ISO TR 14283-2018 PDF

Full title and description

ISO/TR 14283:2018 — Implants for surgery — Essential principles of safety and performance. This technical report sets out the fundamental safety and performance principles manufacturers and regulators should apply to active and non‑active surgical implants to ensure that implants perform as intended without compromising patient or user safety.

Abstract

This technical report describes the essential principles of safety and performance for the design and manufacture of implants for surgery. It explains how manufacturers should identify and control known or foreseeable hazards, ensure compatibility with substances and devices the implant will contact or be used with, address infection and contamination risks, consider mechanical and environmental effects, and provide appropriate labelling and clinical evaluation to demonstrate conformity with the applicable principles. The report is written to support global convergence of regulatory approaches to implants.

General information

• Status: Published.
• Publication date: 3 January 2018 (Edition 3, published January 2018).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 11.040.40 (Implants for surgery, prosthetics and orthotics).
• Edition / version: Edition 3 (2018).
• Number of pages: 20 pages (ISO official publication).

Scope

ISO/TR 14283:2018 gives fundamental principles to be applied when designing and manufacturing surgical implants so each implant can achieve its intended purpose while protecting patients and users. The report applies to both active and non‑active implants and, where relevant, to associated instruments and equipment to the extent necessary to ensure safe combination and use. It is intended for manufacturers, regulatory authorities and conformity assessment bodies to harmonize documentation and assessment approaches across jurisdictions.

Key topics and requirements

• Fundamental principles of safety and performance: design and manufacturing requirements that ensure implants perform as intended and risks are acceptable when weighed against benefits.
• Risk identification and risk‑reduction hierarchy: identify hazards, eliminate where possible, reduce remaining risks, and inform users of residual risks.
• Chemical, physical and biological properties, including biocompatibility and control of leachables and contaminants.
• Infection control and microbial contamination prevention throughout design and manufacturing.
• Requirements for implants that incorporate medicinal substances, biological materials, software, active elements or radiation sources.
• Protection against mechanical risks (strength, stability, vibration, noise, temperature) and energy/substance delivery hazards.
• Labeling and instructions for use: essential content and traceability expectations for labelling and IFUs.
• Clinical evaluation: evidence expectations and how clinical data support conformity with essential principles.
• Consideration of transport, storage, packaging and compatibility with associated instruments and devices.

Typical use and users

Primary users are medical device/implant manufacturers, regulatory authorities, conformity assessment bodies, notified bodies and technical experts involved in pre‑market submissions, conformity assessments, clinical evaluation and post‑market surveillance. The report is also used by standards developers and test laboratories to align product requirements and by legal/regulatory teams preparing documentation for market access.

Related standards

ISO/TR 14283 is intended to be used alongside other device and implant standards such as ISO 14708 (active implantable medical devices), ISO 14630 (non‑active surgical implants — general requirements), ISO 10993 series (biological evaluation), ISO 14971 (application of risk management to medical devices), ISO 15223‑1 (symbols for labelling), and other product‑specific ISO standards. The report also aligns with Global Harmonisation Task Force (GHTF) guidance referenced during its development.

Keywords

Implants for surgery; essential principles; safety; performance; risk management; biocompatibility; clinical evaluation; labelling; infection control; active implants; non‑active implants; conformity assessment.

FAQ

Q: What is this standard?

A: ISO/TR 14283:2018 is a technical report that defines the essential principles of safety and performance for surgical implants to guide manufacturers and regulators in demonstrating conformity and protecting patient and user safety.

Q: What does it cover?

A: It covers high‑level principles for design and manufacture — risk control, chemical/biological safety, infection control, mechanical protection, software and active elements, labelling and clinical evaluation — and how to document conformity with those principles. It also addresses implants that combine with other devices or medicinal substances.

Q: Who typically uses it?

A: Implant manufacturers, regulatory authorities, conformity assessment bodies, notified bodies, clinical evaluators and standards developers use it to structure safety/performance evidence and harmonize regulatory submissions.

Q: Is it current or superseded?

A: The 2018 edition (Edition 3) replaced the earlier 2004 edition. As published by ISO it is a current Technical Report (published January 2018); users should check ISO or their national body for any subsequent revisions or withdrawals if up‑to‑date status is required.

Q: Is it part of a series?

A: It is a stand‑alone technical report within the suite of ISO standards addressing implants and medical devices and is commonly used in conjunction with related ISO product and general standards (for example ISO 14708, ISO 14971, ISO 10993 and ISO 15223‑1).

Q: What are the key keywords?

A: Implants for surgery; essential principles; safety; performance; risk management; biocompatibility; clinical evaluation; labelling; infection control; conformity assessment.