I.S. EN ISO 16061:2015

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INSTRUMENTATION FOR USE IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS (ISO 16061:2015)

Publisher: National Standards Authority of Ireland

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Available Formats: PDF - English, Hardcopy - English
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For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

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

Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Intended performance
5 Design attributes
6 Selection of materials
7 Design evaluation
8 Manufacture
9 Sterilization
10 Packaging
11 Information supplied by the manufacturer
Annex A (informative) - Examples of typical
         instrument applications, together with
         materials found acceptable for instrument
         manufacture
Bibliography
Annex ZA (informative) - Relationship between
         this European Standard and the Essential
         Requirements of EU Directive 93/42/EEC on
         medical devices

Abstract - (Show below) - (Hide below)

Defines general requirements for instruments to be used in association with non-active surgical implants.

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

Published
Document Type	Standard
Status	Current
Publisher	National Standards Authority of Ireland
Pages
ISBN

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

Equivalent Standard(s)	Relationship
ISO 16061 : 2015	Identical
EN ISO 16061 : 2015	Identical
ISO 16061 : 2015	Identical

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

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 15883-1 : 2006(R2009)	WASHER-DISINFECTORS - PART 1: GENERAL REQUIREMENTS, TERMS AND DEFINITIONS AND TESTS
ISO 5832-1 : 2016	IMPLANTS FOR SURGERY - METALLIC MATERIALS - PART 1: WROUGHT STAINLESS STEEL
ISO 11607-2 : 2006(R 2015)	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: VALIDATION REQUIREMENTS FOR FORMING, SEALING AND ASSEMBLY PROCESSES
ISO 5832-11 : 2014	IMPLANTS FOR SURGERY - METALLIC MATERIALS - PART 11: WROUGHT TITANIUM 6-ALUMINIUM 7-NIOBIUM ALLOY
ISO 11138-3 : 2017	STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 3: BIOLOGICAL INDICATORS FOR MOIST HEAT STERILIZATION PROCESSES
IEC 60068-2-27 : 4.0	ENVIRONMENTAL TESTING - PART 2-27: TESTS - TEST EA AND GUIDANCE: SHOCK
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
ISO 10993-13 : 2010(R2013)	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 13: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM POLYMERIC MEDICAL DEVICES
ISO 5832-6 : 1997(R2013)	IMPLANTS FOR SURGERY - METALLIC MATERIALS - PART 6: WROUGHT COBALT-NICKEL-CHROMIUM-MOLYBDENUM ALLOY
ISO 7151 : 1988(R2015)	SURGICAL INSTRUMENTS - NON-CUTTING, ARTICULATED INSTRUMENTS - GENERAL REQUIREMENTS & TEST METHODS
ISO 11737-2 : 2009(R2015)	STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 2: TESTS OF STERILITY PERFORMED IN THE DEFINITION, VALIDATION AND MAINTENANCE OF A STERILIZATION PROCESS
ISO 11737-1 : 2006	STERILIZATION OF HEALTH CARE PRODUCTS - MICROBIOLOGICAL METHODS - PART 1: DETERMINATION OF A POPULATION OF MICROORGANISMS ON PRODUCTS
ISO 5832-5 : 2005(R2014)	IMPLANTS FOR SURGERY - METALLIC MATERIALS - PART 5: WROUGHT COBALT-CHROMIUM-TUNGSTEN-NICKEL ALLOY
ISO 15883-3 : 2006(R2016)	WASHER-DISINFECTORS - PART 3: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING THERMAL DISINFECTION FOR HUMAN WASTE CONTAINERS
ISO 5832-3 : 2016	IMPLANTS FOR SURGERY - METALLIC MATERIALS - PART 3: WROUGHT TITANIUM 6-ALUMINIUM 4-VANADIUM ALLOY
ISO 13485 : 2016(R2020)	MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR REGULATORY PURPOSES
EN 2318 : 1992	AEROSPACE SERIES - ALUMINIUM ALLOY AL-P2024-T3511 - EXTRUDED BARS AND SECTION 1,2 MM <= A OR D <= 150 MM
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
EN 2326 : 1992	AEROSPACE SERIES - ALUMINIUM ALLOY AL-P6082-T6 EXTRUDED BARS AND SECTIONS A OR D <= 200 MM
ISO TR 14969 : 2004	MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003
ISO 4957 : 1999	TOOL STEELS
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
EN 2127 : 1992	AEROSPACE SERIES - ALUMINIUM ALLOY AL-P7075-T73511 EXTRUDED BARS AND SECTIONS A OR D <= 100 MM
IEC 60068-2-31 : 2.0	ENVIRONMENTAL TESTING - PART 2-31: TESTS - TEST EC: ROUGH HANDLING SHOCKS, PRIMARILY FOR EQUIPMENT-TYPE SPECIMENS
ISO 5832-8 : 1997(R2013)	IMPLANTS FOR SURGERY - METALLIC MATERIALS - PART 8: WROUGHT COBALT-NICKEL-CHROMIUM-MOLYBDENUM-TUNGSTEN-IRON ALLOY
ISO 11138-2 : 2017	STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 2: BIOLOGICAL INDICATORS FOR ETHYLENE OXIDE STERILIZATION PROCESSES
ISO 10993-14 : 2001(R2019)	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 14: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM CERAMICS
ISO 11140-1 : 2014	STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 1: GENERAL REQUIREMENTS
ISO 5832-4 : 2014	IMPLANTS FOR SURGERY - METALLIC MATERIALS - PART 4: COBALT-CHROMIUM-MOLYBDENUM CASTING ALLOY
ISO 10993-18 : 2005(R2013)	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 18: CHEMICAL CHARACTERIZATION OF MATERIALS
ISO TS 10993-19 : 2006(R2017)	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 19: PHYSICO-CHEMICAL, MORPHOLOGICAL AND TOPOGRAPHICAL CHARACTERIZATION OF MATERIALS
ISO 18472 : 2006	STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL AND CHEMICAL INDICATORS - TEST EQUIPMENT
IEC 60068-2-47 : 3.0	ENVIRONMENTAL TESTING - PART 2-47: TESTS - MOUNTING OF SPECIMENS FOR VIBRATION, IMPACT AND SIMILAR DYNAMIC TESTS
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
ISO 8601 : 2004	DATA ELEMENTS AND INTERCHANGE FORMATS - INFORMATION INTERCHANGE - REPRESENTATION OF DATES AND TIMES
ISO 13408-1 : 2008(R2017)	ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS
ISO 11137-3 : 2017	STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 3: GUIDANCE ON DOSIMETRIC ASPECTS OF DEVELOPMENT, VALIDATION AND ROUTINE CONTROL
ISO 10993-12 : 2012	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 12: SAMPLE PREPARATION AND REFERENCE MATERIALS
ISO 10993-7 : 2008(R2016)	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 7: ETHYLENE OXIDE STERILIZATION RESIDUALS
ISO 11137-2 : 2013(R2018)	STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 2: ESTABLISHING THE STERILIZATION DOSE
ISO 10993-1 : 2009	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS
ISO 80000-1 : 2009	QUANTITIES AND UNITS - PART 1: GENERAL
ISO 5832-2 : 1999	IMPLANTS FOR SURGERY - METALLIC MATERIALS - PART 2: UNALLOYED TITANIUM
ISO 10993-15 : 2001	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 15: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM METALS AND ALLOYS
ISO 5832-7 : 2016	IMPLANTS FOR SURGERY - METALLIC MATERIALS - PART 7: FORGEABLE AND COLD-FORMED COBALT-CHROMIUM-NICKEL-MOLYBDENUM-IRON ALLOY
ISO 7740 : 1985(R2016)	INSTRUMENTS FOR SURGERY - SCALPELS WITH DETACHABLE BLADES - FITTING DIMENSIONS
EN 2100 : 1992	AEROSPACE SERIES - ALUMINIUM ALLOY AL-P2014A-T4511 EXTRUDED BARS AND SECTIONS A OR D <= 200 MM
ISO 8319-2 : 1986(R2016)	ORTHOPAEDIC INSTRUMENTS - DRIVE CONNECTIONS - PART 2: SCREWDRIVERS FOR SINGLE SLOT HEAD SCREWS, SCREWS WITH CRUCIATE SLOT AND CROSS-RECESSED HEAD SCREWS
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 14155 : 2011	CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - GOOD CLINICAL PRACTICE
ISO 11138-1 : 2017	STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 1: GENERAL REQUIREMENTS
ISO 14971 : 2007(R2010)	MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES
ISO 7000 : 2014	GRAPHICAL SYMBOLS FOR USE ON EQUIPMENT - REGISTERED SYMBOLS
ISO 11607-1 : 2006	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS
EN 2128 : 1992	AEROSPACE SERIES - ALUMINIUM ALLOY AL-P7075-T7351 - DRAWN BARS 6 MM <= A OR D <= 75 MM
ISO 14161 : 2009(R2017)	STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - GUIDANCE FOR THE SELECTION, USE AND INTERPRETATION OF RESULTS
ISO 15223-1 : 2016	MEDICAL DEVICES - SYMBOLS TO BE USED WITH MEDICAL DEVICE LABELS, LABELLING AND INFORMATION TO BE SUPPLIED - PART 1: GENERAL REQUIREMENTS
EN 2384 : 1992	AEROSPACE SERIES - ALUMINIUM ALLOY AL-P2014A-T6511 EXTRUDED BARS AND SECTIONS A OR D <= 150 MM
ISO 15883-2 : 2006(R2016)	WASHER-DISINFECTORS - PART 2: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING THERMAL DISINFECTION FOR SURGICAL INSTRUMENTS, ANAESTHETIC EQUIPMENT, BOWLS, DISHES, RECEIVERS, UTENSILS, GLASSWARE, ETC.
ISO 5832-12 : 2007 (R 2016)	IMPLANTS FOR SURGERY - METALLIC MATERIALS - PART 12: WROUGHT COBALT-CHROMIUM-MOLYBDENUM ALLOY
ISO 17664 : 2017	PROCESSING OF HEALTH CARE PRODUCTS - INFORMATION TO BE PROVIDED BY THE MEDICAL DEVICE MANUFACTURER FOR THE PROCESSING OF MEDICAL DEVICES
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 5832-9 : 2007(R2016)	IMPLANTS FOR SURGERY - METALLIC MATERIALS - PART 9: WROUGHT HIGH NITROGEN STAINLESS STEEL

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I.S. EN ISO 16061:2015

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

Abstract - (Show below) - (Hide below)

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

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

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

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