ISO 11140-1 : 2014

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STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 1: GENERAL REQUIREMENTS

Publisher: International Organization for Standardization

Published: 01-01-2014

Available Formats: PDF - Russian, Hardcopy - Russian, PDF - English, Hardcopy - English, PDF - French, Hardcopy - French
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Table of Contents - (Show below) - (Hide below)

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Categorization
5 General requirements
6 Performance requirements
7 Test methods
8 Additional requirements for process
   (Type 1) indicators
9 Additional requirements for single critical
   process variable (Type 3) indicators
10 Additional requirements for multicritical
   process variable (Type 4) indicators
11 Additional requirements for steam integrating
   (Type 5) indicators
12 Additional requirements for ethylene oxide
   integrating (Type 5) indicators
13 Additional requirements for emulating (Type 6)
   indicators
Annex A (normative) - Method for demonstrating shelf-life
        of the product
Annex B (informative) - Examples of testing indicators
Annex C (informative) - Rationale for the requirements for
        integrating indicators and the link to the requirements
       for biological indicators specified in ISO 11138
        (all parts) and microbial inactivation
Annex D (informative) - Rationale for the liquid-phase
        test method for low temperature steam and
        formaldehyde indicators
Annex E (informative) - Relationship of indicator and indicator
        system components
Bibliography

Abstract - (Show below) - (Hide below)

This part of ISO 11140 specifies general requirements and test methods for indicators that show exposure to sterilization processes by means of physical and/or chemical change of substances, and which are used to monitor the attainment of one or more of the process parameter(s) specified for a sterilization process.

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

Published
Document Type	Standard
Status	Current
Publisher	International Organization for Standardization
Pages
ISBN
Committee	TC 198
Supersedes	ISO/DIS 11140-1 : 60.00 (2014) ISO 11140-1 : 2005

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

Equivalent Standard(s)	Relationship
DS EN ISO 11140-1 : 2014	Identical
NF EN ISO 11140-1 : 2015	Identical
NBN EN ISO 11140-1 : 2014	Identical
NEN EN ISO 11140-1 : 2014	Identical
NS EN ISO 11140-1 : 2014	Identical
I.S. EN ISO 11140-1:2014	Identical
PN EN ISO 11140-1 : 2015	Identical
SN EN ISO 11140-1 : 2015	Identical
UNI EN ISO 11140-1 : 2009	Identical
UNI EN ISO 11140-1:2015	Identical
SS-EN ISO 11140-1:2014	Identical
ABNT NBR ISO 11140-1:2019	Identical
ANSI/AAMI/ISO 11140-1:2014	Identical
UNE EN ISO 11140-1 : 2015	Identical
BS EN ISO 11140-1 : 2014	Identical
EN ISO 11140-1 : 2014 COR 2014	Identical
AAMI ISO 11140-1 : 2015	Identical
CSA ISO 11140-1 : 2016	Identical
DIN EN ISO 11140-1 : 2015	Identical
PN EN ISO 11140-1 : 2015	Identical
DIN EN ISO 11140-1 E : 2015	Identical
SS-EN ISO 11140-1:2014	Identical
GOST R ISO 11140-1 : 2009	Identical
CSA Z11140.1 : 2007	Identical
DS EN ISO 11140-1 : 2014	Identical
GOST ISO 11140-1 : 2011	Identical
NEN ISO 11140-1 : 1995 AMD 1 1999	Identical
UNE EN ISO 11140-1 : 2015	Identical
ABNT NBR ISO 11140-1:2019	Identical
CSA Z11140.1 : 2007 : R2012 : FR	Identical
CSA ISO 11140-1 : 2016	Identical
SAC GB 18282.1 : 2000	Identical
ANSI/AAMI/ISO 11140-1:2014	Identical
AAMI ST60 : 1ED 96	Identical
AAMI ISO 11140-1 : 2015	Identical
BS EN ISO 11140-1 : 2014	Identical
SANS 11140-1 : 1ED 2011	Identical
CSA Z11140.1 : 2007	Identical
UNI EN ISO 11140-1:2015	Identical
DIN EN ISO 11140-1 : 2015	Identical
CSA Z11140.1 : 2007 : R2012	Identical

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

99/562423 DC : DRAFT APR 99	BS:ENISO 14937 - STERILIZATION OF HEALTH CARE PRODUCTS - GENERAL CRITERIA FOR CHARACTERIZATION OF A STERILIZING AGENT AND DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS
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
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
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
PREN 17180 : DRAFT 2017	STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE VAPORIZED HYDROGEN PEROXIDE STERILIZERS - REQUIREMENTS AND TESTING
CSA ISO 11140-4 : 2018	STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 4: CLASS 2 INDICATORS AS AN ALTERNATIVE TO THE BOWIE AND DICK-TYPE TEST FOR DETECTION OF STEAM PENETRATION
UNI EN ISO 21531 : 2009	DENTISTRY - GRAPHICAL SYMBOLS FOR DENTAL INSTRUMENTS
13/30285624 DC : 0	BS EN ISO 16061 - INSTRUMENTATION FOR USE IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS
UNE EN ISO 16061 : 2015	INSTRUMENTATION FOR USE IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS (ISO 16061:2015)
CSA PLUS 1173 : 2012	GUIDE TO THE SELECTION AND USE OF STERILIZATION INDICATORS
UNI EN 868-5 : 2009	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 5: SEALABLE POUCHES AND REELS OF POROUS MATERIALS AND PLASTIC FILM CONSTRUCTION - REQUIREMENTS AND TEST METHODS
PREN ISO 11135 : DRAFT 2011	STERILIZATION OF HEALTH-CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES (ISO/DIS 11135:2011)
BS EN ISO 9687 : 2015	DENTISTRY - GRAPHICAL SYMBOLS FOR DENTAL EQUIPMENT
12/30261215 DC : 0	BS EN 13060 - SMALL STEAM STERILIZERS
CSA Z15882:2009	STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - GUIDANCE FOR SELECTION, USE AND INTERPRETATION OF RESULTS
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
16/30330536 DC : 0	BS EN ISO 18472 - STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL AND CHEMICAL INDICATORS - TEST EQUIPMENT
17/30360908 DC : 0	BS EN 868-5 - PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 5: SEALABLE POUCHES AND REELS OF POROUS MATERIALS AND PLASTIC FILM CONSTRUCTION - REQUIREMENTS AND TEST METHODS
DIN EN ISO 21531 E : 2009	DENTISTRY - GRAPHICAL SYMBOLS FOR DENTAL INSTRUMENTS
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)
VDI 6300-1 : 2016	GENETIC ENGINEERING OPERATIONS IN GENETIC ENGINEERING FACILITIES - GUIDANCE ON SAFE OPERATION OF GENETIC ENGINEERING FACILITIES
EN 868-5 : 2009	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 5: SEALABLE POUCHES AND REELS OF POROUS MATERIALS AND PLASTIC FILM CONSTRUCTION - REQUIREMENTS AND TEST METHODS
CSA Z15882 : 2009	STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - GUIDANCE FOR SELECTION, USE AND INTERPRETATION OF RESULTS
CSA Z17665-2 : 2009 : R2014	STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ISO 17665-1
ISO 11607 : 2003	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES
NBR ISO 11135 : 2018	STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
13/30263416 DC : 0	BS EN ISO 9687 - DENTISTRY - GRAPHICAL SYMBOLS FOR DENTAL EQUIPMENT
DIN EN ISO 21531 : 2009	DENTISTRY - GRAPHICAL SYMBOLS FOR DENTAL INSTRUMENTS
DD CEN ISO/TS 17665-2 : 2009	STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ISO 17665-1
07/30166930 DC : DRAFT AUG 2007	BS EN 868-4 - PACKAGING MATERIALS FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 4: PAPER BAGS - REQUIREMENTS AND TEST METHODS
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
11/30244091 DC : 0	BS EN ISO 11135 - STERILIZATION OF HEALTH-CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
DIN EN ISO 9687 : 2015	DENTISTRY - GRAPHICAL SYMBOLS FOR DENTAL EQUIPMENT (ISO 9687:2015)
04/30081258 DC : DRAFT MARCH 2004	BS EN ISO 11737-1 - STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 1 - DETERMINATION OF A POPULATION OF MICRO ORGANISMS ON PRODUCTS
AAMI ISO 11140-4 : 2007	STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 4: CLASS 2 INDICATORS AS AN ALTERNATIVE TO THE BOWIE AND DICK-TYPE TEST FOR DETECTION OF STEAM PENETRATION
09/30207531 DC : 0	BS EN ISO 14534 - OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - FUNDAMENTAL REQUIREMENTS
13/30278676 DC : 0	BS EN 285 - STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS
DD CEN ISO/TS 11135-2 : 2008	STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 2: GUIDANCE ON THE APPLICATION OF ISO 11135-1 (ISO/TS 11135-2:2008)
99/123128 DC : DRAFT SEP 99	ISO/DIS 11607 - PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES
AAMI ISO 11138-1 : 2017	STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 1: GENERAL REQUIREMENTS
DIN EN 868-5 : 2009	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 5: SEALABLE POUCHES AND REELS OF POROUS MATERIALS AND PLASTIC FILM CONSTRUCTION - REQUIREMENTS AND TEST METHODS
SR CEN ISO/TS 17665-2:2009	STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ISO 17665-1
15/30325861 DC : 0	BS EN 868-4 - PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 4: PAPER BAGS - REQUIREMENTS AND TEST METHODS
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
AAMI ISO 15882 : 2008	STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - GUIDANCE FOR SELECTION, USE AND INTERPRETATION OF RESULTS
NF CEN ISO/TS 11135-2 : 2008	STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 2: GUIDANCE ON THE APPLICATION OF ISO 11135-1
04/30048205 DC : DRAFT JUL 2004	BS EN ISO 17665 - STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
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 : 2014-10	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)
PREN 285 : DRAFT 2013	STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS
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 868-5 E : 2009	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 5: SEALABLE POUCHES AND REELS OF POROUS MATERIALS AND PLASTIC FILM CONSTRUCTION - REQUIREMENTS AND TEST METHODS
04/30030146 DC : 0	BS EN ISO 21531 - DENTISTRY - GRAPHICAL SYMBOLS
NBR 14990-1 : 2004	PACKAGING SYSTEMS AND MATERIALS FOR HEALTH PRODUCTS STERILIZATION - PART 1: GENERAL REQUIREMENTS
BS ISO 11140-5 : 2007	STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 5: CLASS 2 INDICATORS FOR BOWIE AND DICK-TYPE AIR REMOVAL TESTS
NBR ISO 11135-1 : 2014	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
CSA ISO 11140-3 : 2018	STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 3: CLASS 2 INDICATOR SYSTEMS FOR USE IN THE BOWIE AND DICK-TYPE STEAM PENETRATION TEST
BS EN ISO 21531 : 2009	DENTISTRY - GRAPHICAL SYMBOLS FOR DENTAL INSTRUMENTS
AAMI ISO 11140-5 : 2007	STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 5: CLASS 2 INDICATORS FOR BOWIE AND DICK-TYPE AIR REMOVAL TESTS
AAMI ISO 11140-4 : 2007	STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 4: CLASS 2 INDICATORS AS AN ALTERNATIVE TO THE BOWIE AND DICK-TYPE TEST FOR DETECTION OF STEAM PENETRATION
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 Z11135-2 : 2009 : FR	STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 2: GUIDANCE ON THE APPLICATION OF ISO 11135-1
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 Z11135-2 : 2009 : R2014	STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 2: GUIDANCE ON THE APPLICATION OF ISO 11135-1
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
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 11140-3 : 2007	STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 3: CLASS 2 INDICATOR SYSTEMS FOR USE IN THE BOWIE AND DICK-TYPE STEAM PENETRATION TEST
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 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 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
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)
I.S. EN ISO 9687:2015	DENTISTRY - GRAPHICAL SYMBOLS FOR DENTAL EQUIPMENT (ISO 9687:2015)
BS EN ISO 16061 : 2015	INSTRUMENTATION FOR USE IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS
NBR ISO 17665-1 : 2010	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 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
CSA Z11135-2 : 2009	STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 2: GUIDANCE ON THE APPLICATION OF ISO 11135-1
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
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
AAMI ISO 11140-5 : 2007 : R2012	STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 5: CLASS 2 INDICATORS FOR BOWIE AND DICK-TYPE AIR REMOVAL TESTS
CSA Z15882 : 2009(R2019)	STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - GUIDANCE FOR SELECTION, USE AND INTERPRETATION OF RESULTS
07/30166933 DC : DRAFT AUG 2007	BS EN 868-5 - PACKAGING MATERIALS FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 5: SEALABLE POUCHES AND REELS OF POROUS MATERIALS AND PLASTIC FILM CONSTRUCTION - REQUIREMENTS AND TEST METHODS
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 11140-4 : 2007 : R2012	STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 4: CLASS 2 INDICATORS AS AN ALTERNATIVE TO THE BOWIE AND DICK-TYPE TEST FOR DETECTION OF STEAM PENETRATION
CSA ISO 11138-1 : 2017	STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 1: GENERAL REQUIREMENTS
DIN EN ISO 16061 : 2015	INSTRUMENTATION FOR USE IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS (ISO 16061:2015)
UNI CEN ISO/TS 17665-2 : 2009	STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ISO 17665-1
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
DIN EN ISO 16061 E : 2015	INSTRUMENTATION FOR USE IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS (ISO 16061:2015)
PREN 868-5 : DRAFT 2017	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 5: SEALABLE POUCHES AND REELS OF POROUS MATERIALS AND PLASTIC FILM CONSTRUCTION - REQUIREMENTS AND TEST METHODS
DIN EN ISO 18472 : 2006	STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL AND CHEMICAL INDICATORS - TEST EQUIPMENT
17/30364306 DC : 0	BS EN 17180 - STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE VAPORIZED HYDROGEN PEROXIDE STERILIZERS - REQUIREMENTS AND TESTING
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
AAMI ISO 11140-3 : 2007 : R2012	STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 3: CLASS 2 INDICATOR SYSTEMS FOR USE IN THE BOWIE AND DICK-TYPE STEAM PENETRATION TEST
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 11140-5 : 2007	STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 5: CLASS 2 INDICATORS FOR BOWIE AND DICK-TYPE AIR REMOVAL TESTS
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)
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)
NBR ISO 14937 : 2014	STERILIZATION OF HEALTH CARE PRODUCTS - GENERAL REQUIREMENTS FOR CHARACTERIZATION OF A STERILIZING AGENT AND THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF STERILIZATION PROCESS FOR MEDICAL DEVICES
CSA Z11135-2 : 2009	STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 2: GUIDANCE ON THE APPLICATION OF ISO 11135-1
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
I.S. EN ISO 21531:2009	DENTISTRY - GRAPHICAL SYMBOLS FOR DENTAL INSTRUMENTS
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
I.S. EN 868-5:2009	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 5: SEALABLE POUCHES AND REELS OF POROUS MATERIALS AND PLASTIC FILM CONSTRUCTION - REQUIREMENTS AND TEST METHODS
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)
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
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
UNI CEN ISO/TS 11135-2 : 2009	STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 2: GUIDANCE ON THE APPLICATION OF ISO 11135-1
BS EN ISO 18472 : 2006	STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL AND CHEMICAL INDICATORS - TEST EQUIPMENT
EN ISO 18472 : 2006	STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL AND CHEMICAL INDICATORS - TEST EQUIPMENT
I.S. EN 13060:2014	SMALL STEAM STERILIZERS
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)
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
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
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)
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
BS EN 868-5 : 2009	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 5: SEALABLE POUCHES AND REELS OF POROUS MATERIALS AND PLASTIC FILM CONSTRUCTION - REQUIREMENTS AND TEST METHODS
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
CSA Z17665-2 : 2009	STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ISO 17665-1
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
AAMI ISO 18472 : 2007	STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL AND CHEMICAL INDICATORS - TEST EQUIPMENT
SR CEN ISO/TS 11135-2:2008	STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 2: GUIDANCE ON THE APPLICATION OF ISO 11135-1
PREN 868-4 : DRAFT 2015	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 4: PAPER BAGS - REQUIREMENTS AND TEST METHODS
ONORM EN ISO 18472 : 2006	STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL AND CHEMICAL INDICATORS - TEST EQUIPMENT
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)
FD S98 135 : 2005 FD	STERILISATION OF MEDICAL DEVICES - GUIDELINES FOR THE CONTROL OF THE TREATMENTS APPLIED TO THE RE-USABLE MEDICAL DEVICES
UNI 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
17/30362728 DC : 0	BS EN 17169 - TATTOOING - SAFE AND HYGIENIC PRACTICE
CSA ISO 11140-5 : 2018	STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 5: CLASS 2 INDICATORS FOR BOWIE AND DICK-TYPE AIR REMOVAL TESTS
ONORM 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)
AAMI ISO 11140-3 : 2007	STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 3: CLASS 2 INDICATOR SYSTEMS FOR USE IN THE BOWIE AND DICK-TYPE STEAM PENETRATION TEST
AAMI ISO TIR 11135-2 : 2008	STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 2: GUIDANCE ON THE APPLICATION OF ANSI/AAMI/ISO 11135-1
UNE EN ISO 9687 : 2015	DENTISTRY - GRAPHICAL SYMBOLS FOR DENTAL EQUIPMENT (ISO 9687:2015)
UNE-EN 13060:2015	SMALL STEAM STERILIZERS
ISO 9687 : 2015	DENTISTRY - GRAPHICAL SYMBOLS FOR DENTAL EQUIPMENT
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 Z17665-1 : 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
ISO 18472 : 2006	STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL AND CHEMICAL INDICATORS - TEST EQUIPMENT
ISO 11140-5 : 2007(R2016)	STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 5: CLASS 2 INDICATORS FOR BOWIE AND DICK-TYPE AIR REMOVAL TESTS
EN ISO 9687 : 2015 AMD 1 2018	DENTISTRY - GRAPHICAL SYMBOLS FOR DENTAL EQUIPMENT (ISO 9687:2015/AMD 1:2018)
DIN EN ISO 9687 E : 2015	DENTISTRY - GRAPHICAL SYMBOLS FOR DENTAL EQUIPMENT (ISO 9687:2015)
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
I.S. EN ISO 18472:2006	STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL AND CHEMICAL INDICATORS - TEST EQUIPMENT
I.S. EN ISO 16061:2015	INSTRUMENTATION FOR USE IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS (ISO 16061:2015)
EN 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 285 : 2015	STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS
DIN EN ISO 14937 E : 2010	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
DIN EN ISO 17665-1 E : 2006	REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 1: CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
DIN EN 13060 : 2015	SMALL STEAM STERILIZERS
DIN EN 285 E : 2016	STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS
DIN EN 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
DIN EN ISO 14534 E : 2015	OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - FUNDAMENTAL REQUIREMENTS (ISO 14534:2011)
DIN EN ISO 11140-4 : 2007	STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 4: CLASS 2 INDICATORS AS AN ALTERNATIVE TO THE BOWIE AND DICK-TYPE TEST FOR DETECTION OF STEAM PENETRATION
DIN EN ISO 11140-3 : 2009	STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 3: CLASS 2 INDICATOR SYSTEMS FOR USE IN THE BOWIE AND DICK-TYPE STEAM PENETRATION TEST
DIN EN ISO 11138-1 : 2015	STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 1: GENERAL REQUIREMENTS (ISO 11138-1:2017)
DIN EN 868-4 : 2015	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 4: PAPER BAGS - REQUIREMENTS AND TEST METHODS
DIN EN ISO 14937 : 2010	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
DIN EN ISO 15882 E : 2008	STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - GUIDANCE FOR SELECTION, USE AND INTERPRETATION OF RESULTS
DIN EN ISO 15882 : 2008	STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - GUIDANCE FOR SELECTION, USE AND INTERPRETATION OF RESULTS
DIN EN ISO 14534 : 2015	OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - FUNDAMENTAL REQUIREMENTS (ISO 14534:2011)
DIN EN 285 : 2016	STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS
DIN EN 13060 E : 2015	SMALL STEAM STERILIZERS
DIN EN ISO 18472 E : 2006	STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL AND CHEMICAL INDICATORS - TEST EQUIPMENT
DIN EN ISO 11140-3 E : 2009	STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 3: CLASS 2 INDICATOR SYSTEMS FOR USE IN THE BOWIE AND DICK-TYPE STEAM PENETRATION TEST
UNE-EN 285:2016	STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS
BS EN ISO 11135-1 : 2007	STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 1: REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
BS EN ISO 11140-3 : 2009	STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS PART 3: CLASS 2 INDICATOR SYSTEMS FOR USE IN THE BOWIE AND DICK-TYPE STEAM PENETRATION TEST
ISO 21531 : 2009(R2015)	DENTISTRY - GRAPHICAL SYMBOLS FOR DENTAL INSTRUMENTS
ISO 15882 : 2008(R2017)	STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - GUIDANCE FOR SELECTION, USE AND INTERPRETATION OF RESULTS
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
BS EN ISO 11140-4 : 2007	STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 4: CLASS 2 INDICATORS AS AN ALTERNATIVE TO THE BOWIE AND DICK-TYPE TEST FOR DETECTION OF STEAM PENETRATION
ISO 11140-3 : 2007(R2016)	STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 3: CLASS 2 INDICATOR SYSTEMS FOR USE IN THE BOWIE AND DICK-TYPE STEAM PENETRATION TEST
BS EN ISO 11138-1 : 2017	STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 1: GENERAL REQUIREMENTS (ISO 11138-1:2017)
UNE-EN 868-4:2017	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 4: PAPER BAGS - REQUIREMENTS AND TEST METHODS
ISO 11135-1 : 2007	STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 1: REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
BS EN ISO 14534 : 2015	OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - FUNDAMENTAL REQUIREMENTS (ISO 14534:2011)
ISO TS 17665-2 : 2009(R2015)	STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ISO 17665-1
ISO 20857 : 2010(R2016)	STERILIZATION OF HEALTH CARE PRODUCTS - DRY HEAT - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
ISO 16061 : 2015	INSTRUMENTATION FOR USE IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS
ISO 11138-1 : 2017	STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 1: GENERAL REQUIREMENTS
ANSI/AAMI/ISO 15882:2008(R2013)	STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - GUIDANCE FOR SELECTION, USE AND INTERPRETATION OF RESULTS
BS EN 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
BS EN 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 11140-4 : 2007(R2016)	STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 4: CLASS 2 INDICATORS AS AN ALTERNATIVE TO THE BOWIE AND DICK-TYPE TEST FOR DETECTION OF STEAM PENETRATION
UNE EN ISO 11138-1 : 2017	STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 1: GENERAL REQUIREMENTS (ISO 11138-1:2017)
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
BS EN 13060 : 2014	SMALL STEAM STERILIZERS
ISO 14534 : 2011(R2016)	OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - FUNDAMENTAL REQUIREMENTS
BS EN 285 : 2015	STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS
ISO TS 11135-2 : 2008	STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 2: GUIDANCE ON THE APPLICATION OF ISO 11135-1
DIN EN 868-4 E : 2017	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 4: PAPER BAGS - REQUIREMENTS AND TEST METHODS
UNE-EN ISO 14534:2015	OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - FUNDAMENTAL REQUIREMENTS (ISO 14534:2011)
UNE-EN ISO 14937:2010	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
BS EN 868-4 : 2017	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 4: PAPER BAGS - REQUIREMENTS AND TEST METHODS
DIN EN ISO 11140-4 E : 2007	STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 4: CLASS 2 INDICATORS AS AN ALTERNATIVE TO THE BOWIE AND DICK-TYPE TEST FOR DETECTION OF STEAM PENETRATION
BS EN ISO 15882 : 2008	STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - GUIDANCE FOR SELECTION, USE AND INTERPRETATION OF RESULTS

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

ISO/IEC 17025 : 2005	GENERAL REQUIREMENTS FOR THE COMPETENCE OF TESTING AND CALIBRATION LABORATORIES
ISO 11137-1:2006(R2016)	STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 1: REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
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
EN 550 : 1994	STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF ETHYLENE OXIDE STERILIZATION
ISO/IEC 17050-1 : 2004(R2020)	CONFORMITY ASSESSMENT - SUPPLIER'S DECLARATION OF CONFORMITY - PART 1: GENERAL REQUIREMENTS
ISO 11607-2 : 2006(R 2015)	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: VALIDATION REQUIREMENTS FOR FORMING, SEALING AND ASSEMBLY PROCESSES
EN 556-1 : 2001 COR 2006	STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR MEDICAL DEVICES TO BE DESIGNATED "STERILE" - PART 1: REQUIREMENTS FOR TERMINALLY STERILIZED MEDICAL DEVICES
ISO 15882 : 2008(R2017)	STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - GUIDANCE FOR SELECTION, USE AND INTERPRETATION OF RESULTS
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 285 : 2015	STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS
ISO 11138-2 : 2006	STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 2: BIOLOGICAL INDICATORS FOR ETHYLENE OXIDE STERILIZATION PROCESSES
ISO 11138-3 : 2006	STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 3: BIOLOGICAL INDICATORS FOR MOIST HEAT STERILIZATION PROCESSES
ISO TS 17665-2 : 2009(R2015)	STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ISO 17665-1
ISO 13485 : 2016(R2020)	MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR REGULATORY PURPOSES
ISO 11140-3 : 2007(R2016)	STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 3: CLASS 2 INDICATOR SYSTEMS FOR USE IN THE BOWIE AND DICK-TYPE STEAM PENETRATION TEST
ISO 11138-1 : 2006	STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 1: GENERAL REQUIREMENTS
EN 14180 : 2014	STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE STEAM AND FORMALDEHYDE STERILIZERS - REQUIREMENTS AND TESTING
ISO 18472 : 2006	STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL AND CHEMICAL INDICATORS - TEST EQUIPMENT
ISO 11140-4 : 2007(R2016)	STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 4: CLASS 2 INDICATORS AS AN ALTERNATIVE TO THE BOWIE AND DICK-TYPE TEST FOR DETECTION OF STEAM PENETRATION
EN 552 : 94 AMD 2 2000	STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY IRRADIATION
ISO 8601 : 2004	DATA ELEMENTS AND INTERCHANGE FORMATS - INFORMATION INTERCHANGE - REPRESENTATION OF DATES AND TIMES
ISO 20857 : 2010(R2016)	STERILIZATION OF HEALTH CARE PRODUCTS - DRY HEAT - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
ISO TS 11139 : 2006	STERILIZATION OF HEALTH CARE PRODUCTS - VOCABULARY
93/42/EEC : 1993 AMD 5 2007	COUNCIL DIRECTIVE 93/42/EEC OF 14 JUNE 1993 CONCERNING MEDICAL DEVICES
ISO 11138-5 : 2006	STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 5: BIOLOGICAL INDICATORS FOR LOW-TEMPERATURE STEAM AND FORMALDEHYDE STERILIZATION PROCESSES
ISO 11137-2 : 2013(R2018)	STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 2: ESTABLISHING THE STERILIZATION DOSE
ISO 9001:2015	QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS
ISO 11140-5 : 2007(R2016)	STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 5: CLASS 2 INDICATORS FOR BOWIE AND DICK-TYPE AIR REMOVAL TESTS
ISO 11607-1 : 2006	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS
ISO 11138-4 : 2006	STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 4: BIOLOGICAL INDICATORS FOR DRY HEAT STERILIZATION PROCESSES
ISO 14161 : 2009(R2017)	STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - GUIDANCE FOR THE SELECTION, USE AND INTERPRETATION OF RESULTS
EN 1422 : 2014	STERILIZERS FOR MEDICAL PURPOSES - ETHYLENE OXIDE STERILIZERS - REQUIREMENTS AND TEST METHODS
EN 13060 : 2014	SMALL STEAM STERILIZERS
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 11137-3 : 2006	STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 3: GUIDANCE ON DOSIMETRIC ASPECTS OF DEVELOPMENT, VALIDATION AND ROUTINE CONTROL

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ISO 11140-1 : 2014

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