ISO 14602-2010 PDF
Name in English:
St ISO 14602-2010
Name in Russian:
Ст ISO 14602-2010
Original standard ISO 14602-2010 in PDF full version. Additional info + preview on request
Full title and description
ISO 14602:2010 — Non-active surgical implants — Implants for osteosynthesis — Particular requirements. This international standard specifies particular requirements for non-active surgical implants used in osteosynthesis and supplements the general requirements for non-active surgical implants.
Abstract
ISO 14602:2010 gives particular requirements, in addition to ISO 14630, for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and the information supplied by the manufacturer for implants for osteosynthesis. It is targeted at non-active surgical implants and focuses on ensuring safety and performance for these devices.
General information
- Status: Published / confirmed (International Standard).
- Publication date: April 2010 (12 April 2010 — edition published in 2010).
- Publisher: International Organization for Standardization (ISO).
- ICS / categories: 11.040.40 (Implants for surgery, prosthetics and orthotics).
- Edition / version: Edition 2 (2010).
- Number of pages: 13 pages.
Key bibliographic and lifecycle details above are taken from the ISO record for ISO 14602:2010 (edition 2, published April 2010). The 1998 edition was withdrawn and replaced by the 2010 edition.
Scope
ISO 14602:2010 specifies particular requirements applicable to non-active surgical implants intended for osteosynthesis. It is used in conjunction with ISO 14630 (general requirements for non-active surgical implants); level‑2/level‑3 standards provide additional or specific test methods and requirements for particular implant types. The standard addresses aspects necessary to demonstrate that an implant is fit for its intended purpose, taking into account design, materials, manufacturing, sterilization and information for safe use.
Key topics and requirements
- Intended performance and clinical/function objectives for implants used in osteosynthesis.
- Design attributes and design evaluation (including risk-based considerations and performance verification).
- Material selection and relevant material requirements for implantable components.
- Manufacturing controls, process validation and traceability relevant to implants.
- Sterilization validation, packaging and labelling requirements to maintain sterility and safe transport.
- Information supplied by the manufacturer: instructions for use, warnings, and implant identification/traceability data.
The items above reflect the particular requirements set out in ISO 14602:2010 and its role as a Level‑2 standard that complements general implant requirements.
Typical use and users
Primary users include manufacturers and designers of orthopaedic/osteosynthesis implants, conformity assessment bodies, testing laboratories, regulatory affairs specialists and quality managers responsible for medical device compliance. Clinicians and hospital procurement teams may consult the standard indirectly via regulatory or conformity documentation. The standard is used to define product requirements, test and verification strategies, and to support regulatory submissions.
Related standards
ISO 14602:2010 is intended to be used alongside ISO 14630 (Non-active surgical implants — General requirements). Other commonly referenced standards in this domain include ISO 13485 (quality management systems for medical devices), ISO 10993 series (biological evaluation of medical devices) and various material‑specific and test‑method standards (for example standards for metallic implant materials and mechanical testing relevant to osteosynthesis implants). Level‑2 and Level‑3 ISO standards provide additional, device‑specific requirements and test methods.
Keywords
non-active surgical implants; implants for osteosynthesis; orthopedic implants; implant design; sterilization; biocompatibility; manufacturing; packaging; instructions for use; ISO 14630.
FAQ
Q: What is this standard?
A: ISO 14602:2010 is an ISO Level‑2 standard titled "Non-active surgical implants — Implants for osteosynthesis — Particular requirements" that specifies particular technical and documentation requirements for osteosynthesis implants.
Q: What does it cover?
A: It covers intended performance, design attributes and evaluation, materials, manufacturing and process controls, sterilization and packaging, and the information to be supplied by the manufacturer for implants used in osteosynthesis; it complements the general requirements in ISO 14630.
Q: Who typically uses it?
A: Manufacturers/designers of orthopaedic implants, conformity assessors, testing laboratories, regulatory and quality professionals in the medical device sector, and organizations preparing technical documentation for regulatory submission.
Q: Is it current or superseded?
A: The 1998 edition was withdrawn and superseded by ISO 14602:2010 (edition 2, published April 2010). According to ISO's public record the 2010 edition is the active/confirmed edition; users should check the ISO catalogue or national standards body for any revisions or confirmations after publication.
Q: Is it part of a series?
A: Yes — ISO 14602:2010 functions within the family of standards for non‑active surgical implants (level‑1 general requirements ISO 14630 and other level‑2/level‑3 product‑specific standards); it sits in the broader context of medical device standards such as ISO 13485 and the ISO 10993 biocompatibility series.
Q: What are the key keywords?
A: Non-active surgical implants; osteosynthesis; implant design; sterilization; biocompatibility; manufacturing; packaging; instructions for use; traceability.