ISO 16061:2000 PDF

Scope: This International Standard specifies general requirements for instruments to be used in association with non-active surgical implants. These requirements apply to instruments when they are manufactured and when they are resupplied after refurbishment. This International Standard applies to instruments which may be connected to power-driven systems, but does not apply to the power-driven systems themselves. With regard to safety, this International Standard gives requirements for intended performance, design attributes, selection of materials, design evaluation, manufacture, sterilization, packaging and information to be supplied by the manufacturer. This International Standard is not applicable to instruments associated with dental implants, transendodontic and transradicular implants and ophthalmic implants. NOTE References to standards for non-active surgical implants are listed in the Bibliography.

ISO 16061:2000 Referenced Document

EN 1041:1998 Information Supplied by the Manufacturer with Medical Devices
ISO 11134 Sterilization of health care products; requirements for validation and routine control; industrial moist heat sterilization
ISO 11135 Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices AMENDMENT 1: Revision of Annex E, Single batch release*， 2014-01-01 Update
ISO 11137 Sterilization of health care products - Requirements for validation and routine control - Radiation sterilization; Technical Corrigendum 1
ISO 11607 Packaging for terminally sterilized medical devices*， 2003-02-01 Update
ISO 14155 Clinical investigation of medical devices for human subjects - Good clinical practice*， 2020-09-01 Update
ISO 14971-1 Medical devices - Risk management - Part 1: Application of risk analysis
ISO 15223 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied; Amendment 2*， 2004-02-01 Update

2021 ISO 16061:2021 Instruments for use in association with non-active surgical implants - General requirements
2015 ISO 16061:2015 Instrumentation for use in association with non-active surgical implants - General requirements
2008 ISO 16061:2008 Instrumentation for use in association with non-active surgical implants - General requirements
2000 ISO 16061:2000 Instrumentation for use in association with non-active surgical implants - General requirements