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DIN EN ISO 10993-17 E : 2009

Current
Current

The latest, up-to-date edition.

BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 17: ESTABLISHMENT OF ALLOWABLE LIMITS FOR LEACHABLE SUBSTANCES
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2009

Foreword
Introduction
1 Scope
2 Normative reference
3 Terms and definitions
4 General principles for establishing allowable limits
5 Establishment of tolerable intake (TI) for specific
   leachable substances
6 Calculation of tolerable exposure (TE)
7 Feasibility evaluation
8 Benefit evaluation
9 Allowable limits
10 Reporting requirements
Annex A (informative) - Some typical assumptions for
        biological parameters
Annex B (informative) - Risk assessment for mixtures
        of leachable substances
Annex C (informative) - Conversion of allowable limits
        for systemic exposure and for body surface
        contact to maximum dose to patient from a
        medical device
Annex D (informative) - Risk analysis report
Bibliography
Annex ZA (informative) - Relationship between this European
         Standard and the Essential Requirements of EU
         Directive 93/42/EEC on Medical Devices
Annex ZB (informative) - Relationship between this European
         Standard and the Essential Requirements of EU
         Directive 90/385/EEC on Active Implantable
         Medical Devices
National Annex NA (informative) - Bibliography

Describes a method for the determination of allowable limits for substances leachable from medical devices.

DocumentType
Standard
Pages
36
PublisherName
German Institute for Standardisation (Deutsches Institut für Normung)
Status
Current

DIN EN ISO 10993-13 E : 2010 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 13: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM POLYMERIC MEDICAL DEVICES
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)
DIN EN ISO 10993-18 E : 2009 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 18: CHEMICAL CHARACTERIZATION OF MATERIALS
DIN EN ISO 14937:2010-03 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 14937:2009)

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
ISO 14971:2007 Medical devices Application of risk management to medical devices

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