ISO/TS 37137-1:2021
Biological evaluation of absorbable medical devices — Part 1: General requirements
This document specifies the requirements for the evaluation of absorbable medical devices during a biological risk assessment based on ISO 10993-1, including a clarification of the terms "absorb", "degrade" and other related terms (see Annex A).
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General considerations
5 Test article considerations
6 Sterilization considerations
7 Drug-device combination product considerations
8 Evaluation of absorbable medical devices in the context of the ISO 10993 series
8.1 General
8.2 ISO 10993-1, evaluation and testing within a risk management process
8.3 ISO 10993-2, animal welfare requirements
8.4 ISO 10993-3, tests for genotoxicity, carcinogenicity, and reproductive toxicity
8.5 ISO 10993-4, selection of tests for interactions with blood
8.6 ISO 10993-5, tests for in vitro cytotoxicity
8.7 ISO 10993-6, Tests for local effects after implantation
8.8 ISO 10993-7, ethylene oxide sterilization residuals
8.9 ISO 10993-9, framework for identification and quantification of potential degradation products
8.10 ISO 10993-10, tests for skin sensitization
8.11 ISO 10993-11, tests for systemic toxicity
8.12 ISO 10993-12, sample preparation and reference materials
8.13 ISO 10993-13, identification and quantification of degradation products from polymeric medical devices
8.14 ISO 10993-14, identification and quantification of degradation products from ceramics
8.15 ISO 10993-15, identification and quantification of degradation products from metals and alloys
8.16 ISO 10993-16, toxicokinetic study design for degradation products and leachables
8.17 ISO 10993-17, establishment of allowable limits for leachable substances
8.18 ISO 10993-18, chemical characterization of materials
8.19 ISO/TS 10993-19, physico-chemical, morphological and topographical characterization of materials
8.20 ISO/TS 10993-20, principles and methods for immunotoxicology testing of medical devices
8.21 ISO/TR 10993-22, guidance on nanomaterials
8.22 ISO 10993-23, tests for irritation
8.22.1 General
8.22.2 Tests for irritation
Annex A (informative) Nomenclature of absorb, degrade and related terms
Bibliography
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General considerations
5 Test article considerations
6 Sterilization considerations
7 Drug-device combination product considerations
8 Evaluation of absorbable medical devices in the context of the ISO 10993 series
8.1 General
8.2 ISO 10993-1, evaluation and testing within a risk management process
8.3 ISO 10993-2, animal welfare requirements
8.4 ISO 10993-3, tests for genotoxicity, carcinogenicity, and reproductive toxicity
8.5 ISO 10993-4, selection of tests for interactions with blood
8.6 ISO 10993-5, tests for in vitro cytotoxicity
8.7 ISO 10993-6, Tests for local effects after implantation
8.8 ISO 10993-7, ethylene oxide sterilization residuals
8.9 ISO 10993-9, framework for identification and quantification of potential degradation products
8.10 ISO 10993-10, tests for skin sensitization
8.11 ISO 10993-11, tests for systemic toxicity
8.12 ISO 10993-12, sample preparation and reference materials
8.13 ISO 10993-13, identification and quantification of degradation products from polymeric medical devices
8.14 ISO 10993-14, identification and quantification of degradation products from ceramics
8.15 ISO 10993-15, identification and quantification of degradation products from metals and alloys
8.16 ISO 10993-16, toxicokinetic study design for degradation products and leachables
8.17 ISO 10993-17, establishment of allowable limits for leachable substances
8.18 ISO 10993-18, chemical characterization of materials
8.19 ISO/TS 10993-19, physico-chemical, morphological and topographical characterization of materials
8.20 ISO/TS 10993-20, principles and methods for immunotoxicology testing of medical devices
8.21 ISO/TR 10993-22, guidance on nanomaterials
8.22 ISO 10993-23, tests for irritation
8.22.1 General
8.22.2 Tests for irritation
Annex A (informative) Nomenclature of absorb, degrade and related terms
Bibliography