1Key Takeaways
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 with the body;
c) the selection of appropriate tests.
This part of ISO 10993 does not cover testing of materials and…
2Scope / Description
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 with the body;
c) the selection of appropriate tests.
This part of ISO 10993 does not cover testing of materials and devices that do not come into direct or indirect contact with the patient's body, nor does it cover biological hazards arising from any mechanical failure.
NOTE Other parts of ISO 10993 cover specific tests (see also the rationale in A.2).
5Citation Network
Standards that cite ISO 10993-1:2003
6Frequently Asked Questions
What is ISO 10993-1:2003?
ISO 10993-1:2003 — Biological evaluation of medical devices - Part 1: Evaluation and testing is an international standard developed by International Organization for Standardization (ISO). 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 with the body; c) the selection of appropriate...
What does ISO 10993-1:2003 cover?
This standard covers: 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 with the body; c) the selection of appropriate tests. This part of ISO 10993 does not cover testing...
Who should use this standard?
This standard is intended for organizations, professionals, and stakeholders involved in various industries and sectors. It is applicable to manufacturers, service providers, regulatory bodies, and certification organizations.
What is the latest version of ISO 10993-1:2003?
The current published version is ISO 10993-1:2003, published on 2003-08. Always check for amendments or pending revisions.
How do I purchase ISO 10993-1:2003?
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