1Key Takeaways
This part of ISO 10993 gives guidance on a) the fundamental principles governing the biological evaluation of medical devices;
b) the definition of categories of devices based on the nature and duration of contact with the body;
c) the selection of appropriate tests.
devices that do not come into contact with the patie…
2Scope / Description
This part of ISO 10993 gives guidance on a) the fundamental principles governing the biological evaluation of medical devices;
b) the definition of categories of devices based on the nature and duration of contact with the body;
c) the selection of appropriate tests.
devices that do not come into contact with the patient’s body directly or indirectly. Nor does it cover biological hazards arising from any mechanical failure. Other parts of ISO 10993 cover specific tests as indicated in the foreword. (See A.2, clause 1 Scope.)
5Citation Network
Standards that cite ISO 10993-1:1992
6Frequently Asked Questions
What is ISO 10993-1:1992?
ISO 10993-1:1992 — Biological evaluation of medical devices; part 1: guidance on selection of tests is an international standard developed by International Organization for Standardization (ISO). This part of ISO 10993 gives guidance on a) the fundamental principles governing the biological evaluation of medical devices; b) the definition of categories of devices based on the nature and duration of contact with the body; c) the selection of...
What does ISO 10993-1:1992 cover?
This standard covers: This part of ISO 10993 gives guidance on a) the fundamental principles governing the biological evaluation of medical devices; b) the definition of categories of devices based on the nature and duration of contact with the body; c) the selection of appropriate tests. devices that do not come into...
Who should use this standard?
This standard is intended for organizations, professionals, and stakeholders involved in the medical device and healthcare industry. It is applicable to manufacturers, service providers, regulatory bodies, and certification organizations.
What is the latest version of ISO 10993-1:1992?
The current published version is ISO 10993-1:1992, published on 1992-04. Always check for amendments or pending revisions.
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