Source: https://standards.globalspec.com/std/886337/iso-10993-1
Timestamp: 2020-07-14 01:53:49
Document Index: 178264803

Matched Legal Cases: ['art 1', 'art 1', 'art 1', 'art 1', 'art 1', 'art 11', 'art 3', 'art 4', 'art 5', 'art 4', 'art 1']

ISO 10993-1 - Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing | Engineering360
Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing
This document specifies: — the general principles governing the biological evaluation of medical devices within a risk management process; — the general categorization of medical devices based on...
Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process TECHNICAL CORRIGENDUM 1
Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process
This part of ISO 10993 describes a) the general principles governing the biological evaluation of medical devices; b) the categorization of devices based on the nature and duration of their contact...
Biological Evaluation of Medical Devices - Part 1: Guidance on Selection of Tests; (Corrigendum 1-1992) (CEN EN 30993-1: 1994)
ISO 10993-11 - Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
This document specifies requirements and gives guidance on procedures to be followed in the evaluation of the potential for medical device materials to cause adverse systemic reactions.
ISO 10993-3 - Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
This part of ISO 10993 specifies strategies for risk estimation, selection of hazard identification tests and risk management, with respect to the possibility of the following potentially...
ISO 10993-4 - Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood
This document specifies general requirements for evaluating the interactions of medical devices with blood. It describes a) a classification of medical devices that are intended for use in contact...
ISO 10993-5 - Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
This part of ISO 10993 describes test methods to assess the in vitro cytotoxicity of medical devices. These methods specify the incubation of cultured cells in contact with a device and/or extracts...
BS EN ISO 1135-4 - Transfusion equipment for medical use Part 4: Transfusion sets for single use, gravity feed
BS ISO 8600-1 - Endoscopes - Medical endoscopes and endotherapy devices Part 1: General requirements