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BSI PD ISO/TS 37137-1:2021

BSI PD ISO/TS 37137-1:2021

$102.76

Biological evaluation of absorbable medical devices – General requirements

Published By Publication Date Number of Pages
BSI 2021 22
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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).

PDF Catalog

PDF Pages PDF Title
2 National foreword
6 Foreword
7 Introduction
9 1 Scope
2 Normative references
3 Terms and definitions
10 4 General considerations
12 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
13 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
14 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
15 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
16 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
17 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
18 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
19 Annex A (informative) Nomenclature of absorb, degrade and related terms
20 Bibliography

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BSI PD ISO/TS 37137-1:2021
$102.76