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EN ISO 16061:2015

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2015)

Superseded date

10-04-2021

Superseded by

EN ISO 16061:2021

Published date

20-05-2015

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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

ISO 16061:2015 specifies general requirements for instruments to be used in association with non-active surgical implants. These requirements apply to instruments when they are manufactured and when they are resupplied after refurbishment.This International Standard also applies to instruments which may be connected to power-driven systems, but does not apply to the power-driven systems themselves.With regard to safety, this International Standard gives requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging, and information supplied by the manufacturer.This International Standard is not applicable to instruments associated with dental implants, transendodontic and transradicular implants, and ophthalmic implants.

Committee
CEN/TC 285
DevelopmentNote
Supersedes EN 12011. (02/2009)
DocumentType
Standard
PublisherName
Comite Europeen de Normalisation
Status
Superseded
SupersededBy
Supersedes

13/30278952 DC : 0 BS EN 16372 - AESTHETIC SURGERY AND AESTHETIC NON-SURGICAL MEDICAL SERVICES
15/30317874 DC : 0 BS EN 16844 - AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL PROCEDURES
UNE-EN 16372:2015 Aesthetic surgery services
12/30254927 DC : 0 BS EN 16372 - AESTHETIC SURGERY SERVICES
I.S. EN 16372:2014 AESTHETIC SURGERY SERVICES
EN 16844:2017 Aesthetic medicine services - Non-surgical medical treatments
I.S. EN 16844:2017 AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL PROCEDURES
EN 16372:2014 Aesthetic surgery services
BS EN 16372:2014 Aesthetic surgery services
I.S. EN 16844:2017+A2:2019 Aesthetic medicine services - Non-surgical medical treatments
BS EN 16844 : 2017 AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL TREATMENTS

ISO 11137-1:2006 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 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 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 60068-2-27:2008 Environmental testing - Part 2-27: Tests - Test Ea and guidance: Shock
ISO 15882:2008 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 Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices
ISO 5832-6:1997 Implants for surgery Metallic materials Part 6: Wrought cobalt-nickel-chromium-molybdenum alloy
ISO 7151:1988 Surgical instruments — Non-cutting, articulated instruments — General requirements and test methods
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
ISO 11737-1:2006 Sterilization of medical devices Microbiological methods Part 1: Determination of a population of microorganisms on products
ISO 5832-5:2005 Implants for surgery Metallic materials Part 5: Wrought cobalt-chromium-tungsten-nickel alloy
ISO 15883-3:2006 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 Medical devices Quality management systems Requirements for regulatory purposes
EN 2318:1992 Aerospace series - Aluminium alloy AL-P2024-T3511 - Extruded bars and sections 1,2 mm < or = a or D < or = 150 mm
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 2326:1992 Aerospace series - Aluminium alloy AL-P6082-T6 - Extruded bars and sections a or D < or = 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 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 < or = 100 mm
IEC 60068-2-31:2008 Environmental testing - Part 2-31: Tests - Test Ec: Rough handling shocks, primarily for equipment-type specimens
ISO 5832-8:1997 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 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 Biological evaluation of medical devices Part 18: Chemical characterization of materials
ISO/TS 10993-19:2006 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 60068-2-47:2005 Environmental testing - Part 2-47: Test - Mounting of specimens for vibration, impact and similar dynamic tests
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 8601:2004 Data elements and interchange formats Information interchange Representation of dates and times
ISO 13408-1:2008 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 Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals
ISO 11137-2:2013 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 5832-7:2016 Implants for surgery — Metallic materials — Part 7: Forgeable and cold-formed cobalt-chromium-nickel-molybdenum-iron alloy
ISO 7740:1985 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 < or = 200 mm
ISO 8319-2:1986 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 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 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 < or = a or D < or = 75 mm
ISO 14161:2009 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 < or = 150 mm
ISO 15883-2:2006 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 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 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 Implants for surgery Metallic materials Part 9: Wrought high nitrogen stainless steel

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