DS DS/EN ISO 10993-17 Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances
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DS DS/EN ISO 10993-17 Document Information:
Title
Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances
Biologisk vurdering af medicinsk udstyr - Del 17: Fastsættelse af tilladte grænseværdier for udsivende stoffer
Dansk Standard
Publication Date:
Mar 24, 2003
Scope:
This standard specifies a method for the determination of allowable limits for substances leachable from medical devices. It is intended for use in deriving standards and estimating appropriate limits where standards do not exist. It describes a systematic process through which identified risks arising from toxicologically hazardous substances present in medical devices can be quantified. This standard is not applicable to devices that have no patient contact (e.g. in vitro diagnostic devices).
Keywords:
- ALLOWABLE
- ALLOYS
- BIOASSAY
- BIOLOGICAL ANALYSIS AND TESTING
- DECOMPOSITION PRODUCTS
- DEFINITION
- DEFINITIONS
- DEGRADABILITY
- DEGRADATION
- DETERIORATION
- DETERMINATION
- ESTABLISHMENT
- EVALUATIONS
- HEALTH HAZARDS
- IDENTIFICATION
- LIMITS (MATHEMATICS)
- MEDICAL DEVICES
- MEDICAL EQUIPMENT
- MEDICAL PRODUCTS
- METALS
- METHODS
- QUANTIFICATION
- RESIDUES
- RISK ANALYSIS
- SOLUBLE
- TESTING
- TOXICOLOGICAL TESTING
- MATHEMATICS
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