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BS EN ISO 10993-1 : 2009-10

BS EN ISO 10993-1 : 2009-10

Current

Current

The latest, up-to-date edition.

BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS (ISO 10993-1:2009)

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

10-01-2009

Publisher

British Standards Institution

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General principles applying to biological evaluation
  of medical devices
5 Categorization of medical devices
6 Biological evaluation process
7 Interpretation of biological evaluation data and overall
  biological safety assessment
Annex A (informative) - Biological evaluation tests
Annex B (informative) - Guidance on the risk management
        process
Annex C (informative) - Suggested procedure for literature
        review
Bibliography
Annex ZA (informative) - Relationship between this International
         Standard and the Essential Requirements of EU
         Directive 93/42/EEC on Medical Devices
Annex ZB (informative) - Relationship between this International
         Standard and the Essential Requirements of EU
         Directive 90/385/EEC on Active Implantable
         Medical Devices

Specifies: - the general principles governing the biological evaluation of medical devices within a risk management process; - the general categorization of devices based on the nature and duration of their contact with the body; - the evaluation of existing relevant data from all sources; - the identification of gaps in the available data set on the basis of a risk analysis; - the identification of additional data sets necessary to analyse the biological safety of the medical device; - the assessment of the biological safety of the medical device.

Committee
CH/194
DevelopmentNote
Supersedes BS EN 30993-1 & 95/561584 DC. (11/2005) Supersedes 06/30106186 DC. (07/2009)
DocumentType
Standard
Pages
32
PublisherName
British Standards Institution
Status
Current
Supersedes

ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories
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
ISO 10993-16:2017 Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables
ISO/TS 10993-20:2006 Biological evaluation of medical devices — Part 20: Principles and methods for immunotoxicology testing of medical devices
ISO 10993-13:2010 Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices
ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
ISO 10993-2:2006 Biological evaluation of medical devices — Part 2: Animal welfare requirements
ISO 7405:2008 Dentistry Evaluation of biocompatibility of medical devices used in dentistry
ISO 10993-14:2001 Biological evaluation of medical devices — Part 14: Identification and quantification of degradation products from ceramics
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 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
ISO 9004:2009 Managing for the sustained success of an organization A quality management approach
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 10993-17:2002 Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances
ISO 9001:2015 Quality management systems — Requirements
ISO 10993-9:2009 Biological evaluation of medical devices Part 9: Framework for identification and quantification of potential degradation products
ISO 9000:2015 Quality management systems — Fundamentals and vocabulary
ISO 14971:2007 Medical devices Application of risk management to medical devices
ISO 10993-6:2016 Biological evaluation of medical devices Part 6: Tests for local effects after implantation

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Hardcopy - English
PDF - English
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