ISO TS 11139 : 2006

STERILIZATION OF HEALTH CARE PRODUCTS - VOCABULARY

International Organization for Standardization

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Foreword
Introduction
1 Scope
2 Terms and definitions
Bibliography
Alphabetical index

Abstract - (Show below) - (Hide below)

Gives definitions of terms in the field of sterilization technology.

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Published
Document Type	Standard
Status	Withdrawn
Publisher	International Organization for Standardization
Pages
ISBN
Committee	TC 198
Superseded By	ISO 11139:2018

International Equivalents – Equivalent Standard(s) & Relationship - (Show below) - (Hide below)

Equivalent Standard(s)	Relationship
NBR ISO/TS 11139 : 2009	Identical
UNI ISO/TS 11139 : 2016	Identical
NEN NPR ISO/TS 11139 : 2006	Identical
SAC GB/T 19971 : 2015	Identical
DS ISO/TS 11139 : 2006	Identical
SAC GB/T 19971 : 2015	Identical
AAMI ISO TIR 11139 : 2006	Identical
NEN NPR ISO/TS 11139 : 2006	Identical
UNI ISO/TS 11139 : 2016	Identical
CSA ISO/TS 11139 : 2018	Identical
NEN NVN ISO/TS 11139 : 2002	Identical
DS ISO/TS 11139 : 2006	Identical
NBR ISO/TS 11139 : 2009	Identical

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

BS EN ISO 15378 : 2017	PRIMARY PACKAGING MATERIALS FOR MEDICINAL PRODUCTS - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF ISO 9001:2015, WITH REFERENCE TO GOOD MANUFACTURING PRACTICE (GMP) (ISO 15378:2017)
PREN 1422 : DRAFT 2011	STERILIZERS FOR MEDICAL PURPOSES - ETHYLENE OXIDE STERILIZERS - REQUIREMENTS AND TEST METHODS
CSA ISO 11607-1 : 2016	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS
DIN EN ISO 20857 E : 2013	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)
CSA Z15882 : 2009 : R2014	STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - GUIDANCE FOR SELECTION, USE AND INTERPRETATION OF RESULTS
DIN EN ISO 11135-1 : 2007	STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
PREN ISO 14160 : DRAFT 2009	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
DIN EN ISO 13408-6 E : 2013	ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 6: ISOLATOR SYSTEMS (ISO 13408-6:2005 + AMD 1:2013)
04/30048118 DC : DRAFT MAY 2004	BS EN ISO 11135 - STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
AAMI ISO 20857 : 2010	STERILIZATION OF HEALTH CARE PRODUCTS - DRY HEAT - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
BS EN ISO 20857 : 2013	STERILIZATION OF HEALTH CARE PRODUCTS - DRY HEAT - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
BS EN ISO 25424 : 2011	STERILIZATION OF MEDICAL DEVICES - LOW TEMPERATURE STEAM AND FORMALDEHYDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
BS EN ISO 13408-3 : 2011	ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 3: LYOPHILIZATION (ISO 13408-3:2006)
BS ISO 11040-7 : 2015	PREFILLED SYRINGES - PART 7: PACKAGING SYSTEMS FOR STERILIZED SUBASSEMBLED SYRINGES READY FOR FILLING
DIN EN ISO 11607-2 E : 2017	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: VALIDATION REQUIREMENTS FOR FORMING, SEALING AND ASSEMBLY PROCESSES (ISO 11607-2:2006 + AMD 1:2014)
14/30270462 DC : 0	BS EN ISO 5840-1 - CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 1: GENERAL REQUIREMENTS
12/30262894 DC : 0	BS EN 14180 - STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE STEAM AND FORMALDEHYDE STERILIZERS - REQUIREMENTS AND TESTING
17/30363625 DC : DRAFT SEP 2017	BS EN ISO 11138-7 - STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 7: GUIDANCE FOR THE SELECTION, USE AND INTERPRETATION OF RESULTS
02/124462 DC : DRAFT DEC 2002	BS EN 285 - STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS
I.S. EN ISO 15378 : 2017	PRIMARY PACKAGING MATERIALS FOR MEDICINAL PRODUCTS - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF ISO 9001:2015, WITH REFERENCE TO GOOD MANUFACTURING PRACTICE (GMP) (ISO 15378:2017)
DIN EN ISO 5840-1 E : 2015	CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 1: GENERAL REQUIREMENTS (ISO 58401:2015)
AAMI ISO 11137-1 : 2006 : INC : AMD 1 : 2013 : R201000	STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
AAMI ISO 11737-1 : 2006	STERILIZATION OF MEDICAL DEVICES - MEDICAL DEVICES - PART 1: DETERMINATION OF THE POPULATION OF MICROORGANISMS ON PRODUCT
BS ISO 18362 : 2016	MANUFACTURE OF CELL-BASED HEALTH CARE PRODUCTS - CONTROL OF MICROBIAL RISKS DURING PROCESSING
DIN EN ISO 5840-3 E : 2013	CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 3: HEART VALVE SUBSTITUTES IMPLANTED BY TRANSCATHETER TECHNIQUES (ISO 5840-3:2013)
BS EN 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
16/30347647 DC : 0	BS EN ISO 15378 - PRIMARY PACKAGING MATERIALS FOR MEDICINAL PRODUCTS - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF ISO 9001:2015, WITH REFERENCE TO GOOD MANUFACTURING PRACTICE (GMP)
08/30149503 DC : DRAFT JAN 2008	BS EN ISO 14161 - STERILIZATION OF HEALTH CAR PRODUCTS - BIOLOGICAL INDICATORS - GUIDANCE FOR THE SELECTION, USE AND INTERPRETATION OF RESULTS
12/30261215 DC : 0	BS EN 13060 - SMALL STEAM STERILIZERS
BS EN ISO 5840-2 : 2015	CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 2: SURGICALLY IMPLANTED HEART VALVE SUBSTITUTES
I.S. EN ISO 13408-5 : 2011	ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 5: STERILIZATION IN PLACE
CSA Z15882 : 2009	STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - GUIDANCE FOR SELECTION, USE AND INTERPRETATION OF RESULTS
DIN EN ISO 13408-6 : 2013	ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 6: ISOLATOR SYSTEMS (ISO 13408-6:2005 + AMD 1:2013)
AAMI ISO TIR 17665-2 : 2009	STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ANSI/AAMI/ISO 17665-1
04/30090382 DC : DRAFT NOV 2004	ISO 13408-5 - ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 5: CLEANING IN PLACE
13/30254718 DC : 0	BS ISO 11040-7 - PREFILLED SYRINGES - PART 7: PACKAGING SYSTEMS FOR STERILIZED SUBASSEMBLED SYRINGES READY FOR FILLING
DIN EN ISO 13408-2 E : 2011	ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 2: FILTRATION (ISO 13408-2:2003)
DIN EN ISO 13408-5 E : 2011	ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 5: STERILIZATION IN PLACE (ISO 13408-5:2006)
BS PD CEN ISO/TS 16775 : 2014	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - GUIDANCE ON THE APPLICATION OF ISO 11607-1 AND ISO 11607-2
PREN ISO 11140-1 : DRAFT 2012	STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 1: GENERAL REQUIREMENTS (ISO/DIS 11140-1:2012)
UNE EN ISO 5840-3 : 2013	CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 3: HEART VALVE SUBSTITUTES IMPLANTED BY TRANSCATHETER TECHNIQUES (ISO 5840-3:2013)
AAMI 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
UNE EN ISO 20857 : 2013	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)
BS PD ISO/TS 17665-3 : 2013	STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 3: GUIDANCE ON THE DESIGNATION OF A MEDICAL DEVICE TO A PRODUCT FAMILY AND PROCESSING CATEGORY FOR STEAM STERILIZATION
DIN EN ISO 11607-1 : 2014	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 11040-7 : 2015	PREFILLED SYRINGES - PART 7: PACKAGING SYSTEMS FOR STERILIZED SUBASSEMBLED SYRINGES READY FOR FILLING
AAMI TIR52 : 2014 : R2017	ENVIRONMENTAL MONITORING FOR TERMINALLY STERILIZED HEALTHCARE PRODUCTS
11/30252448 DC : 0	BS EN 1422 - STERILIZERS FOR MEDICAL PURPOSES - ETHYLENE OXIDE STERILIZERS - REQUIREMENTS AND TEST METHODS
AAMI TIR52 : 2014	ENVIRONMENTAL MONITORING FOR TERMINALLY STERILIZED HEALTHCARE PRODUCTS
AAMI ISO 13408-3 : 2006 : R2015	ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 3: LYOPHILIZATION
AAMI ISO 13408-1 : 2008	ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS
CSA Z15882 : 2009	STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - GUIDANCE FOR SELECTION, USE AND INTERPRETATION OF RESULTS
AAMI ISO 13408-6 : 2005	ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 6: ISOLATOR SYSTEMS
UNI EN ISO 25424 : 2011	STERILIZATION OF MEDICAL DEVICES - LOW TEMPERATURE STEAM AND FORMALDEHYDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
DIN EN ISO 4833-1 E : 2013	MICROBIOLOGY OF THE FOOD CHAIN - HORIZONTAL METHOD FOR THE ENUMERATION OF MICROORGANISMS - PART 1: COLONY-COUNT AT 30 DEGREES C BY THE POUR PLATE TECHNIQUE (ISO 4833-1:2013)
15/30321502 DC : 0	BS EN ISO 11138-1 - STERILIZATION OF HEALTH PRODUCTS - BIOLOGICAL INDICATORS - PART 1: GENERAL REQUIREMENTS
AAMI ISO 20857 : 2010	STERILIZATION OF HEALTH CARE PRODUCTS - DRY HEAT - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
17/30326683 DC : DRAFT SEP 2017	BS ISO 19979 - OPHTHALMIC OPTICS - CONTACT LENSES - HYGIENIC MANAGEMENT OF MULTIPATIENT USE TRIAL CONTACT LENSES
04/30101211 DC : DRAFT APR 2004	ISO 11607-1 - PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS
DD CEN ISO/TS 17665-2 : 2009	STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ISO 17665-1
17/30302489 DC : DRAFT MAR 2017	BS EN ISO 13408-2 - ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 2: STERILIZING FILTRATION
DIN EN ISO 11607-2 : 2014	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: VALIDATION REQUIREMENTS FOR FORMING, SEALING AND ASSEMBLY PROCESSES (ISO 11607-2:2006 + AMD 1.:2014)
14/30281560 DC : 0	BS EN ISO 5840-2 - CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 2: SURGICALLY IMPLANTED HEART VALVE SUBSTITUTES
DIN EN ISO 13408-1 : 2015	ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS (ISO 13408-1:2008, INCLUDING AMD 1:2013)
12/30252545 DC : 0	BS ISO 15883-1:2006/AMD - WASHER-DISINFECTORS - PART 1: GENERAL REQUIREMENTS, TERMS AND DEFINITIONS AND TESTS
AAMI ISO 11137-1 : 2006 : R2010	STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
14/30287226 DC : 0	BS EN ISO 15378 - PRIMARY PACKAGING MATERIALS FOR MEDICINAL PRODUCTS - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF ISO 9001:2008, WITH REFERENCE TO GOOD MANUFACTURING PRACTICE (GMP)
I.S. EN ISO 25424 : 2011	STERILIZATION OF MEDICAL DEVICES - LOW TEMPERATURE STEAM AND FORMALDEHYDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
PREN 14180 : DRAFT 2012	STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE STEAM AND FORMALDEHYDE STERILIZERS - REQUIREMENTS AND TESTING
BS EN ISO 4833-2 : 2013	MICROBIOLOGY OF THE FOOD CHAIN - HORIZONTAL METHOD FOR THE ENUMERATION OF MICROORGANISMS - PART 2: COLONY COUNT AT 30 DEGREES C BY THE SURFACE PLATING TECHNIQUE
16/30310949 DC : 0	BS ISO 5910 - CARDIOVASCULAR IMPLANTS AND EXTRACOPOREAL SYSTEMS - CARDIAC VALVE REPAIR DEVICES
DIN EN ISO 4833-1 : 2013	MICROBIOLOGY OF THE FOOD CHAIN - HORIZONTAL METHOD FOR THE ENUMERATION OF MICROORGANISMS - PART 1: COLONY-COUNT AT 30 DEGREES C BY THE POUR PLATE TECHNIQUE (ISO 4833-1:2013)
DIN EN ISO 4833-2 : 2014	MICROBIOLOGY OF THE FOOD CHAIN - HORIZONTAL METHOD FOR THE ENUMERATION OF MICROORGANISMS - PART 2: COLONY COUNT AT 30 DEGREES C BY THE SURFACE PLATING TECHNIQUE (ISO 4833-2:2013 + COR. 1:2014)
09/30157765 DC : 0	BS EN ISO 14160 REV - 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
UNE EN ISO 13408-2 : 2011	ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 2: FILTRATION (ISO 13408-2:2003)
NSAI/ISO GUIDE TO ISO 13485:2016 : 2017	ISO 13485:2016 - MEDICAL DEVICES - A PRACTICAL GUIDE
11/30219211 DC : 0	BS EN ISO 5840-3 - CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 3: HEART VALVE SUBSTITUTES IMPLANTED BY MINIMALLY INVASIVE TECHNIQUES
ISO 5910 : 2018	CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - CARDIAC VALVE REPAIR DEVICES
I.S. EN ISO 4833-2 : 2013	MICROBIOLOGY OF THE FOOD CHAIN - HORIZONTAL METHOD FOR THE ENUMERATION OF MICROORGANISMS - PART 2: COLONY COUNT AT 30 DEGREES C BY THE SURFACE PLATING TECHNIQUE (ISO 4833-2:2013)
I.S. EN ISO 5840-3 : 2013	CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 3: HEART VALVE SUBSTITUTES IMPLANTED BY TRANSCATHETER TECHNIQUES (ISO 5840-3:2013)
09/30207531 DC : 0	BS EN ISO 14534 - OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - FUNDAMENTAL REQUIREMENTS
DIN EN ISO 13408-1 E : 2015	ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS (ISO 13408-1:2008, INCLUDING AMD 1:2013)
BS EN ISO 4833-1 : 2013	MICROBIOLOGY OF THE FOOD CHAIN - HORIZONTAL METHOD FOR THE ENUMERATION OF MICROORGANISMS - PART 1: COLONY COUNT AT 30 DEGREES C BY THE POUR PLATE TECHNIQUE
DIN EN ISO 13408-5 : 2011	ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 5: STERILIZATION IN PLACE
12/30238553 DC : 0	BS EN ISO 11140-1 - STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 1: GENERAL REQUIREMENTS
UNI EN ISO 13408-5 : 2011	ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 5: STERILIZATION IN PLACE
13/30278676 DC : 0	BS EN 285 - STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS
CSA Z14161 : 2011 : R2015	STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - GUIDANCE FOR THE SELECTION, USE AND INTERPRETATION OF RESULTS
16/30302485 DC : 0	BS EN ISO 11737-1 - STERILIZATION OF HEALTH CARE PRODUCTS - MICROBIOLOGICAL METHODS - PART 1: DETERMINATION OF A POPULATION OF MICROORGANISMS ON PRODUCT
AAMI ISO 11138-1 : 2017	STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 1: GENERAL REQUIREMENTS
AAMI ISO 20857 : 2010 : R2015	STERILIZATION OF HEALTH CARE PRODUCTS - DRY HEAT - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
UNE EN ISO 13408-5 : 2011	ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 5: STERILIZATION IN PLACE (ISO 13408-5:2006)
CSA Z17665-2 : 2009 : R2014	STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ISO 17665-1
ANSI/AAMI/ISO 11607-1:2006/(R)2015	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS, AND PACKAGING SYSTEMS
DIN EN ISO 4833-2 E : 2014	MICROBIOLOGY OF THE FOOD CHAIN - HORIZONTAL METHOD FOR THE ENUMERATION OF MICROORGANISMS - PART 2: COLONY COUNT AT 30 DEGREES C BY THE SURFACE PLATING TECHNIQUE (ISO 4833-2:2013 + COR. 1:2014)
07/30164697 DC : 0	ISO 20857 - STERILIZATION OF HEALTH CARE PRODUCTS - DRY HEAT - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF AN INDUSTRIAL STERILIZATION PROCESS FOR MEDICAL DEVICES
17/30338806 DC : 0	BS EN ISO 25424 - STERILIZATION OF HEALTH CARE PRODUCTS - LOW TEMPERATURE STEAM AND FORMALDEHYDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
BS EN ISO 13408-5 : 2011	ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 5: STERILIZATION IN PLACE (ISO 13408-5:2006)
AAMI ISO 15882 : 2008	STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - GUIDANCE FOR SELECTION, USE AND INTERPRETATION OF RESULTS
BS EN ISO 5840-1 : 2015	CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 1: GENERAL REQUIREMENTS
DIN EN ISO 13408-3 E : 2011	ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 3: LYOPHILIZATION (ISO 13408-3:2006)
04/30066665 DC : DRAFT MARCH 2004	BS ISO 13408-6 - ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 6 - ISOLATOR SYSTEMS
04/30090379 DC : DRAFT MAR 2004	BS ISO 13408-4 - ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 4: CLEAN-IN-PLACE TECHNOLOGIES
14/30266295 DC : 0	BS ISO 18362 - PROCESSING OF CELL-BASED HEALTH CARE PRODUCTS
DIN EN ISO 11138-1 E : 2017	STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 1: GENERAL REQUIREMENTS (ISO 11138-1:2017)
DIN EN 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 11135:2014)
PREN 285 : DRAFT 2013	STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS
AAMI ISO 11607-1 : 2006	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS, AND PACKAGING SYSTEMS
05/30138310 DC : DRAFT AUG 2005	ISO 15882 ED 2 - STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - GUIDANCE FOR SELECTION, USE AND INTERPRETATION OF RESULTS
DIN EN ISO 13408-3 : 2011	ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 3: LYOPHILIZATION
BS EN ISO 18369-1 : 2017	OPHTHALMIC OPTICS - CONTACT LENSES - PART 1: VOCABULARY, CLASSIFICATION SYSTEM AND RECOMMENDATIONS FOR LABELLING SPECIFICATIONS
NFX 50 796 : 2008	AVAILABILITY OF MEDICAL DEVICES AT HOME - SERVICE COMMITMENTS
I.S. EN ISO 20857 : 2013	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)
CSA Z11138-1 : 2007	STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 1: GENERAL REQUIREMENTS
CSA Z11137-2 : 2007	STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 2: ESTABLISHING THE STERILIZATION DOSE
DIN EN ISO 13408-2 : 2011	ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 2: FILTRATION
CSA Z11137-2 : 2007	STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 2: ESTABLISHING THE STERILIZATION DOSE
07/30157769 DC : DRAFT DEC 2007	BS EN ISO 11737-2 - STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 2: TESTS OF STERILITY PERFORMED IN THE VALIDATION OF A STERILIZATION PROCESS
CSA Z14161 : 2011	STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - GUIDANCE FOR THE SELECTION, USE AND INTERPRETATION OF RESULTS
UNE EN ISO 4833-1 : 2014	MICROBIOLOGY OF THE FOOD CHAIN - HORIZONTAL METHOD FOR THE ENUMERATION OF MICROORGANISMS - PART 1: COLONY COUNT AT 30 DEGREES C BY THE POUR PLATE TECHNIQUE (ISO 4833-1:2013)
CSA Z11135-1 : 2009	STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 1: REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
CSA Z11138-1 : 2007	STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 1: GENERAL REQUIREMENTS
CSA Z11135 : 2015	STERILIZATION OF HEALTH-CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
CSA Z11137-2 : 2007 : R2012	STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 2: ESTABLISHING THE STERILIZATION DOSE
CSA ISO 14937 : 2011	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
CSA Z14161 : 2011 : FR	STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - GUIDANCE FOR THE SELECTION, USE AND INTERPRETATION OF RESULTS
UNI EN ISO 4833-2 : 2013	MICROBIOLOGY OF THE FOOD CHAIN - HORIZONTAL METHOD FOR THE ENUMERATION OF MICROORGANISMS - PART 2: COLONY COUNT AT 30 DEGREES C BY THE SURFACE PLATING TECHNIQUE
AAMI ISO 11140-1 : 2015	STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 1: GENERAL REQUIREMENTS
UNE EN ISO 13408-3 : 2011	ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 3: LYOPHILIZATION (ISO 13408-3:2006)
BS EN ISO 5840-3 : 2013	CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 3: HEART VALVE SUBSTITUTES IMPLANTED BY TRANSCATHETER TECHNIQUES
07/30090385 DC : 0	ISO 13408-1 - ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS
UNE EN ISO 5840-1 : 2016	CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 1: GENERAL REQUIREMENTS (ISO 5840-1:2015)
CSA Z11135-1 : 2009 : R2014	STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 1: REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
AAMI ISO 17665-1 : 2006	STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
CSA Z11138-1 : 2007 : R2012 : FR	STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 1: GENERAL REQUIREMENTS
UNI EN ISO 4833-1 : 2013	MICROBIOLOGY OF THE FOOD CHAIN - HORIZONTAL METHOD FOR THE ENUMERATION OF MICROORGANISMS - PART 1: COLONY COUNT AT 30 DEGREES C BY THE POUR PLATE TECHNIQUE
AAMI 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
CSA ISO 14937 : 2011	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
04/30101215 DC : DRAFT APR 2004	ISO 11607-2 - PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: VALIDATION REQUIREMENTS FOR FORMING, SEALING AND ASSEMBLY PROCESSES
AAMI ISO 13408-1 : 2008 : INC : AMD 1 : 2013 : R201100	ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS
09/30197784 DC : 0	BS EN ISO 11137-2 - STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 2: ESTABLISHING THE STERILIZATION DOSE
CSA ISO 14937 : 2011 : R2016	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
AAMI ISO 13408-6 : 2005	ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 6: ISOLATOR SYSTEMS
I.S. EN ISO 5840-2 : 2015	CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 2: SURGICALLY IMPLANTED HEART VALVE SUBSTITUTES (ISO 5840-2:2015)
CSA Z14161 : 2011	STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - GUIDANCE FOR THE SELECTION, USE AND INTERPRETATION OF RESULTS
CSA Z15882 : 2009(R2019)	STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - GUIDANCE FOR SELECTION, USE AND INTERPRETATION OF RESULTS
CSA ISO 14937 : 2011 : R2016	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
AAMI ISO 13408-6 : 2005 : INC : AMD 1 : 2013	ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 6: ISOLATOR SYSTEMS
CSA Z11137-2 : 2007 : R2012 : FR	STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 2: ESTABLISHING THE STERILIZATION DOSE
CSA ISO 11138-1 : 2017	STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 1: GENERAL REQUIREMENTS
AAMI ISO 22442-3 : 2007 : R2011	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
BS EN ISO 11607-2 : 2006	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: VALIDATION REQUIREMENTS FOR FORMING, SEALING AND ASSEMBLY PROCESSES
UNI CEN ISO/TS 17665-2 : 2009	STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ISO 17665-1
UNE EN ISO 15378 : 2016	PRIMARY PACKAGING MATERIALS FOR MEDICINAL PRODUCTS - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF ISO 9001:2008, WITH REFERENCE TO GOOD MANUFACTURING PRACTICE (GMP) (ISO 15378:2015)
AAMI ISO 14160 : 2011 : R2016	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
I.S. EN ISO 4833-1 : 2013	MICROBIOLOGY OF THE FOOD CHAIN - HORIZONTAL METHOD FOR THE ENUMERATION OF MICROORGANISMS - PART 1: COLONY COUNT AT 30 DEGREES C BY THE POUR PLATE TECHNIQUE (ISO 4833-1:2013)
AAMI ISO 13408-1 : 2008 : R2011	ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS
PREN 13060 : DRAFT 2012	SMALL STEAM STERILIZERS
CSA Z11135-1 : 2009 : FR	STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 1: REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
AAMI ISO 14937 : 2009 : R2013	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
AAMI ISO TIR 17665-3 : 2014	STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - GUIDANCE ON THE DESIGNATION OF A MEDICAL PRODUCT TO A PRODUCT FAMILY AND PROCESSING CATEGORY FOR STEAM STERILIZATION
DIN EN ISO 5840-3 : 2013	CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 3: HEART VALVE SUBSTITUTES IMPLANTED BY TRANSCATHETER TECHNIQUES (ISO 5840-3:2013)
I.S. EN ISO 5840-1 : 2015	CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 1: GENERAL REQUIREMENTS (ISO 5840-1:2015)
CSA Z11138-1 : 2007 : R2012	STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 1: GENERAL REQUIREMENTS
DIN EN ISO 25424 E : 2011	STERILIZATION OF MEDICAL DEVICES - LOW TEMPERATURE STEAM AND FORMALDEHYDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES (ISO 25424:2009)
CSA Z11138-1 : 2007 : R2016	STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 1: GENERAL REQUIREMENTS
UNI EN ISO 20857 : 2013	STERILIZATION OF HEALTH CARE PRODUCTS - DRY HEAT - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
CSA ISO 14937 : 2011	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
AAMI ISO 13408-1 : 2008	ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS
AAMI ISO 13408-6 : 2005 : INC : AMD 1 : 2013 : R201300	ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 6: ISOLATOR SYSTEMS
UNE EN ISO 11135 : 2015	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 20857 : 2013	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 5840-2 : 2016	CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 2: SURGICALLY IMPLANTED HEART VALVE SUBSTITUTES (ISO 5840-2:2015)
AAMI ISO 11607-1 : 2006 : INC : AMD 1 : 2014 : R201000	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS, AND PACKAGING SYSTEMS
DIN EN ISO 5840-1 : 2015	CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 1: GENERAL REQUIREMENTS (ISO 5840-1:2015)
UNI EN ISO 5840-3 : 2013	CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 3: HEART VALVE SUBSTITUTES IMPLANTED BY TRANSCATHETER TECHNIQUES
BS PD CEN/TS 16244 : 2018	VENTILATION IN HOSPITALS - COHERENT HIERARCHIC STRUCTURE AND COMMON TERMS AND DEFINITIONS FOR A STANDARD RELATED TO VENTILATION IN HOSPITALS
AAMI ISO 11607-1 : 2006	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS, AND PACKAGING SYSTEMS
AAMI ISO 5840-3 : 2013	CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 3: HEART VALVE SUBSTITUTES IMPLANTED BY TRANSCATHETER TECHNIQUES
CEN/TS 16244 : 2018	VENTILATION IN HOSPITALS - COHERENT HIERARCHIC STRUCTURE AND COMMON TERMS AND DEFINITIONS FOR A STANDARD RELATED TO VENTILATION IN HOSPITALS
CSA ISO 11137-2 : 2016	STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 2: ESTABLISHING THE STERILIZATION DOSE
AAMI ISO 14161 : 2009	STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - GUIDANCE FOR THE SELECTION, USE, AND INTERPRETATION OF RESULTS
AAMI TIR52 : 2014	ENVIRONMENTAL MONITORING FOR TERMINALLY STERILIZED HEALTHCARE PRODUCTS
AAMI ISO TIR 17665-2 : 2009	STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ANSI/AAMI/ISO 17665-1
CSA Z17665-1 : 2009(R 2019)	STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
CSA Z17665-2 : 2009(R2019)	Sterilization of health care products — Moist heat — Part 2: Guidance on the application of ISO 17665-1 (ISO/TS 17665-2:2009, IDT)
AAMI ISO 11607-2 : 2006 : R2010	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: VALIDATION REQUIREMENTS FOR FORMING, SEALING, AND ASSEMBLY PROCESSES
AAMI ISO 11607-2 : 2006	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: VALIDATION REQUIREMENTS FOR FORMING, SEALING, AND ASSEMBLY PROCESSES
I.S. EN ISO 13408-6 : 2011	ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 6: ISOLATOR SYSTEMS (ISO 13408-6:2005)
UNE EN ISO 13408-6 : 2011	ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 6: ISOLATOR SYSTEMS (ISO 13408-6:2005/AMD 1:2013)
UNE EN ISO 4833-2 : 2014	MICROBIOLOGY OF THE FOOD CHAIN - HORIZONTAL METHOD FOR THE ENUMERATION OF MICROORGANISMS - PART 2: COLONY COUNT AT 30 DEGREES C BY THE SURFACE PLATING TECHNIQUE (ISO 4833-2:2013)
AAMI ISO 11137-2 : 2013	STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 2: ESTABLISHING THE STERILIZATION DOSE
BS EN ISO 13408-1 : 2015	ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS
ISO 19979 : 2018	OPHTHALMIC OPTICS - CONTACT LENSES - HYGIENIC MANAGEMENT OF MULTIPATIENT USE TRIAL CONTACT LENSES
SR CEN ISO/TS 17665-2 : 2009	STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ISO 17665-1
AAMI ISO TIR 17665-3 : 2014 : R2016	STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - GUIDANCE ON THE DESIGNATION OF A MEDICAL PRODUCT TO A PRODUCT FAMILY AND PROCESSING CATEGORY FOR STEAM STERILIZATION
AAMI ISO 11737-1 : 2006	STERILIZATION OF MEDICAL DEVICES - MEDICAL DEVICES - PART 1: DETERMINATION OF THE POPULATION OF MICROORGANISMS ON PRODUCT
PREN ISO 11137-2 : DRAFT 2009	STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 2: ESTABLISHING THE STERILIZATION DOSE
AAMI ISO 5840-1 : 2016	CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 1: GENERAL REQUIREMENTS
DIN EN ISO 11737-1 : 2009	STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 1: DETERMINATION OF A POPULATION OF MICROORGANISMS ON PRODUCTS
SR CEN ISO/TS 16775 : 2014	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - GUIDANCE ON THE APPLICATION OF ISO 11607-1 AND ISO 11607-2 (ISO/TS 16775:2014)
AAMI 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
AAMI ISO 13408-5 : 2006	ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 5: STERILIZATION IN PLACE
AAMI 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
AAMI ISO TIR 16775 : 2014	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - GUIDANCE ON THE APPLICATION OF ISO 11607-1 AND ISO 11607-2
AAMI ISO TIR 17665-2 : 2009 : R2016	STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ANSI/AAMI/ISO 17665-1
AAMI ISO TIR 17665-3 : 2014	STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - GUIDANCE ON THE DESIGNATION OF A MEDICAL PRODUCT TO A PRODUCT FAMILY AND PROCESSING CATEGORY FOR STEAM STERILIZATION
AAMI 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
EN 13060 : 2014	SMALL STEAM STERILIZERS
AAMI ISO 17665-1 : 2006 : R2013	STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
AAMI 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
AAMI ISO 17665-1 : 2006	STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
AAMI ISO 17664 : 2017	PROCESSING OF HEALTH CARE PRODUCTS - INFORMATION TO BE PROVIDED BY THE MEDICAL DEVICE MANUFACTURER FOR THE PROCESSING OF MEDICAL DEVICES
AAMI ISO 13408-5 : 2006 : R2015	ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 5: STERILIZATION IN PLACE
CSA Z17665-1 : 2009 : R2014	STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
AAMI ISO 11737-2 : 2009	STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 2: TESTS OF STERILITY PERFORMED IN THE DEFINITION, VALIDATION AND MAINTENANCE OF A STERILIZATION PROCESS
I.S. EN ISO 13408-3 : 2011	ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 3: LYOPHILIZATION
AAMI ISO 11737-2 : 2009 : R2014	STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 2: TESTS OF STERILITY PERFORMED IN THE DEFINITION, VALIDATION AND MAINTENANCE OF A STERILIZATION PROCESS
AAMI ISO 11737-2 : 2009	STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 2: TESTS OF STERILITY PERFORMED IN THE DEFINITION, VALIDATION AND MAINTENANCE OF A STERILIZATION PROCESS
BS EN ISO 13408-6 : 2011	ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 6: ISOLATOR SYSTEMS
ISO 11607-2 : 2006(R 2015)	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: VALIDATION REQUIREMENTS FOR FORMING, SEALING AND ASSEMBLY PROCESSES
AAMI ISO 5840-2 : 2016	CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 2: SURGICALLY IMPLANTED HEART VALVE SUBSTITUTES
BS EN ISO 17664 : 2017	PROCESSING OF HEALTH CARE PRODUCTS - INFORMATION TO BE PROVIDED BY THE MEDICAL DEVICE MANUFACTURER FOR THE PROCESSING OF MEDICAL DEVICES
AAMI ISO 13408-5 : 2006	ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 5: STERILIZATION IN PLACE
AAMI ISO 13408-3 : 2006	ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 3: LYOPHILIZATION
AAMI ISO 11135 : 2014	STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
UNI EN ISO 11737-1 : 2006	STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 1: DETERMINATION OF A POPULATION OF MICROORGANISMS ON PRODUCTS
ISO 18362 : 2016	MANUFACTURE OF CELL-BASED HEALTH CARE PRODUCTS - CONTROL OF MICROBIAL RISKS DURING PROCESSING
AAMI ISO 11135-1 : 2007	STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
I.S. EN ISO 13408-1 : 2015	ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS (ISO 13408-1:2008, INCLUDING AMD 1:2013)
AAMI ISO 11607-2 : 2006	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: VALIDATION REQUIREMENTS FOR FORMING, SEALING, AND ASSEMBLY PROCESSES
AAMI ISO 11737-1 : 2006 : R2011	STERILIZATION OF MEDICAL DEVICES - MEDICAL DEVICES - PART 1: DETERMINATION OF THE POPULATION OF MICROORGANISMS ON PRODUCT
AAMI ISO 11607-2 : 2006 : INC : AMD 1 : 2014 : R201000	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: VALIDATION REQUIREMENTS FOR FORMING, SEALING, AND ASSEMBLY PROCESSES
CSA Z17665-1:2009(R2019)	STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
UNI EN ISO 13408-6 : 2013	ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 6: ISOLATOR SYSTEMS
CSA Z15882 : 2009 : R2014	STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - GUIDANCE FOR SELECTION, USE AND INTERPRETATION OF RESULTS
CSA Z17665-1 : 2009 : FR	STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
I.S. EN ISO 18369-1 : 2017	OPHTHALMIC OPTICS - CONTACT LENSES - PART 1: VOCABULARY, CLASSIFICATION SYSTEM AND RECOMMENDATIONS FOR LABELLING SPECIFICATIONS (ISO 18369-1:2017, CORRECTED VERSION 2017-10-01)
CSA Z17665-2 : 2009	STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ISO 17665-1
ISO 15378 : 2017	PRIMARY PACKAGING MATERIALS FOR MEDICINAL PRODUCTS - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF ISO 9001:2015, WITH REFERENCE TO GOOD MANUFACTURING PRACTICE (GMP)
BS ISO 19979 : 2018	OPHTHALMIC OPTICS - CONTACT LENSES - HYGIENIC MANAGEMENT OF MULTIPATIENT USE TRIAL CONTACT LENSES
BS EN ISO 11607-1 : 2009	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS
ISO TR 20520 : 1ED 2018	TRADITIONAL CHINESE MEDICINE - INFECTION CONTROL FOR ACUPUNCTURE TREATMENT
ISO 17664 : 2017	PROCESSING OF HEALTH CARE PRODUCTS - INFORMATION TO BE PROVIDED BY THE MEDICAL DEVICE MANUFACTURER FOR THE PROCESSING OF MEDICAL DEVICES
UNI EN ISO 13408-2 : 2011	ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 2: FILTRATION
SR CEN/TS 16244 : 2018	VENTILATION IN HOSPITALS - COHERENT HIERARCHIC STRUCTURE AND COMMON TERMS AND DEFINITIONS FOR A STANDARD RELATED TO VENTILATION IN HOSPITALS
NF EN ISO 13408-2 : 2011	ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 2: FILTRATION
ISO 11607-1 : 2006	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS
AAMI ST15883-1 : 2009	WASHER-DISINFECTORS - PART 1: GENERAL REQUIREMENTS, TERMS AND DEFINITIONS AND TESTS
AAMI ST15883-1 : 2009 : INC : AMD 2 : 2012	WASHER-DISINFECTORS - PART 1: GENERAL REQUIREMENTS, TERMS AND DEFINITIONS AND TESTS
AAMI ST15883-1 : 2009 : INC : AMD 1 : 2014 : R201400	WASHER-DISINFECTORS - PART 1: GENERAL REQUIREMENTS, TERMS AND DEFINITIONS AND TESTS
UNE EN ISO 11607-1 : 2017	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS (ISO 11607-1:2006, INCLUDING AMD 1:2014)
DIN EN ISO 11135 E : 2014	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)
AAMI ISO 11137-1 : 2006	STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
AAMI ISO 11137-1 : 2006	STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
I.S. EN 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 11135:2014)
DIN EN ISO 11607-1 E : 2017	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS (ISO 11607-1:2006 + AMD 1:2014)
17/30362728 DC : 0	BS EN 17169 - TATTOOING - SAFE AND HYGIENIC PRACTICE
I.S. EN ISO 17664 : 2017	PROCESSING OF HEALTH CARE PRODUCTS - INFORMATION TO BE PROVIDED BY THE MEDICAL DEVICE MANUFACTURER FOR THE PROCESSING OF MEDICAL DEVICES (ISO 17664:2017)
UNI EN ISO 11607-2 : 2014	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: VALIDATION REQUIREMENTS FOR FORMING, SEALING AND ASSEMBLY PROCESSES
EN ISO 11607-2 : 2017 COR 2017	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: VALIDATION REQUIREMENTS FOR FORMING, SEALING AND ASSEMBLY PROCESSES (ISO 11607-2:2006, INCLUDING AMD 1:2014)
UNE EN ISO 11607-2 : 2017	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: VALIDATION REQUIREMENTS FOR FORMING, SEALING AND ASSEMBLY PROCESSES (ISO 11607-2:2006)
UNI EN ISO 11607-1 : 2014	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS
ASTM E 3083 : 2017	Standard Terminology Relating to Radiation Processing: Dosimetry and Applications
I.S. EN ISO 11607-1 : 2017 & LC : 2017	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS (ISO 11607-1:2006, INCLUDING AMD 1:2014)
ISO 18369-1 : 2017	OPHTHALMIC OPTICS - CONTACT LENSES - PART 1: VOCABULARY, CLASSIFICATION SYSTEM AND RECOMMENDATIONS FOR LABELLING SPECIFICATIONS
EN ISO 18369-1 : 2017 COR 2018	OPHTHALMIC OPTICS - CONTACT LENSES - PART 1: VOCABULARY, CLASSIFICATION SYSTEM AND RECOMMENDATIONS FOR LABELLING SPECIFICATIONS (ISO 18369-1:2017, CORRECTED VERSION 2017-10-01)
UNI EN ISO 13408-3 : 2011	ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 3: LYOPHILIZATION
CSA ISO 11140-1 : 2016	STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 1: GENERAL REQUIREMENTS
UNE EN ISO 25424 : 2011	STERILIZATION OF MEDICAL DEVICES - LOW TEMPERATURE STEAM AND FORMALDEHYDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES (ISO 25424:2009)
EN ISO 17664 : 2017	PROCESSING OF HEALTH CARE PRODUCTS - INFORMATION TO BE PROVIDED BY THE MEDICAL DEVICE MANUFACTURER FOR THE PROCESSING OF MEDICAL DEVICES (ISO 17664:2017)
AAMI ISO 13408-3 : 2006	ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 3: LYOPHILIZATION
EN ISO 15378 : 2017	PRIMARY PACKAGING MATERIALS FOR MEDICINAL PRODUCTS - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF ISO 9001:2015, WITH REFERENCE TO GOOD MANUFACTURING PRACTICE (GMP) (ISO 15378:2017)
CSA Z11135-1 : 2009	STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 1: REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
CSA Z17665-2 : 2009 : FR(R2019)	STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ISO 17665-1
ANSI/AAMI/ISO 11607-1:2006/(R)2015	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS, AND PACKAGING SYSTEMS
ANSI/AAMI/ ISO 11137-2: 2013(R2019)	STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 2: ESTABLISHING THE STERILIZATION DOSE
UNE EN ISO 5840-2 : 2016	CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 2: SURGICALLY IMPLANTED HEART VALVE SUBSTITUTES (ISO 5840-2:2015)
DIN EN ISO 25424 : 2011	STERILIZATION OF MEDICAL DEVICES - LOW TEMPERATURE STEAM AND FORMALDEHYDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
AAMI ISO 11607-1 : 2006 : R2010	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS, AND PACKAGING SYSTEMS
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
EN ISO 11607-1 : 2017 COR 2017	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS (ISO 11607-1:2006, INCLUDING AMD 1:2014)
ISO TS 17665-3 : 2013(R2017)	STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 3: GUIDANCE ON THE DESIGNATION OF A MEDICAL DEVICE TO A PRODUCT FAMILY AND PROCESSING CATEGORY FOR STEAM STERILIZATION
ISO 13485 - PRACTICAL GUIDE : 2016	ISO 13485:2016 - MEDICAL DEVICES - A PRACTICAL GUIDE
BS EN ISO 11607-1 : 2017	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS
I.S. EN ISO 11607-2 : 2017 & LC : 2017	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: VALIDATION REQUIREMENTS FOR FORMING, SEALING AND ASSEMBLY PROCESSES (ISO 11607-2:2006, INCLUDING AMD 1:2014)
EN ISO 11135 : 2014 COR 2014	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)

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

ISO 13485 : 2016	MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR REGULATORY PURPOSES
ISO 9000 : 2015	QUALITY MANAGEMENT SYSTEMS - FUNDAMENTALS AND VOCABULARY