National foreword

This British Standard is the UK implementation of EN ISO 14630:2012. It supersedes BS EN ISO 14630:2009, which is withdrawn.

The UK participation in its preparation was entrusted to Technical Committee CH/150, Implants for surgery.

A list of organizations represented on this committee can be obtained on request to its secretary.

This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application.

Compliance with a British Standard cannot confer immunity from legal obligations.

This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 December 2012.

Foreword

ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.

International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.

The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote.

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights.

ISO 14630 was prepared by Technical Committee ISO/TC 150, Implants for surgery.

This fourth edition cancels and replaces the third edition (ISO 14630:2008), which has been technically revised.

Introduction

This International Standard provides a method of addressing the fundamental principles outlined in ISO/TR 14283 as they apply to non-active surgical implants. It also provides a method for demonstrating compliance with the relevant essential requirements as outlined in the general terms in Annex 1 of the European Council Directive 93/42/EEC of 14 June 1993 concerning medical devices as they apply to non-active surgical implants, hereafter referred to as implants. It might also help manufacturers comply with the requirements of other regulatory bodies.

There are three levels of standards dealing with non-active surgical implants and related instrumentation. For the implants themselves, they are as follows, with level 1 being the highest.

Level 1: General requirements for non-active surgical implants.
Level 2: Particular requirements for families of non-active surgical implants.
Level 3: Specific requirements for types of non-active surgical implants.

Level 1 standards, such as this International Standard and Reference [4], contain requirements that apply to all non-active surgical implants. They also anticipate that there are additional requirements in the level 2 and level 3 standards.

Level 2 standards (see References [5], [6], [7], [8] and [9]) apply to a more restricted set or family of non-active surgical implants, such as those designed for use in neurosurgery, cardiovascular surgery, or joint replacement.

Level 3 standards (see References [10], [11], [12] and [13]) apply to specific types of implants within a family of non-active surgical implants, such as hip joints or arterial stents.

To address all requirements for a specific implant, it is advisable that the standard of the lowest available level be consulted first.

NOTE The requirements in this International Standard correspond to international consensus. Individual or national standards or regulatory bodies can prescribe other requirements.

This European Standard was approved by CEN on 30 November 2012.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.

Foreword

This document (EN ISO 14630:2012) has been prepared by Technical Committee ISO/TC 150 "Implants for surgery" in collaboration with Technical Committee CEN/TC 285 “Non-active surgical implants” the secretariat of which is held by DIN.

This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by June 2013, and conflicting national standards shall be withdrawn at the latest by June 2013.

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.

This document supersedes EN ISO 14630:2009.

This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive(s).

For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this document.

According to the CEN/CENELEC Internal Regulations, the national standards organisations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.

Endorsement notice

The text of ISO 14630:2012 has been approved by CEN as a EN ISO 14630:2012 without any modification.

1 Scope

This International Standard specifies general requirements for non-active surgical implants, hereafter referred to as implants. This International Standard is not applicable to dental implants, dental restorative materials, transendodontic and transradicular implants, intra-ocular lenses and implants utilizing viable animal tissue.

With regard to safety, this International Standard specifies requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging and information supplied by the manufacturer, and tests to demonstrate compliance with these requirements.

Additional tests are given or referred to in level 2 and level 3 standards.

NOTE This International Standard does not require that the manufacturer have a quality management system in place. However, the application of a quality management system, such as that described in ISO 13485, might be appropriate to help ensure that the implant achieves its intended performance.

2 Normative references

3 Terms and definitions

4 Intended performance

5 Design attributes

6 Materials

7 Design evaluation

7.1 General

7.2 Pre-clinical evaluation

7.3 Clinical evaluation

7.4 Post-market surveillance

8 Manufacture

9 Sterilization

9.1 General

9.2 Products supplied sterile

9.3 Sterilization by the user

9.4 Sterilization residuals

10 Packaging

10.1 Protection from damage in storage and transport

10.2 Maintenance of sterility in transit

11 Information supplied by the manufacturer

11.1 General

11.2 Labelling

11.3 Instructions for use

11.4 Restrictions on combinations

11.5 Marking on implants

11.6 Marking for special purposes

Bibliography

BS EN ISO 14630:2012

Non-active surgical implants. General requirements

Published:

31 Dec 2012

Withdrawn:

18 Dec 2024