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
