BS EN ISO 14630:2009 - Non-active surgical implants. General requirements – BSI British Standards
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BS EN ISO 14630:2009

Non-active surgical implants. General requirements

Status : Revised, Superseded, Withdrawn   Published : November 2009 Replaced By : BS EN ISO 14630:2012

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BS EN ISO 14630:2009 Non-active surgical implants. General requirements

BS EN ISO 14630 is the standard that 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 to demonstrate compliance with the relevant essential requirements 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 assist manufacturers to 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 these 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 BS EN ISO 14630) 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 apply to a more restricted set or family of nonactive surgical implants, such as those designed for use in neurosurgery, cardiovascular surgery, or joint replacement.

Level 3 standards 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.

The requirements in BS EN ISO 14630 correspond to international consensus. Individual or national standards or regulatory bodies can prescribe other requirements.

BS EN ISO 14630 specifies general requirements for non-active surgical implants, referred to as implants. BS EN ISO 14630 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, BS EN ISO 14630 gives 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.

BS EN ISO 14630 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, could be appropriate to help ensure the implant achieves its intended performance.

Contents of BS EN ISO 14630 include:

  • Scope
  • Normative references
  • Terms and definitions
  • Intended performance
  • Design attributes
  • Materials
  • Design evaluation
  • Pre-clinical evaluation
  • Clinical evaluation
  • Post-market surveillance
  • Manufacture
  • Sterilization
  • Products supplied sterile
  • Sterilization by the user
  • Sterilization residuals
  • Packaging
  • Protection from damage in storage and transport
  • Maintenance of sterility in transit
  • Information supplied by the manufacturer
  • Labelling
  • Instructions for use
  • Restrictions on combinations
  • Marking on implants
  • Marking for special purposes
  • Correspondence between this International Standard and ISO/TR 14283:2004
  • Bibliography

Standard NumberBS EN ISO 14630:2009
TitleNon-active surgical implants. General requirements
StatusRevised, Superseded, Withdrawn
Publication Date30 November 2009
Withdrawn Date31 December 2012
Normative References(Required to achieve compliance to this standard)ISO 31, ISO 8601, ISO 10993-1, ISO 10993-7, ISO 11135-1, ISO 11137-1, ISO 11137-2, ISO 11607-1, ISO 13408-1, ISO 14155-1, ISO 14155-2, ISO 14160, ISO 14937, ISO 14971, ISO 17664, ISO 17665-1, ISO 22442-1, ISO 22442-2, ISO 22442-3
Informative References(Provided for Information)ISO/TR 14283:2004, ISO/IEC Guide 51:1999, ISO 16061, ISO 14602, ISO 21534, ISO 5840, EN 12006-2, EN 12006-3, ISO 7197, ISO 14607, ISO 21535, ISO 21536, ISO 1000, ISO 7000, ISO 12891-1, ISO 13485, ISO 16429, IEC 60068-2-27, IEC 60068-2-32, IEC 60068-2-47, IEC 60601-2-33, ASTM F 2052-02, ASTM F 2119-01, ASTM F 2182, ASTM F2213, ASTM F2503-05, 2001/83/EC, 93/42/EEC
Replaced ByBS EN ISO 14630:2012
ReplacesBS EN ISO 14630:2008
International RelationshipsEN ISO 14630:2009,ISO 14630:2008
DescriptorsMedical equipment, Orthopaedic equipment, Implants (surgical), Performance, Sterilization (hygiene), Marking, Packaging, Design, Instructions for use, Test methods
Title in FrenchImplants chirurgicaux non actifs. Exigences générales
Title in GermanNichtaktive chirurgische Implantate. Allgemeine Anforderungen
ISBN978 0 580 68134 9
File Size340.2 KB

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Customer Relations, +44 345 086 9001
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