)
DIN EN ISO 7199:2015-06 (Draft)	CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - BLOOD-GAS EXCHANGERS (OXYGENATORS) (ISO 7199:2016)
DIN EN ISO 11140-1:2015-03	Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2014)
DIN EN ISO 11137-3:2015-08 (Draft)	STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 3: GUIDANCE ON DOSIMETRIC ASPECTS OF DEVELOPMENT, VALIDATION AND ROUTINE CONTROL (ISO 11137-3:2017)
DIN EN ISO 11608-5:2013-01	Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions (ISO 11608-5:2012)
DIN EN ISO 26782:2010-02	Anaesthetic and respiratory equipment - Spirometers intended for the measurement of time forced expired volumes in humans (ISO 26782:2009 + Cor. 1:2009) (includes Corrigendum AC:2009)
DIN EN ISO 13408-1:2015-12	ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS (ISO 13408-1:2008, INCLUDING AMD 1:2013)
DIN EN ISO 22610:2015-12 (Draft)	SURGICAL DRAPES, GOWNS AND CLEAN AIR SUITS, USED AS MEDICAL DEVICES, FOR PATIENTS, CLINICAL STAFF AND EQUIPMENT - TEST METHOD TO DETERMINE THE RESISTANCE TO WET BACTERIAL PENETRATION
DIN EN ISO 23747:2015-12	ANAESTHETIC AND RESPIRATORY EQUIPMENT - PEAK EXPIRATORY FLOW METERS FOR THE ASSESSMENT OF PULMONARY FUNCTION IN SPONTANEOUSLY BREATHING HUMANS (ISO 23747:2015)
DIN EN ISO 4074:2016-05	NATURAL RUBBER LATEX MALE CONDOMS - REQUIREMENTS AND TEST METHODS (ISO 4074:2015)
DIN EN ISO 14971:2013-04	MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007)
VDI 5702 Blatt 1:2017-04	Medical device software - Medical SPICE Process assessment model
VDI/VDE 2657 Blatt 1:2013-01	Middleware in industrial automation - Fundamentals
VDI 6305:2016-12 (Draft)	Technical good manufacturing practice - Application guideline for projects in the GMP environment
VDI 2083 Blatt 8.1:2014-10	Cleanroom technology - Air cleanliness chemical concentration (ACC)
DIN ISO 13022:2014-06	MEDICAL PRODUCTS CONTAINING VIABLE HUMAN CELLS - APPLICATION OF RISK MANAGEMENT AND REQUIREMENTS FOR PROCESSING PRACTICES (ISO 13022:2012)
DIN EN ISO 12870:2015-07 (Draft)	OPHTHALMIC OPTICS - SPECTACLE FRAMES - REQUIREMENTS AND TEST METHODS (ISO 12870:2012)
DIN EN ISO 7396-1:2016-09	MEDICAL GAS PIPELINE SYSTEMS - PART 1: PIPELINE SYSTEMS FOR COMPRESSED MEDICAL GASES AND VACUUM (ISO 7396-1:2016)
DIN EN ISO 11608-1:2015-04	Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems (ISO 11608-1:2014)
DIN EN ISO 22610:2006-10	Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment - Test method to determine the resistance to wet bacterial penetration (ISO 22610:2006)
DIN EN ISO 15194:2009-10	IN VITRO DIAGNOSTIC MEDICAL DEVICES - MEASUREMENT OF QUANTITIES IN SAMPLES OF BIOLOGICAL ORIGIN - REQUIREMENTS FOR CERTIFIED REFERENCE MATERIALS AND THE CONTENT OF SUPPORTING DOCUMENTATION
DIN HDBK 469 : 2ED 2013	QUALITAETS- UND RISIKOMANAGEMENTSYSTEME IM GESUNDHEITSWESEN UND KONFORMITAETSBEWERTUNG VON ZERTIFIZIERUNGSSTELLEN - NORMEN UND SPEZIFIKATIONEN
DIN EN ISO 7198:2017-07	Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches (ISO 7198:2016)
DIN EN ISO 20857:2013-08	Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 20857:2010)
DIN EN ISO 25539-1:2015-07 (Draft)	CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES (ISO 25539-1:2017)
DIN EN ISO 5359:2015-02	ANAESTHETIC AND RESPIRATORY EQUIPMENT - LOW-PRESSURE HOSE ASSEMBLIES FOR USE WITH MEDICAL GASES (ISO 5359:2014)
DIN EN ISO 15197:2015-12	IN VITRO DIAGNOSTIC TEST SYSTEMS - REQUIREMENTS FOR BLOOD-GLUCOSE MONITORING SYSTEMS FOR SELF-TESTING IN MANAGING DIABETES MELLITUS (ISO 15197:2013)
DIN EN ISO 14160:2011-10	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 14160:2011)
DIN EN ISO 14161:2010-03	STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - GUIDANCE FOR THE SELECTION, USE AND INTERPRETATION OF RESULTS
DIN EN ISO 14534:2015-08	Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011)
DIN EN ISO 18113-1:2013-01	IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 1: TERMS, DEFINITIONS AND GENERAL REQUIREMENTS (ISO 18113-1:2009)
DIN EN ISO 13408-3:2011-09	Aseptic processing of health care products - Part 3: Lyophilization (ISO 13408-3:2006)
DIN EN ISO 11737-1:2009-09	STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 1: DETERMINATION OF A POPULATION OF MICROORGANISMS ON PRODUCTS
DIN EN ISO 15883-1:2014-10	WASHER-DISINFECTORS - PART 1: GENERAL REQUIREMENTS, TERMS AND DEFINITIONS AND TESTS (ISO 15883-1:2006 + AMD 1:2014)
DIN EN ISO 11138-1:2015-10 (Draft)	STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 1: GENERAL REQUIREMENTS (ISO 11138-1:2017)
DIN EN ISO 11137-1:2015-11	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, INCLUDING AMD 1:2013)
DIN EN ISO 10451:2010-11	Dentistry - Contents of technical file for dental implant systems (ISO 10451:2010)
DIN EN ISO 11737-2:2010-04	STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 2: TESTS OF STERILITY PERFORMED IN THE DEFINITION, VALIDATION AND MAINTENANCE OF A STERILIZATION PROCESS
DIN EN ISO 11608-3:2013-01	Needle-based injection systems for medical use - Requirements and test methods - Part 3: Finished containers (ISO 11608-3:2012)
DIN EN ISO 5840:2009-08	CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES

DIN EN ISO 11607-1:2014-11	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS (ISO 11607-1:2006 + AMD 1.:2014)
ISO 19011:2011	Guidelines for auditing management systems
ISO 11607-2:2006	Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes
DIN EN ISO 19011:2011-12	GUIDELINES FOR AUDITING MANAGEMENT SYSTEMS (ISO 19011:2011)
VDE 0750-241 : 2016	MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES (IEC 62366:2007 + A1:2014)
DIN EN 62366-1 : 2017	MEDICAL DEVICES - PART 1: APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES (IEC 62366-1:2015 + COR1:2016)
DIN EN ISO 11607-2:2014-11	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: VALIDATION REQUIREMENTS FOR FORMING, SEALING AND ASSEMBLY PROCESSES (ISO 11607-2:2006 + AMD 1.:2014)
DIN EN ISO 9000:2015-11	QUALITY MANAGEMENT SYSTEMS - FUNDAMENTALS AND VOCABULARY (ISO 9000:2015)
ISO 10012:2003	Measurement management systems — Requirements for measurement processes and measuring equipment
ISO 9001:2015	Quality management systems — Requirements
ISO 9000:2015	Quality management systems — Fundamentals and vocabulary
DIN EN ISO 9001:2015-11	QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS (ISO 9001:2015)
ISO 14971:2007	Medical devices Application of risk management to medical devices
ISO 11607-1:2006	Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems