EN 12011 : 1998

Superseded

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INSTRUMENTATION TO BE USED IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS

Available format(s):

Superseded date: 01-12-2008

Language(s):

Published date: 12-01-2013

Publisher: Comite Europeen de Normalisation

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

Foreword
Introduction
1 Scope
2 Normative references
3 Definitions
4 Intended performance
5 Design attributes
6 Materials
7 Design evaluation
8 Manufacturing
9 Sterilization
10 Packaging
11 Information supplied by the manufacturer
Annex A (informative) Bibliography
Annex B (informative) A listing of some of the materials
        found acceptable for instrument manufacture
        together with typical applications
Annex C (informative) Clauses of this European Standard
        addressing essential requirements or other
        provisions of EU Directives

Abstract - (Show below) - (Hide below)

Defines general requirements for instruments for use in association with non-active surgical implants. Applicable to instruments at the time of manufacture and when they are re-supplied following refurbishment. Applicable to instruments for connection to powered driven systems, but not to the powered driven system itself. Does not apply to instruments associated with dental implants, transendodontic and transradicular implants and ophthalmic implants. Regarding safety, states requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging and information supplied by the manufacturer.

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Committee	TC 285
Document Type	Standard
ISBN
Pages
Published
Publisher	Comite Europeen de Normalisation
Status	Superseded
Superseded By	EN ISO 16061:2015

National Adoptions - (Show below) - (Hide below)

Equivalent Standard(s)	Relationship
UNE-EN 12011:1998	Identical
NEN EN 12011 : 1998	Identical
I.S. EN 12011:1998	Identical
UNI EN 12011 : 2000	Identical
NBN EN 12011 : 1998	Identical
SN EN 12011 : 1998	Identical
NS EN 12011 : 1ED 1998	Identical
BS EN 12011:1998	Identical
PN EN 12011 : 2003	Identical
NF EN 12011 : 1998	Identical
DIN EN 12011:1998-03	Identical

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

BS EN ISO 7439:2015	Copper-bearing contraceptive intrauterine devices. Requirements and tests
I.S. EN ISO 7439:2015	COPPER-BEARING CONTRACEPTIVE INTRAUTERINE DEVICES - REQUIREMENTS AND TESTS (ISO 7439:2015)
DIN EN ISO 7439:2015-08	COPPER-BEARING CONTRACEPTIVE INTRAUTERINE DEVICES - REQUIREMENTS AND TESTS (ISO 7439:2015)
UNE-EN ISO 7439:2015	Copper-bearing contraceptive intrauterine devices - Requirements and tests (ISO 7439:2015)
ISO 7439:2015	Copper-bearing contraceptive intrauterine devices — Requirements and tests
EN ISO 7439:2015	Copper-bearing contraceptive intrauterine devices - Requirements and tests (ISO 7439:2015)

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

EN ISO 14602:2011	Non-active surgical implants - Implants for osteosynthesis - Particular requirements (ISO 14602:2010)
EN 556:1994 + A1:1998	STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR TERMINALLY-STERILIZED MEDICAL DEVICES TO BE LABELLED "STERILE"
ISO 10993-3:2014	Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
ISO 10993-4:2017	Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood
EN 550 : 1994	STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF ETHYLENE OXIDE STERILIZATION
EN 27740:1992/A1:1997	INSTRUMENTS FOR SURGERY, SCALPELS WITH DETACHABLE BLADES, FITTING DIMENSIONS
EN 30993-4 : 1993	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 4: SELECTION OF TESTS FOR INTERACTIONS WITH BLOOD
EN ISO 10993-11:2009	Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2006)
EN 1441 : 1997	MEDICAL DEVICES - RISK ANALYSIS
ISO 7151:1988	Surgical instruments Non-cutting, articulated instruments General requirements and test methods
EN 46001 : 1996	QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF EN ISO 9001
EN 30993-3 : 1993	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - TESTS FOR GENOTOXICITY, CARCINOGENICITY AND REPRODUCTIVE TOXICITY
EN 540 : 1993	CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS
EN 868-1 : 1997	PACKAGING MATERIALS AND SYSTEMS FOR MEDICAL DEVICES WHICH ARE TO BE STERILIZED - GENERAL REQUIREMENTS AND TEST METHODS
EN 724 : 1994	GUIDANCE ON THE APPLICATION OF EN 29001 AND EN 46001 AND OF EN 29002 AND EN 46002 FOR NON-ACTIVE MEDICAL DEVICES
EN 1174-1 : 1996	STERILIZATION OF MEDICAL DEVICES - ESTIMATION OF THE POPULATION OF MICRO-ORGANISMS ON PRODUCT - REQUIREMENTS
EN 12010 : 1998	NON-ACTIVE SURGICAL IMPLANTS - JOINT REPLACEMENT IMPLANTS - PARTICULAR REQUIREMENTS
ISO 4957:1999	Tool steels
ISO 10993-2:2006	Biological evaluation of medical devices — Part 2: Animal welfare requirements
EN ISO 10993-10:2013	Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010)
EN ISO 10993-7 : 2008 COR 2009	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 7: ETHYLENE OXIDE STERILIZATION RESIDUALS (ISO 10993-7:2008/COR 1:2009)
ISO 14630:2012	Non-active surgical implants General requirements
EN 30993-6 : 1994	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - TESTS FOR LOCAL EFFECTS AFTER IMPLANTATION
EN 1041:2008+A1:2013	INFORMATION SUPPLIED BY THE MANUFACTURER OF MEDICAL DEVICES
EN 60068-2-27:2009	Environmental testing - Part 2-27: Tests - Test Ea and guidance: Shock
ISO 14602:2010	Non-active surgical implants — Implants for osteosynthesis — Particular requirements
EN 552:1994/A2:2000	STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY IRRADIATION
ISO 10993-10:2010	Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
ISO 10993-11:2017	Biological evaluation of medical devices — Part 11: Tests for systemic toxicity
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 10993-1:2009	Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
EN 46002 : 1996	QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF EN ISO 9002
ISO 7153-1:2016	Surgical instruments Materials Part 1: Metals
ISO 7740:1985	Instruments for surgery Scalpels with detachable blades Fitting dimensions
EN ISO 10993-12:2012	Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2012)
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
EN 30993-5 : 1994	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - TESTS FOR CYTOTOXICITY - IN VITRO METHODS
EN 60068-2-32:1993	Basic environmental testing procedures - Part 2: Tests - Test Ed: Free fall
EN 980:2008	Symbols for use in the labelling of medical devices
EN ISO 10993-1:2009/AC:2010	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS (ISO 10993-1:2009/COR 1:2010)
ISO 10993-6:2016	Biological evaluation of medical devices Part 6: Tests for local effects after implantation
EN 554 : 1994	STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY MOIST HEAT
EN ISO 14630:2012	Non-active surgical implants - General requirements (ISO 14630:2012)
EN 60068-2-47:2005	Environmental testing - Part 2-47: Tests - Mounting of specimens for vibration, impact and similar dynamic tests

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